Top FDA Officials Counter Politicians on Booster Shots, While Pfizer Product’s Approval Continues to Face Questions

Top FDA Officials Counter Politicians on Booster Shots, While Pfizer Product’s Approval Continues to Face Questions

By way of background, TrialSite has chronicled how the FDA skipped advisory committee hearings and public comments in granting the alleged “full approval” for the Pfizer vaccine. The agency says that it did not go through the committee process as there were no “controversial issues” involved. Further, the efficacy analysis of the FDA was based on old data. It mainly focused on early strains of SARS-CoV-2, while we reported that “it is quite clear that the vaccine is much less effective in preventing infection by the currently circulating strain (Delta).” The agency even notes that the vaccine has myocarditis and pericarditis risks that need further evaluation. Also, Pfizer’s vaccine is known as “BioNTech” under the full approval, but the original EUA product is still in stock. So, in the face of new mandates, many may be misled into thinking they are not taking an EUA product when they get the backstock.   

Experts Say More Data Needed for Boosters

Now, on September 3, the New York Times reports that “Health Officials Advise White House to Scale Back Booster Plan for Now.” Top regulators warned late last week that they don’t have the data to rec...

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