The Playground

  • External Content www.youtube.com
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

  • Check BP as this starts again. To avoid a stroke.


    External Content www.youtube.com
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

  • Something to think about.

    External Content youtu.be
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

  • Breakthrough Infections and the Risk for Elderly People & The Prognosis: Perpetual Boosters?


    Breakthrough Infections and the Risk for Elderly People & The Prognosis: Perpetual Boosters?
    Since the start of the pandemic, it was known that those over 65 were at greater risk of hospitalization and death due to COVID-19. After the vaccines
    trialsitenews.com



    Since the start of the pandemic, it was known that those over 65 were at greater risk of hospitalization and death due to COVID-19. After the vaccines were introduced, it was believed that this risk decreased significantly. However, new data suggests that age still constitutes a greater risk of breakthrough infection.


    Johns Hopkins Medicine explains that breakthrough infection is “…an infection with a virus, bacterium or other germs after you have been vaccinated”. The emerging concern about breakthrough infections was exacerbated by the situation in Singapore; on October 10, TrialSite reported that COVID-19 vaccination failed in Singapore even though the country was a pioneer with the restrictions it applied and high rates of vaccination.


    Recent data from Singapore shows that the country had a record in new COVID-19 cases in a day with 5,300 cases on October 27, 2021. Now, as of November, the number of new cases continues to stay around 3,000. The number of deaths also hit a record with 18 deaths on November 16, 2021. 31% of the deaths are breakthrough cases, and these mostly aged 60 or older.


    Singapore is not the only country showing this increment in breakthrough cases. US, UK, South Korea, the Netherlands, and Germany are experiencing similar new waves of infections after the introduction of vaccines. Data shows that the bigger portion of the affected population comprises the elderly. Just recently we reported on 100% vaccinated Gibraltar and that British territory’s skyrocketing SARS-CoV-2 case count.


    In the United States, the Centers for Disease Control and Prevention (CDC) reports that as of October 18, there were 41,100 patients with a breakthrough infection. 10,900 of these infections have resulted in death and 30,300 have resulted in hospitalization, a number which also includes deaths. 85% of the deaths and 66% of hospitalizations were among those 65 years and older.


    CDC has not updated its overall breakthrough data since October. However, different states in the US have published their own data. On November 6, 2021, Oregon reported that the breakthrough cases are 29% of the total cases. In Vermont, the state with the highest vaccination rate, the breakthrough infections among the vaccinated is 31%.


    The data from different states suggest that the efficiency of vaccines across America is waning and the breakthrough infections are more commonly seen in people who are 65 and older and those who got vaccinated first.


    Breakthrough infections are also occurring in the United Kingdom (UK). As of November 19, 2021, 80.1% of the UK population has received two doses of vaccine and 24.1% of the population had the booster shot. However, breakthrough infections are also seen in the UK at noticeable rates, although rates of hospitalization and death are increasing less rapidly.


    South Korea also experienced a sharp increase in cases after vaccination. The country reported a record in severe cases that increased from 300 to 460 on November 10. They also reported that 82% of the severe cases are aged 60 and older. The country has urged the public to get the booster shot. The rate of breakthrough infections in South Korea is 85.5 people in every 100,000 vaccinated.


    The Netherlands is experiencing another wave of COVID-19 infections. The increase in infections is so high that the government reintroduced face masks at the beginning of November. It was not enough to slow down the spread, and they are planning to bring in a partial curfew. 23% of cases are individuals who have at least one dose of vaccine. In the Netherlands, RIVM reported that of 100 vaccinated people admitted to the hospital in October, 82 people were 70 and older.


    Germany also had a record in the number of people who tested positive in a day in November. With a 67% vaccination rate, the country is still behind other countries. The government is bringing new measures against unvaccinated people.


    COVID-Related Factors Behind Breakthrough Infections

    Lisa Maragakis, MD, MPH senior director of infection prevention at Johns Hopkins Health System, and Gabor David Kelen, MD director at the department of emergency medicine at Johns Hopkins Medicine, explain that since the spread of the Delta variant, breakthrough infections are getting more common. Although vaccines protect the body in case of a severe infection, they are not very effective in terms of preventing the infection. This is also commonly reported by the countries with increasing numbers. And it is for this reason that many vaccinated people end up transmitting the virus to others.


    The Delta variant is a strong variant that causes more infections and fights more against our body’s immune response. Jill Foster, MD a pediatric infectious disease physician at the University of Minnesota Medical School explains that the Delta variant is quite different from the virus the vaccines were produced to fight, and the body needs a much higher number of antibodies to fight the variant.


    Age-Related Factors Behind Breakthrough Infections

    The data on breakthrough infections suggests that age continues to be an important risk factor for hospitalization and death due to COVID-19, regardless of vaccination status.


    Age affects the immune response to vaccines. Because of the aging immune system, both the production and quality of t-cells decrease in the elderly therefore their immune system’s response to vaccines is lighter compared to younger people. For example, one in three people who are 70 or older does not respond to flu vaccines. For the COVID-19 vaccines, the situation is different and the mRNA vaccines are more effective than expected.


    However, TrialSite has reported that the effectiveness of the Pfizer-BioNTech vaccine is dropping from 86.9% to 43.3%, Moderna from 89.2% to 58%, and Janssen from 86.4% to 13%. Even before the Delta variant, we knew that effectiveness dropped to 78% after 6 months. This point of view is backed now by several studies although undoubtedly more data is needed for a more accurate depiction of vaccine durability.


    When the Delta variant came into the picture, the effectiveness of vaccines dropped to 64%. In people aged 60 and over, the effectiveness of vaccines against the Delta variant drops dramatically after 4.8 months.


    Another risk factor for elderly people is that they generally have one or more chronic medical condition that will worsen the course of the infection. In the US, 71% of the breakthrough cases had three or more chronic conditions such as autoimmune or heart disease. Even after vaccination, having a chronic disorder remains a risk factor for COVID-19.


    Health Authorities Say Getting Vaccinated Still Is the Best Option

    A recent study from Kaiser Permanente Research has found that vaccinated individuals have a lower death risk compared to unvaccinated individuals. Deepta Bhattacharya, an immunologist at the University of Arizona, William Petri, PhD, MD an immunologist at the University of Virginia, and Eric Verdin, MD president, and chief executive officer of the Buck Institute for Research on Aging, explain that if the vaccines weren’t in place, infection, hospitalization, and death rates amongst the elderly would be much higher.


    Much of the data to strengthen the case for vaccination is based on hospitalization and deaths showing a less sharp curve, even with increasing numbers, since the introduction of vaccination. However, COVID cases after the Delta variant show a sharp decrease after it reaches its peak, as has been seen in India and UK.


    Some experts declare we still do not know why this steep decline occurs, but the evidence suggests that immunity after infection by the Delta variant decreases reinfection by 80.5 to 100%. Another study from Israel found that the immunity gained from natural COVID infection is 13 times stronger than the immunity gained from the Pfizer-BioNTech vaccine.


    Based on the data available, the high risks of COVID-19 continues for the older age group, despite vaccination. Even though the exact reasons for this are still unknown, health authorities are prioritizing people in that age group for booster shots. The US has introduced the booster dose for a wide array of situation. In an interview with the BBC, Dr. Priscilla Hanudel, an emergency doctor from Los Angeles, said, “I think it’s going to look similar to the flu shot once a year, whether that’s a booster or just another annual shot, I think it’s going to happen forever for everyone eventually.”TrialSite will continue to monitor the real-world data on vaccine efficacy, as well as the recommendations for at-risk groups

  • VACCINES HAVE FAILED. IT’S TIME FOR THERAPEUTICS


    VACCINES HAVE FAILED. IT’S TIME FOR THERAPEUTICS
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Have biopharmaceutical companies
    trialsitenews.com

    .


    Have biopharmaceutical companies gone too far? As part of the $144 million publicly financed KidCOVE trial, Moderna evaluates its vaccine known as mRNA-1273 (Spikevax) on children as young as 6 months old while some trial sites report that 4 out of 5 of the young participants come from underrepresented/underserved communities (e.g. ethnic minorities, babies from poor households, etc.) This kind of data point troubles this author’s mind but so does the fact that our public health strategy needs to expeditiously pivo to therapeutic treatment.


    The Devil is in the Assumptions

    This author argues that there is little to no chance of achieving herd immunity if 100% of Americans including children are immunized with the current crop of early-stage vaccines. Underlying the dominant public health narrative today is the assumption that immunizing children will lead to herd immunity for everyone. That is because children (and the remaining unvaxxed holdouts are deemed the last reservoir of the pathogen). But assuming this vaccine is still experimental—which it is—is it ethical to use children as subjects in experiments to improve the health of adults?


    Some argue whether there is more risk to children from the vaccines than from COVID. We know that the actual vaccine used in kidCOVE now is on the radar of several European nations that have halted or temporarily paused use of mRNA-1273 in young people. For example, all nations in Scandinavia have either put the vaccine’s use on people under 30 on hold pending more safety data. This is the case in Denmark, Sweden, Norway, Finland, and Iceland.


    Treatment for At-Risk Children

    Most problems in children who died of the illness have arisen with those at risk. Those children could potentially be treated early with Regeneron or other monoclonal antibodies and fluvoxamine and soon with molnupiravir or Paxlovid. Based on data from the Together trial it is probable that a course of fluvoxamine would benefit all children to prevent long COVID and possibly multisystem inflammatory illness. Mast cell therapies may help as well.


    Why Our Approach Feels Wrong

    This author challenges the underlying premise that children represent the last major reservoir for SARS-CoV-2, the virus behind COVID-19. This challenge then applies to the premise underlying the declaration that children are thus “super spreaders.”


    Sweden, a Scandinavian nation with 10.3 million people, did things a little differently. With 1.1 million cases they report 15,078 deaths according to Worldometer. The ratio of deaths per population is nearly double in America than that of Sweden.


    Yet in Sweden, children went to school with no masks, no social distancing, no vaccines, and no drugs. They had no deaths and teachers were infected less than the general population. Is Sweden smarter? They have similar vaccination rates to us. They have 65% of the overall mortality rate of the USA but could it be because they allowed low risk people to get infected and develop natural immunity, at present their infection and mortality rates are less than a third of the United States? I fear that next the FDA will approve vaccines for 6-month-olds. Does this cross a line? Or am I just not seeing some bigger picture?


    In my opinion, these vaccines have failed their initially intended purpose. Leaky Vaccines and virus spread.


    As the pandemic ultimately moves into the “endemic” stage so will American society (and its medical establishment) move to rid itself of these vaccines while wholly embracing therapeutics. My argument: this will result in a country with natural immunity instead of a country with vaccine-induced immunity and high levels of infection.


    Mass Vaccination vs. Comprehensive Treatment

    The strategy of vaccinating everyone with these vaccines to prevent COVID looks less effective than a single IM injection of Astra Zeneca’s long-acting antibody, AZD 7442, which at 6 months had an 83% decrease in infections and no serious infections. The cost to treat everyone would probably be prohibitive. It is unlikely the government would approve it for everyone. They only have 6-months worth of data.


    There will be a significant fee-for-service market for people who don’t trust vaccines and don’t want to rely on medications to treat them if they get infected. The effectiveness of ivermectin 0.4 mg/kg twice a week for prophylaxis needs to be studied. Studying those who decline the vaccines seems ideal. Unfortunately, because ivermectin is vastly overpriced in the USA at present, it would run about $72 a week for a 60 kg person. Long-term safety has not been proven.


    This author posits that a reasonable strategy would be to treat people when they get infected. We need solid therapeutics available. Presently, three decent repurposed drugs are available. Fluvoxamine didn’t have enough data until Together led by Dr. Ed Mills, was reported 8/6/21 but there was plenty of reason for NIH to sponsor a large trial of ivermectin a year ago due to any number of data points including the impressive and proactive public health model in India’s Uttar Pradesh. Dr. Pierre Kory and the FLCCC testified to the Senate in December of last year.


    Additionally, five articles implicating the value of famotidine and data from two researchers suggest mast cell patients on H1 and H2 blockers fail to succumb to severe COVID illness yet for many months the government chose not to fund large trials of ivermectin or famotidine. If ivermectin and famotidine had been tested and proven safe and effective during the past year there would have been much less morbidity. Since it didn’t happen and neither drug has positive large, randomized trial data, we are left in the dark. This author suggests that the NIH didn’t study these two low-cost, repurposed drugs for two reasons: 1) successful trials would have popularized these approaches. The vaccine rollout would have been much more difficult and 2) Not having repurposed generic drugs to contend with gave drug companies much more incentive to develop new therapeutics. After all, pharmaceutical companies face tremendous risk in developing new therapies and investors demand robust returns, or else.


    The strategy with therapeutics may have deprived Americans of good repurposed drugs for therapy in the past year but incentivized drug companies who have come up with two new potent oral antiviral drugs, Merck’s Molnupiravir, a nucleotide analog, and Pfizer’s protease inhibitor Paxlovid. There is theoretical concern for cancer and birth defects with molnupiravir but Paxlovid looks a little more effective and has no obvious downside.


    Marketing of Therapeutics Underway Already

    Both companies are already marketing their drugs all over the world even though they are not approved yet Merck previously got a 1.2 billion dollar deal with our government. While Pfizer announced they are selling 10 million doses to the US for $5.29 billion and distributing it to 95 poor countries, representing 53% of the world’s population. With about 150,000 new cases a day, it would be enough to treat half the patients in the US for 134 days. Some people aren’t very sick and don’t seek treatment. Some seek treatment late. These drugs work best in the first 5 days when there is a lot of virus around. If every newly diagnosed patient were treated early, a major dent would be put in the pandemic. It is likely that those who decline vaccines would not object to taking an antiviral. With enough government promotion, people could be convinced to get tested and treated quickly. In my opinion, fluvoxamine which has unequivocally positive data and has anti-inflammatory activity should be given with paxlovid or Molnupiravir.


    Yet Why Not Pursue the Others?

    We already have fluvoxamine with a 1497 patient trial in Together with 31% decrease in admissions and mortality. One of the early-on financial supporters of fluvoxamine, technology entrepreneur Steve Kirsch, communicated that no one treated with fluvoxamine gets long COVID. We hope Together is compiling the data. Those who use famotidine and ivermectin report overall positive data points. All of them have reported to have value in already established long COVID but the drugs haven’t been formally tested. Despite this hardly anyone is being treated with fluvoxamine. Molnupiravir and paxlovid are being ordered by many countries and may get EUAs in the US while fluvoxamine hasn’t received little attention.


    What’s the Science behind Famotidine?

    Famotidine, the generic heartburn drug Pepcid, blocks H2 receptors on mast cells. Dr. Lawrence Afrin and others have postulated that mast cell signaling is at least partly responsible for cytokine storm. Dr. Afrin Mast Cells and COVID. He and Dr. Mariana Castells at Harvard have noted that their mast cell patients, all on H1 and H2 blockers never get very sick if they get COVID. 3 retrospective and 2 prospective studies of famotidine showed benefit. In one study, 10 patients were all given an average of 80 mg of famotidine 3 times a day. All were much better in 2 days with modest side effects. That research group will soon be reporting a randomized trial showing a statistical benefit of famotidine 80 mg 3 times a day. A nonrandomized trial of 25 consecutive inpatients, co-authored by Dr. Robert Malone, using famotidine 80 mg 4 times a day plus celecoxib showed significant benefit. 3 large randomized trials are starting.


    Systematic Underdosing or Paranoia?

    The response of governments worldwide to ivermectin has been disappointing, to say the least. The Uttar Pradesh data is ignored or discounted via fact-checkers that actually know little. The randomized trials are picked apart. Therefore, the jury is out until the 4 large, randomized trials are reported. Unfortunately, ivermectin-treated patients got or are getting 20% of the correct dosage in all 4 studies. How can you explain that Together gave patients 0.4 mg/kg for 3 days on an empty stomach when the correct dose for delta is 0.6 mg/kg for 5 days or recovered with food which increases blood levels 2.6 times? On top of that ACTIV-6(NIH), COVID-OUT(U of Minnesota) and PRINCIPLE(Oxford) are giving patients a lower dose of ivermectin than a dose that failed in a previous trial.


    Multiple people involved in ACTIV-6 were notified. It appears there is a very good chance that patients will receive a reasonable dose of ivermectin. They have had over 3 months since the Together study was reported to do something. For 3 months patients have been getting placebo or a dose of ivermectin they know doesn’t work.


    Over two weeks ago 6 editors in chief of important medical journals, the AMA, ACP and IDSA were notified about the ivermectin underdosing. No one wrote anything. Two editors in chief were asked to reach out to Oxford’s PRINCIPLE and University of Minnesota’s COVID-OUT to get a reasonable ivermectin dose used in their trials. If these trials use appropriate ivermectin dosing, ivermectin will have gotten a fair shake. Because of Merck’s conflict of interest with Molnupiravir and their attacks on ivermectin, a brand of ivermectin other than Merck’s stromectol should be used.


    One has to wonder why none of the principal investigators of ACTIV-6, COVID-OUT and PRINCIPLE looked at Together and realized they needed to increase the dose or add an arm with appropriate dosing. Although it could be intentional, it could have been accidental. In Australia, Adjunct Professor Dr. John Skerritt, deputy secretary of the health products regulation group, who has a PhD in Pharmacology stopped GPs from ordering ivermectin 12 mg because he looked on the FDA site and saw that lower doses were used for parasites and feared GPs would poison people. Obviously, an unintentional move. Fortunately, he has been challenged by senator Gerard Rennick of Queensland who noted that doses up to 100 mg have been used safely.


    In less than a year we should have 3 over the counter or generic drugs plus Molnupiravir and Paxlovid for therapy. This doesn’t include H1 blockers, and the many other mast cell stabilizing drugs, quercetin, luteolin, cromolyn etc. Regeneron’s cocktail of monoclonal antibodies (mAbs) cost $2100, require injection and will be less desirable. Some people may choose to pay for AZD 7442, knowing they are very safe for at least 6 months. We don’t know how these drugs stack up against each other and may never know.


    I am concerned that trials of all therapeutic drugs for early COVID in the US will not be able to continue as is. It looks like paxlovid is likely to get an EUA soon. Newly diagnosed patients should be able to get it for free. They will choose not to enroll in randomized trials and risk being randomized to placebo or a less effective product. Trialists will face major ethical issues. Early COVID trials will have to study paxlovid vs. paxlovid plus something else. Fluvoxamine would appear to be the first choice to be added. For patients presenting late, the repurposed drugs will be important.


    A Pragmatic Vision or Fools Dream?

    Moderna developed a delta-specific vaccine, but it has not been adequately tested. ImmunityBio is working on a T cell vaccine. The future of vaccines is very uncertain. Since present vaccines don’t ensure that people won’t get infected or sick, I would think Americans would prefer the “if you get sick, you go to the drugstore and get some medicine” strategy. They would have to be confident that the medicine will shorten their illness, make serious illness extremely unlikely and eliminate long COVID. If Americans knew that they could get free, safe, effective medicine if they got sick and that if they took it early they would be fine, compliance would be high, hospital utilization and death would go way down and herd immunity could be achieved. Fear, which has been promoted heavily by our government healthcare agencies and the media, would drop dramatically and normal life could resume.


    But NIH Swinging for Fences….

    NIH gambled on experimental vaccine technology being a home run when no vaccines for coronaviruses had done very well in animals. Had they succeeded like in measles it would have been a home run but they didn’t. NIH hit a single, which kept the rally going but was not good enough to win against COVID. To effect their strategy they had to not study ivermectin and famotidine which might have been effective. Those drugs may have prevented hundreds of thousands of deaths. We don’t know. If they are subsequently proven to be of great benefit we will know. One has to consider that the FDA’s war against ivermectin is to prevent it from becoming known that it would have worked. Data on famotidine is coming despite our government. Fluvoxamine succeeded by being sponsored by a private citizen. Despite it working well in a large trial, our government ignores it.


    Don’t Count out Pharma

    NIH’s strategy allowed us to give the vaccines a fair shot. They just aren’t good enough in this author’s opinion. While they appear to reduce death and hospitalization the long-term prospect is uncertain for them. Perhaps they offered Pharma time to develop therapeutics? The drug companies came through. The combination of drug company therapies plus repurposed drugs should allow us to win against COVID in the long run. It might also give us time to go back to the drawing board and develop the kind of vaccines we really need. NIH will say the vaccines prevented many deaths and a lot more people would have died in the long run if the antivirals had not been developed. We don’t know what would have happened had famotidine, ivermectin, and fluvoxamine been rushed through like the vaccines were. If they had been rushed through and controlled the pandemic, the drug companies probably wouldn’t have developed the antivirals but then we may not have needed them.


    At this point, the government knows vaccines long-term are not the answer and have embraced drug company therapeutics which look quite promising. The government spending billions on them isn’t such a big deal if they work and are safe. If the government can get most infected people to take the drugs very early, they will wind up with little serious illness, a lot of natural immunity, little, long COVID and a good shot at “herd immunity”. The caseload will drop dramatically in the US and government expenditures will eventually be modest. The benefit to the economy and the wellbeing of Americans—and others around the world–cannot be overstated.


    A major risk is the virus developing resistance to the antivirals as happened with multiple AIDS drugs. Whether people should be treated with both antivirals to lessen resistance is unclear. The repurposed drugs which are mainly about mast cells and inflammation are very unlikely to be affected by viral mutations. Therefore, we must continue to study repurposed drugs which should add to the effectiveness of antivirals, are necessary for those not treated early, will be needed if resistance develops to the antivirals and will be crucial in the places around the world where the new drugs won’t be available.


    Michael B. Goodkin MD, FACC

  • CDC & Bureau of Prisons Bombshell Study: COVID-19 Vaccinated Just as Infectious as Unvaccinated


    CDC & Bureau of Prisons Bombshell Study: COVID-19 Vaccinated Just as Infectious as Unvaccinated
    Scientists and health researchers with the U.S. Centers for Disease Control and Prevention (CDC) and the Bureau of Prisons, U.S Department of Justice,
    trialsitenews.com


    Scientists and health researchers with the U.S. Centers for Disease Control and Prevention (CDC) and the Bureau of Prisons, U.S Department of Justice, recently concluded a study, posting the results on the preprint server medRxiv. Funded by the CDC, the study investigators probed the extent to which vaccinated persons who become infected with COVID-19, so-called breakthrough infections, contribute to transmission. The federally employed investigators sought to better understand transmission among highly vaccinated federal prison inmates during a Delta-variant-driven surge. What were the markers of viral shedding in vaccinated and unvaccinated prisoners? After this federally funded study, it becomes clearer that vaccinated persons remain just as contagious as unvaccinated persons should breakthrough infections be relevant.


    The Study

    The study team secured informed consent of participating incarcerated participants with confirmed COVID-19 infection who provided mid-turbinate nasal specimens daily for ten (10) consecutive days while reporting symptoms via questionnaire.


    The study team tested 978 samples (derived from 95 participants) with real-time reverse transcription-polymerase chain reaction (RT-PCR), viral whole-genome sequencing and viral culture. The investigators analyzed duration of participant RT-PCR positivity and viral culture positivity using survival analysis.


    Results

    Of the 95 participants leading to 978 specimens, 78 (82%) were fully vaccinated and 17 (18%) were not fully vaccinated. The study team detected no significant differences in duration of RT-PCR positivity among fully vaccinated participants (median:13 days) versus those not fully vaccinated (median 13: days; p = 0.50), or in the duration of sample culture positivity (medians: 5 days and 5 days; p = 0.29).


    The authors report that the overall duration of sample culture positivity was shorter with the Moderna vaccine recipients versus Pfizer (p=0.048) or Janssen (p=0.003) vaccine residents.


    Conclusion: A Possible Bombshell

    Individuals who are vaccinated and become infected via breakthrough infection with SARS-CoV-2 are no less infectious than unvaccinated persons. TrialSite suggests these findings build on the case that the vaccinated, if infected via breakthrough infection—which occurs with more frequency, are just as contagious as unvaccinated people. The federal government researchers know this and thus declare health agencies “should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons. These findings are critically important, especially in congregate settings where viral transmission can lead to large outbreaks.”


    Obviously, this study isn’t yet peer reviewed and cannot be used as evidence but it most certainly represents a major data point for further study.


    Lead Research/Investigator

    Liesl M. Hagan, MPH, Epidemiologist, CDC (corresponding author)


    Other authors can be viewed at the source.


    Transmission potential of vaccinated and unvaccinated persons infected with the SARS-CoV-2 Delta variant in a federal prison, July-August 2021


    Transmission potential of vaccinated and unvaccinated persons infected with the SARS-CoV-2 Delta variant in a federal prison, July-August 2021
    Background The extent to which vaccinated persons who become infected with SARS-CoV-2 contribute to transmission is unclear. During a SARS-CoV-2 Delta variant…
    www.medrxiv.org

  • Pandemic Will Not End


    Pandemic Will Not End
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Joel S. Hirschhorn Americans may
    trialsitenews.com


    Americans may not be mentally prepared to hear the really bad news. The COVID pandemic is not going to end. What the government is doing (and not doing) will ensure no end to the pandemic.


    Just released is a new forecast of the coming COVID death toll on March 1, 2022. It comes from the group that has been doing the most thorough studies and modeling of the US pandemic. It is the Institute for Health Metrics and Evaluation (IHME), an independent global health research center at the University of Washington. It forecasts a total of one million COVID deaths by that date.


    That means in about 3.5 months there will be another roughly 250,000 COVID deaths. That is over 70,000 deaths a month. That compares to about 65,000 a month since the pandemic began. Does that sound like progress? Does that sound like the mass vaccination effort is the solution?


    Their projection may underestimate what will be happening because “That forecast may be optimistic because we have not yet built into the modeling that we are releasing right now the explicit analysis around waning immunity for vaccine-derived immunity.” And there is now a strong consensus among medical experts that current vaccines lose their effectiveness in about six months. That is why booster shots are now being pushed so hard. An endless pandemic will mean billions of dollars going to big drug companies for vaccines and a new group of expensive pills announced by Merck and Pfizer; the US government is paying $700 for the former and $500 for the later treatment. They want to compete with cheap, established early treatment protocols.


    Here is the crucial point to keep in mind. Current vaccines, including booster shots, do not kill the virus and do not prevent spread of the virus from fully vaccinated people. And the loss of effectiveness, especially for variants like delta, explains why countless more people will get breakthrough infections that are killing some people, like what happened to Colin Powell recently.


    Breakthrough deaths fit into the category of COVID deaths. On November 15 Fauci admitted: “[Vaccinated people] are seeing a waning of immunity not only against infection but hospitalization and death. It’s waning to the point that you’re seeing more people getting breakthrough infections and winding up in the hospital.” And on November 19 the head of the World Health Organization admitted that the pandemic was surging in countries with high vaccination rates, because vaccines do not stop transmission of the virus.


    This is the ultimate truth: We cannot vaccinate our way out of the pandemic. When more reliable data in other countries are considered, compared to awful data from the CDC, we see that very large fractions of people being hospitalized or dying from COVID are fully vaccinated. Booster shots just create the illusion of doing something really effective. Mostly, they just postpone bad health impacts.


    The entire emphasis by our government on vaccines is the biggest mistake in the history of medicine and pandemic management. As many recent analyses have shown, the CDC data are undercounting both adverse health impacts of vaccines and deaths.


    Steve Kirsch has done a good summary analysis of CDC data undercounting. Here are some excerpts:


    “The COVID vaccines are the most dangerous vaccines in human history. They are 800 times more deadly than the smallpox vaccine which was the previous record holder. The vaccines have killed over 150,000 Americans and permanently disabled even more. They don’t make sense for anyone of any age. The younger you are, the worse it gets. For kids, it is estimated that we kill 117 kids for every COVID death we prevent.”


    “So we are ‘saving’ fewer than 10,000 lives at the expense of over 150,000 (vaccine) deaths. In short, we kill 15 people to save 1. That’s incredibly stupid.”


    Full details defining the vaccine dystopia we have entered are available.


    The eminent Dr. Peter McCollough has emphasized: “You are about five times as likely to die of the vaccine than you are to take your risks with COVID-19. Therefore, those who ‘chose not to get the vaccine,’ in fact ‘made a smarter choice.’” Another point made is that those who have recovered from the disease and have natural immunity have a 56% greater chance of severe side-effects should they afterwards take the jab. [Yet a new CDC survey found that 60% of those who have natural immunity said they were also fully vaccinated.] When such a recognized medical expert says these things, the anti-mandate movement receives credibility.


    A recent medical research article said: “A novel best-case scenario cost-benefit analysis showed very conservatively that there are five times the number of deaths attributable to each inoculation vs those attributable to COVID-19 in the most vulnerable 65+ demographic.” It was also noted that several studies: “have shown independently that the deaths following inoculation are not coincidental and are strongly related to inoculation through strong clustering around the time of injection. …Our independent analyses of the VAERS database confirmed these clustering findings.”


    “This virus may never go away,” said Dr. Michael Ryan of the World Health Organization. “I don’t think anyone can predict when or if this disease will disappear,” he said.


    Sarah Zhang has recently made some incisive observations about the never-ending pandemic. Here is what she said:


    “The coronavirus becomes endemic, and we live with it forever. But what we don’t know—and what the U.S. seems to have no coherent plan for—is how we are supposed to get there.” But talking about an endemic just means a constantly maintained level of COVID-19 infections and transmissions. It means living with the pandemic, but just calling it an endemic. It is a poor semantic solution and deceit as long as there are high levels of hospitalizations and deaths for COVID, and as long as there are continuing lockdowns, vaccine mandates and passports, and other disruptions of normal living.


    Here are more words of wisdom:


    “The Delta variant and waning immunity against transmission mean herd immunity may well be impossible even if every single American gets a shot. So when COVID-related restrictions came back with the Delta wave, we no longer had an obvious off-ramp to return to normal—are we still trying to get a certain percentage of people vaccinated? Or are we waiting until all kids are eligible? Or for hospitalizations to fall and stay steady? The path ahead is not just unclear; it’s nonexistent. We are meandering around the woods because we don’t know where to go.”


    “But the level of COVID-19 risk we can live with is also not an entirely scientific question. It is a social and political one that involves balancing both the costs and benefits of restrictions and grappling with genuine pandemic fatigue among the public.”


    “The Delta variant and waning immunity against transmission mean herd immunity may well be impossible even if every single American gets a shot.”


    Accepting the ugly reality that the pandemic will not end is consistent with the findings of a recent medical research article titled “Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States.” The clear meaning is that mass vaccination does not work effectively to eliminate COVID impacts. Here is a main conclusion: “The sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences needs to be re-examined, especially considering the Delta variant and the likelihood of future variants.”


    Indeed, it is clear that a number of countries, including Gibraltar, with high vaccination rates are still fighting serious COVID outbreaks and impacts, including Israel now pushing booster shots. When Israel rolled out boosters in August, they also saw spikes in infections and deaths.


    Should everyone get booster shots? Especially, those with natural immunity from prior infection and vaccine immunity from full vaccination? This is called hybrid immunity. Here is what MedPage Today said:


    “With a COVID-19 booster shot available for a segment of the U.S. population, an emerging group may wonder if they really need it — those with “hybrid immunity.”


    These are the people who are fully vaccinated but have also recovered from a case of COVID-19. Mounting evidence is clear: a bout with the virus does provide extra immunity, making a booster shot helpful but not necessary, experts say.


    If you have hybrid immunity, “I would call yourself a victor,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. ‘Call it a victory and bow out.’”


    Yet many groups seem on the verge of saying that without a booster shot people will not be considered fully vaccinated and booster mandates are being discussed.


    Justin Hart from Rational Ground who digs into CDC data has concluded: “The vaccines — as we always say — can help (perhaps) with severe disease but there’s no evidence they quell the pandemic overall.”


    What the government has failed to do is promote valid alternatives to COVID vaccines. It has not used a flexible policy using personalized medicine principles that would support use of generic medicines to treat and prevent COVID infection. For example, using fluvoxamine that a recent journal article said was effective, as well as ivermectin and hydroxychloroquine. Nor has the government fully recognized and given mandate credit for natural immunity obtained from prior COVID infection, and that considerable data have shown is better than vaccine immunity.


    This should be clear: Vaccine mandates will not end the pandemic. But there is no hint that government leaders are interested in taking a new fresh approach to addressing the pandemic. Hundreds of thousands of people will die unnecessarily in the US and even more globally. More deadly than the virus are feckless government officials.


    Dr. Joel S. Hirschhorn, author of Pandemic Blunder and many articles, podcasts and radio shows on the pandemic, worked on health issues for decades. His work is available on Substack as the Pandemic Blunder Newsletter. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between the colleges of engineering and medicine. As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings. He has served as an executive volunteer at a major hospital for more than 10 years. He is a member of the Association of American Physicians and Surgeons, and America’s Frontline Doctors.


    COVID Vaccine Dystopia: A Manifesto by Dr. Joel S. Hirschhorn | Principia Scientific Intl.
    The views of many distinguished medical experts paint a bleak view of COVID vaccines.
    principia-scientific.com

  • Harvard-Affiliated Study of Healthcare Workers Evidences Robust Natural Immunity


    Harvard-Affiliated Study of Healthcare Workers Evidences Robust Natural Immunity
    A group of Harvard-affiliated researchers monitored both vaccinated and unvaccinated Massachusetts healthcare workers revealing zero infections in 74,557
    trialsitenews.com


    A group of Harvard-affiliated researchers monitored both vaccinated and unvaccinated Massachusetts healthcare workers revealing zero infections in 74,557 person-days for those who were previously infected with SARS-CoV-2 as compared to 49 infections out of 830,084 person-days for fully vaccinated patients. This study provides strong evidence as to the robustness of natural immunity. The healthcare workers that were infected previously appear to have greater immunity—the data suggests they aren’t a threat to transmit the pathogen. This runs contrary to the dominant narrative today that only universal vaccination leads to lower transmission rates. The study hasn’t been peer-reviewed as of yet thus shouldn’t be used for evidence until the findings can be substantiated.


    The study period ran from December 16, 2020, to September 30, 2021, when 4615 healthcare workers contributed a total of 1,152,486 person-days at risk (excluding 309 health care workers with prio6r infection) and had a COVID-19 incidence rate of 5.2/10,000 (114 infections out of 219,842 person-days) for unvaccinated person-days and 0.6/10,000 (49 infections out of 830,084 person-days) for fully vaccinated person-days leading adjusted vaccine effectiveness of 82.3% (95% CI: 75.1-87.4%).


    The team conducted a secondary analysis during the period that the Dela variant was most common from July 1 to September 30, 2021. The study team observed that the adjusted vaccine effectiveness was 76.5% (95% CI: 40.9-90.6%).


    Importantly the study authors report that independently they found absolute no reinfection among those healthcare workers who had prior COVID-19 infections, contributing to 74,557 re-infection-free person days, “adding to the evidence base for the robustness of naturally acquired immunity.”



    Study Population

    As reported in the preprint server, medRxiv a total of 4,615 Healthcare workers participated in this study. The average age was 45.0±13.3 years and female predominance (76.0%)) contributed to 1,152,486 person-days at risk during the study period. Forty-five percent of the study population was non-White (including 20% African American, 13.5% Hispanic, and 9.0% Asian).


    Of all healthcare workers participating, 4,418 (95.7%) had received at least one dose by the end of the study. Among them, 58.3% got Moderna, 39.4% Pfizer, 2.3% J&J/Janssen, and one (0.02%) got mixed doses of J&J/Janssen and Moderna. The results showed that throughout the study period, for fully vaccinated healthcare workers the vaccine effectiveness is 82.3% (95% CI: 75.1–87.4%) after multivariable adjustment.


    Conclusion

    The study authors write that to their knowledge this is “one of the fist in healthcare setings regarding continued vaccine effectiveness during delta variant predominance.” In addition to exposing robust natural immunity the study found vaccine effectiveness of 76% against the delta variant.

    Lead Research/Investigator


    · Fan-Yun Lan, Harvard T.H. Chan School of Public Health


    · Amalia Sidossis, post doctoral research fellow, Harvard T.H. Chan School of Public Health


    · Eirini Llaki, Occupational Medicine, Cambridge Health Alliance, Harvard Medical School


    · Jane Buley, Director of Occupational Health, Cambridge Health Alliance


    · Neetha Nathan, Cambridge Health Alliance


    · Lou Ann Bruno-Murtha, DO, Assistant Professor of Medicine, Cambridge Health Alliance


    · Stefanos N. Kales, MD, MPH Professor Department of Environmental Health, Harvard T.H. Chan School of Public Health


    Call to Action: Recovered healthcare workers appear to have robust natural immunity based on these study results. This would imply that those patients that recover from COVID-19 don’t pass it on—even if not vaccinated. It is not clear what happens to this cohort if subsequently immunized. TrialSite community—what are your thoughts


    Continued Effectiveness of COVID-19 Vaccination among Urban Healthcare Workers during Delta Variant Predominance
    Background Data on COVID-19 vaccine effectiveness (VE) among healthcare workers (HCWs) during periods of delta variant predominance are limited. Methods We…
    www.medrxiv.org


    Abstract

    Background Data on COVID-19 vaccine effectiveness (VE) among healthcare workers (HCWs) during periods of delta variant predominance are limited.


    Methods We followed a population of urban Massachusetts HCWs (45% non-White) subject to epidemiologic surveillance. We accounted for covariates such as demographics and community background infection incidence, as well as information bias regarding COVID-19 diagnosis and vaccination status.


    Results and Discussion During the study period (December 16, 2020 to September 30, 2021), 4615 HCWs contributed to a total of 1,152,486 person-days at risk (excluding 309 HCWs with prior infection) and had a COVID-19 incidence rate of 5.2/10,000 (114 infections out of 219,842 person-days) for unvaccinated person-days and 0.6/10,000 (49 infections out of 830,084 person-days) for fully vaccinated person-days, resulting in an adjusted VE of 82.3% (95% CI: 75.1–87.4%). For the secondary analysis limited to the period of delta variant predominance in Massachusetts (i.e., July 1 to September 30, 2021), we observed an adjusted VE of 76.5% (95% CI: 40.9–90.6%). Independently, we found no re-infection among those with prior COVID-19, contributing to 74,557 re-infection-free person-days, adding to the evidence base for the robustness of naturally acquired immunity.

  • COVID-19 mRNA Vaccines Triggering Problematic Elevation in Endothelial Inflammatory Markers & ACS Risk


    COVID-19 mRNA Vaccines Triggering Problematic Elevation in Endothelial Inflammatory Markers & ACS Risk
    The COVID-19 vaccines have been associated with warnings of heart inflammatory issues such as myocarditis.  In fact, all of the Scandinavian
    trialsitenews.com



    The COVID-19 vaccines have been associated with warnings of heart inflammatory issues such as myocarditis. In fact, all of the Scandinavian countries (Denmark, Sweden, Norway, Finland and Iceland) have paused or halted the use of Moderna to better understand the risks associated with this particular mRNA-based vaccine. In what could represent bombshell data a recent entry in the American Heart Association (AHA) journal Circulation authored by the provocative Dr. Steven R. Gundry connects the COVID-19 mRNA vaccines with endothelial inflammatory markers and ACS risk in a foreboding cautionary assessment. A cardiac surgeon by training, Dr. Gundry left traditional medicine to embrace a healthy lifestyle, nutritional/plant-based diets and the microbiome movement—the health of bacterial flora for example. By using a state-of-the-art diagnostic called PULS Cardiac Test the author sought to clinically verify the measurements of multiple protein biomarkers producing a probability score for new Acute Coronary Syndrome (ACS). What are the concerns of Dr. Gundry and why isn’t this kind of information more prevalent? The answers to this real-world study, based on continuous testing of 566 patients should be further investigated.


    TrialSite offers a summarized and hopefully simplified snapshot of this recent research conducted with the PULS (Protein Unstable Lesion Signature) Test. Produced by GD Biosciences located in Irvine, California the PULS Test measures the most clinically significant protein biomarkers that measure the body’s immune response to arterial injury. Typically, such injuries contribute to the formation and advancement of cardiac lesions, which over time become unstable and consequently rupture. This becomes a cardiac event.


    The Investigator

    Dr. Gundry is no ordinary guy. An author as well as practicing doctor and former cardiac surgeon he has run his own clinic conducting investigations into how lifestyle and diet impact health. An important and noble cause particularly in a world with rapidly growing obesity challenges—and all that follows such a trend. Gundry supports his operations with the sales of various supplements and can be seen on the internet with some of those long infomercials.


    Dr. Gundry runs practices at waitlist-only clinics such as the Center for Restorative Medicine and the International Heart & Lung Institute both in tony Palm Springs and Santa Barbara, CA respectively.


    Monetizing on A Notable Past

    Back in the 1990s Dr. Gundry conducted cardiac surgery research and in fact emerged as a pioneer in infant heart transplant surgery. He became a New York Times best-selling author cranking out books including The Plant Paradox: The Hidden Dangers in “Healthy” Foods That Cause Disease and Weight Gain.


    Gundry has claimed that a particular protein derived from certain plants (lectins) trigger inflammation leading to myriad modern diseases. He introduced the “Plant Paradox diet” precluding lectins yet critics suggest this body of research a “pseudoscience.” For example, some of the healthiest cultures are associated with a lectin rich diet. Gundry has been monetizing his work which opens him up to claims of conflict of interest. Regardless, Gundry’s recent piece in AHA’s Circulation merited review.


    The Test

    PULS is used by cardiologists as it can validate risks in multi-ethnic populations, produce outcome data that demonstrates clinical utility associated with identification of at-risk patients while confirming to various medical industry standards and guidelines.


    Dr. Gundry and team used the PULS to predict the probability of Acute Coronary Syndrome (ACS), any condition caused by a sudden reduction or blockage of blood flow to the heart.


    How is the score derived?

    The test score is based on the delta from a normal baseline score of multiple protein biomarkers, such as:


    Biomarker Brief Overview

    IL-16 A proinflammatory cytokine

    Soluble Fas Inducer of apoptosis

    Hepatocyte Growth Factor (HCG) Marker for chemotaxis of T-cells into epithelium & cardiac tissue, among others

    Once these various biomarkers are aggregated and analyzed the score is applied. The PULS score is elevated if the norm increases while if below a certain baseline it is considered below the norm.


    The Baseline

    This study included a patient population under continuous care for eight years. Dr. Gundry reports that the practice has measured the patient’s scores for every 3 to 6 months for the duration. Over the eight-year period the data has settled into particular patterns.


    Historical Event Leads to Big Change

    By March 2020 the COVID-19 pandemic swept the globe including Dr. Gundry’s practices in Palm Springs and Satna Barbara, California. Gundry and staff observed marked changes in the cardiac biomarker-focused, predictive scores.


    Of course, a big change starting in December 2020 and into 2021 was the first mass vaccination –that is where an entire national population was exposed to a novel mRNA-based vaccine in the middle of a pandemic. With vaccination rates high in California undoubtedly a good percentage of the Gundry practice patient base was vaccinated with either Moderna (mRNA-1273 or Spikevax) or Pfizer-BioNtech (BNT162b2 or Comirnaty).


    The Test Results

    So, what happened before the mass vaccinations in response to the COVID-19 pandemic and after?


    Dr. Gundry’s patient base involved those in an ongoing preventive cardiology practice. As part of that practice, he designed a real-world study to measure before and after vaccination cardiac-focused biomarkers.


    Gundry and staff ran tests on 566 patients split evenly between males and females who ranged in age from 28 to 97 years old. Each patient had a new PULS test conducted from two (2) to ten (10) weeks after the second COVID-19 vaccine shot.


    What did Gundry and team find? See the table for test score results before and after COVID-19 vaccination with either mRNA-1273 or BNT162b2.


    PULS Biomarker Test Results Pre-Post Full COVID Vaccination


    Biomarker Before COVID Vaccine After COVID Vaccine

    Baseline IL-16 35=/120 above the norm 82=/- 75 above the norm

    sFas 22 +/-15 above the norm 46 = /-24 above the norm

    HCG 42+/- 12 above the norm 86 +/-31 above the norm

    In the aggregate Dr. Gundry reports in Circulation that the PULS score increased from 11% 5-year ACS risk to 25% 5-year ACS risk. This means that the probability for a cardiac event has more than doubled due to the vaccination event.


    By the time Gundry and staff authored the study results for the review, the changes in scores persisted for at least 2.5 months after the second jab of the mRNA-based vaccine.


    Conclusion

    Based on the methodical testing of 566 patients at two preventive cardiac care clinics in both Palm Springs and Santa Barbara, California the lead physician in this real-world study came to the conclusion that based on the PULS cardiac test measuring multiple relevant biomarkers a disturbing observation must be shared with the TrialSite community.


    Dr. Gundry concluded that both the Moderna and Pfizer-BioNTech mRNA-based COVID-19 vaccines problematically boost inflammation on the endothelium and T cell infiltration of cardiac muscle and could likely correlate to observations of increased thrombosis, cardiomyopathy as well as other adverse events post COVID-19 immunization.


    Lead Research/Investigator

    Steven R. Gundry, MD


    Call to Action: Review the source at the AHA journal Circulations: Abstract 10712: mRNA COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: A Warning Obviously this data needs further verification, socialization and elaboration


    https://www.ahajournals.org/doi/10.1161/circ.144.suppl_1.10712

  • Those VAERS figures (from antivax reporting):


    Of the 8,664 U.S. deaths reported as of Nov. 12, 10% occurred within 24 hours of vaccination, 15% occurred within 48 hours of vaccination and 26% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

    In the U.S., 436.9 million COVID vaccine doses had been administered as of Nov. 12. This includes: 254.5 million doses of Pfizer, 166.3 million doses of Moderna and 16.1 million doses of Johnson & Johnson (J&J).


    Expected number of deaths within 48 hours of vaccination (background for population):


    1 death / 100 years => 440M * 2/265 / 100 = 24,000 people.

    Compare that with 0.15 *6664 = 100 deaths in VAERS.


    Of course VAERS will not include every death of a recently vaccinated person - many of the normal deaths are obviously not covid. But it only needs misclassification of 30% to account for all the reported VAERS deaths

  • In less than a year we should have 3 over the counter or generic drugs plus Molnupiravir and Paxlovid for therapy.

    Trialsite's approach is not very convincing. Mentioning Merck crap (Molnupiravir) makes the whole story a mere disorientation piece. Fluvoxamine is not well working and has suicide risk. To mention this crap is outraging.

    HCQ, Nitazoxanine, Black cumin not even mentioned and still using the fake meme for an Ivermectin trial where we just had one with > 100'000'000 people taking it. Such postings are not serious.

  • Clowns believe that US background deaths can explain vaccination deaths. I agree that gun shots (30'000/year) are pretty similar to vaccination and, may be, some doctors mix this up. Also car accidents have a strong vaccination component especially if victims end up in a hospital...


    Lets do the following summary: Children dying from RNA gene therapy shots - "vaccine" - did it for a good thing... They wanted to help protecting the share value of Pfizer. OR . may be they did believe, else, their pet cat, dog was in a high danger situation.


    US (UK...) citizen always die for good things like in Vietnam, Iraq or Afghanistan, mostly together with experimental vaccines or plenty of opioid's... So USA still has less CoV-19 deaths than deaths from opioid's - an other very good thing given by big greedy pharma or the "sucker family"....

  • COVID-19 Mortality Risks AND VITAMIN D3


    COVID-19 Mortality Risks AND VITAMIN D3
    A German study published in MDPI in October 2021 investigated the correlation between vitamin D levels as a marker of a patient’s immune defense and
    trialsitenews.com



    A German study published in MDPI in October 2021 investigated the correlation between vitamin D levels as a marker of a patient’s immune defense and resilience against COVID-19 and other respiratory infections.


    The study is titled: COVID-19 Mortality Risk Correlates Inversely with Vitamin D3 Status, and a Mortality Rate Close to Zero Could Theoretically Be Achieved at 50 ng/mL 25(OH)D3: Results of a Systematic Review and Meta-Analysis and represents a systemic literature review conducted to identify retrospective or past cohorts as well as clinical studies on COVID-19 mortality rates versus D3 blood levels.


    Mortality rates for clinical studies were corrected for age, sex, and diabetes. The data sets provided strong evidence that low D3 is a predictor rather than a side effect of the COVID- 19 infection. The study demonstrates that vitamin D3 deficiency is one of the main reasons for severe SARS-CoV-2 infections.


    According to the study, the fatality rates correlate with the findings that elderly black people with comorbidities show very low vitamin D3 levels. With only a few exceptions, the highest infection rates occur in the winter months in northern countries, which are known to suffer from low vitamin D3 levels due to low endogenous sun-triggered vitamin D3 synthesis.


    Subscribe to the Trialsitenews "SARS-CoV-2" Channel

    No spam - we promise

    Email address

    Long before the SARS-CoV-2 pandemic, many scientific publications showed the effectiveness of a sufficient vitamin D3 blood level in curing many human diseases caused by a weak or unregulated immune system. This includes all types of virus infections, with an emphasis on lung infections that cause acute respiratory distress syndrome, as well as autoimmune diseases.


    The study states that routine vitamin D3 testing, and supplementation are still not established today. And it seems that new findings of vitamin D3 have not been well accepted in the medical community, adding many recommendations for vitamin D3 are much too low to guarantee the optimal blood level of 40-60 ng/ml.


    It points to several important functions of vitamin D3 in supporting immune defense, including suppression of inflammation by reducing the generation of inflammatory cytokines, as well as reduction of the severity of cytokine release syndrome, which causes multiple organ damage and is the leading cause of death in late-stage SARS-CoV-2 infection. Vitamin D3 also acts against invading respiratory viruses by disrupting viral envelopes and altering the viability of host target cells.


    The study concludes with the recommendation to combine vaccination with the routine strengthening of the immune system of the whole population by vitamin D3 supplementation to consistently guarantee blood levels above 50 ng/mL (125 nmol/L). Adding that from a medical point of view, this will not only save lives but increase the success of vaccination. From a social and political point of view, it will lower the need for further contact restrictions and lockdowns. From an economic point of view, it will save billions of dollars worldwide since vitamin D is inexpensive, and together with vaccines, provides an opportunity to get the spread of SARS-CoV-2 under control.


    Authors: Lorenz Borsche 1,*, Bernd Glauner 2 and Julian von Mendel 3 Citation: Borsche, L.; Glauner, B.; von Mendel, J. COVID-19 Mortality Risk Correlates Inversely with Vitamin D3 Status, and a Mortality Rate Close to Zero Could Theoretically Be Achieved at 50 ng/mL 25(OH)D3: Results of a Systematic Review and Meta-Analysis.


    1 Independent Researcher, D-69117 Heidelberg, Germany


    2 Independent Researcher, D-72076 Tübingen, Germany; [email protected]


    3 Artificial Intelligence, IU International University of Applied Sciences, D-99084 Erfurt, Germany; [email protected]


    * Correspondence: [email protected]

  • First FDA Batch of Pfizer Documents Includes Hint as to What is to Come


    First FDA Batch of Pfizer Documents Includes Hint as to What is to Come
    Recently TrialSite raised more awareness about a group called the Public Health and Medical Professionals for Transparency (PHMPT) and their FOIA lawsuit
    trialsitenews.com



    Recently TrialSite raised more awareness about a group called the Public Health and Medical Professionals for Transparency (PHMPT) and their FOIA lawsuit against the U.S. Food and Drug Administration (FDA) to compel them to disclose the documents in the Pfizer COVID-19 Biologics License Application (BLA). Represented by the law firm of Siri Glimstad the U.S. District Court Northern District of Texas sided with Pfizer not allowing full disclosure until 2076! In an absurd ruling the court proposed they share with the public 500 pages per month until all has been shared—and of course that’s 55 years. Aaron Siri, partner of Siri Glimstad reported in his blog that the first batch of documents were produced—precisely, 91 pdf pages, one xpt file, and one txt file which can be downloaded. In this first batch was a significant hint as to what could be in store for all in the years to come.


    Acknowledging that only the appropriately trained scientists and experts could analyze nonetheless common sense never is far from relevant. One of the fist documents perhaps was released as a hint as for what is in store. One of the released artifacts, a document titled “Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021 was actually originated 2.5 months after the vaccine received the emergency use authorization (EUA) grant. Siri shared “This document reflects adverse events following vaccination that have completed Pfizer’s workflow cycle” both in and outside the U.S. up to February 28, 2021.”


    ‘Large #s Spontaneous Adverse Events’

    On page 6 Mr. Siri points us to a quote in the report “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritized the processing of serious cases…” and that Pfizer has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional full time employees (FTEs).


    In the 2.5 months beyond the EUA the disclosed report captured 42,086 reports inclusive of 158,893 events. Siri shares that the U.S. is the origin of most of the reports and that they involved women far more than men (29,914 vs. 9,182). 25,987 of these events were tagged as “Nervous system disorders.”



    Just Business As Usual

    Pfizer points out that “The findings of these signal detection analyses are consistent with the known safety profile of the vaccine.” And this message aligns with a recent October 21 press release titled Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of their COVID-19 Vaccine” which emphasized first that the clinical trial generated positive efficacy data (95.6%); that with over 10,000 participants 16 years of age and up that the booster “was found to have a favorable safety profile” and finally that Pfizer planned to submit the data to appropriate regulatory bodies such as the FDA to support licensure in America and beyond.


    In the press release Pfizer declared “The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified.”


    Yet, Aaron Siri points out that if the adverse event reports were expected, why would they declare “large numbers of spontaneous adverse event report” while also needing to hire more personnel to deal with the deluge of reports? Wouldn’t their business planning have taken that into account?


    Clearly the numbers of adverse events caught Pfizer by surprise or at least caught them off guard—needing adjustments to handle.


    One Interpretation of Reality

    COVID-19 has been a grave geopolitical health catastrophe, hitting developed societies in many cases worse than most low-and-middle-income countries (LMICs).


    For example, more Americans have died (approaching 800,000) than any other nation. When reviewing COVID-19 by total numbers of reported deaths the impact on what has been the most powerful nation on the planet since the end of World War 2 is striking. America is joined by what would traditionally be considered developing (or emerging) nations in the globe’s pecking order of economic power. America is followed by Brazil, India, Mexico and Russia as the places most devastated by COVID-19.


    The number of new orphans, or loss of a caregiver to a child created by the disease is just one indicator of the severity of this situation. A recent study in the journal Pediatrics in the U.S. alone one child loses a parent or caregiver for every four COVID-19 associated deaths. On this point the CDC points out that the findings “illustrate orphanhood as but one hidden and ongoing secondary tragedy caused by the COVID-19 pandemic.”


    With 48.5 million cases in America conservatively around 10% to 20% will experience ongoing Long COVID while the subset of total cases that involve critical illness leads to a significant probability of death and/or new material symptoms. And the list of problems mounts.


    In normal times the number of “spontaneous adverse events” associated with all of these vaccines would have probably triggered wide-spread pauses in the public health programs now underway. In that more normal scenario, the vaccine companies would have had to go back to the labs to figure out how to stabilize their investigational products.


    However, we have gone down the path of no return. Put another way, due to the confluence of forces worldwide in response to this severe contagion the current rapid mass vaccination program is the only means of beating this pandemic according to top decision makers.


    Undoubtedly this profound decision results from a collective set of parallel activities over time. Driven by a top-down set of elite directives, what emerges is an unfolding movement for a globally integrated, digitally centric, unified public health-driven set of actionable directives. This movement didn’t just arrive with the pandemic. Rather it resulted from the last couple of decades as new or modified paradigms for better public health and welfare—supportive of economic growth–influenced by change agents such as Bill Gates and other influential players’ foundations, industry, and importantly global finance. With money, prestige, and power comes a new kind of public health, heavily intertwined with life science-based investment and private equity financial logic ultimately leading to robust demands for financial returns.


    TrialSite’s founder Daniel O’Connor shared “One cannot underestimate the societal impacts of decisions made by prominent and influential, well-placed change-agents a decade ago on today’s reality…and the ultimate capital calls…that will follow” O’Connor commented that this is the reason why so many people feel like the response to COVID-19 is some kind of “conspiracy” or “planned agenda.” But rather it’s just a logical set of unfolding outcomes based on decisions and actions already done.


    But in all actuality the current unfolding of events represent the evolution (or devolution) of ideas combined with actions led by a top-down cadre of scientist, public health bureaucrat, financier and industry executive driven point of view: all directed by companies and capital-infused nonprofits as well as private equity bankers more than governments in shaping the visions and associated strategies that ultimately led to pragmatic goals and objectives that now drive our collective behavior.


    So, this is all to say that the current adverse events (those known, as well as those suppressed) are frankly the cost of doing pandemic-fighting business for those in the driver’s seat. What is the acceptable threshold for those in power? Clearly that point isn’t anywhere near close, at least not yet


    FDA Produces the First 91+ pages of Documents from Pfizer’s COVID-19 Vaccine File
    Only 54 years, 11 months to go…
    aaronsiri.substack.com