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An independent committee of experts recommended on Thursday that the Food and Drug Administration authorize the Pfizer and BioNTech COVID-19 vaccine for people age 16 and older. Now the FDA will decide whether to follow that recommendation. The agency could announce a decision in a few days. If they authorize the vaccine, healthcare workers could start getting the shots almost immediately.
“I am hopeful that the FDA will act soon to accept this,” Mark Mulligan, director of the NYU Langone Vaccine Center (a testing center for the Pfizer and BioNTech vaccine), said in a news conference after the meeting.
The Vaccines and Related Biologicals Advisory Committee (VRBPAC) met throughout the day to review vaccine data, discuss distribution plans, and outline plans for ongoing research.
FDA scientists released a report on the vaccine on Tuesday, which analyzed data from pharmaceutical companies and found that the vaccine was safe and 95 percent effective in preventing symptomatic COVID-19. Data from the clinical trial, which included more than 43,000 participants, was published in the New England Journal of Medicine on Thursday and reported the same findings.
In addition to the recommendation, the committee meeting also outlined the ways that researchers will continue to study the vaccine after its authorization. The initial trial was in tens of thousands of people, enough to understand how well it works and how safe it is, but the vaccine will eventually be given to hundreds of millions of people.
“Despite the completely appropriate size and scope of the trials, it is always important to monitor vaccines after licensing and subsequent authorization,” said Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, in a presentation to the committee Thursday. . “And that’s especially true with COVID-19 vaccines.”
The Centers for Disease Control and Prevention (CDC) and the FDA will track vaccine safety with multiple monitoring systems, including some focused on residents in long-term care facilities and people in the military. . Pfizer and BioNTech will also monitor the safety of the vaccine. FDA I ask The companies will include anaphylactic reactions as part of the risks they monitor, after two people had allergic reactions after receiving the vaccine in the UK this week.
Messonnier outlined priorities for further tracking the vaccine’s ability to protect against COVID-19. In the first few months, experts will see if the vaccine appears to prevent disease as well in the real world as it did in clinical trials. They will also track whether the vaccine can prevent infection with the coronavirus or transmission of the virus, not just symptomatic disease. Pfizer said during the meeting that it is collecting data that will show whether the vaccine prevented asymptomatic infections, and that it will have that analysis in early 2021.
“We don’t have data from humans, but from non-human primate studies that would argue that the vaccine prevents infection,” Kathrin Jansen, Pfizer’s head of vaccine research and development, told the meeting.
The committee also discussed the delicate question of whether Pfizer and BioNTech should tell people who were in the placebo group of the clinical trial that they were in that group and offer them the vaccine. That would allow everyone in the trial to reap the benefits of vaccination, but it would cut off the drug company’s ability to collect placebo-controlled data on the vaccine.
Pfizer proposed offering the vaccine to people in the placebo group either six months after their second test dose or when they are eligible to receive it under FDA clearance. The first group in the US Eligible for vaccines based on CDC recommendations will be healthcare workers. Enough participants would remain in the placebo group even if the healthcare workers in the trial took a vaccine to continue the study until the next wave of people became eligible, said William Gruber, senior vice president for vaccine research and clinical development at Pfizer, at the meeting.
Next week, the committee will meet again to discuss the COVID-19 vaccine developed by Moderna. That vaccine is the same type of vaccine as the one created by Pfizer and BioNTech, and it had similar efficacy in clinical trials.
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