Posts by Fm1

U.S. concerned about "superspreader event" at U.N. as diplomats challenge New York City vaccine requirement

U.S. concerned about "superspreader event" at U.N. as diplomats challenge New York City vaccine requirement

The Biden administration worries that this year's U.N. General Assembly could become a COVID-19 "superspreader event" as world leaders descend on New York City.

www.cbsnews.com

United Nations – The Biden administration worries that this year's U.N. General Assembly could become a COVID-19 "superspreader event" as world leaders descend on New York City without necessarily abiding by local vaccine requirements. On Friday, President Biden's U.N. Ambassador, Linda Thomas-Greenfield, told CBS News at a press conference, "We are concerned about the U.N. event being a superspreader event, and that we need to take all measures to ensure that it does not become a superspreader event."

Unlike last year, when COVID-19 pandemic forced the largest annual gathering of world leaders to go virtual, this year, a hybrid format means that heads of state can either send in a video or appear in person.

Despite a note from Thomas-Greenfield urging diplomats to send in videos, more than 100 presidents, prime ministers and others are set to give in-person speeches at the two-week event. Mr. Biden will be attending with a scaled-down White House entourage.

Brazil's President Jair Bolsonaro, who says he is unvaccinated but has antibodies from a COVID-19 infection last year, announced he would attend in person, defying the New York City vaccine requirement.

In a letter on September 9, New York City Mayor Bill de Blasio's Office for International Affairs and the city health commissioner informed the president-elect of the General Assembly, Abdulla Shahid, that the gathering would be covered by a local law requiring proof of vaccination for indoor venues like dining and entertainment.

"Indoor entertainment also includes 'convention centers,' and the U.N. General Assembly Hall qualifies as a convention center," the letter said.

Shahid wrote to all U.N. member states "strongly" supporting the measure and pledging to implement it. But then, in a diplomatic accommodation, Shahid sent a new letter Thursday saying, "I would like to advise delegations that the honour system related to vaccinations … remains in place."

The decision to invoke the "honour system" came after Russian Ambassador Vassily Nebenzia weighed in, saying he was "surprised and disappointed" by the idea of requiring proof of vaccination to enter the General Assembly Hall. Nebenzia called it "discriminatory" and contrary to the 1947 agreement between the U.S. and the U.N. that establishes the world body's international status.

Asked about the Russian opposition to the requirement on Thursday at his press conference, the mayor was defiant.

"My simple statement to begin is if the Russian ambassador is against it, I'm for it," de Blasio said.

"I spoke to Secretary General Guterres two weeks ago, and we had a very good conversation. He's been outstanding in trying to push the highest health standards for the General Assembly," de Blasio said, adding, "We understand the United Nations is a particular organization, has its own rules and its own jurisdiction."

The honor system, the Secretary General's spokesperson Stephane Dujarric said Friday, means that "by swiping a badge to enter the General Assembly Hall, delegates attest that they are fully vaccinated, that they have not tested positive for COVID‑19 in the last 10 days [and] have no symptoms."

The mayor also announced that the city would be opening a pop-up testing and vaccination site at U.N. headquarters to provide free COVID-19 tests as well as the single-dose Johnson & Johnson vaccine.

Thomas-Greenfield said she'll be getting a test there herself Monday morning.

Asked by CBS News about the risk of so many people coming into New York from so many countries, she said, "Leaders have to be responsible, and they have to take responsibility for their actions and ensure that their actions do not lead to jeopardizing the health and safety of the people of New York, of all of the participants here at the United Nations, and that they don't take COVID back to their home countries."

The General Assembly meeting comes after a rough year at U.N. Headquarters, where COVID-19 has taken a toll. Hundreds of staff, diplomats, and members of the press were infected, and meetings and other work went remote for months. Contact tracing was voluntary, and a confidential WhatsApp group, seen by CBS News, was the main way that many diplomats found out about colleagues who were infected with COVID.

-Scientists are getting closer to classifying long COVID as an autoimmune disease

Long COVID could be an autoimmune disease, new research suggests

New research may finally answer why long COVID patients are still sick, suggesting one "auto-antibody" may be responsible for harmful inflammation.

www.businessinsider.com

Long COVID patients may finally get an answer as to why they're still sick.

The National Institutes of Health announced Wednesday that it's kicking off a $470 million study to figure out why COVID-19 symptoms persist for so long among many patients.

Already, research has started to coalesce around a theory: The virus may set off an autoimmune reaction that causes lingering symptoms such as fatigue, shortness of breath, loss of smell, muscle aches, or brain fog.

"We can't say for sure that it's an autoimmune disease now, but it's really starting to look like it," John Arthur, a researcher at the University of Arkansas for Medical Sciences, told Insider.

Development of ACE2 autoantibodies after SARS-CoV-2 infection

Development of ACE2 autoantibodies after SARS-CoV-2 infection

Background Activation of the immune system is implicated in the Post-Acute Sequelae after SARS-CoV-2 infection (PASC) but the mechanisms remain unknown.…

journals.plos.org

Abstract

Background

Activation of the immune system is implicated in the Post-Acute Sequelae after SARS-CoV-2 infection (PASC) but the mechanisms remain unknown. Angiotensin-converting enzyme 2 (ACE2) cleaves angiotensin II (Ang II) resulting in decreased activation of the AT1 receptor and decreased immune system activation. We hypothesized that autoantibodies against ACE2 may develop after SARS-CoV-2 infection, as anti-idiotypic antibodies to anti-spike protein antibodies.

Methods and findings

We tested plasma or serum for ACE2 antibodies in 67 patients with known SARS-CoV-2 infection and 13 with no history of infection. None of the 13 patients without history of SARS-CoV-2 infection and 1 of the 20 outpatients that had a positive PCR test for SARS-CoV-2 had levels of ACE2 antibodies above the cutoff threshold. In contrast, 26/32 (81%) in the convalescent group and 14/15 (93%) of patients acutely hospitalized had detectable ACE2 antibodies. Plasma from patients with antibodies against ACE2 had less soluble ACE2 activity in plasma but similar amounts of ACE2 protein compared to patients without ACE2 antibodies. We measured the capacity of the samples to inhibit ACE2 enzyme activity. Addition of plasma from patients with ACE2 antibodies led to decreased activity of an exogenous preparation of ACE2 compared to patients that did not have antibodies.

Conclusions

Many patients with a history of SARS-CoV-2 infection have antibodies specific for ACE2. Patients with ACE2 antibodies have lower activity of soluble ACE2 in plasma. Plasma from these patients also inhibits exogenous ACE2 activity. These findings are consistent with the hypothesis that ACE2 antibodies develop after SARS-CoV-2 infection and decrease ACE2 activity. This could lead to an increase in the abundance of Ang II, which causes a proinflammatory state that triggers symptoms of PASC.

Quote from THHuxleynew

Your conspiracy theory would have to include independent-minded regulators in UK, Sweden, etc, none of whom recommend ivermectin at the moment bbased on the totality of data seen so far.

Admittedly were it not for the unscientific campaign to push ivermectin from FLCC etc I think there would be less specifically "don't take ivermectin - you are not a cow" counter-propaganda. But the decision not to recommend it based on negative evidence so far would remain for any science-based regulatory system.

Remdesivir !!!!

Big gap between Pfizer, Moderna vaccines seen for preventing COVID-19 hospitalizations

https://www.post-gazette.com/news/health/2021/09/18/Big-gap-between-Pfizer-Moderna-vaccines-seen-for-preventing-COVID-19-hospitalizations/stories/2021091800

Big gap between Pfizer, Moderna vaccines seen for preventing COVID-19 hospitalizations

Los Angeles Times

SEP 18, 2021 3:43 PM

LOS ANGELES — Amid persistent concerns that the protection offered by COVID-19 vaccines may be waning, a report released Friday by the Centers for Disease Control and Prevention finds that America’s workhorse shot is significantly less effective at preventing severe cases of disease over the long term than many experts had realized.

Data collected from 18 states between March and August suggest the Pfizer-BioNTech vaccine reduces the risk of being hospitalized with COVID-19 by 91% in the first four months after receiving the second dose. Beyond 120 days, however, that vaccine efficacy drops to 77%.

Meanwhile, Moderna’s vaccine was 93% effective at reducing the short-term risk of COVID-19 hospitalization and remained 92% effective after 120 days.

Overall, 54% of fully vaccinated Americans have been immunized with the Pfizer shot.

A vaccine provider prepares a dose of the COVID-19 vaccine at a clinic run by the Allegheny County Health Department at Casa San Jose, a non-profit serving Latino immigrants, Tuesday, September 14, 2021, in Beechview.

PETER SMITH

Many faith leaders say no to endorsing vaccine exemptions

The surprising findings came as a Food and Drug Administration advisory panel recommended against offering booster doses of the Pfizer vaccine to all Americans ages 16 and older. In a striking rebuke, 16 of 18 experts told the agency it had not mustered enough data to make a third shot the norm.

In lengthy briefings to the panel, representatives from Pfizer pointed to clinical trial results involving 306 mostly healthy participants to argue that a booster “restores” the 95% vaccine effectiveness rate seen earlier in the pandemic.

Company officials also touted evidence from Israel, which rolled out boosters after seeing a rise in hospitalizations among people who were fully vaccinated. Those hospitalizations dropped dramatically after third doses were given, Israeli scientists have said.

But panel members made clear that despite Pfizer’s aggressive stance, it had not gathered enough evidence that a third shot was safe for young people and for those at lesser risk of becoming severely ill with COVID-19.

“We need age-specific data” on the safety and protective benefits of a further booster, said Dr. Ofer Levy, a panel member who directs the Precision Vaccines program at Boston Children’s Hospital.

FDA clearance for booster shots for everyone 16 and older would be seen as something “close to a mandate,” said Dr. Eric Rubin, a panel member and infectious-disease expert at the Harvard T.H. Chan School of Public Health. Rubin worried that such a move could redefine what it takes to be considered fully vaccinated against COVID-19.

“None of us are there yet,” he said.

But others apparently are. Dr. Anthony Fauci, President Joe Biden’s top adviser on vaccines, has come out strongly in favor of booster shots, saying before Friday’s vote that a failure to endorse the shots “would be a mistake.”

And in mid-August, Biden himself said his administration would begin making booster shots available the week of Sept. 20 to those vaccinated for at least eight months.

Biden cautioned at the time that his plan was contingent on FDA approval. But his announcement stoked concerns of political meddling in a matter that required the unhindered evaluation of scientists.

“This should demonstrate to the public that the members of this committee are independent of the FDA,” Dr. Archana Chatterjee, dean of the Chicago Medical School, said after the vote. “In fact, we do bring our voices to the table when we are asked to serve on this committee.”

The panel unanimously agreed that a third shot of the vaccine now sold under the brand name Comirnaty should be offered to select groups: individuals 65 and older, people at risk of developing severe disease, and those, including health-care workers, whose occupations put them at high risk of infection.

Dr. Peter Marks, who leads the FDA’s evaluation of drugs and vaccines, told panel members that the agency could give its blessing to booster shots with an emergency use authorization — a regulatory step that falls short of the full approval Pfizer had sought.

The company issued no statement Friday in response to the panel’s vote.

Researchers in the United States have been warning for months that the immunity afforded by COVID-19 vaccines might be waning. The CDC reported that in late July, close to three-quarters of the 469 people swept up in a Massachusetts outbreak were fully vaccinated. And the agency has launched several studies aimed at detecting changes in vaccine effectiveness in healthcare workers and others who were vaccinated early.

But virtually all of those infections appeared to be mild. And health officials eager to induce vaccine skeptics to step up for their shot — including Fauci and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention — have repeatedly praised the vaccines for keeping most fully vaccinated people out of hospitals.

The new report on waning vaccine efficacy challenges that expectation.

Researchers from around the country found striking differences between two mRNA vaccines long thought to be interchangeable.

When the Moderna vaccine received emergency use authorization in December, the company reported that 30 people in its clinical trial developed severe cases of COVID-19, including nine who required hospitalization. All 30 patients were in the placebo group, resulting in a vaccine efficacy against severe disease of 100%.

Ten people in Pfizer’s initial clinical trial developed severe cases of COVID-19. Nine of them was in the placebo group, including seven who were hospitalized, resulting in a vaccine efficacy against severe disease of 88.9%.

Once the Moderna and Pfizer vaccines were rolled out to the public, their records of preventing COVID-19 hospitalizations in the first four months were neck and neck — 93% and 91% effective, respectively. But the degree of protection diverged after that.

When they focused specifically on the period 120 days beyond the second dose, the study authors found that the Moderna vaccine remained 92% effective at preventing COVID-19 hospitalizations. But the equivalent figure for the Pfizer vaccine was 77%.

The results were published in the CDC’s Morbidity and Mortality Weekly Report.

Both the Pfizer and Moderna vaccines are based on mRNA technology, which delivers temporary instructions to the body’s muscle cells that help it learn to recognize the spike protein, a key part of the coronavirus’ structure. But “they’re actually not necessarily interchangeable,” said Dr. Timothy Brewer, a professor of medicine and epidemiology at UCLA.

Each vaccine is formulated and administered differently, Brewer said, and those differences could affect the strength and duration of the two vaccines’ protection.

Moderna’s shot contains 100 micrograms of vaccine, more than three times the 30 micrograms in the Pfizer shot. And Pfizer’s two doses are given three weeks apart, while Moderna’s two-shot regimen is administered with a four-week gap.

Brewer also pointed to evidence that the Moderna vaccine seemed to elicit higher levels of a key antibody than the Pfizer vaccine.

“We know from other studies the neutralizing antibody levels will decay over time, so starting at a higher level will mean that you have farther to go before you decay to a point where efficacy drops off,” he said.

Dr. Robert Murphy, who directs Northwestern University’s Institute for Global Health, said the Pfizer vaccine’s reduced protection against severe disease may bolster the case for boosters for all who got the vaccine, not just the specific groups identified by the FDA advisory panel.

“Based on the data I have seen, persons who received the Pfizer vaccine would benefit from a booster dose at this time,” he said. “I don’t see why we have to wait until the younger people get sick and become hospitalized.”

But Dr. Arnold Monto, who chairs the FDA advisory panel, applauded the agency’s willingness to withhold a full-throated call for boosters until a stronger case can be made. And he suggested that as more evidence accumulates, boosters for all might still get the nod.

“That’s the beauty of the emergency use authorization,” said Monto, an epidemiologist at University of Michigan. “It can be changed based on changing data.”

©2021 Los Angeles Times. Visit latimes.com. Distributed by Tribune Content Agency, LLC.

Overall, 54% of fully vaccinated Americans have been immunized with the Pfizer shot.

Dr. Tom Frieden on COVID-19 Pandemic: Eradication via Vaccination Not Possible

Dr. Tom Frieden on COVID-19 Pandemic: Eradication via Vaccination Not Possible

As TrialSite has reported, an independent U.S. Food and Drug Administration (FDA) Advisory Panel voted overwhelmingly against the mass booster program at

trialsitenews.com

As TrialSite has reported, an independent U.S. Food and Drug Administration (FDA) Advisory Panel voted overwhelmingly against the mass booster program at this point. The independent advisory panel put a screeching halt on an imminent mass booster access and rather elected that the third jabs should only be available for a far more narrow subsection of the population, from the elderly to severely ill, and select occupations facing higher risks of exposure. On this point, Dr. Tom Frieden shares his thoughts via Twitter, “…an FDA committee voted to recommend booster doses of Covid vaccines for people ages 65 and older and those at high risk of severe disease. Unlike Israel, they decided there is currently insufficient evidence of the need or benefit for everyone to get boosters.”

Moving forward, he suggests, “Given what we know and don’t know at this point, a sensible way forward is becoming clearer based on filling our knowledge gaps, protecting the most vulnerable, and reducing the risk of new dangerous variants emerging.

No one knows what will happen next in the pandemic. Longer-term predictions are just guesses. But we do know the endgame has shifted. Eradication is not possible. Even control will be difficult. We can reduce transmission and severe disease, but we can’t eliminate them.”

Regarding booster shots, he states, “I agree with the FDA group that a third dose makes sense for people 65+ and at high risk. Though we aren’t certain it will be necessary or effective, it’s reasonable to conclude that it will be. Even more important is to increase vaccine uptake among these groups.”

In a similar sentiment to those of TrialSite, Frieden says, “We can’t rely on vaccination alone to contain Covid. Masks, testing, and other measures are also necessary. But we must still increase vaccinations—our most powerful tool—around the world to prevent deaths, preserve health care, and reduce spread as much as we can.”

Frieden concludes, “Finally, we must learn this lesson and act accordingly: Health protection and public health matter. Microbes outnumber us, we must work together to outsmart them.” What about low-cost treatment options? In the developing world, at least 20 countries use ivermectin; however, in America, a coordinated effort to vilify what has been a safe and effective drug for other indications suggests material forces dedicated to intensive monetization of the space for early-onset care—representing about 90% of all COVID-19 cases.

China Passes Law Granting Doctors the Right to use Off-Label Drugs

China Passes Law Granting Doctors the Right to use Off-Label Drugs

A new law in China grants physicians explicit rights to prescribe or try out off-label drugs in a bid to bring greater opportunity to drug makers in the

trialsitenews.com

A new law in China grants physicians explicit rights to prescribe or try out off-label drugs in a bid to bring greater opportunity to drug makers in the world’s most populous nation and second-largest economy. Starting March 1, 2022, physicians may use off-label drugs that can benefit both patients and pharmaceutical companies. Patients will have new options to potentially treat any number of conditions, while drug makers could benefit from the expanded use of their drugs. While American physicians have long had the right to prescribe off-label drugs during the pandemic, government health agencies, regulators, and medical licensing societies have put increasing pressure on physicians to not prescribe ivermectin, for example, pointing to a centralization of control over local physicians.

Recently, China’s Pharma DJ reported on the new law based on the Chinese Pharmacological Society definition of an off-label drug as in the “use of drugs for an unapproved indication or in an unapproved dosage, treatment course, route of administration and patient group.” In reality, the State in China is merely codifying what physicians have long done anyway, writes Minhua Chu. That’s because Chinese drug law has lagged other nations, thus slowing down drug approvals and associated label updates.

The Crux of the Law

Ms. Chu informs that the law “stipulates that when no effective treatments are available, physicians may upon patient consent, use drugs in a way that is not indicated in the package insert but is supported by medical evidence.” Based on Article 29 of the new law, physicians must adhere to several principles behind the law.

Hospital Practice in China

A recent survey by the Chinese Pharmacological Society reveals that 24 hospitals, representing half of the respondents, support off-label prescribing. According to Ms. Chu, 24 hospitals recorded 1,652 off-label uses of 998 drugs, mostly indicated for oncology, immunomodulatory, cardiovascular, digestive, endocrine, and infectious disease.

China—A Rising Drug Market Powerhouse but Still Small

China recently updated its drug development laws to become more competitive in the global market for clinical trials. Perhaps not known to many, China now represents the second-largest pharmaceutical market in the world next to the United States.

Of course, the difference between America’s drug market and China is orders of magnitude in size and amount of revenue. America controls just under 50% of the world’s market, while China has emerged with 8%.

Israel to Take a ‘Fresh Look at Policy’ of COVID-19 Vaccinations in October

Israel to Take a ‘Fresh Look at Policy’ of COVID-19 Vaccinations in October

Israel has become a sort of real-world experiment for combatting SARS-CoV-2 with mass vaccination. The eastern Mediterranean nation of over 9 million

trialsitenews.com

Israel has become a sort of real-world experiment for combatting SARS-CoV-2 with mass vaccination. The eastern Mediterranean nation of over 9 million people is among the most inoculated against COVID-19 on the planet. With about 62% fully vaccinated, 90%+ of those in high-risk groups (middle-ages to the elderly), the nation faces unprecedented spikes in SARS-CoV-2 infections. The current wave surpasses all previous spikes during the pandemic. While deaths are not as high as previous spikes, viral transmission has never been higher, despite the implementation of the Green Pass System. This controversial program affords only Israelis classified as “immune” to COVID-19 or who can provide a recent COVID-19 negative test into spaces with lots of people (restaurants, gyms, and even synagogues). Yet the viral reproduction number or “R0 “used to identify if viral transmission wanes or grows now equals 1.01, which means that each infection in the country causes more than one new infection. Indicating a raging pandemic condition, this wasn’t supposed to happen with such pervasive immunization. While the United States press generally avoids the topic, real-world evidence in Israel indicates the current strategy isn’t working. Israeli’s health leadership carefully agrees. Although they recognize that vaccination, mainly with Pfizer-BioNTech’s BNT162b2, can reduce disease severity, the nation’s COVID-19 czar already plans for a fifth wave of infection while still in the middle of a terrible fourth wave. Salman Zarka indicates to the Israeli press that a “fresh look at their policy, including strategy, is planned for October.

Good science centers need a legitimate hypothesis, a series of well-designed tests, and lots of data to enable the scientist to verify or refute the premise. Data is fundamental to the scientific process. In this case, the data points and associated measurements leading to indicators associated with viral transmission, number of infections, severity of the condition, and more are constantly observed, analyzed, and hopefully used to determine whether the experiment is working or not.

Is this real-world experiment working in Israel? Mounting data indicate, at best, a mixed result for the BNT162b2 product. On the one hand, the vaccine does afford protection against more severe disease, at least for a handful of months, despite months of booster activity. On the other hand, a combination of A) widespread contagion, B) growing incidence of breakthrough infection and breakthrough hospitalization, and C) uncertainties as to the health and welfare of the population subjected to continuous boosters, raises the specter of uncertainty as to long-term viability of the current approach.

Ominous Indicators

Recently the Israel Ministry of Health, Director-General Nachman Ash, indicated that an average of 8,000 new infections occur each day, with that number reaching over 10,000 on some days. On September 8 alone, a record 22,291 new cases were recorded. Despite months of a third booster program, new infections are significantly higher than previous spikes in cases.

By late September 2020, the average new daily infection rate ranged from 5,000 to 7,000 cases, while a more severe spike occurred during January 2021, where average new cases also hovered between 5,000 to 10,000 cases. This surge of cases was the deadliest on record, with the highest number of deaths recorded.

Israel’s SARS-CoV-2 infection rates are among the world’s highest. With just over 9 million people, the country has recorded 1.21 million cases, according to Johns Hopkins University COVID-19 Data Repository by the Center for Systems Science and Engineering (CSSE). In addition, the country has recorded 7,494 deaths.

The First Mover

The fastest nation out of the gate to execute a mass vaccination program, by December 20, 2020, a methodically executed program centering on the Pfizer-BioNTech mRNA vaccine (BNT162b2) positioned the nation to emerge out of the pandemic first. Leveraging the country’s four health maintenance organizations (HMOs), they immunized the population in rapid successive waves. Starting with high-risk cohorts such as the elderly, nursing home residents and healthcare workers, and other at-risk candidates such as people with severe comorbidities, the immunization campaign moved by February 4 to all eligible persons 16 years and older. All the while, the country’s HMOs emphasized vaccinating any high-risk people skipped over during the first phase of the program.

The program appeared to be working as new case counts precipitously declined, starting in early April 2021 to early June 2021. During that relatively stable period, the average of new coronavirus cases remained under 50 per day. However, by mid-June, COVID-19 trend-watchers observed a concerning uptick in cases. With the emergence of the Delta variant (B.1.617.2), first identified in India in May, health authorities faced a far more virulent and transmissible pathogen as compared to the original “wild-type” SARS-CoV-2 from Wuhan, China. A new health crisis emerged as cases skyrocketed despite the heavily immunized population.

The waning effectiveness of BNT162b2 combined with the overpowering Delta variant led Israel to its second mass booster program starting in July 2021. Fast forward a couple of months, and unfortunately, abundant data shows the Pfizer vaccine does little to spare the population of continuous transmission.

Mixed Signals

By August 2021, the Delta variant raged, circulating throughout the country. TrialSite reported the growing cases and noticeably high breakthrough infections followed by disturbing reports of breakthrough hospitalizations. To combat the pathogen’s attack, Israeli leadership doubled down on COVID-19 vaccine boosters betting on BNT162b2, and for at least a moment, some hospital leadership reported success.

On August 26, TrialSite had a series of communications with the management of Herzog Hospital. Leaders there reported that the unvaccinated aged 60 and above had at the time, an 11-fold increase of COVID-19 infection as compared to individuals that received BNT162b2.

TrialSite’s founder, Daniel O’Connor, interacted via email with the hospital leadership, commenting, “the leadership was concerned about a report we did on the sky-high rate of breakthrough hospitalizations. We learned of Herzog Hospital’s challenges from an Israeli TV interview, when Dr. Koby Haviv, the hospital’s director, described an extremely high number of breakthrough hospitalizations.” These are cases where the vaccinated wind up severely ill with SARS-CoV-2 infections.

TrialSite’s O’Connor continued, “But the hospital was in touch with us and wanted to clarify the importance of informing the world that the booster program was working. TrialSite is an open platform available to help any healthcare system, hospital, or clinic involved in research and care to impart important health-related messages to the public. So we engaged via email, and we were able to learn more about some powerful successes associated with the vaccine.”

The TrialSite founder concluded, however,

“The signals are really mixed in Israel. On the one hand, there is some evidence that in a concentrated way—for at least a period of time—the Pfizer vaccine affords people protection from more serious problems associated with the Delta variant.

However, we also continued to observe a tremendous number of new infections over there, including breakthrough infections involving severely ill, vaccinated people. So we were perplexed as to what was actually unfolding in Israel. Interestingly, the Herzog leadership was part of a group that was regularly communicating with Dr. Anthony Fauci and others from the United States, so most certainly there are a lot of eyes on Israel.”

Those with a critical eye became increasingly pessimistic. By August 16, Meredith Wadman writing for Science wrote Israel was becoming “the world’s real-life COVID-19 lab.” In “A grim warning from Israel: Vaccination blunts, but does not defeat Delta,” the science writer chronicled that overall, 78% of the population 12 years and up were fully vaccinated, mostly with BNT162b2 (Pfizer). Wadman noted, “Yet the country is now logging one of the world’s highest infection rates, with nearly 650 new cases daily permission. More than half are fully vaccinated people.”

Vaccination Nation

Ms. Wadman wasn’t incorrect. The vaccination rates were among the highest worldwide. By August 26, Herzog Hospital shared with TrialSite the nation’s immunization rates. For example, nearly a month ago, 78.3% of the 30-39 age cohort were already covered by the booster shot, while those aged 40 to 49 were 81.7% immunized. The coverage was even higher for the age 50-59 cohort equaling 85.3%, and for the even more vulnerable age range of 60 to 69, 87.7% received a third Pfizer shot. Finally, 93% of people aged 70 to 79 were vaccinated in the country.

Yet, the infections and deaths were on the rise. Herzog Hospital’s Dr. Yehezkel Caine informed TrialSite on August 26 that the program was working from their vantage. From this point of view, what matters most is that the vaccine kept people out of the hospital and therefore alive while those not vaccinated faced far graver risk. But growing numbers of vaccinated people were also going to the hospital with worsening conditions. Moreover, transmission rates and overall deaths climbed by late August despite the intensive nationwide booster campaign initiated in July.

Look at the Data Objectively

In the 23 days since the interaction with Herzog Hospital, what has unfolded in Israel represents even higher rates of SARS-CoV-2 infection and unacceptable levels of fatalities given the pervasiveness of the immunization program.

While constrained from deviating too much from any standard messaging parameters, the Israeli press acknowledged changes may be on the horizon. In a recent Times of Israel piece, Health Minister Director-General Nachman Ash all but recognized significant failures in the mass vaccination program, with over 10,000 new cases on some days. The Director-General indicated he hoped a recent downward trend would have continued. But in the age of COVID-19, messaging is key, and most politicians, health leaders, and journalists don’t dare deviate from established communication protocols.

In comments to the Knesset Constitution, Law and Justice Committee, the top health official shared his concern about Israel’s climbing SARS-CoV-2 infections. With 8,000 new infections daily, Ash told the group, “That is a record that did not exist in the previous waves.” Times of Israel reporter Stuart Winer reminded all that these current numbers in this post-booster period beat the “massive third wave at the end of last year.”

During the video call, Ash also shared cases involving the seriously ill now spike at 670 and 700, which is slightly less than weeks ago but dangerously high compared to months ago. Meanwhile, the Minister shared concerning data involving growth in the number of patients needing ventilators—from 150 to 190 in the past ten days and growth in cases involving ECMO machines—from 23 to 31.

With an “R’ rate moving upwards at pandemic levels, the COVID-19 positivity rate grew from Sunday, September 12 to Tuesday, September 14, from 5.24% to 5.93%. The overall infection rate in this country is among the highest in the world.

Moving Forward

Israel’s unfolding situation should be a lesson for other nations. While the population is among the most immunized on the planet, the current data indicates real challenges with the current strategy depending on the Pfizer-BioNTech vaccine.

Although this vaccine does appear to reduce the risks associated with severe symptomatic COVID-19, ongoing breakthrough infections suggest a rethink of vaccine product strategy. TrialSite reported on a recent study led by a team at Japan’s Osaka University, suggesting vaccine makers need to develop a product specifically engineered to attack Delta. Numerous data points indicate the Pfizer-BioNTech vaccine loses its defensive powers within a handful of months when confronted with variants such as Delta. Studies in the U.S., such as one led by Mayo Clinic, point to the superiority of the Moderna mRNA-based vaccine over Pfizer.

While Pfizer will generate an unprecedented $33 billion for the current vaccine product, powerful people are taking notice.

Yesterday an independent U.S. FDA advisory panel voted to slow down America’s mass vaccination program, despite Pfizer’s position that the situation merits a broad-based booster immunization now. Significantly, the POTUS and his top physician, Dr. Anthony Fauci, also went on the record concurring with Pfizer to immunize mass numbers of the population now.

Israel’s coronavirus czar, Salman Zarka, indicated recently that the Health Ministry assumes a forthcoming fifth pandemic wave. Mr. Zarka was quoted by the Times of Israel that while preparing to continue the Green Pass system in a bid to prevent viral transmission, the hope is that the nation will get through September and “stabilize in October.” Interestingly, Zarka inserted, “Then we will take a fresh look at the policy.”

Does Zarka mean that Israel’s public health leadership questions the dependence on the Pfizer product? TrialSite suggests that health officials everywhere review the unfolding data carefully. Does real-world data associated with the Pfizer vaccine indicate success? Are the current booster program results considered a success, failure, or some form of mixed result? Do health authorities need a fresh look at their strategy and approach to transcending this pandemic?

Evidence Against the Veracity of SARS-CoV-2 Genomes Intermediate between Lineages A and B

Evidence Against the Veracity of SARS-CoV-2 Genomes Intermediate between Lineages A and B

Evidence Against the Veracity of SARS-CoV-2 Genomes Intermediate between Lineages A and B Jonathan Pekar, Edyth Parker, Jennifer L. Havens, Marc A. Suchard,…

virological.org

Early SARS-CoV-2 genomic diversity can be separated into two primary lineages. Lineage B includes the reference genome Hu-1 and is defined by nucleotides C8782 and T28144, whereas lineage A is defined by substitutions C8782T and T28144C, relative to the reference genome. Intermediate sequences, containing either C8782T or T28144C—but not both—have been reported from early 2020. We refer to these genomes as C/C or T/T, because they have the same nucleotide at these two key sites. Here, we investigate the veracity of these sequences and conclude it is probable that neither C/C nor T/T genomes circulated at the start of the COVID-19 pandemic; they are likely the result of sequencing or bioinformatics issues.

Methods

We downloaded from GISAID all complete, high-coverage SARS-CoV-2 consensus genomes collected by 28 February 2020 and submitted by 31 December 2020—a table with acknowledgments is given below (1). We restricted our analysis to this time period because we were concerned with diversity at the start of the pandemic. We excluded all animal samples (i.e., bat and pangolin), along with any sequences that had an incomplete collection date, leaving 1716 sequences. These genomes were aligned with MAFFT v7.453 (2) (options --auto --keeplength --addfragments) to reference genome MN908947.3 (GISAID accession EPI_ISL_402125). Genomes with an ambiguous nucleotide at site 8782 or 28144 were excluded. We masked all problematic sites associated with common sequencing errors identified by De Maio et al. (2020) (3).

We then looked for pairs of genomes comprising an intermediate genome (C/C or T/T) and a major lineage (lineage A or B) that shared derived mutations. As demonstrated in Figure 3 of Worobey et al. (2020) (4), the repeated observation of pairs of genomes with apparent homoplasies can more parsimoniously be explained by sequencing error. In other words, we looked at whether putative A/B intermediates shared with “pure” A or “pure” B virus genomes one or more mutations outside of those that define the two pure lineages. If so, then either those mutations arose independently in both the putative intermediate and its pure counterpart, or (more likely) the putative intermediate is not an intermediate at all, and is actually a pure A or B lineage very closely related to its pure-lineage counterpart. This latter scenario implies that the C/C or T/T pattern in the putative intermediate was due to an error in inferring either site 8782 or site 28144.

Results

There were 28 C/C genomes collected by 28 February 2020. Of the 28 C/C genomes, 6 have no additional mutations other than at 28144. We identified 16 C/C genomes that share nucleotide substitutions also found in lineage A (Fig. 1). For example, one C/C sequence from Anhui (EPI_ISL_1069206) shares the mutation A11430G with 7 lineage A genomes. Occasionally multiple such mutations are shared: for example, a C/C genome from Thailand (EPI_ISL_437614) sharing G20134T, A895G, and G24047A with 3 other lineage A genomes from Thailand.

We also identified 11 C/C genomes that share substitutions found within lineage B (Fig. 2), including a Spanish C/C sequence (EPI_ISL_539558) sharing C22444T with 4 lineage B genomes and C26088T with an additional lineage B genome (Fig. 2). This latter example showcases potential sequencing issues beyond the occurrence of putative homoplasies, where apparent mutations prevent straightforward pairing of sequences from separate lineages based on one or several mutations. There are multiple occurrences of several taxa from a particular lineage (e.g., C/C) containing different subsets of mutations from a (set of) taxa from another lineage (e.g., A), as indicated by the brackets on the line connecting sequences in Figures 1 and 2. Notably, 9 of the C/C genomes share substitutions with both A and B lineages, whereas 4 contain substitutions not seen in other lineages.

There were 10 T/T genomes collected by 28 February 2020. Two T/T genomes (EPI_ISL_418251 and EPI_ISL_418247) have additional mutations C3037T and A23403G common among later lineage B sequences. Another two T/T sequences (EPI_ISL_728154 and EPI_ISL_416615) possess mutations G11410A and G26211T. However, aside from the T/T lineage, these two mutations are only seen separately, with G11410A found frequently in lineage B sequences from Japan and the Diamond Princess cruise ship, and G26211T seen in a lineage B Chinese genome (EPI_ISL_411952). Additionally, one T/T genome sampled in Wuhan (EPI_ISL_493180) contains the mutation C13730T, which, though not seen in other sequences in our dataset, persists within a lineage B clade through early 2021 (e.g., EPI_ISL_1322330). One of the T/T sequences has a mutation not seen in other lineages, and 4 do not have any additional mutations.

Conclusion

As discussed in Worobey et al. (2020) (4), the repeated occurrence of numerous derived mutations on either side of a given mutation is difficult to reconcile through homoplasy events. Of the 77 mutations seen in C/C intermediate genomes, 32 (41.6%) would need to be homoplasies if these C/C intermediates actually existed. Similarly, 7 (58.3%) of the 12 mutations seen in T/T genomes would need to be homoplasies if the T/T intermediates truly existed. These apparent homoplasies can arise from issues regarding sample preparation, contamination, sequencing technology, and/or consensus calling approaches (3). In particular, it seems likely that the nucleotide of the Hu-1 lineage B reference is frequently being called at these two sites.

These findings cast substantial doubt on the veracity of C/C or T/T intermediate genomes in early 2020. We suggest that these early C/C and T/T genomes are erroneous and should be excluded from phylogenetic analyses

Japanese Researchers Investigate Intracranial Hemorrhage Deaths Possibly Caused by Pfizer’s COVID-19 Vaccine

Japanese Researchers Investigate Intracranial Hemorrhage Deaths Possibly Caused by Pfizer’s COVID-19 Vaccine

A clinical pharmacology and medical informatics professional from two Japanese universities recently analyzed potential adverse events associated with the

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A clinical pharmacology and medical informatics professional from two Japanese universities recently analyzed potential adverse events associated with the COVID-19 mRNA-based vaccine called tozinameran—the Pfizer-BioNTech vaccine known as BNT162b2. The Japanese report indicates that reports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) after receiving COVID-19 vaccination point to concerns involving safety. Rumiko Shimazawa, with the Department of Clinical Pharmacology, Tokai University School of Medicine and Masayuki Ikeda, Department of Medical Informatics, Kagawa University Hospital, Miki-Cho, Kagawa, shared that presently no regulatory authority recognizes ICH as an adverse event associated with BNT162b2. But they share that in Japan, fatal and non-fatal cases are known. For example, in Japan, ten people have died in association with this vaccine. The dead included both five men and five women. Of note, four of the five women died of ICH, and the other died of aspiration pneumonia. Apparently, all five of the males died due to causes other than a stroke.

Shimazawa and Ikeda write that “Cumulatively…a disproportionately high incidence of death by ICH in Japanese women” who were inoculated with BNT162b2. The researchers suggest “a potential association of ICH with the vaccine.” The authors do declare that at least at this state, the benefits of vaccination outweigh the risks. Meanwhile, they cannot provide a causal relationship associating with the vaccine and ICH, but they believe this topic deserves more investigation.

The Data

In Japan, by April 18, 2021, an estimated 1.21 million people had received one jab, while .72 million received the second dose of BNT162b2, known as tozinameran in Japan. The Japan Ministry of Health, Labor and Welfare (MHLW) reported ten fatal cases as of April. Four of the incidents included death by ICH, and all deaths involved women passing after the first jab.

The remaining cases involved five men and one woman. The one woman not dying from ICH passed due to aspiration pneumonia four days post the first jab. At the same time, the five men passed due to a number of issues other than a stroke, such as acute heart failure, sepsis, and others.

The authors provide a case series to describe the patients and situation. The authors strongly suspect causal links but haven’t proven this as of yet.

Lead Research/Investigator

Rumiko Shimazawa, the department of Clinical Pharmacology, Tokai University School of Medicine

Masayuki Ikeda, Department of Medical Informatics, Kagawa University Hospital, Miki-cho, Kagaw

Call to Action: Review the entire paper at the Journal of Pharmaceutical Policy and Practice.

FDA Advisory Panel Overwhelmingly Votes Against The Powers-that-be: Opting For Rational, Risk-based & Data-Driven Approach

FDA Advisory Panel Overwhelmingly Votes Against The Powers-that-be: Opting For Rational, Risk-based & Data-Driven Approach

An independent U.S. Food and Drug Administration (FDA) Advisory Panel today voted overwhelmingly against the mass booster program at this point. This is

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An independent U.S. Food and Drug Administration (FDA) Advisory Panel today voted overwhelmingly against the mass booster program at this point. This is an unprecedented situation, one where the U.S. White House and the nation’s top doctor, Dr. Anthony Fauci, went on the record promoting the booster for much of society. The independent advisory panel put a screeching halt on an imminent mass booster access and rather elected that the boosters should only be available for a far more narrow subsection of the population, from the elderly to severely ill, and select occupations facing higher risks of exposure. But this decision will undoubtedly create more tension as, on the one hand, Biden, VP Kamala Harris, Dr. Fauci, and others had essentially marketed this program as imminent before the experts were, in fact, ready to conclude that was the right option.

The Vote

In a move that may further confuse the public, given POTUS’ aggressive declaration that a booster program would be ready for all this month, the advisor panel of experts voted to recommend that the third jabs only be made available to select groups, such as elderly Americans aged 65 and up, as well as other cohorts considered at high risk. This includes, for example, people with severe illness or select occupations such as healthcare workers and teachers.

TrialSite suggests that today the panel did the right thing, rejecting Pfizer’s push for full booster approval covering everyone across America 16 years of age and up. Instead, the advisory panel has aligned with a more rational, risk-based, and data-driven approach, authorizing booster access for select and targeted groups. Will the FDA honor this decision?

POTUS Playing a Dangerous Game

Biden, Fauci, and others have been doubling down on the vaccine-centric strategy in the hope of eradicating COVID-19, perhaps thinking that is not only the best way to transcend the pandemic but also to ensure an at-risk U.S. economy moves out of ever more dangerous waters.

Earlier today, Reuters reported that the White House was keen on a mass booster rollout of the Pfizer-BioNTech booster vaccine to as many people as possible.

An unexpected vote for many, the decision may trigger further political, socioeconomic, and scientific-related tensions as a clash of pandemic fighting paradigms manifest in this age of COVID-19. TrialSite suggests today’s decision was a sound, rational one, concurring with the departing FDA vaccine regulators who recently published an article suggesting the time was not now for massive vaccine boosters for all. Two top regulators announced their resignation recently, as reported by TrialSite.

TrialSite’s Founder Daniel O’Connor shared, “Today’s advisory panel vote isn’t what President Biden and his team expected—the White House made a serious blunder, getting too far ahead of regulators in declaring vaccination schedules.” O’Connor continued, “Biden and Vice President Harris are seasoned politicians, and they should have known better than to make such declarations. Because of their overzealous, almost promotional cheerleading for the imminent program, the American public may become even more confused than they were before.” O’Connor emphasized, “Today’s vote, while focused, offers a broad interpretation for high-risk populations—meaning that the door is somewhat open to vaccinate more people than may be readily apparent.”

The Biden administration was on the record declaring that the general population would have access to the vaccine by September 20. However, with this overwhelming vote, a strong precedent is set to follow a more conservative approach, favoring targeted, risk-based access over mass vaccination.

If the FDA follows today’s vote, the Gold Standard agency will start to at least head in the right direction, working to repair its’ image, which has recently taken a hit from the perception that industry and political bias sways decisions one way or another.

University of Liverpool-led AGILE Study Suggests Promise of Nitazoxanide for COVID-19

University of Liverpool-led AGILE Study Suggests Promise of Nitazoxanide for COVID-19

The University of Liverpool in the United Kingdom led the AGILE platform master protocol known as the AGILE trial, a Phase 1 study evaluating a range of

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University of Liverpool-led AGILE Study Suggests Promise of Nitazoxanide for COVID-19

The University of Liverpool in the United Kingdom led the AGILE platform master protocol known as the AGILE trial, a Phase 1 study evaluating a range of potential therapies including Nitazoxanide, an FDA approved antiparasitic medicine. The Phase 1/2 multicenter, multi-arm, multi-dose, and multi-stage, open-label adaptive seamless study was designed to determine the optimal dose, activity, and safety of multiple candidate agents, including Nitazoxanide, for the treatment of COVID-19. The drug was well-tolerated and safe. TrialSite also reports that the drug’s maker, Rowmark International, reported promising results in April 2021.

Background

One key public health goal of many academic medical centers, apex research institutes, and national regulators should be investigating repurposed approved drugs that may lead to effective interventions during this pandemic. To date, unfortunately, in America, the National Institutes of Health (NIH) in the first year of the pandemic focused solely on vaccines and novel monoclonal antibodies and expensive pharmaceuticals such as the antiviral remdesivir.

An inherent bias in the drug development system favors novel, branded pharmaceuticals over economic, repurposed drugs for apparent reasons.

The Study Drug

University of Liverpool and collaborators at the University of Southampton, Liverpool School of Tropical Medicine, Liverpool University Hospitals NHS Foundation Trust, and the University of Cambridge set to investigate repurposed antivirals, including an antiparasitic medicine called Nitazoxanide.

Sold under the brand name Alina, this broad-spectrum antiparasitic and broad-spectrum antiviral medication is used in medicine to treat various helminthic, protozoal, and viral infections. The drug presently is indicated for the treatment of infection by Cryptosporidium parvum and Giardia Iamblia in immunocompetent individuals and has been repurposed for the treatment of influenza.

It is a prototype member of the thiazolides, a class of drugs that are nitro thiazolyl-salicylamide derivatives with antiparasitic and antiviral activity. Tizoxanide is an active metabolite of Nitazoxanide in humans and is also an anti-parasitic drug of the thiazolide class.

In 2020, Nitazoxanide tablets were approved as a generic medication in the United States.

Other uses are investigated in various research initiatives. For example, the drug has been used in phase 3 clinical trials to treat influenza viruses resistant to neuraminidase inhibitors like oseltamivir.

COVID-19

The drug has been under investigation as a possible treatment for COVID-19. A search in Clinicaltrials.gov turns up 29 clinical trials involving the use of the drug. Out of those was one Phase 3 trial sponsored by Romark Laboratories L.C. https://www.romark.com/

Back in April, Roark reported on the study results declaring that in regards to the primary endpoint—median time to sustained response (recovery time)—the study drug performed comparably to the placebo (approximately 13 days). However, in the pre-defined subgroup of patients with mild disease, the median time to sustained response was reduced by 3.1 days with NT-300 (Nitazoxanide).

In regards to the secondary endpoint, the study drug was associated with an 85% (0.5% of NT-300-treated patients vs. 3.6% of patients treated with placebo) reduction in progression to severe illness (shortness of breath at rest with SpO2.

The AGILE Phase 1 Study Results

In this open-label, adaptive Phase 1 trial in healthy adult participants, adults were administered 1500 mg nitazoxanide orally twice-daily with food for seven days. The endpoints for this study centered on safety, tolerability, optimum dose, and schedule.

The UK-based study authors reported that 14 healthy participants joined the study between February 18, 2021 and May 11, 2021. The participants completed all 10 out of the 14 participants. While the drug was well tolerated with no significant adverse events, 8 of the participants did experience gastrointestinal disturbance (loose stools) with urine and sclera discoloration in 12 and 9 participants, respectively, without clinically significant bilirubin elevation.

The study team wrote that PBPK predictions were confirmed on day 1, leading to underprediction by day 5. They reported that median Cmin was above the in vitro target concentration by the first dose while maintained during the study. The University of Liverpool-led study team shared that the study drug administered at 1500mg twice per day was safe and well-tolerated. Consequently, the study team has initiated a Phase 1b/2a study involving COVID-19 patients.

Study Funding

· This study was funded by Unitaid as part of a supplement to the project LONGEVITY in response to the pandemic.

· NIH

· European Commission

· Wellcome Trust

· Medical Research Council

· Lead Research/Investigator

Lead Research/Investigator

Dr. Lauren Walker, BSc (Hons) MBChB, (Hons), PhD MRCP (UK)

Why the new A.23.1 variant is so troubling

Experts identified a new variant — titled A.23.1 — that reveals a troubling sign of what’s possibly to come next

Why the new A.23.1 variant is so troubling

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A new COVID-19 variant has been found in Africa, and it offers a troubling sign of what could come from COVID-19 variants in the future.

What is the A.23.1 COVID variant?

The new variant — titled A.23.1 — was first discovered in Uganda back in October 2020. Now, it has reached 26 different countries and represents just under 2,000 cases of COVID-19 across the world. Details of the variant were published in the medical journal Nature.

The variant has not been deemed a variant of concern or of interest by the World Health Organization yet.

Why is A.23.1 COVID variant different?

The variant “contains several mutations found in variants of concern as well as six unique substitutions,” according to Forbes.

But, more interestingly, the variant “does not share a common origin with all of the variants of interest or concern, including alpha, beta, gamma, delta and mu,” according to Forbes.

All of those variants have a mutation that shows its comment origin. But A.23.1 does not share that.

In fact, it has more connections to the A.30 variant, which was originally found in Angola, and might have originated in Tanzania. Both of these variants don’t share an origin with the other major strains, Forbes reports.

“The discovery of two distinct but distantly related variants in East Africa is concerning in and of itself,” according to Forbes. “The observations that these variants arose independently from all others in the world, lacking the distinctive triad of mutations that link all other current variants demonstrates the versatility of SARS-CoV-2 adaptations to local conditions.”

Why the A.23.1 COVID variant is so dangerous

Scientists in Africa are concerned about the spread of COVID-19 variants in the continent. COVID-19 variants continue to emerge from Africa — somewhat because there is low vaccine availability and vaccination rates there — that could lead to a mutation that might evade vaccines, according to Bloomberg.

Per Bloomberg, the scientists — a group of 112 African and 25 international organizations — said that a “slow rollout of vaccines in most African countries creates an environment in which the virus can replicate and evolve. This will almost certainly produce additional VOCs, any of which could derail the global fight against COVID-19.”

Nicki Minaj was right and all the world’s COVID vaccine experts were wrong

Nicki Minaj was right and all the world’s COVID vaccine experts were wrong

Opinion Editorial By: Steve Kirsch Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of

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Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. This article is currently FREE to read and SHARE without paying.

Nicki Minaj made a tweet about a friend of her cousin who got vaccinated and had orchitis (swelling of the testicles) afterwards.

Nicki was globally mocked for this tweet by COVID vaccine experts and the mainstream media from around the world. As far as I could tell, not a single medical expert supported her position. Nobody in a position of authority came to her rescue. Nobody.

It turns out Nicki was absolutely right. And all the world’s authorities and medical experts were incorrect (aka FOS).

This is known as an “inconvenient truth.”

I posted the scientific evidence on Nicki’s Twitter feed: the VAERS results, the Fisher Exact tests. Twitter blocked my main tweet (with all the sub tweets) shortly after I posted it so no one would learn the truth.

So I decided to write this article for TrialSiteNews so that everyone can decide for themselves who to believe.

Misinformation and VAERS

But first, let’s get a few housekeeping issues out of the way about me and about the Vaccine Adverse Event Reporting System (VAERS), the reporting system relied upon by the FDA and CDC to track adverse events.

I am not a medical expert. I am just an engineer from MIT who graduated in 1980 with a couple of degrees. I understand science, math, and statistics. I have no conflicts of interest. I have no history of giving out medical misinformation.

I’m also knowledgeable about the VAERS system. When you have an adverse event that you report to the V-SAFE application, you are directed to VAERS to report it. This doesn’t work so well if you are dead. This is why deaths are somewhat under-reported.

I’ve written articles showing that the VAERS data shows that over 150,000 deaths are due to the vaccine. But people dismiss that and cite the CDC disclaimer about VAERS. The CDC disclaimer gives people “permission” to ignore VAERS. The people who dismiss my arguments are not VAERS experts.

I have 5 independent ways that arrive at the same number. Nobody has been able to supply a comparable analysis (with 6 different independent approaches) that all converge on a different number. They just claim my number is wrong. How can they know I’m wrong if they don’t have the “correct” analysis??

The CDC disclaimer is wrong on so many fronts. My favorite article on the lunacy of believing that CDC disclaimer is If Vaccine Adverse Events Tracking Systems Do Not Support Causal Inference, then “Pharmacovigilance” Does Not Exist.

To counter the CDC disclaimer, I offered to bet anyone $1M that there are over 20,000 deaths vs. under 500 deaths. I’d have bet a higher number, but nobody believes that even 20,000 deaths is remotely possible so 20,000 is sufficient to prove my point.

I discovered that nobody would bet me. Which tells us all that nobody in the world strongly believes that there are <500 deaths from the vaccine, because if they truly were confident of that, then this is a quick way to make $1M for a few hours of work. The CDC still says there are NO deaths caused by the vaccine. Just 500 deaths would stop the vaccine; it was around 50 deaths in 1976 when they halted the H1N1 vaccine nationwide.

Unfortunately, people think the CDC is correct in their VAERS disclaimer. So they attack me as being incorrect. The FDA dismisses my analysis with the hand-waving argument that they disagree with me and there is nothing further to discuss. This is precisely why they never see a safety signal in VAERS: the FDA and CDC will ignore any rational person who challenges their set of (incorrect) beliefs.

It isn’t just me they won’t talk to; it is all of the VAERS experts, statisticians, doctors, and medical scientists that I confer with who all would love to challenge the false narrative. See the list at the end of this document.

If you are looking for a safety signal and have found nothing, why aren’t the CDC and FDA interested in what we have to say?

How to find out who is telling you the truth on issues you don’t understand

One easy way to find the truth tellers is to see which side will put their money where their mouth is on important issues under discussion.

Another way is a public debate. Truth tellers LOVE recorded public debates. Liars hate that and depend on censorship. Sound familiar? Censorship also takes the form of not running my op-eds, doing hit pieces on me, defaming me in Wikipedia, and making sure all reporters who support my position have their stories killed.

None of the “experts” who attack me will ever agree to a neutral public debate about this because they will be exposed as pushing an unsafe vaccine. There is no way they can explain all the evidence that is out there. The evidence is consistent with my hypothesis, not theirs.

Any open debate on vaccine safety would completely obliterate the narrative that the vaccines are safe and effective. That’s why the White House uses censorship as their weapon against people like me who are trying to tell the truth.

And just like they are unfairly attacking me, they are also unfairly attacking Nicki Minaj who did nothing more than tell the truth. They should all be ashamed of their behavior.

The “experts” all aligned to discredit Nicki

Here’s the Trinidad expert criticizing Nicki.

Here’s Sanjay Gupta laughing at Nicki Minaj:

Sanjay simply stated the vaccines don’t cause swollen testicles. That’s it. No evidence. Basically Sanjay is making this stuff up out of thin air. This is irresponsible medical journalism at its finest. Listen to him. He cites no evidence. He simply says the vaccines don’t cause this. That’s opposite to what the primary evidence (VAERS) says. Doesn’t seem to matter to him.

Fauci couldn’t resist commenting. He’s full of shit. “No evidence that it happens.” Are you kidding me? He’s a buffoon. He never even looked for the evidence that was in plain sight the entire time. This is how all this misinformation happens.

Here’s what I mean by hiding in “plain sight”… a web page summarizing all this that anyone can load:

It’s right there. There are line items for miscarriage, testicular pain/swelling. All the stuff Fauci said the vaccine didn’t cause… it’s all there in plain sight: miscarriages, menstrual disorders, testicular pain/swelling, erectile dysfunction, vaginal/uterine hemorrhage, etc.

Or there are article like this one:

If Fauci really wants to stop the medical misinformation, all he has to do is stop talking. Simple. Effective. Problem solved.

Comedians chimed in their expertise in the vaccine field:

Trinidad officials said it was a wild goose chase.

Basically, these experts ignore all the negative data that doesn’t fit their agenda. And they gang up on anyone who has the courage to speak the truth to silence and ridicule them.

And Congress enables all this by doing absolutely nothing to stop the censorship.

All the evidence shows that all the experts were wrong and Nicki is right

Instead of people issuing opinions on whether vaccines cause orchitis or not, isn’t it time for us to look at the scientific data?

Did anyone produce any evidence that her cousin’s friend was lying? Nope.

That’s our first clue that she’s telling the truth.

So I did a full investigation in VAERS and posted the result. But because it started heavily trending, Twitter censored it within hours of posting.

Here’s the first message. Nobody is allowed to see the sub-tweets… all censored.

Through censorship, Twitter is basically preventing the spread of legitimate scientific data so that NOBODY WILL EVER FIND OUT the truth.

There was nothing misleading at all about the tweet. It was 100% factual. But you cannot argue with the Twitter censors. They are ALWAYS right and there is no appeal.

Truth about the vaccine must be censored because if it wasn’t censored, they wouldn’t be able to get anyone to take it. Censorship is hugely important, especially on social media platforms. When you have a product that is so unsafe that anyone informed wouldn’t take it, you can’t do it without censorship help.

Suppressing the truth is bad enough, but then you are given a very biased statement that fails to point out that the drug company’s own studies do not agree with these health officials.

Twitter never mentions that Pfizer’s own data shows that the vaccines kill more people than they save (18 vaccine group vs. 14 in placebo group). Why not give a balanced picture? Why are you giving expert opinions of experts who are wrong (and won’t debate the safety in a fair debate) rather than telling the world that the actual DATA from Pfizer doesn’t support the safety story?

In evidence based medicine, a double-blind randomized controlled trial data always out ranks expert opinion. But Twitter can’t figure that out. They probably never will.

Will any of these people ever apologize to Nicki? I doubt it. Because that would be an admission that 1) the vaccines caused an event that the FDA and CDC missed, and 2) it would expose all the world’s experts as giving out misinformation and 3) that Twitter was deliberately censoring truthful medical information. It’s not going to happen.

How could all the experts be wrong? Simple. They don’t check the data before they criticize people for making truthful statements. If you make any statement that is against the false narrative that the vaccines are safe and effective, you will get shot down, even when the facts don’t support it.

So, with that out the way, let’s get into the data.

An impossible anecdote

First we have a really interesting anecdote from one of my Twitter followers who saw my post. I just talked to him on the phone. It’s legit. There were 10 kids in the group:

So this is statistically IMPOSSIBLE (i.e., “highly unlikely to ever happen in your lifetime”) if the vaccines don’t cause this condition. I suspect this anecdote is not isolated. This is likely under-reported due to embarrassment.

Does this really affect half of teenage boys? I don’t know. The URF of this symptom would be really high.. Much higher than the 41 we’ll use below.

At this point, we have two anecdotes from people we trust suggesting that this is real.

VAERS analysis confirms testicular swelling events are elevated after the COVID vaccines

Let’s see if we can also confirm in VAERS as that would really add a lot of weight to the argument that this wasn’t just a “coincidence.” And then we’ll talk about mechanisms of action confirmation for even more credibility.

It’s always nice when we use a large primary safety data source like VAERS. It will also show everyone just how under-reported VAERS is. Even if just one of those 10 kids was telling the truth, the under-reporting factor in VAERS for this condition is likely huge.

So now let’s dig into the data. We’ll use a VAERS under-reporting factor (URF) of 41 based on my previous work. This is very conservative. The article also discusses the propensity to report and that allows us to compare previous years with this year with a correction factor (we are not trying to get a super accurate answer but just get in the ballpark).

Now we run some VAERS comparative analysis between what gets reported in a typical year vs. this year.

The second analysis was over 10 years (all vaccines). 64/3.6 is a 17.7X higher incidence rate than for a typical vaccine side effect. That’s clearly an elevated condition.

If we multiply each event by the URF of 41, we can then do a test for statistical significance over 200M people and that easily passes:

VAERS analysis confirms orchitis events are elevated after the COVID vaccines

Now we do the same test for orchitis which is another name for the same class of symptoms:

So we have 20 / 1.3 = 15.3 X elevation so not that much different than we found earlier (17.7X).

Clearly both are elevated. Now we multiply by the URF of 41 (which is very conservative) and test for significance:

In short, so far, all the data we have shows Nicki was right and the experts were wrong.

VAERS analysis confirms erectile dysfunction events are elevated after the COVID vaccines

Here’s the search for COVID vaccines:

Here’s the search for 10 years worth of all previous vaccines:

So 171/1.8 = 95X

In other words, your chance of impotence is elevated by nearly 100X after the COVID vaccine vs other vaccines. We have all the Bradford-Hill criteria now satisfied for causality. In addition we can add dose dependency (97 dose 1 and 43 on dose 2) as shown below.

But 15% fewer people get the second dose, and the vast majority of the people who skip the second dose are those who either (1) had a bad reaction to the first dose or (2) saw their friends having a bad reaction and decided to skip it (the slide showing this is midway in the deck). So the number should be 15% lower on the second dose reports. It isn’t. So there is dose dependency here as well, likely that people after the second dose reacted so badly they didn’t come back for a second dose.

As for the test for significance, here it is:

So once again, all the experts were wrong. The effect is highly statistically significant.

Mechanism of action

Is there a plausible mechanism of action here that can be causing the swelling.

Absolutely. Physicians are experiencing swelling in other parts of the body. Why would the testes be an exception? If you do a VAERS search for “swelling” you see that I’m right. It’s happening all over people’s bodies.

Here’s a plot of the biodistribution of the lipid nanoparticles that are used to deliver the mRNA instructions. Note that some organs are omitted so you can see the detail more clearly.

Clearly the ovaries are having much more uptake than the testes.

So if we refer to the original Pfizer data, and look for the heart on page 16 and the testes on page 17. We see comparable concentrations at 48 hours!

We know the vaccines injure kids’ hearts (myocarditis). Since it looks like we’re delivering similar amounts to the testes, it is plausible to believe that the testes might be damaged in a similar way due to the blood clots and inflammation that the spike protein causes.

Finally, keep in mind that the spike protein is toxic and it is being delivered to every part of your body. Even if Wikipedia doesn’t agree with me, the scientific literature does. Here is a mix of papers and articles referencing papers on this:

Be aware of SARS-CoV-2 spike protein: There is more than meets the eye

Toxicological insights of Spike fragments SARS-CoV-2 by exposure environment: A threat to aquatic health?

SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2

Pay no attention to the spike proteins behind the curtain

Clearing up misinformation about the spike protein and COVID vaccines

Attacks on this analysis

If you think I’m wrong and the vaccines cannot cause this symptom, I will make the same $1M bet. The terms would be similar to the term sheet I use for betting people on vaccine deaths (we’d substitute “vaccine causes testicular swelling” as the item to be decided upon).

So if you think Fauci is right, see my term sheet and have your attorney contact my attorney.

Attacks on this analysis like “VAERS is over-reported this year” or “there are 2 false report in VAERS” or “you are not a doctor” or anything else like that are all instantly defeatable by the bet. If you think any of your criticisms are valid, then why not take my money? If you are not willing to back your arguments with cash, that tells me you are not confident at all in your position and you are just trying to create FUD and waste my time. That’s counter-productive. The bet simply makes it crystal clear who is serious and who is not.

In short, none of the world experts who criticized Nicki will put their money where their mouth is. Instead, they will continue to spread misinformation and not be held accountable for it.

Recently, I was in a debate with Honourable Fitzgerald Ethelbert Hinds, the Minister of National Security for Trinidad/Tobago on Power102fm radio. The radio station booted me off the zoom call when it was clear that Minister Hinds was losing badly. The comments from the Trinidad listeners were telling. None of them supported their own official. This is why nobody wants to debate me; because the public can see who is telling the truth when a liar and a truth teller get into a debate.

Summary

This sums things up pretty nicely:

Thank you Nicki Minaj for telling the truth and not backing down when you were unfairly attacked.

I hope you will take a look at the vaccine information I’ve posted at skirsch.io and help people to become aware of it.

A note to the fact checkers

Before you fact check this article and spew out more misinformation doing so, why don’t you educate yourself on the facts first by at least reading the 600 pages of material I prepared for you here so you will at least know something.

Not that it will make any difference.

After this article is falsely fact checked, I’ll modify the article to respond to the fact check.

And the fact checkers will never debate me or bet me that they are right. They are faceless and nameless and operate in the shadows and don’t respond to corrections.

If you want to fact check me, show yourself and debate me in a public forum.

But they will never do this. They would lose. Badly. Just like Minister Hinds. That’s why they never dare show their names or faces. The evidence is not supportive.

A simple law could restore freedom of “true” speech

It would be great if there were a federal law enabling anyone to recover statutory damages of $50,000 anytime a large social media company blocked information that was factual (and not illegal). That’s a simple law. Wouldn’t it be great if truth would be protected in America?

This would REALLY fix the censorship problem in a heartbeat.

A note about censorship

I’m also sure that all the social media companies will block any message or tweet that tries to reference this article. They do not want you to read this article. Because if you read this article, you will realize how they have been lying to you about the safety and side-effects of the vaccine from the very beginning.

Sadly, no one in Congress wants to ensure that “truth” is protected from censorship on the popular communication platforms.

We live in a new world today. I’ve never seen anything like this.

Israel’s Booster Program’s Not Stopping Sky Rocketing Cases and Higher Number of Deaths—What’s Going On?

Israel's Booster Program's Not Stopping Sky Rocketing Cases and Higher Number of Deaths—What's Going On?

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Starting in July Israel

trialsitenews.com

Starting in July Israel commenced the most aggressive booster vaccination program worldwide. The nation has one of the highest COVID-19 vaccination rates at 63%. What follows are some graphs depicting the situation there. Despite the booster program Israel now has one of the highest infection rates per million in the world.

1) Here is the URL for the site that I used the data to build the graphs: https://ourworldindata.org/coronavirus

2) Here is my first graph to show the % of the populations fully vaccinated, with Israel as of Sept 14th being 63%

Graph A

Israel=as of Sept 13th fully vaccinated population 63%, US 53%, India 12%

3) Here is the graph I built for the infections per million persons to normalize and I used Israel, the US to compare and India given India’s very low vaccination rate; as you see Israel has extensively more infections and the question is, what transpired post the implementation of the booster (3rd vaccine) program on August 1. It must have had a good result by turning the increase in cases downward. Right? Well, lets see:

Graph B

Israel as of Sept 14th, per million, 1254/million, US 457/million, India 22/million infections

So what do we see? Well, Israel has the highest vaccination rate as above (graph A), but highest daily cases (graph B)…if vaccine was working this would not be the case

On August 1st, Israel started its 3rd booster and the daily cases was 246/million on that day and US 240/million on that day, August 1st…so what happened over the next month?

Here is the official evidence that the booster started on Aug 1st in case you were wondering where I got that from:

“Israel — the first country to officially offer a third dose — began its COVID booster campaign on August 1, rolling it out to all those over age 60. It then gradually dropped the eligibility age, expanding it last week to anyone 30 and older. As of Sunday, over 1.9 million Israelis had received the third dose”.

Israel widens 3rd COVID booster shot to those aged 12 and over

Those who've had 3rd dose, or 2nd dose within past half-year, will be exempt from full 7-day quarantine when returning from abroad; 'Green Pass' to expire 6…

www.timesofisrael.com

It seems, however, over the month of August and onwards (August 1st onwards), with the 3rd booster, Israel’s daily cases exploded; the booster is driving the new infections, the vaccine has failed.

In the month of August, Israel gave 2 million 3rd boosters but from August 1st you can see an explosion. We can only conclude that the vaccine is not working. The booster is a disaster, a failure. The rate of increasing cases remains steady and likely we wont be able to plot it any further as the increasing cases will go off the chart. The infections after 3rd booster show no sign of stopping.

If you look at the prior peek on Jan 18th 2021 (green dotted vertical line), Israel has 929/million infections so now with 3rd booster (Sept 14th), it is even dramatically higher than the former highest peak in January 2021 (green dotted vertical line).

Even when we compare Israel to nations in the vicinity and not the US or India, so if we added the middle eastern nations, we see Israel as the nation with the highest vaccination rate and now 3rd booster, has most cases relative to nations that are similar as to climate, location in middle east etc:

What does this mean? It means the booster has failed and may actually be driving infections (maybe facilitating antibodies), and actually causing enhanced transmission; this is a catastrophe and no 3rd booster must be given in the US; this is my argument for your consideration based on the data.

Graph C

This graph C has 3 key points:

1) the surge in infections in Israel post 3rd booster start Aug 1st 2021 is greater than the peak seen in the prior highest level (green dotted line, January 18th, 2021)

2) You can see that from August 1st 2021 to Sept 14th 2021, the infections are sky rocketing and the key issue is that the booster program was started on August 1st. It has failed. It is likely that the vaccinated are carrying the Delta and participating in the transmission of it and fuelling the transmission and it can be argued that the booster is driving this3) If you look at Israel and compare it to other middle eastern nations, you see the clear difference in infections and especially how Aug 1st 2021, their infections are going down while Israel’s escalated up and mainly due to the booster initiation

COVID-19 infections have skyrocketed in Israel post-Aug 1st with the implementation of the third shot booster program—the expectation would be by now cases would be on the decline. Israel has far greater than other similar nations geographically…and the new peak with this 4th wave post booster is even higher than the prior highest peak on Jan 18th, 2021.

Another trial shows no benefit from Remdesivir, yet it's still being administered thousands of times a day in US hospitals. Why should anyone trust the experts running the show in the US?

DisCoVeRy Trial Results Mean More Bad News for Remdesivir—No Clinical Benefit

DisCoVeRy Trial Results Mean More Bad News for Remdesivir—No Clinical Benefit

INSERM, a successor to the French National Institute of Health, recently had results from the Phase 3 DisCoVeRy clinical trial published in The Lancet,

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INSERM, a successor to the French National Institute of Health, recently had results from the Phase 3 DisCoVeRy clinical trial published in The Lancet, Infectious Diseases. The major French investigation explored the antiviral efficacy of remdesivir, the only therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19. A controversial move by the FDA as the pivotal American clinical trial included controversial moves by the sponsor—the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH)—to change the primary endpoint toward the end of the study. It turns out that the drug didn’t meet this endpoint, so as directed by NIAID Director Anthony Fauci, the apex government research institute worked with the industry sponsor, Gilead, to merely modify the endpoint to reduce the duration of hospitalization. The final results in that American trial weren’t impressive—a mere few days reduction in hospitalization. Meanwhile, the World Health Organization (WHO) Solidarity trial concluded remdesivir brought no benefit. The FDA proceeded first to issue an emergency use authorization (EUA). A few months later, they issued a formal approval paving the way for Gilead to generate approximately $3 billion in revenue during the first twelve months of the pandemic. Now more evidence backs the position that the drug does little to help hospitalized COVID-19 patients. After evaluating the clinical efficacy of remdesivir plus standard of care compared with standard of care alone in hospitalized COVID-19 patients, the study team found no clinical benefit in symptomatic patients hospitalized for over seven (7) days also in need of oxygen support.

Background

TrialSite has reported on the unorthodox way in which Gilead was able to secure the EUA—when Dr. Fauci declared for the world to hear that the drug was a “new standard” for treating COVID-19. Fauci quickly followed up, however, that remdesivir was “no knock out drug.”

Gilead had what it needed to generate blockbuster returns in the middle of a pandemic, charging thousands of dollars per treatment with the true benefit of the drug up in the air. The move greatly benefited the company management, who could drive unprecedented revenue in the middle of the pandemic.

By January 2021, TrialSite reported that the WHO Solidarity trial indicated that the drug neither helped reduce mortality nor hospitalization. Yet demand for the drug in key markets soared regardless. By October 2020, the FDA formally approved the drug, the first such approval for COVID-19 in America.

INSERM DisCoVeRy Study

Enter the INSERM-sponsored, randomized controlled DisCoVeRy study (NCT04315948) testing multiple drugs, including remdesivir, on those 18 and up hospitalized for COVID-19.

This is an adaptive, multi-center, and country trial comparing the standard of care with various study drugs, including remdesivir.

INSERM led this Phase 3, open-label, adaptive, multi-center randomized controlled trial conducted at 48 trial sites across Europe, from France and Belgium to Austria, Portugal, and Luxembourg.

Findings

With findings generated during much of the initial year of the pandemic, the arm of the study investigated 857 participants, with 429 assigned to remdesivir plus the standard of care and 428 assigned to only standard of care. Using the WHO ordinal scale as an endpoint measure, the study authors communicated the following:

WHO Ordinal Scale Stud Drug vs. Standard of Care

Not hospitalized/No limitations on activities 61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control group

not hospitalized, limitation on activities 129 [31%] vs 132 [32%]

hospitalized, not requiring supplemental oxygen 50 [12%] vs 29 [7%]

hospitalized, requiring supplemental oxygen 76 [18%] vs 67 [16%]

hospitalized, on non-invasive ventilation or high flow oxygen devices 15 [4%] vs 14 [3%]

hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation 62 [15%] vs 79 [19%]

death 21 [5%] vs 24 [6%]

The authors disclosed that the delta associated with treatment groups was not “significant.” (odds ratio 0·98 [95% CI 0·77–1·25]; p=0·85). They couldn’t find any significant differences in the occurrence of serious adverse events between treatment groups (remdesivir, 135 [33%] of 406 vs. control, 130 [31%] of 418; p=0·48).

Moreover, the investigator associated remdesivir to three deaths involving acute respiratory syndrome, bacterial infection, and hepatorenal syndrome. The sponsor’s safety team acknowledged only one of the deaths associated with hepatorenal syndrome.

INSERM

With approximately 13,000 scientists, including 5,100 permanent research staff, INSERM is the only public research institution solely focused on human health and medical research in France. The public institution operates with a scientific vocation under the dual auspices of the Ministry of Health and the Ministry of Research. Similar to the American NIH, INSERM sponsored research from translational to late state clinical trials via 339 research units.

Study Funding

This study was funded by a group of prominent governments and organizations, including:

· European Union Commission

· French Ministry of Health

· Domaine d’intérêt majeur One Health Île-de-France

· REACTing

· Fonds Erasme-COVID-Université Libre de Bruxelle

· Belgian Health Care Knowledge Centre

· Austrian Group Medical Tumor

· European Regional Development Fund

· Portugal Ministry of Health

· Portugal Agency for Clinical Research and Biomedical Innovation

Lead Research/Investigator

Prof. Florence Ader, MD, Corresponding Author, département des Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France

Legiopath, Université Claude Bernard Lyon 1, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, Lyon, France

Call to Action: Follow the link to read the study at The Lancet Infectious Diseases.

Spectrum Health’s Vaccine Mandate now Excludes Those who can Prove Natural Immunity

Spectrum Health’s Vaccine Mandate now Excludes Those who can Prove Natural Immunity

In a similar move seen by many hospital systems and administrations, Spectrum Health announced a COVID-19 vaccine mandate for all employees in July.

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In a similar move seen by many hospital systems and administrations, Spectrum Health announced a COVID-19 vaccine mandate for all employees in July. However, unlike many other officials, the health system will now allow exemptions for those with natural immunity to the virus. A few studies indicate the possibility that natural immunity may actually be stronger than vaccine-based immunity, although more study is undoubtedly needed. TrialSite reported that a large HMO in Israel sponsored a study indicating that natural immunity was, in fact, superior to vaccine immunity. A notable Cleveland Clinic observational study involving health care workers also indicated a strong natural immunity associated with COVID-19. However, that prestigious institution recently pointed out that the study focused on subjects before the emergence of the Delta variant. Regardless, numerous factors are relevant for this complex topic. More study is required for a broader systematic understanding of COVID-19 natural immunity versus vaccine-based immunity. The topic becomes more top-of-mind now as some hospitals are introducing the natural immunity exemption. This suggests natural immunity may emerge as a prominent discussion in the broader vaccination policy context.

TrialSite provides a brief overview of this topic reported by several local media in the Midwest, including WWZM13, Grand Rapids, Michigan.

What are the details of exemption?

Employees with a positive PCR or antigen test from a CLIA-certified lab, plus a positive qualitative antibody test within the past three months, are allowed an exemption.

How did they justify this decision?

The medical exemptions for the mandate are determined by a committee of clinical vaccine and infectious disease experts.

Does this exemption follow FDA guidelines?

Spectrum says their decisions are consistent with the FDA and available research.

What do Spectrum Health officials say about a vaccine?

Hospital officials stated they still recommend a vaccine for everyone, even those with prior COVID-19 infection. Although, they say new research shows that a natural infection affords protection from reinfection and severe symptoms for a period of time. It is not known how long natural immunity remains effective.

“Vaccine trials and real-world data have shown that it is safe for previously infected individuals to receive the COVID-19 vaccine; side effects following vaccination were no greater in this group,” said the hospital system in a statement.

Could this mandate and exemption change in the future?

Officials say if further research shows a significant waning of protection, longer-lasting protection, or proof of full immunity, their requirements will be updated as they see fit.

Philippines President: Doctors & Patients Have A Right to Use Ivermectin Off-Label to Target COVID-19

Philippines President: Doctors & Patients Have A Right to Use Ivermectin Off-Label to Target COVID-19

Recently the Philippines News Agency reported on President Roberto Duterte’s move, possibly to the chagrin of the World Health Organization (WHO), to

trialsitenews.com

Philippines President: Doctors & Patients Have A Right to Use Ivermectin Off-Label to Target COVID-19

Recently the Philippines News Agency reported on President Roberto Duterte’s move, possibly to the chagrin of the World Health Organization (WHO), to leave the determination of what approved, off-label drugs to use with physicians and their consenting patients—the way it used to work in the United States. In this case, a presidential edict declared that this right is applicable to ivermectin as an off-label treatment for COVID-19. President Duterte’s remarks were pre-recorded in a major speech delivered to the Philippines population.

Duterte has a reputation as a strong-armed nationalist, hostility to the West aside; the Philippines president declared the use of ivermectin was a “good gamble” for those physicians and their consenting patients seeking a treatment targeting COVID-19.

Reporting for the government’s official news agency, Ruth Abbey Gita-Carlos wrote on the mounting tension in the country between most medical authorities that demand the drug only be used in a clinical trial and large numbers in civil society that have followed the dozens of clinical trials, primarily in low- and middle-income countries (LMICs). The reporter included a quote from Duterte, declaring, “I leave it really to the doctor-patient relationship. If the doctor believes in good faith that it can help, and the patient also believes in his heart that he will get well, we leave it up to you to decide.”

Duterte said he could not ignore the claims that ivermectin is effective in treating Covid-19 patients.

“Kasi mahirap naman masisi na kung totoo talagang effective tapos pipigilan mo with the testimony bound, plus ‘yung maraming taong nagsabi na gumaling sila (So, it’s hard to be blamed if it’s really effective and you will stop them despite testimonies and claims of some that they recovered [because of Ivermectin]. So for some people, it would be quite a good gamble to embark on,” he said.

Different Reality

Now travel over to Australia and discover that the nation’s drug regulator, the Therapeutic Goods Administration (TGA), has all but banned any off-label prescribing for general practitioners (GPs). This undoubtedly makes it extremely difficult for specialists to get a hold of the drug for any reason remotely close to COVID-19.

Meanwhile, a similar theme emerges in the United States. Recently, the powerful licensing boards have warned physicians their licenses will be yanked (and thus their livelihood) if they put forth any “misinformation.” Who determines the definition of misinformation increasingly points to a tripartite of a politicized executive branch, elites in academia, and the licensing boards themselves, perhaps with a whisper from the industry lobby.

Back in the Philippines, while their Food and Drug Administration allows for compassionate use, the Department of Science and Technology (DOST) has been planning for months to launch a clinical trial testing ivermectin. According to the official government media, the plan is to launch the eight-month study this month.

Major ICMR Study of Indian Healthcare Workers Reveals COVID-19 Vaccine Antibodies Wane within 2 Months for Covaxin & 3 Months for Covishield (AstraZeneca)

Major ICMR Study of Indian Healthcare Workers Reveals COVID-19 Vaccine Antibodies Wane within 2 Months for Covaxin & 3 Months for Covishield (AstraZeneca)

In what could be considered problematic implications for COVID-19 vaccination in India, a recent study involving 614 Indian health workers found a

trialsitenews.com

In what could be considered problematic implications for COVID-19 vaccination in India, a recent study involving 614 Indian health workers found a “significant” drop in the study participant’s COVID-19-fighting antibodies within a couple of months of the second dose in the case of the COVID-19 vaccine product Covaxin. Of course, more data is needed for a better understanding of these results, but such an outcome may indicate a need for a booster program in the world’s second-most populous nation. Led by the prestigious Indian Council of Medical Research (ICMR)—Regional Medical Research Centre, Bhubaneswar, a state-run research institute and apex trial site organization, the findings don’t necessarily indicate that all vaccinated subjects lose their immune resistance, as memory cells may still be at work suggested Sanghamitra Pati in discussion with Reuters. However, the study findings suggest that those participants that received India’s first “indigenous” vaccine called Covaxin produced significantly less antibodies by the second month after the second jab, while with the Covishield vaccine (Oxford/AstraZeneca), antibodies materially dissipate by month number four. Emerging evidence suggests antibodies are important for not only blocking infection but also preventing transmission, while T cells may be highly relevant for preventing advanced disease and death.

While research in the West, such as the United States and Britain, also indicates waning protection associated with advanced mRNA vaccines such as Pfizer-BioNTech (Comirnaty) and Moderna (mRNA-1273), the new Indian-based research results raise serious questions. The ICMR-RMRC-Bhubaneswar study results are uploaded on the preprint server Research Square.

The Vaccines

Generally, vaccines are considered effective with a rate of ≥50% with a >30% lower limit of the 95% confidence interval, according to a study authored by the Organization Solidarity Trial Expert Group. Of course, vaccine efficacy, closely related to effectiveness, does wane over time in all cases, as declared recently by Australian researchers.

The latest ICMR-sponsored study investigated “India’s first indigenous COVID-19 vaccine” known as “Covaxin,” developed by Bharat Biotech, as well as Covishield, the vaccine originally developed at the University of Oxford (ChAdOx1 nCoV-19). The latter vaccine was licensed from the university to AstraZeneca—thereafter, the British pharmaceutical company inked a co-development, production, and distribution deal with the Serum Institute of India (SII), the largest vaccine producer in the world as measured by volume of output.

What follows is a brief introduction to the COVID-19 vaccine.

Covaxin—India’s first ‘Indigenous’ COVID-19 Vaccine

Produced in Bharat Biotech’s BSL-3 high containment facility, Covaxin was developed using whole-virion inactivated Vero Cell-derived platform technology reports the maker. This class of vaccine doesn’t replicate and hence according to Bharat Biotech, is “unlikely to revert and cause pathological effects.” This particular class of COVID-19 vaccine contains a dead virus incapable of infecting people; however, the product can trigger the immune system to mount some defense against SARS-CoV-2.

TrialSite has reported on some controversy associated with this vaccine candidate, including what some critics have called a rushed approval to purported ethical breaches identified at a trial site in Bhopal associated with the clinical trials program.

Bharat Biotech disclosed their vaccine was 64% (95% CI, 29-82%) effective against asymptomatic cases, 78% (65-86%) effective against symptomatic cases, 93% (57-100%) effective against severe COVID-19 infection, and 65% (33-83%) effective against the Delta variant as reported by the COVAXIN Study Group.

Covishield—the Oxford/AstraZeneca Vaccine

SII inked a deal with AstraZeneca to co-develop, produce, and distribute the “Oxford” vaccine known originally as ChAdOx1 nCoV-19 (AZD1222), developed from a virus (ChAdOx1), a weakened version of what is the common cold virus known as the adenovirus. The Oxford team added genetic material to produce the Spike glycoprotein (S).

With mixed results, many nations have adopted this vaccine due to its overall economy and practicality—studies disclosed the candidate was 76% effective at preventing symptomatic COVID-19 starting at 22 days following the first dose and 81% after the second jab. A study in Scotland demonstrated an 81% effective rate against the Alpha variant (B.1.1.7) and 61% against the Delta variant (B.1.617.2).

This vaccine, while representing enormous promise, triggered enough adverse effects that numerous counties have suspended its use. Although statistically considered rare, nonetheless, from South Africa to numerous nations in Europe stopped the use of this vaccine. The United States never completed Phase 3 clinical trials.

ICMR Study

The recent study was led by the government-financed Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination, and promotion of biomedical research and one of the oldest and largest medical research institutes in the world. ICMR, Bhubaneswar led the investigation into two vaccines in India, including Covaxin and Covishield.

Published in Research Square, the study results are still not reviewed and, consequently, cannot be declared as any evidence.

The study team sought to investigate the “dynamicity of vaccine-induced IgG antibodies against SARS-CoV-2. A 614-patient cross-sectional cohort study, the team investigated IgG antibodies among healthcare workers with a completed dose of either Covaxin or Covishield by monitoring the subjects for 24 weeks after the first dose of either vaccine to document periodic changes in titer, concentration, clinical growth, and persistence of vaccine-induced SARS-CoV-2 antibodies.

Among the 614 study subjects, 308 (50.2%) received Covishield, while 306 (49.8%) took Covaxin.

Results

The study team collected serum samples from the 614 participants during established monitoring schedules while testing them in two CLIA-based platforms for testing SARS-CoV-2 antibodies both qualitatively and quantitatively.

The ICMR-led investigators discovered 81 breakthrough cases (13%) among cohort participants for whom infection served as a form of booster. Of the total study subject count, 257 of the participants had actually been infected with SARS-CoV-2 prior to the study.

The study team found that in the remaining 533 health care workers without any history of post-vaccination infection, a significant waning of antibody in both vaccines–by month two in Covaxin and month three in Covishield.

For example, the authors reported “a significant decline of antibody post 2 months and 4 months among Covaxin and Covishield recipients after two doses of BBV-152 and AZD1222 vaccines.”

The production of vaccine-induced IgG antibodies was found to be notability higher in Covishield as compared to Covaxin. In seronegative individuals, upon 28 days of the first jab, the rate of seroconversion was 81.9% for Covishield and 16.1% for Covaxin.

Discussion

Overall, the vaccines appear to be helpful in reducing more severe infection and hospitalization, although some of the breakthrough infections led to hospitalization for lower respiratory infection, reported Sumita Behera, Assistant Professor of Transfusion Medicine at MKCG. However, none of these subjects required a ventilator.

However, rapid decline of the subject’s antibody production—in just two months for Covaxin and three for Covishield—could be deemed problematic. On the other hand, ICM-RMRC investigator Dr. Debdutta Bhattacharya suggested that just because antibody production wanes within a couple of months doesn’t mean that the subject is vulnerable to infection, declaring, “Memory cells develop due to natural immunity after the infection and vaccine-based immunity and these protect the body against the virus.”

Dr. Behera advocates for a booster dose based on the study data declaring to Indian media Odishabytes, “It’s difficult to say how long the memory cells will provide the needed protection.”

Meanwhile, ICMR-Regional Medical Research Centre, Bhubaneswar’s Sanghamitra Patti, revealed to all Indian media that the study will include a follow-up after six months, with plans to continue the study. Dr. Patti informed Reuters that “After six months, we should be able to tell you more clearly whether and when a booster would be needed.”

The Trial Site Hub

ICMR’s Regional Medical Research Centre, Bhubaneswar, was established in 1981 to focus on investigation into locally prevailing communicable and non-communicable diseases, tribal health, and malnutrition in Odisha and neighboring states. Dr. Pati serves as the present-day director.

Lead Research/Investigator

Debdutta Bhattacharya, ICMR Regional Medical Centre, Bhubaneswar

Sanghamitra Pati, ICMR Regional Medical Centre, Bhubaneswar

In Dr. Pati’s own words, he is a “physician turned laboratory epidemiologist and public health researcher.

Call to Action: The study team suggests these findings indicate the need for a larger cohort study which would help to define correlates of protection to determine whether there is a need to produce modified vaccines or booster doses. Note that the authors shared that this study includes a follow-up plan for two years which will further help in understanding the kinetics model and also to provide a better estimate of the antibody response in both seropositive and seronegative individuals over a significant period.

Persistence of antibodies against Spike glycoprotein of SARS-CoV-2 in health care workers post double dose of BBV-152 and AZD1222 vaccines

Research Square is a preprint platform that makes research communication faster, fairer, and more useful.

www.researchsquare.com

US approaching Delta wave peak but Covid-19 virus expected to become endemic

US approaching Delta wave peak but Covid-19 virus expected to become endemic

Experts warn against complacency and expect the virus will be part of everyday life for years to come.. Read more at straitstimes.com.

www.straitstimes.com

WASHINGTON (AFP) - The latest coronavirus wave in the United States driven by the Delta variant could soon peak, but experts warn against complacency and expect the virus will be part of everyday life for years to come.

The seven-day-average of daily cases as of Monday (Sept 13) was 172,000, its highest level of this surge even as the growth rate is slowing and cases are headed down in most states, according to data compiled by the Covid Act Now tracker.

But more than 1,800 people are still dying a day, and over 100,000 remain hospitalised with severe Covid-19 - a grim reminder of the challenges authorities have faced in getting enough Americans vaccinated in the face of misinformation and a polarised political climate.

Bhakti Hansoti, an associate professor in emergency medicine at John Hopkins University and expert in Covid-19 critical care told AFP she saw the US following a similar trajectory to India.

Countries in western Europe have also seen similar downturns in their Delta surges.

But while Hansoti breathed a sigh of relief when the spring wave ended, "I'm a little hesitant this time around," she admitted.

The possible emergence of newer variants of concern and the advent of colder weather leading to more socialization indoors could lead to a rebound, "unless we learn from the lessons of the fourth wave."

Angela Rasmussen, a virologist at University of Saskatchewan in Canada, added she was not certain the fourth wave was over.

"If you look at the fall-winter wave, there were periods in which there was a steep exponential increase, and then it looked like it was falling - and then there would be another increase." To ensure gains are sustained, rapidly increasing the number of people vaccinated is vital. Currently 63.1 percent of the eligible population over-12 are fully vaccinated, or 54 per cent of the total population.

This places the United States well behind global leaders like Portugal and the UAE (81 and 79 percent fully vaccinated), despite its abundance of shots.

The administration of President Joe Biden last week announced a number of new measures to ramp up the immunization campaign, including new vaccine requirements on companies of over 100 employees, but the impact is yet to be clearly seen.

Two Americas

Beyond vaccinations, experts want to see other interventions continue.

Thomas Tsai, a surgeon and health policy researcher at Harvard, said hotspots need to follow through on masking, adding that the US should also look to other countries that have adopted widespread rapid testing for schools and businesses.

Such tests are available either for free or at a very nominal cost in Germany, Britain and Canada but remain around US$25 (S$33.60) for a two-pack in the US, despite the Biden administration's efforts to drive costs down through a deal with retailers.

Of course, the impact of all measures depends on their uptake, and in this regard, a clear and consistent pattern has emerged of two Americas: liberal-leaning regions are far more compliant than conservative.

Prior to the Delta wave, some experts declared that, between the percent of people vaccinated and those who had gained immunity through natural infection, the country was approaching the point of herd immunity.

Rasmussen said those predictions had proven incorrect and it remained too early to say when this threshold would be reached.

"There are still parts of the country where the adult vaccination rate is less than 50 percent," she noted.

Going endemic

Though Delta has out-competed all previous variants and is currently dominant, SARS-CoV-2 continues to evolve rapidly and virologists fear that more dangerous variants might emerge.

"I don't want to be a doomsayer, but I also want to have some humility, because I don't think we know a lot about the basic function of many of these mutations," said Rasmussen.

Still, experts are hopeful that vaccines will continue to blunt the worst outcomes for most people and look forward to their authorisation in children under-12 in the months to come.

It's expected that certain populations like the elderly and those with weakened immune systems may need boosters as well as high community vaccination rates to protect them.

Rather than eradication, the goal has shifted toward taming the virus for vaccinated people such that in rare cases of breakthrough infections, the disease is more flu-like.

However, uncertainties remain: for instance, people with breakthrough Covid infections might still get long Covid.

Greg Poland, an infectious diseases expert at Mayo Clinic, predicted humanity would be dealing with Covid "well past the lifespan of the next many generations." "We are still immunising against aspects of the 1918 influenza virus," he said.