Covid-19 News

Quote from Fm1

What are the detailed implications for transmissibility—e.g., what’s happening now?

What’s different about Delta—and is far more disturbing—is that the actual levels of the virus in a vaccinated person’s nasopharynx is approximately 1,000 times higher than the alpha variant type, reported Dr. Anthony Fauci to MSNBC during a recent interview.

There was some early evidence that COVID disease severity depended on initial dose. Given a higher initial dose the immune response is more easily overwhelmed - therefore serious disease more likely.

Researchers are now pointing to this cruise ship outbreak, in which all passengers were provided surgical masks, as evidence that universal masking may result in a higher proportion of asymptomatic COVID-19 cases. Other outbreaks of mostly asymptomatic cases where widespread masking was implemented, in places like jails and meatpacking plants, provide epidemiological data that masks could reduce viral inoculum -- and as a result, decrease the severity of illness.

Writing in the New England Journal of Medicine, Monica Gandhi, MD, and George Rutherford, MD, of the University of California in San Francisco, hypothesized that widespread population masking may act as a sort of "variolation," exposing individuals to a smaller amount of viral particles and producing an immune response.

Gandhi told MedPage Today that the viral inoculum, or the initial dose of virus that a patient takes in, is one likely determinant of ultimate illness severity. That's separate from patients' subsequent viral load, the level of replicating virus as measured by copies per mL.

The "variolation" hypothesis holds that, at some level, the inoculum overwhelms the immune system, leading to serious illness. With less than that (and the threshold may vary from one person to the next), the individual successfully fights off the infection, with mild or no clinical illness.

"Diseases in which your immune system has a big role to play in how sick you get -- and your immune system contributes to pathogenesis -- do not seem to be able to handle a large viral inoculum," Gandhi said in an interview.

One (possible - I'm not very confident) take home from this is that vaccinated people should worry less about very small doses, but take care to avoid very high doses. The problem is that exact dose is very very difficult to gauge, what you think is small may turn out to be high.

What are the known very high doses? 1. Talking face-to-face unmasked with somone who is infected, where a significant quantity of aerosol droplets pass directly from mouth to mouth.

2. Staying in a badly ventilated area where infected people have also been for some time, so that aerosols can build up in the air and be inhaled in decent quantity.

in case 1. masks help particularly the other person, because large droplets get caught or diverted by the mask. they probably help you a bit, but becasue by the time they get to you the droplets will have had time to evaporate a bit and become smaller i'm less sure about this.

in case 2. masks do not help you personally. they do help the environment because a significant fracation of contaminated droplets are caught by the mask.

I'm not sure how much masks help in these cases, maybe delta is now so transmissable that a factor of 2 or so in reduction is irrelevant. But, because there is a lot of uncertainty, and anyone can see that masks might help, it seems really nasty to everyone else not to wear one in public in these high risk scenarios.

Quote from Fm1

I guess you haven't read today's headlines

Be specific. Which headlines, where? All of the news I have seen, and the video with Ashish Jha, say that the vaccines are still effective against delta.

Quote from Zephir_AWT

I find somehow surprising to hear such a proclamations just from person who is perfectly aware how deeply scientific community ignored and dismissed subject of cold fusion just from primitive egoistic economical reasons.

Obviously the scientific community gets it right sometimes, and wrong at other times. Any institution, any group, or individual is right sometimes and wrong at other times. The scientific community is manifestly right about many things, because otherwise airplanes would routinely fall out of the sky, as I said before. Most modern technology and science works well. The community was wrong about cold fusion. It is definitely right that the vaccines are effective against delta, because most hospitalized patients have not been vaccinated. If the vaccines did not work, half the patients would be vaccinated, and they would die at the same rate as unvaccinated people. Every report from every hospital says that is not the case.

You cannot assume that the establishment is always right. It is equally fallacious to assume the establishment is always wrong. Sometimes egotistic economical reasons rule. At other times, rationality, the public interest, and professional responsibilities rule.

Quote from Zephir_AWT

What leads you into conviction, that Ivermectin/HCQ wasn't boycotted on the ground of the same motivation like cold fusion?

I have no such conviction. I do not know enough to judge either of those. Most mainstream researchers say they do not work, so I expect that is the case, but I have not looked into it.

Anyway, that has nothing to do with the effectiveness of the vaccine. I don't know why you brought it up. In any case, you have that wrong. I have no conviction, but only an assumption from reading a few news articles.

Frankly, I do not see why it matters whether ivermectin or HCQ work. The vaccines eliminate the disease. You don't need these other two. They resemble the many therapeutics, exercises, iron lungs and other treatments for polio. After the polio vaccine eliminated the disease there was no need for these things. Doctors and nurses who knew how to use them retired and died long ago.

Quote

Obviously the scientific community gets it right sometimes, and wrong at other times.

Of course - but why did you decide to trust it just at the case of such an immense conflict of interest, like the development of vaccines vs. distribution of cheap prophylaxis drugs is? Because in such a cases scientific community gets biased quite routinely.

Quote

Anyway, that has nothing to do with the effectiveness of the vaccine. I don't know why you brought it up.

I didn't talk about it, maybe it's misunderstanding on your side...

Quote from Zephir_AWT

Of course - but why did you decide to trust it just at the case of such an immense conflict of interest, like the development of vaccines vs. distribution of cheap prophylaxis drugs is?

I doubt these cheap prophylaxis work. They are marginal at best. I do not think the doctors in the U.S. would have allowed 600,000 people to die if there had been effective ways to save them. It cannot be that every doctor in the U.S. is part of a conspiracy to hide the effectiveness of these drugs, and all have a conflict of interest. Not all U.S. doctors profit from drug sales. (Some do.) It seems more likely that if these drugs work, they are marginal at best. They might reduce a hospital stay from 10 days to 8 days, which is what one positive study showed, as I recall.

Doctors in the UK and many other countries would not be part of conspiracy to inhibit the distribution of cheap prophylaxis. They are not paid from drug company sales. They could not profit. That conflict of interest is not allowed. So, if these drugs work, they would be widely used in those countries, but they are not.

The per capita infection and death rate in Japan was 30 times lower than the U.S. for 2020, without the use of ivermectin or HCQ. As of Jan. 2021 they were still thinking about using ivermectin. (https://asia.nikkei.com/Spotli…arasite-drug-for-COVID-19). So, you do not need these things to keep COVID-19 at bay. Masks, quarantine, and case tracker were the only things the Japanese public health system made use of to keep the disease from spreading. Perhaps ivermectin would have helped, but Japan proved masks and case tracking were far more effective.

I don't know whether ivermectin or HCQ have any efficacy, but I am certain the vaccines do. They reduce sickness and deaths by a factor of ~100. You can see that in the data from every country that has a significant fraction of the population vaccinated, including countries that have not authorized ivermectin or HCQ.

You describe these two as "cheap prophylaxis drugs." They are not cheap. They are far more expensive than the vaccine, because they have to be administered many times, whereas only 1 or 2 doses of the vaccine are needed. Actually, even if they work, they are hundreds of times more expensive than the vaccine, because the vaccine nearly always eliminates the disease completely, whereas ivermectin reportedly only reduces the severity of the illness, meaning you spend fewer days in the hospital. A few days in the hospital costs thousands of times more than a vaccine.

Quote from Zephir_AWT

I didn't talk about it, maybe it's misunderstanding on your side...

You sure did.

Should the UK’s Health Secretary be Held Accountable for Mass COVID-19 Deaths Throughout Britain’s Long-Term Care Homes During Pandemic?

Should the UK’s Health Secretary be Held Accountable for Mass COVID-19 Deaths Throughout Britain’s Long-Term Care Homes During Pandemic?

No group was hit harder during the pandemic than the elderly residing in long-term care facilities, known as nursing homes, rest homes, or care homes in

trialsitenews.com

No group was hit harder during the pandemic than the elderly residing in long-term care facilities, known as nursing homes, rest homes, or care homes in the United Kingdom (UK). With governments blocking early treatment options such as ivermectin (with continuous demands for ever more granular proof of efficacy), the elderly had no options for many months and died in record numbers in America, Canada, and the UK. With monoclonal antibodies came little benefit for some patients, and of course, vaccination has now helped, but the general plight of those living in these facilities in the UK now is coming into sharp focus. This has been exemplified by the human rights group Amnesty International, which recently shared a summary of its reports with the Mail on Sunday prior to publication. This was a gut-wrenching “excoriating verdict” that must empower and drive reform, but the lives lost due to gross negligence cannot be brought back. These were our parents, grandparents, and even great-grandparents. UK elderly nursing homes violated fundamental human rights of the most vulnerable class during the COVID-19 pandemic, summarizes Amnesty International in this new report.

Gross negligence, if not intentional murder, describes what was done. What else describes facilities that not only first exposed elderly residents to the SARS-CoV-2 pathogen but then blocked them from receiving any life-saving medical care? The net results: tens of thousands of unnecessary deaths in the UK, according to the non-governmental organization.

Foreknowledge

The Amnesty International report demonstrates that UK Ministers “knew from the outset that the nation’s 400,000 elderly residing in care homes were in profound danger yet continuously failed to implement policies that protected this vulnerable class. Egregiously, Ministers would claim that the safety and security of seniors were an apex health policy concern, but this was all talk.

Death Facilities

With homes “overwhelmed” with infection, the residents were repeatedly subjected to “inhumane and degrading treatment.” Within just a few months, “a tsunami of deaths” led to 28,186 excess deaths reported in these care homes, with about 18,562 of all deaths directly related to the pandemic. This represents about 40% of all deaths in the UK. With fingers pointed directly at government culpability, “sinister edicts” are called out by Amnesty International, making this sound more like a script from a horror movie than what was once the great nation of Great Britain.

Independent Inquiry

The Daily Mail reports that Amnesty International calls out for an independent public investigation immediately into this matter. Officials guilty need to be held accountable now. To date, much of the records associated with these incidents have apparently been shielded from the public. The ultimate buck stops with Matt Hancock, Secretary of State for Health.

Call to Action: Follow the link to Amnesty International.

Florida Becomes Hub for the Delta COVID-19 Surge

Florida Becomes Hub for the Delta COVID-19 Surge

A few days ago, according to the Wall Street Journal (WSJ), the State of Florida had the dubious distinction as the number one COVID-19 hotspot in the

trialsitenews.com

A few days ago, according to the Wall Street Journal (WSJ), the State of Florida had the dubious distinction as the number one COVID-19 hotspot in the nation. With every one in five cases recorded here in the Sunshine State, to some extent, this isn’t a surprise considering the type of laissez-faire governing regime. Arian Campo-Flores wrote that the state reported 73,181 SARS-CoV-2 cases over the past week based on data from the U.S. Centers for Disease Control and Prevention (CDC). With a case rate of 341 per 100,000 people, Florida ranks just behind Louisiana in case rates. But again, total case magnitude makes Florida number one in cases with a “fourfold” increase in the last few weeks. Florida’s death rate is now 1.5 per 1,000,000, making it the fourth-highest in the nation. What do the WSJ’s journalists declare as the forces behind this surge? Undoubtedly, these include the emergence of the highly transmissible Delta strain and large congregations of people indoors during the long, hot, and muggy summer. While WSJ suggests,” large numbers of unvaccinated people, a relaxation of preventative measures like mask-wearing and social distancing” are important factors. As has come to be predictable, the mainstream press doesn’t touch the racial and ethnic elements behind vaccine hesitancy.

The Situation

So what are the current trends in Florida? Like most states, Florida’s vaccination rate has slowed to a crawl, and Governor Ron DeSantis is now on the record encouraging vaccinations. Presently, 56.7% have received at least one dose, while 48.23% are fully vaccinated in this state of 21.6 million people.

The Delta-variant-driven surge has also led to a steep rise in hospitalizations. According to a recent entry from ClickOrlando, the total number of COVID-19 related hospitalizations has surged from 1,880 on July 3rd to 6,639 cases by July 24th, reported Florida Health and Human Services or “HHS.”

AdventHealth reports that about 90% of the hospitalizations at its facilities are in those unvaccinated. In March, a report from the Florida Health Justice Project showcased that a majority of the COVID-19 cases occurred among ethnic minorities (Black and Hispanic primarily) but that whites (elderly, comorbidity, etc.) were most at risk for death.

For example, by the spring of this year, the Florida Health Justice Project revealed that Floridians classified as “white” or “Caucasian” represent 54% of the population. Yet by the end of March, this population represented just 25% of the people who have tested positive for SARS-CoV-2 while Hispanics (Latinos) make up 29% of those positive cases yet just 26% of the entire state population. Blacks represent 17% of the state’s population and account for 18% of the cases, except the Florida Health Justice Project suspects the Florida Department of Health data severely undercounts minority cases.

Hospitalization a Common Theme

Much like we reported recently in Los Angeles County, Blacks are bearing the brunt of this pandemic in many ways. Back in late March, Blacks accounted for 26% of all hospitalizations even though they represent only 17% of the state population. When just counting “test confirmed cases,” Blacks account for 24.3% of all hospitalizations here, while whites were at 23.8% and Hispanics at 17.2%. Some experts suspect the higher rates in Florida among whites correlate with a greater incidence of comorbidity from obesity, diabetes, and cardiovascular problems.

As one travels south to the urbanized southeastern conglomerate, the data remains uneven between the races and ethnicities. With nearly 3 million inhabitants in Dade County, Blacks make up about 15% of the population. Yet by the end of March, they represented 23.3% of those hospitalized compared to their White counterparts at 17.5%.

Blacks die at higher rates than whites or Hispanics here. While the ratio isn’t as extreme as a place like Los Angeles, in Dade County, for example, Blacks die at nearly double the rates of whites.

University of Miami

The University of Miami recently shared data observations that the Delta strain in Florida has skyrocketed, growing from a few cases just in June to 63% of the total number of cases based on a sampling of cases in the Jackson Memorial Health System and the University of Miami’s UHealth Tower. The researchers also note that 20% of patients in this state were infected with Gamma, the Brazilian variant, 9% with the Colombian variant known as B.1.621, and 3% with the Peruvian-originated Lambda.

Dr. Lilian Abbo, a professor working in the Miller School of Medicine’s Division of Infectious Diseases, believes the Delta will soon dominate the state, pushing Florida and other parts of the United States into another pandemic surge. For example, she reports to her university press that “I’m seeing a more than 350% increase in COVD-19 hospitalizations.”

Dr. Abbo reports that at least in this Florida health system, about 90% of the hospitalizations are associated with the unvaccinated. But the breakthrough infections are coming here, like everywhere else, as with time and variant virulence, the current crop of vaccine products may lose efficacy.

But who are the Unvaccinated in Florida?

Although Blacks make up about 16% of the Florida population, according to the Kaiser Family Foundation (KFF), this racial group represents a lack of vaccinations at just 8%—by far the lowest of any racial or ethnic cohort. In Florida, whites are vaccinated at double the rates of Blacks, according to KFF, as 51% of the total white population has received at least one dose of a COVID-19 vaccine, while that figure for Blacks is 26%. Hispanics in Florida generally get vaccinated more than comparable Hispanic groups in California, for example. Note that the Hispanic population in Florida is majority Caribbean and South American in root compared to California, which is of greater Mestizo descent from Mexico and Central America.

Minority Push

Although most mainstream media’s depiction of the unvaccinated often conjures stereotypical caricatures, ethnic mistrust of healthcare systems, pharmaceutical companies, and the government is no trivial matter. As the Biden administration is more than likely investing hundreds of millions of dollars to flood the country with vaccination messaging, from educational campaigns to programs and initiatives, some locations see positive movement. For example, from March 1st to July 19th, Hispanic outreach was paying dividends with more significant numbers of vaccinations while progress was made in the Black community as well. For example, vaccination among Blacks in Mississippi grew from 25% to 37%.

Declines Among White Populations

Across a handful of states, KFF reports that much of the white (Caucasian) population is opting not to get vaccinated. Some states may surprise Beltway pundits, as they include predictable ones such as Tennessee, Virginia, Mississippi, Arkansas, and Arizona and some surprises such as New York, Illinois, Maine, and New Jersey.

Final Thoughts

KFF provides a robust portal of vaccine data for the public. The unvaccinated population in American runs the gamut of experiences, perspectives, and socio-demographic categories, and there are some high-level summary trends. According to KFF, unvaccinated adults tend to be younger (and thus overall face a lower risk profile for COVID), part of a minority group, Republican-leaning, and overall less educated. KFF emphasizes, “But the unvaccinated isn’t an entirely uniform group, with significant differences by intention.” For example, there is the “wait and see” category that is more likely to be people of color, while the “definitely not” cohort tends to fall more in the Republic-leaning political world, residing in more rural regions. As TrialSite has emphasized, to the discomfort of many, a taboo topic dared not uttered by mainstream media are material concerns of safety based on mounting data not addressed by the CDC.

(This post was updated July 29 to correct the name of the Governor)

Quote from Fm1

For example, there is the “wait and see” category that is more likely to be people of color, while the “definitely not” cohort tends to fall more in the Republic-leaning political world, residing in more rural regions. As TrialSite has emphasized, to the discomfort of many, a taboo topic dared not uttered by mainstream media are material concerns of safety based on mounting data not addressed by the CDC.

TSN seems to want to have its cake and eat it. On the one hand it appears to support higher vaccination. On the other hand it prides itself on promoting vaccine misinformation that encourages vaccine hesitancy.

material concerns of safety based on mounting data not addressed by the CDC.

The problem is that TSN is not seriously engaging with the risk balance between COVID and vaccine. Instead it is raising hypothetical highly unlikely long term problems, and presenting real side effects, such as pericarditis, in an unbalanced way (for example conflating vaccine-induced pericarditis risk with normal pericarditis risk - much much higher).

It is pretty loathsome.

THH

Politicisation of Health is an endemic disease

exacerbated by Covid

The Politics of the WHO

Chinese appeasement, lifestyle initiatives, and social justice — how the UN health agency passes off a political agenda as a medical mission

www.thenewatlantis.com

Politics of course impinges on bias mentioned below..to a certain extent

It is interesting that the WHO metaanalysis is quite positive..

however politics appears to have influenced its public pronouncement on ivermectin..

"Discussion
Publishing is often biased towards positive results, which we would need to adjust for when analyzing the % of positive results.

For ivermectin, there is currently not enough data to evaluate publication bias with high confidence

One method to evaluate bias is to compare prospective vs. retrospective studies.

Prospective studies are likely to be published regardless of the result,

while retrospective studies are more likely to exhibit bias.

For example, researchers may perform preliminary analysis with minimal effort and the results may influence their decision to continue.

Retrospective studies also provide more opportunities for the specifics of data extraction and adjustments to influence results. Figure 21 shows a scatter plot of results for prospective and retrospective studies.

The median effect size for prospective studies is 74% improvement, compared to 76% for retrospective studies, showing no significant difference.

[Bryant] also perform a funnel plot analysis, which they found did not suggest evidence of publication bias.

News coverage of ivermectin studies is extremely biased. Only one study to date has received significant press coverage in western media [López-Medina], which is neither the largest or the least biased study,

and is one of the two studies with the most critical issues as discussed earlier

3 of the 60 studies compare against other treatments rather than placebo.

Currently ivermectin shows better results than these other treatments, however ivermectin may show greater improvement when compared to placebo. 15 of 60 studies combine treatments, for example ivermectin + doxycycline. The results of ivermectin alone may differ. 4 of 30 RCTs use combined treatment, three with doxycycline, and one with iota-carrageenan.

1 of 60 studies currently have minimal published details available.

Typical meta analyses involve subjective selection criteria, effect extraction rules, and study bias evaluation, which can be used to bias results towards a specific outcome.

In order to avoid bias we include all studies and use a pre-specified method

to extract results from all studies (we also present results after exclusions).

The results to date are overwhelmingly positive, very consistent, and very insensitive to potential selection criteria, effect extraction rules, and/or bias evaluation.

Additional meta analyses confirming the effectiveness of ivermectin can be found in [Bryant, Hill, Kory, Lawrie]. Figure 22 shows a comparison of mortality results across meta analyses. [Kory] also review epidemiological data and provide suggested treatment regimens."

This site obviously feels that TrialSiteNews is a useful source of information. Personally, I find it useful when it links preprints etc. However mostly when it does this it summarises the preprint with errors: and it has a very poor record of correcting clear errors. Here is a fact check description of why journalistically, it has a very low rating.

Journalistic integrity, in a news site such as TSN, matters.

Journalists who are professional don't like errors. When they are pointed out, they correct them. And they try to avoid having them.

TSN is rather different

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Quote from THHuxleynew

Since ICU admission lags cases you would need to look at a lagged version of the case rate and compare that with ICU data.

You are a clever baby. That's exactly what I did 14 day lag. That's standard!

Quote from THHuxleynew

The US has been weird (publicly) in claiming the vaccine offers almost perfect protection against symptomatic delta infection, when in the UK we know it does not do that. It

Pfizer, Moderna are by today's definition a gen therapy and not vaccines! Why?

1) A vaccine contains a weakened pathogen

2) The first step of the immune system action is to cut the pathogen RNA/DNA into pieces

3) These pieces then are transported to special cells that look whether this pattern is known

4) If yes the code goes to a storage (memory T-Cells that then uses a precanned program to reproduce old working antibodies

5) If no then an other type of cells start to produce a whole range of antibodies based on the fragments presented by the immune cells. (The vanishing ones will be amplified but this takes some days usually what is th problem.)

Now what happens with the e.g. Pfizer immune therapy? The process directly jump to step 5 and the new antibodies are produced.

The parallel process 2..5 cuts the S protein into pieces what leads to crippled antibodies of no use. This also triggers any kind of weird reaction based on the junk delivered.

Fact is - according several specialist in the field - so far no memory T-cells for the S-protein (S= spike) could be found after the Pfizer gen therapy. So after this gen therapy you are unable to react on a new CoV-19 infection. Your immunity is just based the the first run produced antibodies and if these are consumed then you are back on square 1.

This is a simplified description that does not include the genome coding step for new pathogens and the production of new memory T-Cells.

After a normal vaccination the body is able to constantly reproduce the once learned anti bodies. Not so after the Pfizer/Moderna/Astra gen therapy.

Quote from THHuxleynew

I have no political reason to like or dislike ivermectin or HCQ. I strongly think that science and medical advice should be separated from politics.

Nobody said this. You simply support your FM (fascist) buddies to make tons of money!

Quote from RobertBryant

In order to avoid bias we include all studies and use a pre-specified method to extract results from all studies (we also present results after exclusions).

The problem is that many studies of IVM are (positive) biased. This is not unique to IVM, it is generally bound to be the case because of file drawer effect and the natural human wish of people to present what they believe true in the best light. Non-RCTs have special problems here, but RCTs with poor recording (details missed out, lack of correct registration, endpoints or outcomes different from what was originally stated without very good reason) also have special problems

So, any meta-analysis which includes all studies will (for any drug) typically have unrealistically positive results.

That is why meta-analyses need to consider those aspects of a study that allow bias - lack of detail, lack of registration, significant unexplained changes of endpoints or outcomes - and select for reliable studies.

Quote from THHuxleynew

The problem is that TSN is not seriously engaging with the risk balance between COVID and vaccine.

Trail site is still more than serious. They still use the term vaccine despite this now has been debunked as gen therapy. The risk from current "vaccines" - see Israel - is a much higher hospital rate for vaccinated. It's easy to extrapolate what will happen in the future. Thanks to the gen therapy you, to a certain extent, did spoil the Memory T-cells, what will result in a much slower reaction upon re-infection, when once all primary anti-bodies have been consumed.

I personally believe that most vaccinated will become long time dependent on Ivermectin because their body will be, to a certain extent, unable to fight CoV-19.

Only fools kill themselves!

Tip: Find a study that shows reproduction of spike antibodies after a "vaccination" - re-infection! A study that excludes vaccinated that already did have contact with CoV-19.

Quote from Wyttenbach

That's exactly what I did 14 day lag. That's standard!

It is not what you said, and your accuracy has been poor over these matters. So I'd need more details before supposing you were making this comparison fairly.

I'd also need the data you use.

I don't know why you are so full of yourself that you do not do others the courtesy of linking sources, and/or being clear, when making extreme and contentious claims, so that others can check what you say.

As you can see, such behaviour makes me, from time to time, a bit tetchy.

I don't mind RBs sarcasm and veiled insults. What he says is clear and I can either ignore it, if it has no content, or correct it, or occasionally agree it. And a poor attitude does not matter, it is content that matters.

I don't mind Mark U's conspiracy theories. They are self-critiquing.

I don't mind FM1s random and often wrong comments. They can be corrected because it is clear what he says.

I don't mind Zephir's conspiracy theories. They shed great insight on his thought processes which are certainly different from mine, and were I him would make me pretty miserable.

In your case you make continual strong claims which, when I can check them (as with the claim that ratio of vaccinated to non-vaccinated deaths in hospitals determines quality of the vaccine), usually turn out methodologically incorrect.

I don't suppose what you say is always incorrect, but your track record makes you not believable unless you provide enough info for me to check.

Hence I get annoyed. It is actually a (mild) complement. If I thought you were always wrong, or did not attempt to be correct, I would not bother.

Lack of Compelling Safety data for mRNA COVID Vaccines in Pregnant Women

Lack of Compelling Safety data for mRNA COVID Vaccines in Pregnant Women

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Peter A. McCullough, MD, MPH,

trialsitenews.com

Peter A. McCullough, MD, MPH, FACC, FACP, FAHA, FASN, FNKF, FNLA, FCRSA, Professor of Medicine, Texas Christian University and the University of North Texas Health Sciences Center School of Medicine, Dallas, TX, [email protected]

Ira Bernstein, MD, CCFP, FCFP, University of Toronto, Toronto, ON, [email protected]

Sanja Jovanovic, MD, MSc Community Health and Epidemiology, The Evidence-Based Medicine Consultancy Ltd, Bath, UK, [email protected]

Deanna McLeod, HBSc, Principal, Kaleidoscope Strategic, [email protected]

Raphael B. Stricker, MD, Union Square Medical Associates, San Francisco, CA, [email protected]

Response to the Shimabukuro et al. (2021) NEJM Publication

The article by Shimabukuro et al. (2021) presents preliminary safety results of coronavirus 2019 (COVID-19) mRNA vaccines given to pregnant women from the V-Safe Registry.1 These findings are of particular importance, as pregnant women were excluded from the phase III trials assessing mRNA vaccines.

In Table 4, the authors report a rate of spontaneous abortion (Sab) in early pregnancy (<20 weeks) of 12.6% (104 Sabs/827 completed pregnancies). This number is misleading, however, as this subset represents only 20.9% of women enrolled in the registry, and 84.6% (n=700) of women received their first vaccine dose in the third trimester. For all other pregnancy outcomes, the authors calculated event proportions by dividing the number of events by the number of participants eligible for that event. However, for Sab they divide the number of events by the entire cohort of completed pregnancies, rendering the statistic meaningless.

Moreover, although authors fail to report the median follow-up at the time of the analysis, they do state that limited follow-up calls were placed every 10 to 12 weeks, and pregnancies were ongoing in the vast majority of women who were vaccinated in their first and second trimesters. Therefore, the effect of the vaccines on early pregnancy losses (<20 weeks) is concerning and remains to be determined. Presumably, the Sab rate will be higher than 12.6% when more of the data on women vaccinated in early pregnancy is fully disclosed. Additionally, the authors indicate that the rate of Sabs in the published literature is between 10% and 26%.2-4 However, this range includes clinically-unrecognized pregnancies2,5,6 so the upper limit should be closer to 10% because the study relied on self-reporting that would only detect clinically recognized pregnancies.2,5,7 Reporting a Sab rate of 12.6% in Table 4 may lead some to conclude that there is no increased vaccine-associated risk of Sab in early pregnancy by comparing it to the background rate of 10% to 26%, whereas in reality the analysis cannot address this question in a meaningful fashion.

Finally, the authors conclude that “no obvious safety signals were detected among pregnant persons who received mRNA COVID-19 vaccines”. However, this does not seem to account for the >12.6% of reported grade 3 adverse events or 8% of women who reported a temperature ≥38 °C among those receiving 2 doses where it is known fever itself can induce miscarriage or premature labor.8-10 Additionally, administration of mRNA COVID-19 vaccines results in the production of the spike protein, which has been implicated in pathogenic mechanisms that affect the uterus, placenta, and possibly the fetus.11-21 To our knowledge these biologically active agents lack studies of teratogenicity, oncogenicity, and genotoxicity that assure their safety.22-24 As mentioned previously, these agents have not been proven safe in phase III trials of pregnant women nor have they been studied long-enough to ensure their continued safety through the nine-month development trajectory of the unborn infants and into their early years.

We therefore suggest that it would be more appropriate for the authors to exercise the precautionary principle and conclude that the “mRNA COVID-19 vaccines may be associated with severe adverse events; their effect on pregnancy outcomes, especially when administered in early pregnancy, have yet to be determined and their use should be limited to clinical trials”. Given that the V-safe registry is the best source of vaccine safety data in pregnant women, we request that the authors make the data available for public scrutiny, conduct a temporal association analysis to explore vaccine-related events in pregnant women, and calculate Sab rates based on cohorts at risk of the event, especially when the vaccines are given in early pregnancy. Thus, according to the Requirements for Pregnancy and Lactation Labeling by the US DHHS and the FDA,25,26 the vaccines should contain a narrative summary equivalent to a “Category X” labeling in pregnancy, indicating that the potential risks involved in use of the COVID-19 vaccine in pregnant women clearly outweigh any future benefits since COVID-19 is mild27 and treatable28 for the majority of pregnant women.

* The populations from which these rates are derived are not matched to the current study population for age, race and ethnic group, or other demographic and clinical factors.

† Data on pregnancy loss are based on 827 participants in the v-safe pregnancy registry who received an mRNA COVID-19 vaccine (BNT162b2 [Pfizer–BioNTech] or mRNA-1273 [Moderna]) from December 14, 2020, to February 28, 2021, and who reported a completed pregnancy. A total of 700 participants (84.6%) received their first eligible dose in the third trimester. Data on neonatal outcomes are based on 724 live-born infants, including 12 sets of multiples.

‡ A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation.

§ The denominator includes live-born infants and stillbirths.

¶ The denominator includes only participants vaccinated before 37 weeks of gestation.

‖ Small size for gestational age indicates a birthweight below the 10th percentile for gestational age and infant sex according to INTERGROWTH-21st growth standards (http://intergrowth21.ndog.ox.ac.uk). These standards draw from an international sample including both low-income and high-income countries but exclude children with coexisting conditions and malnutrition. They can be used as a standard for healthy children growing under optimal conditions.

** Values include only major congenital anomalies in accordance with the Metropolitan Atlanta Congenital Defects Program 6-Digit Code Defect List (http://www.cdc.gov/ncbddd/birthdefects/macdp.html); all pregnancies with major congenital anomalies were exposed to Covid-19 vaccines only in the third trimester of pregnancy (i.e., well after the period of organogenesis).

†† Neonatal death indicates death within the first 28 days after delivery.

No potential conflict of interest relevant to this letter were reported.

REFERENCES

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5. Wilcox AJ, Weinberg CR, O’Connor JF, et al. Incidence of early loss of pregnancy. N Engl J Med 1988;319:189-94.

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12. Kulkarni HS, Atkinson JP. Targeting complement activation in COVID-19. Blood 2020;136:2000-1.

13. Wang H, Chen Q, Hu Y, et al. Pathogenic antibodies induced by spike proteins of COVID-19 and SARS-CoV viruses. (preprint) 2021;doi:10.21203/rs.3.rs-612103/v1.

14. Colaco C. Thrombosis, Spike and Complement activation in COVID19 (Response to: Thrombosis after covid-19 vaccination). BMJ 2021;373:n958/rr-6.

15. Lei Y, Zhang J, Schiavon CR, et al. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circ Res 2021;128:1323-6.

16. Biancatelli RC, Solopov P, Sharlow ER, Lazo JS, Marik PE, Catravas JD. The SARS-CoV-2 Spike Protein Subunit 1 induces COVID-19-like acute lung injury in Κ18-hACE2 transgenic mice and barrier dysfunction in human endothelial cells. Am J Physiol Lung Cell Mol Physiol (online ahead of print) 2021;doi:10.1152/ajplung.00223.2021.

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Quote from Wyttenbach

Thanks to the gen therapy you, to a certain extent, did spoil the Memory T-cells, what will result in a much slower reaction upon re-infection, when once all primary anti-bodies have been consumed.

I personally believe that most vaccinated will become long time dependent on Ivermectin because their body will be, to a certain extent, unable to fight CoV-19.

Personal beliefs are free, and when you state them they allows others to judge your reliability. The vaccinated certainly seem to fight CoV-19 better than the unvaccinated at next infection.

However it is important to distinguish between speculative ideas about immune system operation with no support, and facts. The immune system is immensely complex, as is the way COVID interferes with it. I do not believe either you (or I) have the competence to do more than evaluate definite claims made by experts - and even in that we are at severe danger because we do not have the deep understanding and uptodate knowledge to work out which claims are more likely.

You are of course at liberty to believe that you are much more expert than everyone else in this area. I'll just point out that this will not be very credible to others.

Best wishes, THH

Quote from THHuxleynew

I'd also need the data you use.

How many servants can you pay ? Must I type in the link for you I gave??? Which bot is just responding behind TH this case? Then one that never reads posts or looses the memory due to over excitation?

Quote from THHuxleynew

Personal beliefs are free, and when you state them they allows others to judge your reliability.

It's not a personal believe: You must show us that the gen therapy will reproduce the spike antibodies e.g. 6..12 months after the inoculation. Israel data shows nada. Experts say so far no memory T-Cell found for the complete S-protein = Gen therapy RNA.

Best wishes too as you took the vaccine!

Quote from Wyttenbach

Best wishes too as you took the vaccine!

Quote from Fm1

Category X” labeling in pregnancy, indicating that the potential risks involved in use of the COVID-19 vaccine in pregnant women clearly outweigh any future benefits since COVID-19 is mild27 and treatable28 for the majority of pregnant women.

The 'va ine' might help with macular degeneration... but a pregnancy test is advisable..

there should be a new category just for $Pf mRNA.. to replace Category X.

Category ( AGC)..

I find this surprising, and disturbing:

Covid Live Updates: Florida Gives Parents Final Say on Masks for Children

Deaths from the virus are surging in Africa as the global number of new cases rises. Broadway audiences will need proof of vaccination and masks to attend…

www.nytimes.com

A third of white-tailed deer tested in a survey were exposed to the coronavirus.

A third of the white-tailed deer tested in four states during a federal study had been exposed to the coronavirus, in yet another indication of the unpredictable nature of the disease. The percentage was highest in Michigan, where 60 percent of the animals tested positive.

The presence of the virus in wild deer is not just a curiosity for scientists. The virus has shown it can jump from one species to another, and in the worse case, it could become established in a common animal species, creating a reservoir from which the virus could spill back into humans. . . .

Quote from JedRothwell

I find this surprising, and disturbing:

Which one...the deer or the children?