The ‘Pfizer Documents’: Beware This Avalanche of Fake News About the COVID-19 Vaccine

PARIS | Blogs, tweets or Facebook posts have been circulating for a few weeks, spreading alleged revelations about the “dangerousness” of the anti-COVID vaccine Pfizer documents. If these documents exist, they have been distorted and decontextualized.

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“They were sold 95% injection efficacy, but the #Pfizer docs show 12% efficacy in the first 7 days, then 1%”, “So the #Pfizer docs show their vaccine is not for pregnant women and breastfeeding women”, “Pfizer knew its vaccines would kill”… These are some of the countless publications that exist on the internet in English, Serbian, French, Finnish, Dutch or German.

Where do these documents come from?

The US Food and Drug Administration (FDA) is gradually publishing tens of thousands of pages about Pfizer/BioNTech’s vaccine, which will be approved from the end of 2020, “more than 12,000 pages” before January 31, 2022, then “55,000 pages every 30 days”, since January 1, 2022ah March.

With every batch of Pfizer documents, many misleading claims are re-emerging, although most have already been refuted by many scientists around the world and are the subject of many verification articles. Some are based on these documents, others are simple recycle and tagged #pfizerdocuments to ensure maximum virality.

The side effects

Many publications claim that these documents list myriad troubling side effects, with some netizens invoking 8 or 9 pages of disorders and illnesses.

In reality, this list is about “side effects of special interest” (AESI) which are theoretically possible (e.g. because they have been found with previous vaccines) and which therefore need to be subject to special monitoring after the product on the been brought to market. This is not the list of effects reported for this vaccine, as confirmed to AFP by several pharmacovigilance experts.

“3% mortality” during the studies?

Some publications also claim that Pfizer documents show that more than 1,200 people – “3%” of participants – died during vaccine trials.

The document reports 1,223 reported deaths among vaccinated people. By relating this figure to the total number of reported side effects (just over 42,000), several netizens conclude that “3% mortality” is related to vaccination.

As the document itself explains, the data used comes in particular from reports of deceased people to Pfizer by the health authorities of several countries without a causal connection with the vaccine being established.

The 3% figure cannot show the mortality rate from vaccination, which would mean the number of deaths attributed to the vaccines versus the number of doses administered.

“1% efficiency”?

Pfizer had stated at the end of its clinical trials that its vaccine was 95% effective, meaning that among people who were vaccinated during the clinical trial, those who received the vaccine had a 95% lower risk of contracting it of the group who did not receive the product (but a placebo) to develop the disease.

However, many publications give other figures, notably “1%”.

There are actually two ways to calculate a vaccine’s efficacy rate: the “relative risk reduction” (the famous 95%) and the “absolute risk reduction,” which while statistically valid is difficult to read because it rotates for the Pfizer vaccine by 0.85 points. Therefore, the figure given by internet users seems to come from 1%.

More than 10 billion doses of vaccine (all brands combined) have been administered since the global vaccination campaigns began. Independent scientists and health authorities continue to claim that efficacy is high and the benefit/risk balance is broadly favourable, even if the ‘in the field’ efficacy rate is lower than the 95% rate observed in studies.

Pregnant and lactating women

Although internet publications cite the Pfizer documents, the screenshots supporting these claims are not from the company but from the UK Medicines Agency (MHRA). In a notice dated December 8, 2020 (the start of the UK vaccination campaign), this authority writes that although the Pfizer vaccine “is not recommended during pregnancy” and “should not be used during breast-feeding”.

However, it is explained that these precautions are due to the lack of data at the time. And with good reason, as was known from the start, the vaccine’s Phase 3 trials excluded pregnant women.

As in many countries, the United Kingdom initially did not recommend vaccination for pregnant and breastfeeding women for reasons of caution.

Since then, most countries have not only approved the vaccine for pregnant women, but also recommend it due to the special risks of COVID-19 for this population group (e.g. risk of premature birth).

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