Enlarge/ An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.
68 with 43 posters participating
The COVID-19 vaccine developed by Pfizer and BioNTech should be granted an Emergency Use Authorization from the US Food and Drug Administration, according to a committee of independent experts advising the agency.
The committeethe Vaccines and Related Biological Products Advisory Committee (VRBPAC)made the recommendation today in a vote of 17 in favor, 4 against, and 1 abstain. Specifically, committee members voted in the affirmative to the question:
Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?
If the FDA follows the recommendation and grants authorization, the vaccine will be widely accessible to people 16 years and older and distribution of the vaccine will likely to begin in the coming days.
Distribution
The federal government inked a deal with Pfizer and BioNTech in July, which guarantees the country 100 million dosesenough to vaccinate 50 million peoplewith an option to purchase an additional 500 million doses. The federal government has said it expects to get 25 million doses from Pfizer this month, as well as 15 million doses of vaccine from Moderna, whose EUA request will be reviewed by the VRBPAC next week.
Pfizer and BioNTech have said that they expect to produce up to 50 million vaccine doses in 2020 globally and up to 1.3 billion doses by the end of 2021.
VRBPACs vote followed a daylong public meeting reviewing all of the data from Pfizer/BioNTechs nearly 44,000-participant Phase III trial. Last month, the companies announced that the trial indicated the vaccine is 95 percent effective at preventing symptomatic COVID-19. Pfizer and BioNTech submitted a request for the EUA on November 20.
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On Tuesday, the FDA released its own briefing documents from its review of the detailed data submitted by Pfizer and BioNTech. The agency endorsed the efficacy and safety of the vaccine, writing in the briefing that it appeared highly effective and had a favorable safety profile.
Reactions and discussion
In todays meeting, committee members brought up reports from the UK that the vaccine had sparked severe allergic reactions in two people who received the vaccine. Marion Gruber, director of the FDAs Office of Vaccines Research and Review, said that the agency is looking into more information about the reactions. But she added that the agencys own safety analysis had been aware of the potential problem, though the agency didnt regard it as a severe problem. She noted that the FDA has been working with Pfizer to develop administration guidance for the vaccine, which would warn against giving the vaccine to anyone who has known allergic reactions to any components of the vaccine.
Some committee members raised concern over the limited data on how effective the vaccine is at preventing severe diseasethere were only 10 cases reported in the trial so far; nine in people who received a placebo, and one in a person who received the vaccine. However, the impressive efficacy rate in general was enough to sway the committee that an emergency authorization was warranted. Overall efficacy is indicative of efficacy against severe disease, several committee members noted.
Last, the committee debated whether the EUA should cover people aged 16 and 17, which would allow that group to access the vaccine initially. Pfizers Phase III study only included people aged 18 and above. Some argued that 16- and 17-year olds tend to have the same efficacy and safety profiles as young adults. However, people 16-17 are relatively unlikely to get severely ill from COVID-19 and are also unlikely to be high up on the list to get the first doses of vaccine. In the end, the majority of the committee agreed with the authorization question as it was, including 16- and 17-year olds.
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Trial participants
In addition to the data, the committee heard opinions and discussed downstream effects of an EUA, such as how the federal government will monitor safety and efficacy moving forward and plans for distribution. A particularly difficult issue to grapple with is how the EUA will affect ongoing trials and trial data.
The committee considered whether participants of the Pfizer/BioNtech Phase III trial who were randomly assigned to get a placebo should now be automatically given the vaccine. On one hand, the participants put their health at risk to help test the vaccine, which may warrant giving them immediate access to the vaccine. On the other hand, with limited vaccine inventory, vaccinating trial participants would mean they would essentially jump the line ahead of people in groups deemed more at risk and in need of vaccine. Those they would jump ahead include frontline health workers and medically-vulnerable people in long-term care facilities.
In addition, vaccinating people in the placebo group could unblind participants, who then may be less likely to participate in trial follow-up. Up to this point, participants have not been told whether they received the vaccine or a placebo. The longer the placebo group stays in the trial and unvaccinated, the more data the companies can collect on long-term efficacy and safety issues in comparison to the vaccinated group.
Looking forward
A proposed revision to the trial under the EUA is to keep trial participants blinded and vaccinate them in the order in which they would receive the vaccine if they were not part of the trialor after six months, whichever is shorter. Trial participants would then still be followed for two years after they received their second dose. Its unclear, for now, if Pfizer will follow this plan.
In the meantime, Pfizer will also be working to collect efficacy and safety data on pediatric populations. The company will also be looking at whether the vaccine prevents asymptomatic infections, which it hopes to have data on early next year. In addition, Pfizer expects to have data from animal studies in the coming days relating to safety and efficacy in pregnant and breastfeeding people.