In March, Pfizer and Moderna launched trials testing their COVID-19 vaccines in children between 6 months and 12 years old. The trials are expected to produce results this fall, after which the FDA will review the data.
Pfizer hopes to apply for FDA approval for its vaccine’s use in children between ages 5 and 11 in September. The drugmaker said trial results for children between ages 2 and 5 could be available in October or November.
The FDA is asking for four to six months of safety follow-up data for COVID-19 vaccine trials involving children under 12, compared to the two months of follow-up data it required for COVID-19 vaccine trials involving adults.
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