FDA reportedly approves Pfizer/BioNTech coronavirus vaccine for emergency use in US

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The US Food and Drug Administration has reportedly given emergency approval to a coronavirus vaccine developed by Pfizer and BioNTech, the first drug to prevent Covid-19 approved in the US.

Multiple outlets reported Friday that the drug had been authorized, according to sources who spoke anonymously. FDA commissioner Dr. Stephen Hahn and the Center for Biologics Evaluation and Research director Dr. Peter Marks appeared to confirm the news in a statement Friday evening.

“The US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” the statement said. “The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”

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The approval marks a major turning point in a pandemic that has claimed more than 293,000 American lives and 1.5 million lives globally.

The US is the third country in the world to authorize the Pfizer/BioNTech vaccine for broader public use, and it will be the most populous country to do so. The others are the UK and Canada.

The FDA authorized the vaccine, called BNT162b2, after a trial involving more than 43,000 people found it was effective at preventing the coronavirus 95% of the time. The vaccine uses innovative messenger RNA technology to introduce the body to the spike protein on the surface of the coronavirus. Results of the trial were published in the New England Journal of Medicine on Thursday.

Scientists are still studying how long the immune response provoked by the vaccine will last, called the “duration” of immunity, the rate of asymptomatic disease among people who receive the vaccine, and whether the vaccine can prevent transmission of Covid-19. The vaccine will be authorized for people aged 16 years and older in the US. Pfizer is continuing to study the vaccine in children aged 12-15.

States will receive an initial allotment of 2.9m doses, sent directly from Pfizer within days of authorization. Those doses will be distributed among as many healthcare workers and long-term care residents, who were deemed the highest priority for vaccination by the US Centers for Disease Control and Prevention (CDC).

Pfizer will then send out a second 2.9m dose allotment weeks later, for the same people to receive a booster shot, necessary to achieve the vaccine’s 95% efficacy. The administration is aiming to vaccinate 20 million health workers and residents of long-term care homes before the end of the year.

Distributing the vaccine is expected to be among the most logistically complex public health campaigns in history. The vaccine requires storage at -94F (-70C), and Congress has failed to provide funding needed to advance the effort, leaving stretched public health authorities on their own to distribute the advanced vaccine.

Even as a highly effective vaccine is on the eve of distribution, experts continue to warn it will not immediately herald a return to normalcy. Initial supplies of the vaccine will be extremely constrained, with some experts predicting the vaccine will not reach lower-risk adults until mid- to late-2021.

That means individual Americans will need to continue to wear masks, social distance, hand-wash and avoid crowds, while public health agencies continue to test and contact trace, to eventually bring the pandemic to heel.

Experts believe the US will need to vaccinate upwards of 80% of all adults to reach “herd immunity”. That is an exceptionally high level of vaccination that has never been reached by, for example, a seasonal flu campaign.

The FDA’s decision to approve the vaccine on Friday night is likely to draw consternation from experts, who have said the agency must closely balance speed needed to save lives against a public perception that the vaccine is rushed.

The authorization comes after the White House chief of staff, Mark Meadows, reportedly called the head of the FDA, Stephen Hahn, to push for approval on Friday evening. An FDA vaccine advisory panel recommended the agency give the company emergency authorization to distribute the vaccine on Thursday evening.

The administration’s reported move to heap on pressure was heavily criticized by health experts, some of whom argued the FDA would save more lives if it waited, because it would not stoke vaccine hesitancy among the American public.

In total, federal health authorities hope to vaccinate 20 million people before the year is out. That number would still fall short of vaccinating all of the nation’s 21 million healthcare workers and 3 million long-term care residents.

An FDA advisory panel will hear evidence on a second vaccine next week, this one developed by Moderna and the National Institute of Allergy and Infectious Diseases and called mRNA-1273.

The Trump administration issue another indication of support for the Moderna vaccine on Friday evening, when it announced the government purchased an additional 100m doses. That brings the total doses purchased to 200m, and will allow for “continuous delivery” of vaccine through June 2021.