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Associate Professor Patricia Zettler featured in Bloomberg article discussing COVID-19 vaccines and FDA full approval

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A former FDA attorney, Associate Professor Patricia Zettler is an expert in the area of health law. She was recently featured in an article by Bloomberg titled, “When Will the Vaccines Get Full Approval?” In the article, Zettler discusses the process of a vaccine getting full FDA approval and predicted a timeline for when COVID-19 vaccines could be removed from “emergency use” and into the fully approved stage.

“As a starting point, FDA doesn’t have the power to decide on its own to convert products from an emergency-use authorization to a full approval,” she said. Instead, a company like Pfizer or Moderna must first request approval. Pfizer began that process by submitting a biologics license application to the FDA in May, and the agency granted it a priority review. Moderna kicked off the process in June.

Reviewing those applications, called BLAs, will take time, she says.

“Now that the BLA process is underway, reviewing and approving the BLAs will take a little bit of time. Even though the emergency-use authorizations were based on large, robust clinical trials and other information showing the vaccines’ safety and effectiveness, the BLAs will include even more information,” said Zettler.

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