FDA says Pfizer COVID-19 vaccine authorization likely: What happens next

The US FDA plans to grant Pfizer's COVID-19 vaccine emergency use authorization, the agency has confirmed today, in a move that could see deployment of the drug as early as next week. BNT162b2, the mRNA vaccine developed by the pharmaceutical company this year amid the spreading coronavirus pandemic, received the blessing of the FDA's vaccine committee yesterday.

In what amounted to almost a full day's hearing, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) ended up voting 17 to 4 in favor of granting emergency use authorization (EUA) for the treatment. Among the evidence the committee reviewed was the Phase 3 clinical study into BNT162b2 which Pfizer announced results from last month.

While the FDA is under no obligation to proceed with the recommended suggestions of the VRBPAC, the hearing was widely seen as the last stage in the pre-EUA process for Pfizer's vaccine. The Phase 3 trial – which is, alongside a Phase 2 study, ongoing – has shown a 95-percent efficacy rate among participants, both among those who have not previously been infected with COVID-19 and those who have.

"The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," Pfizer highlighted. "Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety."

Although an EUA has not yet been granted, a statement today from the FDA indicated just where the agency's intent lies.

"Following yesterday's positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization," the FDA said today. "The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution."

Although there is no set timescale for when an EUA may be granted, the time-pressures of the coronavirus pandemic could see the FDA move to green-light use of BNT162b2 as soon as this weekend. Following that, the Advisory Committee on Immunization Practices – a committee within the United States Centers for Disease Control and Prevention (CDC) – will meet to decide how the vaccine should be deployed.

That's going to be a serious topic, since the ACIP has already warned that demand for vaccination is likely to outstrip supply in the US, at least initially. According to the CDC committee, "even if one or more vaccine candidates receive authorization for emergency use, demand for COVID-19 vaccine is expected to exceed supply during the first months of the national vaccination program."

The expectation is that healthcare settings will be the first to get the vaccination, according to a new interim recommendation paper published by the ACIP, along with residents of long-term care facilities. "As of December 1, 2020, approximately 245,000 COVID-19 cases and 858 COVID-19-associated deaths had been reported among U.S. health care personnel," the ACIP writes. "Early protection of health care personnel is critical to preserve capacity to care for patients with COVID-19 or other illnesses."

Pfizer and its vaccine partner BioNTech have said that they expect to have the potential to supply globally up to 50 million vaccine doses in 2020, rising to up to 1.3 billion doses by the end of 2021. Vaccinations using the drug have already begun in the UK.