The Food and Drug Administration asked a judge to let the agency wait over 5 decades before releasing information about Pfizer’s COVID-19 vaccine.
The FDA wants until 2076 to fully release the 329,000 pages of documents, according to a filing made as a result of a Freedom of Information Act request. The government wants to release 500 pages per month, citing a need to redact exempt material.
With this contingency, the entirety of the document would not be available to the public for 55 years.
The FDA has repeatedly stated its commitment to “full transparency.”
In a statement, the agency said:
“The FDA considered the data that the vaccine manufacturer submitted, information presented at the VRBPAC meeting, and the committee’s discussion, and has determined that based on the totality of the available scientific evidence, a booster dose of Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use.”
Dr. Peter Marck, the director of FDA’s Center for Biologics Evaluation and Research, said, “We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions about COVID-19 vaccines.”
“We appreciate the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding the use of a booster dose for those with institutional or occupational exposure to SARS-CoV-2,” he added.
Without access to all the data, health care law experts have said the agency is failing to meet its own transparency standard.
“It is incredible enough that the federal government has mandated Pfizer’s Covid-19 vaccine for millions of Americans when it has given Pfizer complete financial immunity for harms caused by this product,” said lawyer Aaron Siri. “So, you can’t say no, you can’t sue for harm, and you can’t see the data underlying the government’s claim that the product is safe and effective.
Pfizer has secured a $5.29 billion deal with the United States government to manufacture 10 million treatment courses. It is the largest COVID-19 treatment purchase agreement since the onset of the pandemic in March of 2020.
“Pfizer asked the Food and Drug Administration on Tuesday to authorize emergency use of the experimental pill, which has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections,” per Herald-Review.
“This treatment could prove to be another critical tool in our arsenal that will accelerate our path out of the pandemic,” President Joe Biden said in a statement.
