The Food and Drug Administration plans to authorize the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents aged 12 to 15 years later this week or early next week, according to a report by The New York Times.
The Times quoted unnamed federal officials who were not allowed to speak publicly about the FDA’s plans. If the FDA approves the use of the vaccine in the group of teenagers during the week, the advisory committee of the Centers for Control and Prevention of Vaccines will probably meet a day later to review the data from clinical trials and give a recommendation for use, reports the Times.
On March 31, Pfizer announced that the vaccine had fully protected adolescents aged 12 to 15 years against COVID-19 in a small phase III clinical trial. The vaccine is also well tolerated in the age group, causing mostly standard side effects.
In a study of 2,260 people, 1,131 adolescents aged 12 to 15 received the vaccine, while 1,129 received a placebo. There were 18 cases of symptomatic COVID-19 in the study, all of which were in the placebo group. The vaccinated group appears to produce neutralizing antibodies at higher levels than those previously seen in people between the ages of 16 and 25, Pfizer noted.
“We share the urgency of extending the marketing authorization for our vaccine to younger populations and are encouraged by data from clinical trials in adolescents between the ages of 12 and 15,” said Albert Burla, CEO of Pfizer. “We plan to provide this data to the FDA as a proposed change to our emergency authorization in the coming weeks and to other regulators around the world, hoping to start vaccinating this age group before the start of next school year.”
Pfizer and BioNTech are working on clinical trials in children aged 6 months to 2 years, 2 to 5 years and 5 to 11 years. Pfizer-BioNTech is currently only approved for use in people over 16 years of age.
So far, more than 105 million adults in the United States – about 32 percent of the population – have been fully vaccinated against COVID-19. More than 147 million – about 44 percent – have at least one dose.
But the vaccination rate in the United States has declined since mid-April, falling from an average of about 2.6 million vaccinations per day to the current 2.3 million or so. Permission to use the Pfizer-BioNTech vaccine for teenagers may again increase demand for vaccines in the country, before summer activities and the start of school in the autumn.