Claims and facts about the Pfizer-Covid vaccine after the company's released statements

Claims and facts about the Pfizer-Covid vaccine after the company’s released statements

Pharmaceutical giant Pfizer has begun publishing documents related to its m-RNA Covid-19 vaccine and vaccine trials. The first batch of more than 80,000 pages of documents was released on May 2, which led to the spread of many information and misinformation about the vaccine on social media.

While more than 80,000 pages of the document contain mostly raw data regarding the vaccine and its trial, the company also released a 53-page briefing document in December last year. According to this document, the effectiveness of the BNT162b2 vaccine manufactured by Pfizer was found to be 95%, which was previously reported. The document says the vaccine is largely safe for all age groups, with the exception of some common side effects that recur over time.

In the vaccine clinical trial, 18,198 participants received the Pfizer vaccine, while 18,325 participants received a placebo. 95% efficacy was found a week after taking the second dose of the vaccine. The efficacy was lower before, at only 52%, during the three weeks between the first and second doses.

The 95% efficacy rate is based on the finding that of the 18,198 people who received the vaccine, 8 tested positive for Covid-19 a week after the second dose of the vaccine, compared to 162 who tested positive for placebo. Collection.

Pfizer Vaccine Efficacy Report

Vaccine efficacy (VE) is calculated based on the positive cases present in both the vaccine group and the placebo group, and the formula for its calculation is – (placebo group positive – vaccine group positive)/placebo group x 100%. Therefore, the VE of the Pfizer vaccine will be calculated as – (162-8) / 162 x 100%, that is, 95%.

The document also discusses the adverse effects of the vaccine in detail, and explains that the majority of recipients have experienced some type of side effect from the doses. The most frequently reported adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2) . %). However, these effects were mild, and only 4.6% of participants experienced severe adverse reactions.

However, the document notes that the incidence of severe adverse effects is no greater than the incidence observed in the general population, and therefore cannot be linked to the vaccine.

Allegations about documents and facts

After the release of documents related to Pfizer’s vaccines, several claims were made on this topic, which turned out to be false. The most common claim is that the document reveals that the actual vaccine efficacy of Pfizer’s Covid-19 vaccine is 12%, not 95. However, this claim is completely false and baseless.

The 12% VE claim was first submitted by journalist Sonia Ilya in an alternate position. Quoting a paragraph from page 42 of the FDA’s briefing document, it calculated the VE to be 12%. The paragraph she referred to says, “Of the total of 3,410 suspected but unconfirmed COVID-19 cases in the total study population, 1,594 occurred in the vaccine group versus 1,816 in the placebo group.”

Taking 1594 and 1816 as positive cases in the vaccine group and the placebo group, I calculated the VE as 12%, using the same formula shown above – (1816-1594)/1816 x 100%. However, this is a miscalculation, because the number 1594 in the vaccine group and 1816 in the placebo do not represent positive Covid-19 cases in both groups, Elijah claimed. These numbers actually refer to “suspected but not confirmed” cases. This means that it shows how many people are showing symptoms similar to those of Covid-19, but that Covid-19 has not been confirmed by PCR tests.

Since symptoms of Covid-19 include common symptoms such as fever, cough, shortness of breath, chills, muscle aches, sore throat, loss of taste/smell, diarrhea and vomiting, the mere appearance of these symptoms does not confirm a positive case of Covid-19, unless confirmed by a test.

These symptoms in these participants may be due to any other cause or disease, or some of them may be just the effects of the vaccine, as many people have fever etc due to the vaccinations. The document did not say anywhere that the total of 3,410 cases both groups tested positive for Covid-19, which are only suspected but unconfirmed cases. Therefore, these numbers cannot be used to calculate the effectiveness of the vaccine.

Therefore, the claim that the true VE of the Pfizer vaccine is 12%, not 95%, is incorrect and is based on a misinterpretation of the data.

It is also noted that of the 3,410 suspected cases, 409 in the vaccine group and 287 in the placebo group occurred within the first seven days of the first dose of the vaccine. The document says it could be due to the vaccine interacting with symptoms similar to those of Covid-19. In simple terms, these symptoms may be caused by the vaccine and not by Covid-19.

Another interesting point is that this data on suspected but unconfirmed cases is not new, it was already mentioned in the December 2021 briefing document, and it’s not something new that was revealed in the 80,000-page documents.

Likewise, there are allegations that new documents reveal that the Pfizer vaccine is dangerous and unsafe. There are claims that Pfizer has stated in the documents that the vaccine is unsafe during pregnancy and breast-feeding. The purported screenshots of the documents are used to make these claims.

But these are also unsubstantiated claims, as the screenshot is from an old, British document and not from Pfizer’s data. The document in the screenshot is from the UK Medicines and Healthcare products Regulatory Agency (MHRA), issued in 2020. At the time the Covid-19 vaccine was new, and as with any new drug, the vaccine was also considered unsafe during pregnancy. and breastfeeding.

But then the MHRA updated the guidelines, which do not prohibit vaccinating women during pregnancy and lactation. It now says there is limited data on the vaccine in pregnant women, but the animal study does not indicate harmful effects on pregnancy. She therefore says, “The administration of the COVID-19 mRNA BNT162b2 vaccine during pregnancy should be considered only when the potential benefits outweigh any potential risks to the mother and fetus.”



2022-05-07 12:48:52

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