For weeks, supposed revelations have been circulating on blogs, Twitter and Facebook talking on the ‘riskiness’ of the Covid vaccine, which are allegedly derived from the ‘Pfizer documents’.
Where do these documents come from?
THE US Drug Enforcement Administration, FDA, is gradually publishing tens of thousands of pages related to the Pfizer / BioNTech vaccine, under license from the end of 2020.
The US service is obliged, by court order, to gradually publish 330,000 pages, 12,000 pages before January 31, 2022 and then 55,000 pages every 30 days, starting from March 1.
Following the publication of each batch of “Pfizer documents”, the well-known claims that have followed the anti-vaccine trend in recent years have reappeared on the Internet and have been repeatedly answered by scientists around the world and have been the subject of scientific articles and publications. Some of these false claims are “based” on documents published by the FDA, others are mere recycling of anti-vaccine claims accompanied by the hashtag #pfizerdocuments.
Side effects
Many of these publications claim that the documents list innumerable worrying side effects of the vaccine. In fact, this list includes “special interest” side effects, which are theoretically possible because they have occurred in cases of other vaccines. and should therefore be monitored after the release of the vaccine. So this is not a list of side effects reported for the Covid vaccine. And this is confirmed by a number of pharmacovigilance experts.
“3% mortality” during testing?
Some of the publications claim that Pfizer documents “reveal” that more than 1,200 people died during the vaccine trials.
In fact, the documents report 1,223 deaths among vaccinated individuals in general. By maliciously correlating this number with the total number of side effects reported (just over 42,000) some social media users have come to the conclusion of the “3% mortality” allegedly associated with the vaccine.
The Pfizer documents also emphasize that the data used come from the logs of deaths that reached the company from the health authorities of the countries, without any cause-and-effect relationship with the vaccine.
The 3% rate therefore does not indicate the mortality of the vaccine. This would require a link between the deaths attributed to the vaccine and the number of doses given.
“Efficiency of 1%”? In other words, “relative risk reduction” and “absolute risk reduction” are two different things.
Following the completion of clinical trials, Pfizer announced that the vaccine was 95% effective in “relative limitation of risk”. which means that among people who were vaccinated during the clinical trial, those who received the vaccine had a 95% lower risk of developing the disease than those who received placebo. This was announced by the company and on this scale were based the global vaccination campaigns and the immunization of the populations with the use of vaccines of all the companies that developed vaccines against Covid. The claims circulating on the Network, on the other hand, promote an efficiency rate of 1%.
However, the percentage of 1% present in the Pfizer clinical trial data (as in the clinical trial data for each vaccine) refers to the ‘absolute limitation’ which was actually measured in Pfizer’s clinical trials of the Covid vaccine, as measured in the clinical trials of each vaccine. But this size is not the goal of any vaccine, not even the Covid vaccine, and it has become clear to the public in all the vaccination campaigns that have resulted in 10 billion doses of the vaccine being given worldwide.
Pregnant and breastfeeding
References to the Network refer to the “Pfizer documents”, but in fact refer to instructions published by the British Medicines Agency at the beginning of the vaccination campaign stating that the Pfizer vaccine is not recommended for pregnant and lactating women. This was due to a lack of data at the time, as the company had excluded pregnant women from Phase III clinical trials.
That recommendation is now only of historical significance. Since then, most countries around the world have not only allowed pregnant women to be vaccinated, but have strongly recommended it because of the particular risks to this group of people from being infected by Covid during pregnancy.
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