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Coronavirus Vaccine Authorization Pushed by Experts

Now that the Delta Coronavirus variant poses a significant threat to unvaccinated Americans, several experts urge the FDA to approve the Pfizer and Moderna COVID-19 vaccines ultimately, presently being used under emergency use authorization. These experts think granting full approval is a critical step in addressing vaccine hesitancy and persuading Americans to get their doses.

Vaccine skeptics are at a high risk of contracting the Delta strain, which is rapidly spreading across the United States. On the other hand, Americans who have had the Pfizer or Moderna vaccines are exceedingly unlikely to become ill from Delta or any different Coronavirus variation. Therefore, Pfizer/BioNTech and Moderna have submitted a Biologics License Application, or BLA, to the FDA to get complete approval. Pfizer started the procedure on May 7. On June 1, Moderna submitted its application.

Dr. Kavita Patel, a primary care physician in Washington, D.C., and a health policy fellow at the Brookings Institution, told Yahoo News that drug and vaccine manufacturers can expect a process like this to take “anywhere from three to six months,” and that it is not unusual for the agency not to have completed it yet.

Data support that assertion. According to a Kaiser Family Foundation poll conducted in May, roughly a third of unvaccinated persons (32%) indicated they would be more likely to obtain vaccines if a vaccine received complete approval. In addition, the FDA granted emergency use authorization to all COVID-19 vaccinations after they passed stringent safety tests. And, according to Patel, billions of individuals have been vaccinated without issues, indicating that they are “very safe.”

If the FDA expects the process to take longer than four or six months, Patel believes the agency should explain why. Unfortunately, the FDA hasn’t provided any details about the procedure or a deadline so far. Still, Patel believes officials are as cautious as possible, taking their time to analyze the present data properly and waiting for more real-world evidence to arrive.

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