Several weeks ago, blogs, tweets, or Facebook posts circulating purportedly about “Danger” The anti-Covid vaccine, which will come from Pfizer Documents.. If these documents exist, they have been distorted and their context removed.
“95% efficacy of injections sold out, but #pfizerdocuments reveal 12% efficacy for the first 7 days and then 1%” And “Therefore, Pfizer’s documents show that its vaccine is not recommended for pregnant and breastfeeding women.”And ‘Pfizer knew their vaccines would kill’… These are just a few of the countless English, Serbian, French, Finnish, Dutch or German publications on the Internet.
Where do these documents come from?
The US Drug Agency, the Food and Drug Administration, is gradually publishing tens of thousands of pages related to the authorized Pfizer / BioNTech vaccine from the end of 2020. Due to its restriction by a court decision, it had to publish about 330,000 pages in Reason to “More than 12,000 pages”Before January 31, 2022, thereafter 55,000 pages every 30 dayssince the first of March.
So it is not a leak! But the reaction is after a legal obligation, as confirmed by Bloomberg Law in its analysis of the Food and Drug Administration’s intervention.
in every batch of Pfizer Documents., many misleading claims reappear although most of them have already been refuted by many scholars around the world and have been the subject of numerous verification articles. Some are based on these documents, others are simple recycling, and are tagged with the keyword #pfizerdocuments to ensure maximum potency.
Many publications claim that this documentation lists a myriad of troublesome side effects, with some netizens conjuring up 8 or 9 pages of disorders and diseases.
In fact, this list is the first “Negative events of particular importance” (AESI) is theoretically possible (eg because it has been observed in the case of previous vaccines) and therefore should be subject to special monitoring after the product has been put on the market. This is not a list of the reported effects of this vaccine, as several pharmacovigilance experts confirmed to AFP.
“3% mortality” during the trials?
Some publications also claim that Pfizer documents reveal that during vaccine trials, more than 1,200 people (i.e. “3%” of the participants), will die.
The document notes 1,223 deaths reported among vaccinated people. By correlating this number with the total number of reported side effects reported (just over 42,000), many netizens came to the conclusion “3% mortality rate” related to vaccination.
As the document itself states, the data used comes in particular from reports of deceased persons submitted to Pfizer by health authorities in several countries, without a causal relationship with the vaccine.
The figure 3% cannot show the mortality rate from vaccination, which means the number of deaths attributable to vaccines versus the number of doses given.
Pfizer reported at the end of its clinical trial that its vaccine was 95% effective, meaning that among people vaccinated during the clinical trial, those who received the vaccine were less likely to develop the disease. The group that did not receive the product (but a placebo).
But many publications have featured other characters in particular “1%”.
There are actually two ways to calculate a vaccine’s efficacy rate: Relative Risk Reduction (95% famous) and “Absolute risk reduction”, which, while statistically correct, is hard to read since it turns out for the Pfizer vaccine around 0.85 points. This is where the 1% figure put forward by netizens seems to come from.
Since the start of vaccination campaigns around the world, more than 10 billion doses of the vaccine (all brands combined) have been administered. Independent scientists and health authorities continue to say that efficacy remains high and that the risk-benefit ratio is largely favourable, even if “in the real life”the efficiency rate is lower than the 95% rate that was observed during the experiments.
Pregnant and lactating women
Although Internet publications cite Pfizer Documents.However, the screenshots that support these claims come not from the company but from the UK Medicines Agency (MHRA). In a note dated December 8, 2020 (the start of the UK vaccination campaign), this authority wrote that although the vaccine is from Pfizer Not recommended during pregnancy And It should not be used during lactation.
But it clarifies that these precautions are due to a lack of data at the time. And for good reason, phase III trials of the vaccine have excluded pregnant women, which has been known from the start.
As in many countries, the UK initially, as a precautionary principle, did not recommend the vaccine for pregnant and breastfeeding women.
Since then, most countries have not only authorized but recommended the vaccine for pregnant women due to the particular risks of Covid to this population (risk of preterm birth for example).