The Food and Drug Administration plans to approve the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 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 teen group during the week, the Center for Disease Control and Prevention’s vaccine advisory panel will likely meet a day later to review the clinical trial data and make a recommendation for use, the Times reported.
On March 31, Pfizer announced that the vaccine completely protected teens ages 12 to 15 against COVID-19 in a small Phase III clinical trial. The vaccine was also well tolerated in the age group and mainly produced standard side effects.
In the trial of 2,260 people, 1,131 adolescents aged 12 to 15 received the vaccine, while 1,129 received placebo. There were 18 cases of symptomatic COVID-19 in the trial, all of which were in the placebo group. The vaccinated group appeared to produce neutralizing antibodies at higher levels than those seen previously in humans aged 16 to 25, Pfizer noted.
“We share the urgent need to extend the approval of our vaccine for use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Albert Bourla, Pfizer’s CEO, said in a press release at the time. . “We plan to submit this data to the FDA as a proposed amendment to our emergency use approval in the coming weeks and to other regulators around the world with hopes of starting to vaccinate this age group before the start of next school year.”
Pfizer and BioNTech are working on clinical trials with children aged 6 months to 2 years, 2 to 5 years and 5 to 11 years. The Pfizer BioNTech vaccine is currently only approved for use in individuals 16 years of age and older.
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 – approx. 44 percent – have at least one dose.
However, the vaccination rate in the United States has fallen since mid-April, down from an average of approx. 2.6 million vaccinations a day to the current 2.3 million or so. Permission to use the Pfizer-BioNTech vaccine in teens could again increase the demand for vaccines in the country prior to summer activities and school start in the fall.