Pfizer and BioNTech stated Monday their COVID-19 vaccine remained 100 per cent efficient in youngsters 12 to fifteen years previous, 4 months after the second dose.
The corporations stated that the brand new knowledge, which concerned 2,228 trial individuals, will assist help their purposes for full approval within the United States and worldwide.
No severe security considerations have been noticed in people with not less than 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,” stated Pfizer CEO Albert Bourla in an announcement.
“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 businesses plan to quickly search full approval. The vaccine is at present solely totally authorized in folks aged 16 and older.
Among the two,228 individuals, 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 essential security concern amongst this age group is vaccine-linked myocarditis (coronary heart irritation) in males.
But 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 type.
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