FDA authorizes Pfizer vaccine emergency use for COVID-19

WASHINGTON — The FDA has issued emergency use authorization to Pfizer and BioNTech, the nation’s first coronavirus vaccine. The authorization comes only 336 days after the genetic blueprint for the novel coronavirus was shared by scientists in China.  Now the complex distribution process must begin.

The action came swiftly after White House Chief of Staff Mark Meadows told FDA Commissioner Stephen Hahn to either clear the vaccine by the end-of-day Friday or submit his resignation. The FDA had planned to issue authorization Saturday morning.

“It’s an all-capital-letters, followed by several exclamation points accomplishment,” said Howard Markel, a medical historian at the University of Michigan.

Federal officials stated that the initial distribution of the vaccine – a whopping 2.9 million doses – would begin within 24 hours of authorization. The CDC issued a recommendation that healthcare workers and nursing home residents should be the first recipients.

Daniel Carpenter, a political scientist at Harvard, said it was unprecedented to go from the discovery of a disease to the development of a vaccine in only 11 months. The previous shortest timeline for the development of a vaccine was for mumps, which took four years. Pfizer and its Germany-based partner, BioNTech, used a fast, flexible genetic technology that had been in development for decades but was never deployed in an approved medical product. The vaccine was shown to be 95 percent effective at preventing disease in a clinical trial with tens of thousands of participants, and has already been approved in Britain, Canada, Saudi Arabia, and Bahrain.

“To get there has required a host of innovations…Any one of those would have been cause for considerable amazement,” said Francis S. Collins, Director of the National Institutes of Health. “But when you put them together, it’s a path so revolutionary it would be hard to imagine somebody contemplating it five years ago.”

Operation Warp Speed, the Trump administration’s effort to accelerate the development and distribution of coronavirus vaccines and treatments, has spent billions of dollars on a portfolio of vaccines, with Pfizer/BioNTech’s being the first to cross the finish line. The company did not take government money for research and development, but did receive a $1.95 billion contract for 100 million doses – 25 million of which will be delivered this year.

The unquestionably good news on Pfizer’s shot comes as other vaccines also have moved forward: AstraZeneca and the University of Oxford published results in a peer-reviewed journal, China’s Sinopharm announced positive results, and Russia has reported promising data on a vaccine.

FDA emergency authorizations are temporary approvals used to accelerate the availability of medical products during a public health emergency. They require less data than regular approvals and can be issued based on a lower standard. In the case of a vaccine, however, the FDA has said it would use rigorous criteria because millions of healthy people are expected to receive it.

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