The Food and Drug Administration on Friday scheduled three days of public meetings with its panel of independent vaccine experts for later this month, as the agency prepares to make high-profile decisions on whether to authorize emergency use of the Pfizer-BioNTech vaccine for children ages 5 to 11 and booster shots for adult recipients of the Moderna and Johnson & Johnson vaccines.<\/p>\n
The F.D.A. typically issues its decisions within a few days of advisory committee meetings, during which members discuss safety and efficacy data. The timing of the upcoming meetings indicates that the agency intends to move quickly to decide whether to authorize both the booster and children\u2019s shots.<\/p>\n
The committee will meet on Oct. 14 and 15 to discuss booster doses, and is tentatively scheduled to discuss Pfizer\u2019s pediatric vaccine on Oct. 26, the agency said.<\/p>\n
\u201cIt\u2019s critical that as many eligible individuals as possible get vaccinated as soon as possible,\u201d Dr. Peter Marks, the agency\u2019s top vaccine regulator, said in a statement.<\/p>\n
He added that \u201cthe available data make clear that protection against symptomatic Covid-19 in certain populations begins to decrease over time, so it\u2019s important to evaluate the information on the use of booster doses in various populations.\u201d<\/p>\n
The decision to have the committee discuss the evidence for Moderna and Johnson & Johnson booster shots two weeks before it does so for Pfizer\u2019s children\u2019s vaccine appears to reflect the F.D.A.\u2019s priorities and the availability of data. But the agency\u2019s decisions on those emergency use authorizations could come in quick succession.<\/p>\n
Pfizer and BioNTech have yet to formally ask the F.D.A. to authorize emergency use of their vaccine for pediatric doses; they are expected to do so next week, according to people familiar with the companies\u2019 plans. If regulators grant that request, it could help protect as many as 28 million children and ease the anxiety of parents across the nation. Dr. Scott Gottlieb, a Pfizer board member, has said the F.D.A. could decide as early as Halloween.<\/p>\n
Children rarely become severely ill from the coronavirus, but the Delta variant drove nearly 30,000 of them into hospitals in August. Over the course of the pandemic, at least 125 children ages 5 to 11 have died from Covid, and nearly 1.7 million others in that age group have been infected with the virus.<\/p>\n
They account for 5 percent of Covid cases and 9 percent of the nation\u2019s population, according to the Centers for Disease Control and Prevention.<\/p>\n
Pfizer\u2019s vaccine has already been authorized for children 12 to 15 on an emergency basis, and is fully approved for those 16 and older. Moderna has also sought emergency authorization to offer its vaccine to adolescents, but regulators have yet to rule on that request.<\/p>\n