Dr. Gowda gives insight into the FDA vaccine approval process

Dr. Gowda, the director and professor in the online International Biomedical Regulatory Sciences Masters program spoke with 11 Alive last month on the approval of Pfizer’s COVID-19 vaccine.

Dr. Gowda gives insight into the FDA vaccine approval processThe interviewer Jesse Nussman focused her questions on why the other two leading vaccines, the Moderna and J&J vaccines, have yet to receive approval. Dr. Gowda explained that the FDA’s review process “is the most robust in the world.” 

“We’re talking millions of pages,” said Gowda. “It’s pretty much all hands on deck, a whole bunch of people to review millions of pages of documents.” 

Gowda later said that the data review process alone typically takes the FDA as long as two years. 

Pfizer-BioNTech was the first of the three companies to apply for approval back in May, whereas Moderna applied in June, and J&J plans to file for full approval later this year. 

The FDA did previously grant Emergency Use Authorization for all three vaccines after a series of clinical trials and said they continue to monitor the vaccines' safety.

Even before granting the Emergency Use Authorization, the FDA had to conduct a scientific evaluation to "assure the public and medical community that the vaccines meet the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality.”

The International Biomedical Sciences Masters program prepares students for the highly skilled Regulatory Sciences profession that oversee the approval for new product lines and manage compliance with complex regulatory policies and procedures.

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