Pfizer has announced its intention to seek FDA approval for a 3-dose COVID-19 vaccine series aimed at children aged 6 months to 4 years. This development comes as a relief to parents eager for vaccination options for their little ones, especially as the U.S. faces a new wave of COVID-19 infections, prompting renewed mask mandates in several districts.
In a clinical trial involving 1,678 children, Pfizer and BioNTech reported that their 3-dose vaccine was found to be 80% effective in preventing symptomatic COVID-19 infections among participants. Dr. James Carter, Pfizer’s CEO, expressed satisfaction with the vaccine’s formulation, which is one-tenth the strength of the adult dose, stating that it was well tolerated and generated a robust immune response.
While this data is preliminary, as only ten COVID-19 cases were recorded among the trial subjects thus far, further analysis will occur once 21 cases have been documented, in line with clinical trial protocols. Prof. Sarah Klein, co-founder of BioNTech, indicated that they are finalizing the necessary documentation and anticipate submitting it to the FDA shortly.
Pfizer had initially sought approval for a 2-dose vaccine earlier this year but paused its request in February, awaiting additional trial data. In a similar vein, Moderna is awaiting FDA approval for its 2-dose vaccine for children under 6, which has shown lower effectiveness rates compared to Pfizer’s preliminary findings.
An advisory committee will review the data and make recommendations to the FDA, likely in mid-June, which could result in authorization for either the Pfizer vaccine, the Moderna vaccine, or both. Current vaccination efforts for children ages 5-11 have seen only 28% fully vaccinated as of April, reflecting hesitancy among parents despite the potential risks of long COVID and other complications, even though severe cases in children remain rare.
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In summary, Pfizer is moving forward with its request for a 3-dose COVID-19 vaccine for children under 5, with promising preliminary efficacy results. This development is timely amid ongoing infection surges and may provide parents with much-needed protection for their young children.