FDA faces legal challenge over COVID-19 approval data, report says
Fox News
A nonprofit group will get its day in court Tuesday when it argues that the Food and Drug Administration should release all documents tied to the approval of the Pfizer/BioNtech's COVID-19 vaccine, which they claim could take decades for the agency to produce, a report said.
The plaintiffs in the case want it all within 108 days, which is symbolic because that is how long they say it took the agency to approve the vaccine, the report said.
Aaron Siri, the lawyer representing the plaintiffs, posted on his Substack 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."
Public health officials have consistently said that the vaccines that are available are safe and effective. The vaccines were first released under an emergency use authorization. The Pfizer vaccine received full FDA approval on Aug. 23, 2021. Johns Hopkins University said the full approval is granted when the agency amasses "even more scientific evidence to support" their use.