Pfizer Inc. and its German partner BioNTech SE have applied to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine booster for children aged 6 months through 4 years.
The bivalent vaccine targets the original strain of the COVID-19 virus, plus the BA.4 and BA.5 omicron subvariants.
An authorization from the FDA would mean that children would receive the primary vaccine series — two doses of the original Pfizer-BioNTech COVID-19 vaccine — and then one shot of the omicron-adapted bivalent vaccine.
The omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine was authorized as a booster dose for ages 5 years and older in the U.S. in October.
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