Preliminary clinical trial results showed that a triple dose of the BioNTech/Pfizer COVID-19 vaccine is 80.3% effective against the omicron variant of the SARS-CoV-2 virus in children aged 6 months to 5 years. A third dose of the vaccine elicited a strong immune response and was well tolerated by the children, with most side effects being mild to moderate, the companies said.
BioNTech Chief Executive Ugur Sahin said the companies plan to complete their application to the U.S. Food and Drug Administration this week for emergency use authorization. Pfizer CEO Albert Bourla said he hopes the vaccine will be available to young children as soon as possible.
Initial data is encouraging
“ Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our dosage for the youngest children, which we carefully selected at one-tenth the adult dose strength, was well tolerated and produced a strong immune response “, says Albert Bourla. The initial data on safety, immunogenicity and effectiveness are encouraging.
Pfizer studied a subset of children to determine the immune response of children under 5 years old. The 80.3% effectiveness against Omicron is based on a preliminary analysis. The final analysis will be published as soon as it is completed.
Pfizer originally wanted to apply for approval in February so that parents could have their children vaccinated now, while the results of the clinical trial for the third dose were still pending. However, the first two vaccinations only showed an effectiveness of 30 to 40%, which is why the application for approval was withheld.
Application for approval possibly in the next few weeks
Studies in adults, adolescents and children over 5 years of age continue to suggest that three doses of the Pfizer-BioNTech COVID-19 vaccine increase protection compared to two doses. The safety, immunogenicity and efficacy data for three doses of the vaccine in children under 5 years of age are consistent with the data in adults, suggesting that a third dose in children provides similar benefit.
If the final data do not differ much from the preliminary data, an application for approval to the EU Medicines Agency Ema is expected in the next few weeks. However, due to the small number of cases in the preliminary data (1,678 children took part in the study phase), the final results can still change significantly.
Sources: Pfizer , BioNTech , BusinessWire
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