Pfizer, BioNTech Vaccine 73.2% Effective In Children Under 5
According to new data that was gathered from Pfizer Inc and BioNTech on Tuesday, their vaccine was 73.2% effective in preventing COVID-19 among children aged 6 months to 4 years, two months after the U.S. vaccine rollout for that age group.
Based on the data which showed that the vaccine had generated a similar immune response as in older age groups, the Pfizer-BioNTech vaccine was then authorized for children under 5 years of age in June.
An early analysis based on 10 symptomatic COVID-19 cases in the study had suggested a vaccine efficacy of 80.3%.
However, experts had warned that the data was preliminary due to a low number of symptomatic cases.
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The updated data released on Tuesday showed 13 children had COVID-19, 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.
Most cases were caused by the Omicron BA.2 variant that was dominant in March and April when the study was conducted.
Pfizer and BioNTech also said they were preparing an application seeking U.S. authorization for a so-called bivalent vaccine that targets the BA.4/BA.5 subvariants of Omicron for children under 12.
On Monday, both companies applied for U.S. authorization of the bivalent vaccine as a booster for children aged 12 and above.
According to Pfizer, a pediatric trial for the Omicron-adapted vaccine would begin in the fall and it would work with regulators to determine the necessary data for authorization.