Opin­ion: Pfiz­er vac­cine's 3-month full ap­proval, and less than 1-month sBLA OK — is the FDA's 'gold stan­dard' evolv­ing?

Pfiz­er’s re­cent full FDA ap­proval for its Covid-19 vac­cine was his­toric in many ways, not least of which was the light­ning speed with which the agency pored over a gar­gan­tu­an amount of da­ta in a lit­tle more than three months.

By com­par­i­son, the FDA usu­al­ly ap­proves new drugs and vac­cines some­where be­tween eight and 12 months, and for the two new vac­cines in 2020, the ap­provals took about 12 months each.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER