FDA authorises Pfizer, BioNTech's COVID-19 vaccine for emergency use

The FDA on Friday evening granted an emergency-use authorisation (EUA) for Pfizer and BioNTech's BNT162b2, the first issued for a COVID-19 vaccine in the US, with the decision coming a day after it won 17-4 backing from an advisory panel. The EUA, which is for use to prevent COVID-19 in individuals ages 16 and older, comes amid rumours that the White House told FDA Commissioner Stephen Hahn to resign if the agency did not authorise the country's first coronavirus vaccine by day's end.

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is now scheduled to meet on December 12 to vote on recommending the vaccine. Meanwhile, Health and Human Services Secretary Alex Azar said the FDA would work with Pfizer to get the vaccine shipped "so we could be seeing people get vaccinated Monday, Tuesday of next week."

'Significant milestone'

President Donald Trump posted a video tweet in which he called the achievement a "medical miracle," adding "we've delivered a safe and effective vaccine in just nine months…This is one of the greatest scientific accomplishments in history." In a statement, Hahn echoed the sentiment, calling the authorisation a "significant milestone in battling this devastating pandemic." The FDA Commissioner indicated that the EUA "follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists" to ensure BNT162b2 met standards for safety, effectiveness, and manufacturing quality.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, stated that the available safety and effectiveness data support the authorisation of BNT162b2 "because the vaccine's known and potential benefits clearly outweigh its known and potential risks." He added that the data provided by Pfizer and BioNTech "have met the FDA's expectations as conveyed in our June and October guidance documents."

Fifth country to authorise

Pfizer and BioNTech filed their EUA request last month shortly after BNT162b2, which is administered as two doses given 21 days apart, demonstrated an efficacy rate of 95% at the final analysis of an ongoing Phase III study. The mRNA-based candidate received its first authorisation for emergency use in the UK on December 2, with similar decisions following in Bahrain, Canada and Saudi Arabia.

According to the FDA, Pfizer has submitted a pharmacovigilance plan to monitor the safety of BNT162b2. This includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials, as well as ensuring that any safety concerns are identified and evaluated in a timely manner. Shortly after the UK rollout began on December 8, regulators there warned that anyone with a "significant history" of allergic reactions should not receive BNT162b2 after two NHS workers experienced anaphylactoid reactions shortly after being dosed.

EUA kick-starts distribution

The US government has prepared to deliver 2.9 million doses of Pfizer and BioNTech's vaccine within 24 hours of the EUA, followed by an additional 2.9 million doses 21 days later for patients to get their second dose, according to Gen. Gustave Perna, who oversees logistics for the US government's Operation Warp Speed programme. The vaccine will initially be earmarked for front-line healthcare workers, as well as staff working at long-term care facilities. Those two groups in Phase 1 of the vaccine rollout together represent around 24 million people.

Earlier this year, the US government agreed to pay nearly $2 billion for an initial order of 100 million doses of BNT162b2, with an option to acquire up to 500 million more. Pfizer and BioNTech recently slashed the amount of vaccine they said they would be able to ship globally this year to 50 million doses, down from an initial target of 100 million, with a recent report suggesting this was due to supply chain hurdles that have since been fixed. However, Moncef Slaoui, chief advisor overseeing Operation Warp Speed, has said that this would not change Pfizer's vaccine commitment to the US. An FDA advisory committee is scheduled to meet on December 17 to discuss Moderna's coronavirus vaccine mRNA-1273.

Hahn dismisses rumours

Meanwhile, Hahn downplayed rumours about the pressure for him to resign if the EUA had not been granted by the end of the day Friday. He said "this is an untrue representation of the phone call" he had with White House chief of staff Mark Meadows, who is alleged to have made the comments. "The FDA was encouraged [by the White House] to continue working expeditiously on Pfizer/BioNTech's EUA request," Hahn explained, adding that the agency was "committed to issuing this authorisation quickly, as we noted in our statement [Friday] morning."


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