The Food and Drug Administration has scheduled a three-day public meeting with an independent group of vaccine experts on Friday for the end of this month as the agency makes key decisions around the emergency use of Pfizer BioNTech vaccine for children ages 5-11 and admitting refresh photos for adults are ready to receive it. . Moderna & Johnson & Johnson vaccine recipients.
The FDA typically makes a decision within days of an advisory committee meeting where members discuss safety and efficacy data. The schedule for subsequent meetings suggests that the agency wants to act quickly to decide whether to allow boosters and photos of the children.
The agency said the commission would meet on October 14 and 15 to discuss booster doses and would discuss Pfizer’s pediatric vaccine on October 26.
“It is important that as many eligible people as possible are vaccinated as soon as possible,” said the agency’s top vaccine regulator, Dr. Peter Marx.
He added that “The available data clearly show that protection against symptomatic COVID-19 is likely to decrease over time in some populations.
Pfizer’s decision to discuss evidence of moderna and Johnson & Johnson booster vaccinations two weeks before adoption of the infant vaccine reflects FDA priorities and data availability. But agency decisions about these emergency use permits can be made quickly and consistently.
Pfizer and BioNTech have not formally asked the FDA to approve the emergency use of their pediatric metered-dose vaccine; They are expected to do so next week, according to people familiar with the company’s plans. If regulators act on this call, it could help protect 28 million children and reduce parenting anxiety across the country. Pfizer board member Dr. Scott Gottlieb said the FDA could make a decision as early as Halloween.
Children are rarely seriously ill with the coronavirus, but the Delta Edition transported nearly 30,000 of them to hospitals in August. At least 125 children, ages 5-11, died from COVID during the pandemic, and some 1.7 million more in that age group were infected with the virus.
According to the Centers for Disease Control and Prevention, they account for 5% of Covid cases and 9% of the country’s population.
Pfizer’s vaccine is now approved for emergency use in children ages 12-15 and is fully approved for children over the age of 16. Moderna has also sought urgent permission to offer its vaccine to teens, but regulators have yet to decide on the application.