Pfizer says vax is safe for kids 5+
Rise in child COVID cases underscores need for vaccine
As pediatric coronavirus cases spike in the U.S. amid the surging delta variant, Pfizer on Monday announced that its COVID19 vaccine is safe and effective for kids ages 5 to 11.
The vaccine trial results — the first from any COVID-19 vax in children under 12 — showed that the vax at a lower dose was “safe, well tolerated and showed robust neutralizing antibody responses,” Pfizer said in its announcement.
The pharma megagiant now plans to submit its trial results to the Food and Drug Administration “as soon as possible” in the hopes of receiving emergency use authorization to get kids vaccinated ahead of the winter.
Hundreds of millions of people 12-plus from around the world have received Pfizer’s coronavirus vax this year.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children,” Albert Bourla, chairman and CEO of Pfizer, said in a statement.
“Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. — underscoring the public health need for vaccination,” he added.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
As of last week, more than 5 million U.S. children have tested positive for the virus since the start of the pandemic.
Child cases have increased significantly since the summer, with nearly 500,000 reported cases in the past two weeks.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” Ugur Sahin, CEO and co-founder of BioNTech, said in a statement.
“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The Pfizer vax trial used a two-dose regimen of 10 micrograms administered 21 days apart, a smaller dose than the 30-microgram dose used for people 12 and older.
The antibody responses in the participants given 10-microgram doses were comparable to those recorded in a previous Pfizer study in people 16 to 25 years of age immunized with 30-microgram doses.
The 10-microgram dose was “carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said.
Trial results in children under 5 years of age are expected as soon as later this year.