WASHINGTON: Pfizer and BioNTech mentioned Monday their COVID-19 vaccine remained 100% efficient in kids 12 to 15 years outdated, 4 months after the second dose.
The businesses mentioned that the brand new knowledge, which concerned 2,228 trial members, will assist assist their functions for full approval in the USA and worldwide.
No critical security considerations had been noticed in people with not less than six months of follow-up after the second dose.
“As the worldwide well being neighborhood works to extend the variety of vaccinated individuals all over the world, these extra knowledge present additional confidence in our vaccine’s security and effectiveness profile in adolescents,” mentioned Pfizer CEO Albert Bourla in a press release.
“That is particularly necessary as we see charges of COVID-19 climbing on this age group in some areas, whereas vaccine uptake has slowed. We sit up for sharing these knowledge with the FDA and different regulators.”
The vaccine was granted “emergency use authorization” for adolescents by the US in Might and the businesses plan to quickly search full approval. The vaccine is at the moment solely totally accepted in individuals aged 16 and older.
Among the many 2,228 members, there have been 30 confirmed symptomatic COVID circumstances with out proof of prior an infection, all within the placebo group.
This corresponds to a vaccine efficacy of 100%. Efficacy was constantly excessive throughout gender, race, weight problems ranges and comorbidity standing.
The primary security concern amongst this age group is vaccine-linked myocarditis (coronary heart irritation) in males.
However such circumstances are very uncommon, and the advantages of vaccination proceed to strongly outweigh the dangers, knowledge has proven. COVID itself could cause myocarditis, each extra usually and a extra extreme kind.