“Pfizer documents”: no, there are not 9 out of 10 women vaccinated against Covid who lose their babies

in collaboration with

Dr Gérald Kierzek (Medical Director of Doctissimo)

These Pfizer documents have been made public by the FDA, the Food and Drug Administration, which is the American drug agency. They contain the laboratory’s authorization request for its vaccine against Covid-19.

It’s thousands of pages of data and information about Pfizer’s product safety and efficacy trials. Post-authorisation surveillance data can also be found there, as the company continues to monitor its product.

238 downloadable documents

The “Pfizer documents” are available on the website of a non-governmental organization called “Public Health and Medical Professionals for Transparency” (PHMPT). There are “238 documents” downloadable, published between November 17, 2021 and May 2, 2022.

These documents made available to the public soon became the subject of persistent rumors, although denied many times by scientists around the world.

“Nine out of ten vaccinated women lose their babies”

Among this false information, shared thousands of times in different languages, there is that concerning pregnant women.

“Confidential Pfizer documents that the FDA was forced to release by court order revealed that 82% to 97% of women who were mistakenly exposed to the Covid-19 mRNA injection miscarried or had to witness the death of their newborn child during childbirth“, claim authors of blog posts or tweets. The figures presented in reality are misinterpreted and taken out of context.

Correlation but no causation

A Pfizer document entitled “Cumulative analysis of post-authorization adverse event reports for pf-07302048 (bnt162b2) received as of 28-Feb-2021”, constitutes an analysis of events reported for the Pfizer vaccine after obtaining its authorization, before the February 28, 2021. This therefore concerns people who were vaccinated between December 11, 2020 and February 28, 2021 and their reported adverse events.

Although the document states that “this report reflects reported adverse events, not the likelihood of these events occurring in the vaccinated population”and that these reports “do not necessarily indicate that an adverse event was caused by the drug (the Pfizer vaccine), rather the event may be due to an underlying disease or another factor, such as medical history or concomitant therapy”the rumor got carried away.

No link with vaccination established

As of February 28, the document reports that a “A total of 42,086 people who received the Pfizer vaccine reported adverse events during this study”. Among them, 270 said they were pregnant.

For 238 of these cases, the women did not declare the outcome of their pregnancy. In addition, five other pregnancies were awaiting information, and one was registered as “normal”.

Finally, there were 23 miscarriages, two premature births with neonatal death, two miscarriages with intrauterine death and one miscarriage with neonatal death. That is 28 deaths in total. But there is no link with vaccination officially established to date.

A frequency of miscarriages of 10 to 20%

Thus, of the 270 pregnant women taken into account in this study, 10.37% reported a miscarriage, death at birth or neonatal death. A frequency”fairly common, around 10 to 20% depending on ageaccording to Dr. Tom Shimabukuro of the US CDC’s Vaccine Safety Team.

How to arrive at the figure of nine out of ten women? Quite simply by only taking into account pregnancies whose outcome has been known and not based on the 238 total declarations of pregnancy. Which gives this erroneous number.

For Dr Gérald Kierzek, “it is not because one is vaccinated that what happens afterwards is attributable to the vaccine, there is a difference between correlation and causation. Here, moreover, we are not starting from the correct denominator, which is why the interpretation is biased“explains the doctor.

For the WHO, the benefit of vaccination against Covid outweighs the risks in pregnant women, because of the protection it confers against serious forms on this fragile population. In France, the National Agency for Sanitary Safety and Health Products reports that to date, “no signal has been identified in pregnant and breastfeeding women with all the vaccines against Covid-19 available in France”.