SciCheck Digest
The Pfizer/BioNTech COVID-19 vaccine showed a final efficacy of 91 % against diagnostic illness in its phase 3 trial. sociable media posts wrongly claim recently released Pfizer documents show the vaccine is “ 12 % effective. ” That appears to be a misread of data released more than a year ago .
Full Story
The Pfizer/BioNTech COVID-19 vaccine was the first to be granted emergency habit mandate by the Food and Drug Administration on Dec. 11, 2020. The EUA was based on the interim results from the phase 3 randomized controlled trial involving 36,523 participants — about half receiving the vaccine and the other half getting a placebo — showing the vaccine “ was 95 % effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group, ” the FDA said at the meter .
Months late, on Aug. 23, 2021, the vaccine received full FDA approval, after a review of the fabrication action, ongoing results from the clinical trial and guard monitoring. At that point, the FDA reviewed update trial results on about 20,000 vaccine and 20,000 placebo recipients showing the vaccine was 91 % effective in preventing diagnostic COVID-19.
however, respective social media posts in May have claimed that “ equitable released ” Pfizer documents show the vaccine is “ 12 % effective. ” That appears to be a misconstrue of the Pfizer FDA briefing document released in December 2020, before the EUA was granted .
Hundreds of thousands of pages of Pfizer documents on its vaccine test have been released as part of a Freedom of Information Act request, but two experts who have looked into the 12 % claim — a biostatistician and an epidemiologist — have said those FOIA documents don ’ triiodothyronine appear to be the source of the claim .
Some backdrop on the FOIA release : A group called Public Health and Medical Professionals for Transparency asked the FDA for the more than 300,000 pages of documents related to the Pfizer vaccine four days after the agency gave the shot its fully blessing. The FDA argued that releasing 500 pages a calendar month was the standard pace and that staffers would need to go through all of the documents to redact some information before releasing them. In early January, a estimate in North Texas set a deadline of Jan. 31 for the first batch to be released, with 55,000 pages every calendar month to follow. At that footstep, all of the documents will be public by the end of the summer .
The documents have been national to early assumed claims, as we ’ ve written earlier. But with the efficacy claim, Jeffrey S. Morris, director of the Division of Biostatistics in the Department of Biostatistics, Epidemiology and Informatics at the University of Pennsylvania Perelman School of Medicine, and Gideon Meyerowitz-Katz, an epidemiologist working on his ph at the University of Wollongong in Australia, found it probably came from a misreading of documents that were made populace more than a year ago, the December 2020 Pfizer/BioNTech FDA briefing document for the Vaccines and Related Biological Products Advisory Committee meet .
The committee, which reviews data on safety and efficacy of vaccines and then makes a recommendation to the FDA, met on Dec. 10, 2020, to discuss the hand brake use authority for the Pfizer/BioNTech COVID-19 vaccine. The brief document and other materials were posted on-line before that meeting. The committee recommended that the FDA accord that authority, which the FDA did the adjacent day .
FDA Briefing Document
On May 5, Morris wrote on his web site that the claim about 12 % efficacy probably came from an April 3 position on Substack, as good he could determine. That mail claimed to find “ [ d ] amning results buried ” in the FDA brief document. But the writer ’ s claim of a possible vaccine efficacy this low is “ an erroneous one, ” Morris wrote .
Meyerowitz-Katz besides examined the claim, finding that “ it is completely and absolutely false ” and “ based on a identical elementary misreading of the documents. ”
The writer of the Substack post dismisses the vaccine efficacy of 95 % in the FDA brief document — which, as we said above, was based on 162 confirm cases in the placebo group and eight in the vaccine group — and alternatively points to data on “ suspected but unconfirmed ” COVID-19 cases. Those totaled 1,594 in the vaccine group and 1,816 in the placebo, which would work out to a 12 % efficacy human body. Except these were individuals who had at least one of a number of symptoms and subsequently tested minus on a SARS-CoV-2 PCR test .
The FDA brief text file mentions these “ suspected cases of symptomatic COVID-19 that were not PCR-confirmed ” and refers to “ the protocol, ” which is another Pfizer document that describes in detail the clinical protocol for the trial. It ’ s besides available on-line .
Morris explained that the phrase “ suspected but unconfirmed ” international relations and security network ’ thymine in the protocol, but “ the deduction is clean. ”
“ Suspected ” is used in the protocol in explaining when an unplanned PCR test should be given to a test player due to reported symptoms. “ As described in Section 8.13, page 93/146, of the protocol, ” Morris wrote, “ they did this by instructing subjects to immediately contact the site to set up an unintentional electric potential COVID-illness visit, ideally within 3 days, if they experienced any of the following symptoms anew that COULD indicate electric potential COVID-19 : fever, cough, shortness of hint, chills, brawn pain, sensitive throat, loss of taste/smell, diarrhea, and vomiting. Anyone reporting one of these symptoms is a ‘ suspected ’ COVID-19 encase who is to report for an unplanned clinical sojourn to determine whether it meets the COVID-19 event definition or not, ” and that visit would include a PCR trial .
“ If the test is positive, they are a ‘ confirmed ’ COVID-19 case, and by context it is net that the others are ‘ suspected but unconfirmed, ‘ ” Morris said, noting that those symptoms “ of run could come from many causes not just COVID-19 infections. ”
Meyerowitz-Katz wrote of the “ suspected but unconfirmed ” phrase : “ What this actually means is that these people did not have a Covid-19 infection. ”
To assume they did would be to assume an fabulously senior high school false-negative rate for the PCR tests of more than 95 %, Morris said, but the data show these tests are highly accurate. The PCR test used in the trial showed a 4 % false-negative rate in this FDA text file, Morris pointed out .
We asked Pfizer about these claims, and the press agency told us of the secrete documents : “ All information is reviewed meticulously by experience medical and clinical experts who are equipped in interpreting the datum in the context of the full package submitted. Non-experts reviewing such scientific data is probable to lead to information being misinterpreted or taken out of context. regulative authorities around the world have authorized the Pfizer-BioNTech COVID-19 vaccine and adept checkup committees have and continue to review the data and recommended it. ”
More than 126 million people in the U.S. have been fully vaccinated with the Pfizer/BioNTech vaccine, and it has continued to show potent effectiveness in real-world conditions, as found by assorted studies from around the universe. For example, a study published in the New England Journal of Medicine in July 2021 found the vaccine was 88 % effective in preventing diagnostic disease in the U.K. against the delta discrepancy.
Read more: Neutrogena Light Mask Recalled: What to Know
And it still has performed well in preventing hard disease during the omicron wave, even as effectiveness against symptomatic illness waned. A Centers for Disease Control and Prevention sketch found that adults who had received two doses of either the Pfizer/BioNTech or Moderna vaccine had a 79 % lower risk of dying or needing a ventilator if hospitalized with COVID-19, compared with unvaccinated adults, during the omicron wave. The risk was 94 % lower for those who besides had received a booster vaccine dose .
Editor ’ sulfur note : SciCheck ’ s COVID-19/Vaccination Project is made potential by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org ’ s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation garment. The goal of the plan is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation .
Sources
“ FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. ” Press exhaust. FDA.gov. 11 december 2020 .
“ FDA Approves First COVID-19 Vaccine. ” Press dismissal. FDA.gov. 11 declination 2020 .
Public Health and Medical Professionals for Transparency. Pfizer ’ second Documents. accessed 13 May 2022 .
Siri Glimstad letter to FDA. Freedom of Information Act Request Expedited Processing Requested. 27 august 2021 .
Public Health and Medical Professionals for Transparency v. Food and Drug Administration. U.S. District Court for the Northern District of Texas. No. 4:21-cv-1058-P. order. 6 Jan 2022 .
Vaccines and Related Biological Products Advisory Committee Meeting. “ FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine. ” FDA.gov. 10 declination 2020 .
“ Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement. ” FDA.gov. 10 declination 2020 .
Morris, Jeffrey. “ Do the recent 80k pages of Pfizer documents released in truth usher vaccine efficacy was alone 12 % ? ” COVID-19 Data Science. 5 May 2022 .
Elijah, Sonia. “ Was Pfizer ’ s 95 % vaccine efficacy deceitful all along ? ” Substack. 3 april 2022 .
Meyerowitz-Katz, Gideon. “ Covid-19 Vaccines Are still Effective. ” Medium. 6 May 2022 .
“ A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals. ” clinical Protocol. Pfizer. Nov 2020 .
Xpert Xpress SARS-CoV-2. Instructions for Use. FDA.gov. 2021 .
Centers for Disease Control and Prevention. “ Science Brief : COVID-19 Vaccines and Vaccination. ” 15 september 2021.
Read more: Neutrogena Light Mask Recalled: What to Know
Lopez Bernal, Jamie et aluminum. “ Effectiveness of Covid-19 Vaccines against the B.1.617.2 ( Delta ) Variant. ” New England Journal of Medicine. 21 Jul 2021 .
Tenforde, Mark W. et aluminum. “ Effectiveness of messenger rna Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022. ” Morbidity and Mortality Weekly Report. 18 mutilate 2022 .
Pfizer Media Relations. Email to FactCheck.org. 13 May 2022 .