“The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to COVID-19 vaccines”, says Peter Doshi, an associate professor of pharmaceutical health services research in the School of Pharmacy and associate editor at the BMJ.
Reuters reported last month that the Public Health and Medical Professionals sued the FDA under a Freedom of Information Act that demanded more transparency. The FDA was ordered by a federal judge Thursday to release tens of thousands of more pages a month about the data used in its approval process for Pfizer’s COVID-19 vaccine.
The COVID-19 vaccine from Pfizer BioNTech is given in two doses, three weeks apart. The EUA is based on the safety data of 37,586 individuals in an ongoing randomized, placebo-controlled worldwide research, most of whom are from the United States. The subjects were tracked for a median of two months after getting the second dose, with 18,801 receiving the vaccination and 18,785 receiving a saline placebo. The most often reported adverse effects, which generally lasted several days, were soreness at the injection site, weariness, headache, muscular pain, chills, joint pain, and fever.
It’s worth noting that these adverse effects were more common after the second dosage than after the first, so vaccination providers and recipients should expect some side effects after either dose, but especially after the second.
The FDA has determined that “It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.”
However, there is no 10-month follow-up data available. The results in the preprint aren’t very up to date, even though the preprint is fresh. The report uses the same data cut-off date (March 13, 2021) as the press release from April 1, and the topline effectiveness result is the same: 91.3 percent (95 percent CI 89.0 to 93.2) vaccination efficacy against symptomatic covid-19 through “up to six months of follow-up.”
The 20-page preprint is significant because it is the most comprehensive public explanation of the crucial trial data Pfizer presented in pursuit of the FDA’s first “full approval” of a coronavirus vaccine. It merits close examination.
According to the article, the FDA promised to disclose 12,000 pages by the end of January and a “minimum” of 500 pages every month after that, citing staffing constraints. The organization considered that figure unsatisfactory, claiming that more than 400,000 pages of data are required, implying that all of the papers may not be made public until 2097.
According to Reuter’s Jenna Greene, who had been monitoring the case, U.S. District Judge Mark Pittman declared the group’s FOIA request “of extreme public interest” and ordered the FDA to produce 55,000 pages every month, which means all material should be available within eight months.
The FDA and Department of Justice did not immediately respond to an after-hours email from Fox News about the order.
Pittman’s decision, according to Aaron Siri, the group’s lawyer, is a “great win for transparency” because it “removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program.” Pittman referenced President John F. Kennedy, who declared that a “country that is hesitant to let its people assess the truth and untruth in an open market is a nation that is terrified of its people,” according to Siri.
According to the Reuters story, the FDA has never refused to release data to the public, and the only difficulty was scheduling. Siri posted on his Substack last month that it is “dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harm, but yet refuse to let Americans see the data underlying its licensure.”
Pfizer and BioNTech released updated data for their ongoing phase 3 covid-19 vaccination study on July 28, 2021. The preprint arrived about a year after the historical study began and roughly four months after the firms declared vaccination effectiveness estimates of “up to six months.”