Pfizer and BioNTech said Monday their COVID-19 vaccine remained 100 percent effective in children 12 to 15 years old, four months after the second dose.
The companies said that the new data, which involved 2,228 trial participants, will help support their applications for full approval in the United States and worldwide.
No serious safety concerns were observed in individuals with at least six months of follow-up after the second dose.
“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents,” said Pfizer CEO Albert Bourla in a statement.
“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed. We look forward to sharing these data with the FDA and other regulators.”
The vaccine was granted “emergency use authorization” for adolescents by the US in May and the companies plan to soon seek full approval. The vaccine is currently only fully approved in people aged 16 and older.
Among the 2,228 participants, there were 30 confirmed symptomatic COVID cases without evidence of prior infection, all in the placebo group.
This corresponds to a vaccine efficacy of 100%. Efficacy was consistently high across gender, race, obesity levels and comorbidity status.
The main safety concern among this age group is vaccine-linked myocarditis (heart inflammation) in males.
But such cases are very rare, and the benefits of vaccination continue to strongly outweigh the risks, data has shown. COVID itself can cause myocarditis, both more often and in a more severe form.
An Israeli panel of experts advising the Health Ministry on COVID-19 inoculation policy reportedly recommended on Sunday that children aged 12-15 be given a third booster vaccine shot against the coronavirus.
Booster shots are already recommended for all those aged 16 and above, a trailblazing policy that Israel was the first country in the world to adopt.
A clear majority among the panel’s members were said to back the idea at a meeting, according to Hebrew-language media reports. The boosters will be given five months after the second vaccine shot.
The experts’ opinion was based on information about the reduction of vaccine effectiveness among teens aged 16-19 who received just the first two shots, according to reports.
No decision was made whether teens aged 12-15 will be required to have the third booster in order to maintain their Green Pass, a vaccination certificate that grants access to public venues, Channel 12 reported. Currently, all Israelis over the age of 16 must eventually get all three shots in order to maintain a valid Green Pass.