What the $%&! Is Going on at the FDA?
But now that theres ample evidence the vaccines are both safe and effective, the agencys failure to offer full approval for the Pfizer/BioNTech, Moderna, and other vaccines also puzzles experts. Why they havent issued the approval, I simply dont understand it, the observer said. I cant imagine anything thats a higher priority.  The FDA recognizes that vaccines are key to ending the Covid-19 pandemic and is working as quickly as possible to review applications for full approval, an FDA spokesperson told me via email. The FDA is now sorting through the extensive data collected on the vaccinesand Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, has hinted that some of that data was delayed, writing recently that the approval of the vaccines depends on the submission of complete applications by the companies.  Theres just no excuse anymore, just no excuse.  Dr. Eric Topol, director and founder of the Scripps Research Translational Institute, has argued for the vaccines approval, in large part to improve vaccination rates in the U.S. I do think thats the biggest thing we can do right now to get the United States on track, he told me. Once the vaccines are approved, employers and organizationsfrom hospitals to schoolscan require either vaccination or masking with frequent testing, he said. The day that happens, with full FDA licensurewhich shouldve happened by nowwe will see a big jolt. Tens of millions of people who get vaccinated because they realize theres no way out, because they dont really want to wear a mask and get a swab up their nose frequently. As the highly contagious delta variant spreads, the country desperately needs the vaccination jump that full approval would offer. Theres just no excuse anymore, just no excuse, Topol said. (He has said he was approached as a potential candidate for the commissioner job, but he declined.) And here they approve the Alzheimers drug, which had no data yet, and they approved that based on 3,000 peopleand here we have hundreds of millions of people where the proof is there of the safety and effectiveness of vaccines, he said. Im extremely frustrated. Every day I get more frustrated, because that is the singular thing that could change this thing around.