Pfizer to Ask for Approval of COVID-19 Vaccine for Children 12–15

A vial of the Pfizer-BioNTech COVID-19 vaccine is seen in a file photograph. Justin Sullivan/Getty Images

Pfizer and its German partner on Monday said they plan to file for expanded approval from U.S. regulators for their COVID-19 vaccine after a new study indicated the shot remains effective for over four months.

Vaccinated children 12 to 15 saw 100 percent effectiveness against COVID-19 in an ongoing clinical trial, Pfizer and BioNTech said in a statement. That conclusion was drawn from measurements taken seven days through over four months after the second dose of the two-dose regimen. Data from 2,228 participants were analyzed.

Thirty COVID-19 cases were detected but all 30 patients received a placebo, not the vaccine, according to the companies.

The data have not been peer-reviewed and much of it has not been made public. There are plans to submit them for scientific peer review “for potential publication,” Pfizer and BioNTech said.

The companies also said the safety data was “generally consistent” with other safety data for the vaccine and there were no serious safety concerns observed in the age group through six months of follow-up after the second dose.

The longer-term data will be the core of an application to the Food and Drug Administration (FDA). Regulators in August approved Pfizer’s shot, but only for those 16 and older. For the 12- to -15-year-old group, the vaccine remains under emergency use authorization, which was granted in May. Pfizer and BioNTech also plan to use the new data to apply for higher levels of clearance in other countries.

Pfizer’s jab is the only COVID-19 vaccine available for people under 18 in the United States.

About 15 million children between 12 and 17 have been fully vaccinated, according to federal data.

Moderna, Pfizer’s chief rival, applied for emergency use authorization for its jab for children 12 to 17 earlier this year. But regulators delayed a decision on the application because of concerns over post-vaccination heart inflammation, which has been seen at higher-than-expected rates in youth, especially males, who have gotten the Moderna or Pfizer jabs.

The FDA may not clear or reject the submission until next year.

Moderna recently said its shot confers a higher level of protection than Pfizer’s, but that it also triggers a higher number of cases of myocarditis, a heart inflammation condition.

Dr. Peter Marks, an FDA official, told The Associated Press last week that the rate of myocarditis in men between 18 and 24 “is probably somewhere between one in 5,000 and one in 10,000 with Moderna.”

“You know, the exact number, I can’t tell you, because it depends on what study you’re you’re using,” he said.