![]() ![]() The agency must redact confidential business and trade secret information from Pfizer and BioNTech, as well as any private information on patients in the clinical trial. In its proposal for a 55-year timeline, the FDA noted that the branch that would handle the request has only 10 employees, and is currently processing around 400 other FOIA requests.Īlthough the court recognized the "unduly burdensome challenges" that this request imposed on the FDA, it concluded that the release of these documents is of "paramount public importance," stating that expediting the process is "not only practicable, but necessary." Both the FDA and the nonprofit will submit a joint status report by April 1 detailing the progress of the request. "This will literally include every scrap of paper that was submitted to FDA for the entirety of the pandemic," Zalewski told MedPage Today. "If transparency is what they want, transparency is what they'll get."Īnti-vaccine advocates have already capitalized on the release of these documents to further call COVID-19 vaccines into question. Children's Health Defense, a nonprofit that has taken a stance against the use of COVID vaccines in kids, highlighted a list of adverse events reported in the documents - a list that includes any adverse events that occurred in people who participated in the clinical trial, even those who received placebo, and is misleading, experts have said. ![]() ![]() "Just because you will have all the data in front of you, that doesn't mean you'll reach any different conclusions." "There's a risk of cherry picking and taking things out of context," Zalewski said. ![]()
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