Enlarge /. An illustration shows vials of Covid-19 vaccine stickers with the US pharmaceutical company Pfizer's logo on November 17, 2020.
The COVID-19 vaccine developed by Pfizer and BioNTech should receive emergency approval from the U.S. Food and Drug Administration, according to a committee of independent experts advising the agency.
The committee – the Advisory Committee on Vaccines and Related Biological Products (VRBPAC) – issued the recommendation today by 17 votes in favor, 4 against and 1 abstention. In particular, the committee members agreed to the question:
Based on all of the available scientific evidence, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh the risks for use in individuals 16 years and older?
If the FDA follows the recommendation and grants approval, the vaccine will be generally available to anyone 16 years of age and older, and the vaccine is expected to begin spreading in the coming days.
The federal government signed a contract with Pfizer and BioNTech in July that guarantees the country 100 million doses – enough to vaccinate 50 million people – with the option to buy an additional 500 million doses. The federal government has announced it will receive 25 million doses this month from Pfizer and 15 million doses of vaccine from Moderna, whose EUA application will be considered by the VRBPAC next week.
Pfizer and BioNTech have announced that they will produce up to 50 million vaccine doses worldwide by 2020 and up to 1.3 billion doses by the end of 2021.
The VRBPAC vote followed a one-day public meeting that reviewed all of the data from the Pfizer / BioNTech Phase III trial, which comprised nearly 44,000 participants. Last month, the companies announced that the study found the vaccine was 95 percent effective at preventing symptomatic COVID-19. Pfizer and BioNTech filed an application for the EEA on November 20th.
On Tuesday, the FDA released its own briefing from its review of the detailed data submitted by Pfizer and BioNTech. The agency endorsed the effectiveness and safety of the vaccine and wrote in the briefing that it was "highly effective" and had a "favorable safety profile".
Reactions and discussion
At today's meeting, committee members brought reports from the UK that the vaccine had caused severe allergic reactions in two people who received the vaccine. Marion Gruber, director of the FDA Office of Vaccines Research and Review, said the agency is looking at more information about the reactions. However, she added that the agency's security analysis identified the potential problem, even though the agency did not consider it a serious problem. She noted that the FDA worked with Pfizer to develop vaccine administration guidelines that would warn against giving the vaccine to anyone known to have allergic reactions to components of the vaccine.
Some committee members expressed concern about the limited data on how effective the vaccine is in preventing serious diseases. So far, only 10 cases have been reported in the study. nine in people who received a placebo and one in a person who received the vaccine. However, the impressive rate of effectiveness in general was enough to convince the committee that emergency clearance was warranted. Overall effectiveness is an indication of effectiveness against serious illness, as several committee members found.
Most recently, the committee discussed whether the EEA should cover people aged 16 and 17 to give this group access to the vaccine first. Pfizer's Phase III study only included subjects 18 years of age and older. Some have argued that 16- and 17-year-olds tend to have the same efficacy and safety profiles as young adults. However, people between the ages of 16 and 17 are relatively unlikely to get seriously ill with COVID-19, and they are also unlikely to be at the top of the list to get those first doses of vaccine. In the end, the majority of the committee agreed on the admission issue, including the 16- and 17-year-olds.
In addition to the data, the committee heard comments and discussed the downstream effects of an EEA, e.g. B. How the federal government will monitor safety and effectiveness in the future and plans for distribution. A particularly difficult issue is how the EEA will affect ongoing studies and experimental data.
The committee considered whether participants in the Pfizer / BioNtech Phase III study who were randomly assigned a placebo should now automatically receive the vaccine. On the one hand, participants put their health at risk to test the vaccine, which may warrant immediate access to the vaccine. On the flip side, vaccine participants with limited vaccine stocks would mean they would essentially jump in front of people in groups who are considered more at risk and in need of a vaccine. Those who would move it forward include frontline health workers and the medically vulnerable in long-term care facilities.
In addition, vaccinating people in the placebo group could “unblind” participants who may then be less likely to attend the study follow-up. Until then, participants had not been told whether they received the vaccine or a placebo. The longer the placebo group stays in the study and is not vaccinated, the more data companies can collect on long-term efficacy and safety issues compared to the vaccinated group.
I'm looking forward to
One proposed revision of the study under the EEA is to keep study participants blind and vaccinate them in the order they would receive the vaccine if they weren't part of the study – or after six months, whichever Period is shorter. Study participants would then be followed for two years after receiving their second dose. It is currently unclear whether Pfizer will follow this plan.
In the meantime, Pfizer will also work to collect data on the efficacy and safety of pediatric populations. The company will also look into whether the vaccine will prevent asymptomatic infections, which it plans to have data on early next year. In addition, Pfizer expects data from animal studies on safety and efficacy in pregnant and breastfeeding women in the coming days.