A panel of outside experts on Thursday recommended the Food and Drug Administration issue an emergency use authorization to the Covid-19 vaccine being developed by Pfizer and BioNTech, a vaccine that appeared to be highly efficacious in a Phase 3 clinical trial.
The vote came after a long day in which members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, discussed a wide range of issues related to the vaccine. Although the FDA does not have to follow the panel’s recommendation, it is widely expected to do so.
The rollout of Covid-19 vaccine could then begin in the United States in a matter of days.
STAT’s coverage of the meeting is below, with updates and analysis posted in reverse chronological order.
5:37 p.m.:After eight-plus hours of data presentations, discussion and debate, today’s Covid vaccine advisory panel finally got down to voting on the penultimate 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?
The results:
17 Yes, 4 No, 1 abstention.
And with that, the FDA will very likely grant an emergency use authorization to the Pfizer/BioNTech Covid vaccine within days, if not sooner.
One thing to watch: There was a lot of disagreement among the panel members about whether the data support the inclusion of people 16-17 years of age in the EUA. Will FDA make changes to the EUA to exclude this group?
Pfizer pushes back against “crossover” design for placebo patients
5:05 p.m.: Earlier in the day, there was an enthusiastic presentation of a proposal that tried to allow volunteers who had received placebo to receive the vaccine while minimizing the problems this would present for collecting new data about the vaccine.
The idea, summarized by Helen this morning, is that all volunteers would get two more shots. Those who had received placebo would get the vaccine; those who got the vaccine would get placebo.
But William Gruber, a Pfizer senior vice president, pushed back on this idea. It was, he pointed out, potentially impractical. “44,000 individuals would have to be brought in for two additional visits,” he noted. That means they would need to sign new consent forms. And, if they already suspected they received the vaccine because they noticed aches or chills, they might decide not to come in for those additional visits. Gruber has said previously that he is worried that volunteers will leave the study if they are not offered the vaccine, and that he will not get data from them at all.
In an email earlier today, a Pfizer spokesperson confirmed the company is not currently planning to use the crossover design.
“The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic,” Pfizer said in a statement. “We also believe that we have an ethical duty to create a pathway within the study for interested, eligible participants in the placebo group to have access to the vaccine as regulatory authorities make decisions about authorization or approval of the vaccine candidate around the world.”
Pfizer added: “In turn, we have developed a protocol amendment that is subject to input from and alignment with regulatory authorities but is designed so that all interested participants 16 years and older in the placebo group would have the option to receive the vaccine at scheduled timepoints in the study.”
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