Pfizer expects to seek authorization for COVID-19 vaccine for younger kids in September

Bourla is employed by Pfizer. Biden reports no relevant financial disclosures.

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Pfizer expects to be able to submit its COVID-19 vaccine to the FDA for emergency use authorization in children as young as age 2 years in September, Chairman and CEO Albert Bourla, DVM, PhD, said Tuesday.

By then, the company will have results from ongoing trials being conducted in young children and will be able to submit to the FDA for an emergency use authorization (EUA) in children aged 2 to 5 years and 5 to 11 years, Bourla said in prepared remarks for a quarterly earnings call.

Source: Adobe Stock

Source: Adobe Stock.

Currently, the Pfizer-BioNTech vaccine is approved for people aged 16 years or older — the only COVID-19 vaccine available for use in any pediatric age group. The FDA is expected to decide soon — perhaps this week — on expanding the EUA to include children aged 12 to 15 years, based on phase 3 data showing it was highly effective in this age group.

“I want American parents to know that if that announcement comes, we are ready to move immediately,” President Joe Biden said in an address on Tuesday, announcing that the White House would make around 20,000 pharmacy sites ready to vaccinate adolescents and would ship doses directly to pediatricians, pending an EUA.

“We know that adolescents are at risk from COVID-19. Though serious illness at that age range is rare, they can still get sick and spread the virus to others,” Biden said. “So, my hope is that if the vaccine is authorized, parents will take advantage of it and get their kids vaccinated.”

Elsewhere, Canada has already announced that the vaccine will be made available to children aged 12 to 15 years.

“It is our hope that the Pfizer-BioNTech vaccine will continue to have a global impact by helping to get the devastating pandemic under control and helping economies around the world not only open, but stay open, creating a scenario in which Pfizer can continue to be both a leader and a beneficiary,” Bourla said in his remarks.

According to the AAP, more than 3.7 million American children have tested positive for COVID-19, which represents 13.8% of all cases in the U.S.. There were 71,649 new pediatric COVID-19 cases reported in the week ending April 29, representing 22.4% of all cases, the AAP said.

More than 148 million Americans have received at least one dose of COVID-19 vaccine in the U.S., including more than 107 million who are fully vaccinated, according to the CDC. Biden on Tuesday announced several steps to get 160 million Americans at least partially vaccinated by July 4, including focusing on vaccinating adolescents, people who have had trouble locating a vaccine, and people who are vaccine hesitant.

In his remarks, Bourla said the vaccine contributed $3.5 billion in global revenues during the first quarter, and that Pfizer and BioNTech had shipped around 430 million doses to 91 countries.