The Food and Drug Administration plans to approve the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years old later this week or early next week, according to a New York Times report.
The Times cited anonymous federal officials who were not authorized to speak publicly about the FDA’s plans. If the FDA allows the vaccine to be used in the adolescent group during the week, the Centers for Disease Control and Prevention’s Vaccine Advisory Committee will likely meet a day later to review clinical trial data and make an assessment. recommendation for use, the Times reported.
On March 31, Pfizer announced that the vaccine completely protected adolescents ages 12 to 15 against COVID-19 in a small Phase III clinical trial. The vaccine was also well tolerated in the age group, producing mostly standard side effects.
In the 2,260-person trial, 1,131 adolescents aged 12 to 15 received the vaccine, while 1,129 received a placebo. There were 18 symptomatic COVID-19 cases in the trial, all of them in the placebo group. The vaccinated group appeared to produce neutralizing antibodies at higher levels than those seen earlier in people aged 16 to 25, Pfizer noted.
“We share the urgency to expand the authorization of our vaccine for use in younger populations and are encouraged by the data from clinical trials in adolescents aged 12 to 15,” said Albert Bourla, CEO from Pfizer, in a press release at the time. . “We plan to submit this data to the FDA as a proposed amendment to our emergency use authorization in the coming weeks and to other regulators around the world, in the hope of starting to vaccinate this age group before the start of the 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. The Pfizer-BioNTech vaccine is currently only approved for people 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 immunized 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, from an average of around 2.6 million vaccines per day to around 2.3 million currently. Authorization for the use of the Pfizer-BioNTech vaccine in adolescents could once again boost demand for vaccines in the country, before summer activities and the start of the school year in the fall.