On Monday, the US Food and Drug administration approved the Pfizer/BioNTech COVID vaccine, the first vaccine against the novel coronavirus to receive full approval.
The vaccine, which will be marketed as Comirnaty, can be used for individuals ages 16 and older for COVID prevention. However, the vaccine is still under emergency use authorisation (EUA) for adolescents ages 12-15, the agency said.
FDA Acting Commissioner, Janet Woodcock, MD, said in a statement: “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved COVID vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
At a media briefing, Peter Marks, MD, PhD, the director for the Center for Biologics Evaluation and Research at FDA, detailed the meticulous process used for conducting a review of a biologics license application for full approval, including invidivual analysis of adverse events.
Since 11 December, 2020, the vaccine has been under an EUA for individuals ages 16 and older. Evidence for the full approval comes from expanded phase III trial safety and efficacy data released by the manufacturer this April. An analysis of 927 confirmed cases in the trial’s 44 000 participants found that 7 days after the second dose, Comirnaty had a 91.3% efficacy against symptomatic COVID through 6 months.
More than half of the participants had over 4 months of safety data, including 12 000 people who were followed up through 6 months. Injection site pain, fatigue, headache, muscle or joint pain, and fever were the most common adverse events. A slight increase in risk for myocarditis and pericarditis up to 7 days after the second dose was noted, particularly in males under 40 (peaking in ages 12-17), but symptoms resolved completely.
Trial data was collected before the Delta variant became the dominant strain in the US, Dr Marks noted, Israeli “real world” suggest the vaccine still retains effectiveness but wanes. This is something the agency will follow.
Former FDA commissioner Dr. Mark McClellan, who now directs the Duke-Margolis Center for Health Policy, spoke to the media about the approval, saying surveys showed that it will help sway vaccine holdouts.
“I do think it will make a difference. Maybe not a large number of people running out and getting a vaccine today. At this point we’ve got a little bit over 70 percent of Americans who are eligible for the vaccine have gotten at least one dose. That’s about 87 million Americans who are eligible who haven’t. Out of those, according to some recent surveys, about 30 percent say the full approval of the Pfizer vaccine would make a difference in their decisions.”
Source: MedPage Today
