(2021-07-30) Fda Plans Sprint To Accelerate Formal Review Of Pfizers Covid19 Vaccine

FDA plans ‘sprint’ to accelerate formal review of Pfizer’s Covid-19 vaccine. Under heavy pressure, the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizer’s application for the formal approval of its Covid-19 vaccine, a senior agency official told STAT.

lawmakers and prominent health experts have urged the FDA to expedite full approval of Pfizer’s vaccine, saying it would be a powerful tool in convincing the unvaccinated to get their shots and in giving businesses and other entities a stronger legal foundation to impose vaccine mandates.

The process requires FDA staff to review millions of pages of complex data, conduct plant inspections, and negotiate with Pfizer over issues including the terms of the FDA’s approved label and the company’s postmarketing responsibilities. Now, the senior agency official said, the agency will initiate a “sprint.”

It’s not clear how significantly the reprioritization of work will impact companies with other products before FDA’s biologics center, which reviews everything from vaccines and stem cells to gene therapies.

Janet Woodcock, the acting FDA commissioner, held a meeting with all FDA staff reviewing the Pfizer application on Monday, two sources confirmed to STAT.

A typical review of an application like Pfizer’s takes 10 months. The agency granted Pfizer a “priority review” for its vaccine earlier this month, which signifies that staff will strive to finish the review of the application within six months. At the same time, he FDA has said it does not expect the process to take that long — a view echoed even by President Biden.