Pfizer and vaccine partner BioNTech shared positive long-term data last week that shows their COVID-19 vaccine remains effective for at least four months in adolescents 12 to 15 years of age. The vaccine also maintained a good safety profile with no serious side effects. The top line results could set the stage for approval of the vaccine for this age group. The vaccine was authorized for emergency use by the US Food and Drug Administration (FDA) in May 2021.
A longer-term, follow-up analysis of the Pfizer COVID-19 vaccine showed that it was 100 percent effective in preventing symptomatic COVID-19 infection in a measured window of seven days to four months after administration of the second dose of the two-dose vaccination series.
Results from the analysis of the Phase III trial data show that there were no serious safety concerns for those followed for at least six months post-vaccination.
“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 through 15 years of age,” said Ugur Sahin, CEO and co-founder of BioNTech in a joint press release from the company and Pfizer. “The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our COVID-19 vaccine across adolescent and adult populations.”
The most recent analysis from the Phase III trial included 2,228 participants between the ages of 12 and 15. All 30 of the symptomatic COVID-19 cases identified in the trial were in the placebo group and none in the vaccine group, amounting to an efficacy of 100 percent for the shot.
Pfizer and BioNTech say the results were consistent across demographics of gender, race and ethnicity as well as obesity and comorbidity status.
This month, the FDA authorized the Pfizer COVID-19 vaccine for children five to 11 years old, which was a pivotal move as COVID-19 infections in the US are currently high in this age group. According to the Centers for Disease Control and Prevention (CDC), rates of hospitalization remain high in kids five to 11.
Vaccinating kids against COVID-19 has been met with hesitancy among some parents with respect to concerns of side effects like myocarditis, which have been rare and readily treatable. The risk of inflammatory heart effects like myocarditis and pericarditis appears to be lower in younger children.
In addition, the FDA also expanded eligibility of booster doses of both Pfizer and Moderna’s mRNA COVID-19 vaccines for individuals 18 years of age and older. It remains to be seen whether the booster authorization will be extended to adolescents and children.
Pfizer and BioNTech say they plan to submit the latest 12 to 15 age group long-term vaccine data for peer-reviewed publication, as well as part of their supplemental Biologics License Application (sBLA) to the FDA for expanded approval of the vaccine for use in individuals 12 years and older.
“These additional data provide further evidence in our vaccine’s safety and effectiveness profile in adolescents,” Pfizer CEO Albert Bourla said in the press release. “This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed.”
Moderna is still awaiting expansion of the authorization for its COVID-19 vaccine Spikevax for children 12 to 17 years of age. The FDA said it is delaying its decision on the authorization because it wants more time to evaluate the risk of myocarditis.
Moderna also filed for authorization of its vaccine in Canada and the EU for kids six to 11 years of age after sharing top line positive data from a Phase II/III study trialing the vaccine in this age group. It has yet to file for expanded authorization with the FDA in the US.