With new safety and efficacy data in hand, the pharmaceutical giant seeks to expand authorization of its Covid-19 vaccine to people as young as age 12.
(CN) — Following promising results from its tests in adolescents and younger teenagers, Pfizer has submitted a request to the U.S. Food and Drug Administration to expand emergency use of the company’s Covid-19 vaccine to people 12 to 15 years old.
Pfizer’s vaccine is the only one in the U.S. currently authorized down to age 16, while the Moderna and Johnson & Johnson vaccines are being given to people ages 18 and up.
At the end of March, Pfizer released early data showing its vaccine is safe and strongly protective in the younger age group. Participants, in fact, showed a stronger antibody response in trials than did people ages 16 to 25, the company said.
Pfizer said it hopes to begin vaccinating people down to age 12 before the start of the next school year.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, Pfizer’s chairman and chief executive officer, when the data was released.
Now, the company has taken the next step toward expanding the distribution of its vaccine.
Pfizer and its partner BioNTech “plan to request similar rulings by other regulatory authorities worldwide in coming days,” the companies wrote in a release on Friday, citing Phase 3 trials that demonstrated 100% efficacy in the younger age group.
“All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose,” the companies noted.
Both Moderna and Johnson & Johnson are also studying their vaccines in younger teens and kids, but have not yet submitted data to change FDA authorization.
Experts say looking at safety data in kids is particularly important, since children respond differently to challenges to their immune system.
Unlike the most common vaccine side effect, pain at the injection site, other symptoms are systemic, or affect the whole body. Fever, malaise, poor appetite and vomiting, when seen in children, can also be signs of other illnesses, like meningitis or pneumonia.
For that reason, a child with a fever can be evaluated differently from an adult with a fever, making it necessary for separate studies that focus specifically on kids.
Adults were prioritized in the vaccine development process because older people are more likely than kids to develop severe symptoms of Covid-19.
Doctors and public health officials point out, however, that kids make up nearly a quarter of the population. So vaccinating younger people will inevitably be part of the fight to curb the pandemic and reach herd immunity.
If the FDA approves Pfizer’s new submission, the country — and perhaps other nations, pending approval — will get closer to being able to vaccinate as many people as possible.
“These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support governments in broadening global vaccination efforts,” the companies said on Friday. “The companies look forward to working closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory authorities as part of the companies’ efforts to expand emergency or conditional authorization of their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible.”