Pfizer to seek FDA approval to vaccinate children ages 2-11

Pfizer-BioNTech will seek the US Food and Drug Administration’s approval to administer its COVID-19 vaccine to children ages 2-11, the company said Tuesday in its quarterly earnings call.

The company is applying for clearance to start administering the vaccine to young children in September. In addition, Pfizer said it will have trial data on the safety of its vaccine for pregnant individuals by August.

The FDA is expected to authorize Pfizer’s COVID-19 vaccine for youngsters ages 12 to 15 by next week.

Israeli health officials have said they will launch a vaccination drive for teens in that age group as soon as US authorities approve it.

A pregnant woman receives a Covid-19 vaccine injection, at Clalit Covid-19 vaccination center in Or yehuda, on Purim, February 25, 2021. (Flash90)

Pfizer in late March released preliminary results from a vaccine study of 2,260 US volunteers age 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.

The study will continue to track participants for two years for more information about long-term protection and safety.

Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a US study of Moderna’s vaccine in 12- to 17-year-olds.

File: Children wearing face masks make their way to school in Safed on their first day back to classes on November 1, 2020 (David Cohen/Flash90)

US officials hope that extending vaccinations to teens will further accelerate the nation’s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.

Currently, the Pfizer vaccine is being distributed to Americans under an emergency use authorization, which can be revoked when the COVID-19 crisis ends. The company announced that it was seeking full FDA approval, which would allow the vaccine to remain on the market and be sold to customers directly.

This move could help increase vaccination rates in the US, where demand for vaccines among adults has dramatically slowed in recent weeks, as it would boost confidence in the vaccine’s safety and make it more widely accessible.

Vials of the Pfizer-BioNTech COVID-19 vaccine at the Palais des Sports venue in Lyon, hosting a vaccination center, on March 29, 2021, as France faces a new wave of infections of the novel coronavirus. (JEAN-PHILIPPE KSIAZEK / AFP)

More than 131 million doses of Pfizer’s vaccine have already been administered in the US.

Last month, Israel signed deals to purchase millions of Pfizer-BioNTech and Moderna vaccine doses to ready the country for another inoculation campaign that would also include young adolescences.

The Israeli Pediatric Association has called for parents and family doctors to vaccinate children ages 12 and up when the Pfizer-BioNTech vaccine gets approval in the US for those ages. Currently, the vaccine has emergency authorization for use in people 16 and older.

Agencies contributed to this report.