
The Pfizer-BioNTech vaccine was authorised for children under 5 years of age in June, based on data that showed the vaccine generated a similar immune response as in older age groups. An early analysis based on 10 symptomatic COVID-19 cases in the study suggested a vaccine efficacy of 80.3%. But experts warned that the data was preliminary due to a low number of symptomatic cases.
The updated data showed 13 children had Covid, at least seven days after receiving a third dose of the Pfizer-BioNTech COVID-19 vaccine, compared with 21 cases among those who received a placebo.
New data from the companies showed that the vaccine was 73.2% effective in preventing COVID-19 among children aged 6 months through 4 years.
Most cases were caused by the Omicron BA.2 variant that was dominant in March and April, when the study was conducted.
The companies on Monday applied for U.S. authorization of the bivalent vaccine as a booster for those aged 12 and above.
Pfizer said a paediatric trial for the Omicron-adapted vaccine would begin in the fall, and it would work with regulators to determine what data is needed for authorization.
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