The Pfizer Papers (?)

 

Continuing their long-standing practice of jumping on ANYTHING that they think might sow fear, the anti-vaxxers have recently jumped on a number of documents that were released related to the clinical trials of the Pfizer mRNA COVID vaccine.

The Claims:

There are a multitude of claims made by the anti-vaxx "community".  Here are some:

• Pfizer was trying to hide 80,000 pages of clinical trial data.
• Pfizer wanted to seal those documents for 75 years.
• Those documents show only a 12% efficacy rate
• The vaccine harms fetuses and trials weren't done on pregnant women.
• and so on....

What do we know?

Pfizer did not attempt to seal "those documents" for 75 years.  In fact, the documents weren't even in the hands of Pfizer.  Following the clinical trials, the documents were turned over to the FDA for evaluation.

The delay in releasing those "documents" had to do with all the personal data contained therein.  The FDA was claiming that redacting all that personal data was going to take time (likely in the range of 5 years, realistically), but the anti-vaxxers immediately started talking about 50 years, or 75 years, or whatever.  Neither the courts not the FDA mentioned 75 years.  That only came from groups trying to create an issue when there wasn't one to begin with.

This article explains a number of salient points:

Did Pfizer Try To Hide 158K Vax Adverse Events for 75 Years?

The differences in efficacy numbers seems to come from this:

Fact-Check - Pfizer Documents do not show that COVID-19 vaccine has 12% efficacy

It seems to be a difference between "confirmed" COVID cases or "suspected".  Clearly, it makes better sense to use confirmed cases, partly because COVID does share a number of symptoms with other diseases, like the flu, colds, and so on.  

As for pregnant women, it is true that the initial clinical trials did not include them.  There was, however, substantial information that pregnancy put women at a higher risk of serious outcomes from the SARS-CoV-2 virus.  Any pregnant women with other conditions, such as diabetes, hypertension or obesity, were at an even higher risk.  So initially, it was believed that pregnant women would benefit from being vaccinated, as was the case with pretty much everyone else.

This article from the New England Journal of Medicine addresses mRNA vaccines and pregnancies.

Note that the article dates from June 2021.  Much more information is available now than was available then.  This article from Johns Hopkins in February 2022 takes another look.

In fact, if anyone is really interested in studies on COVID and COVID vaccines related to pregnant women, this study from Trends in Molecular Medicine in May 2022 is useful.  It's somewhat technical, but there are clear language statements here and there that convey the important take-home message.  The introduction is as follows:

COVID-19 during pregnancy is associated with a higher risk of stillbirth and preterm birth.

The current COVID-19 vaccines were not tested in pregnant women in the initial clinical trials, but information on their safety, immunogenicity, and effectiveness has been generated from observational studies.

No major safety concerns on the use of mainly the mRNA COVID-19 vaccines in pregnant women have been identified.

Pregnant women mount immune responses to COVID-19 mRNA vaccines comparable to non-pregnant counterparts.

Anti-SARS-CoV-2 IgG are detected in cord blood following maternal vaccination at concentrations that strongly correlated with both maternal antibody levels and the time elapsed since vaccination.

Vaccination of pregnant women with mRNA COVID-19 vaccines has been shown to be effective in protecting the women against disease.

More detailed explanations appear in the body of the article.

Notwithstanding all the good information available, I have zero hope that the anti-vaxx community will look for anything that might run counter to their beliefs.