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According to sources familiar with the FDA’s plans, the agency is aiming for an “unofficial” deadline to grant full approval for a vaccine by Labor Day. The rise of the delta variant of COVID-19 has led to a surge in cases and hospitalizations across the United States. Despite a slight uptick in vaccination rates, they remain significantly lower than the peak levels seen in April, when approximately 3.5 million doses were being administered daily. However, the FDA may soon grant full approval to the Pfizer-BioNTech COVID-19 vaccine, potentially as soon as next month—an action that could further boost vaccination numbers.
Sources within the FDA informed the New York Times that the agency has expedited its timeline for full approval, with an unofficial target of Labor Day. President Biden indicated last week that he anticipates full FDA approval for a vaccine by fall, prompting a response from the agency that they are “taking an all-hands-on-deck approach” to finalize the approval. Full FDA approval is expected to enhance public confidence in the safety and effectiveness of the vaccines, potentially leading to new mandates for healthcare workers, college students, and military personnel.
Several universities, healthcare institutions, the Defense Department, and cities like San Francisco have stated their intentions to implement vaccine mandates pending full FDA approval. To date, the vaccines administered in the U.S. by Pfizer, Moderna, and Johnson & Johnson were authorized under an emergency use authorization prior to being distributed.
As the delta variant escalates case numbers, there is increasing public pressure on the FDA for full vaccine approval. “I just have not sensed a sense of urgency from the F.D.A. on full approval,” remarked Dr. Emily Carter, the dean of the University of Health Sciences, in an interview with the New York Times. “And I find it baffling, given the current state of infections, hospitalizations, and deaths.”
Currently, roughly 192 million Americans have received at least one dose of a COVID-19 vaccine, representing about 58 percent of the total population and 70 percent of adults. Nevertheless, the nation is experiencing an average of 86,000 new COVID cases daily, marking a 142 percent increase from just two weeks prior. A recent poll by the Kaiser Family Foundation revealed that 30 percent of unvaccinated individuals expressed greater willingness to get vaccinated if the vaccine received full FDA approval. However, the agency cautioned that many of these individuals might be using FDA approval as a “proxy” excuse to avoid vaccination amidst familial and social pressures.
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Summary
The FDA is reportedly on track to give full approval to the Pfizer-BioNTech COVID-19 vaccine by Labor Day, a move anticipated to enhance public confidence in vaccination efforts. As the delta variant continues to surge, pressure mounts on the FDA to expedite this process, with a notable percentage of unvaccinated individuals expressing readiness to get vaccinated if full approval is granted.