Pfizer and its German partner have asked U.S. regulators to clear their updated COVID-19 vaccine for children as young as 6 months of age, the companies announced on Dec. 5.
The companies want emergency clearance for the administration of the new shot as a third dose to children aged 6 months to 4 years.
People above 4 are currently able to receive the updated vaccine as a booster.
The new vaccine contains components of both the Wuhan virus strain and the BA.4/BA.5 subvariants of the Omicron strain. The old vaccine features only the Wuhan variant, which has not been in circulation since 2020.
The application for emergency use authorization (EUA), lodged with the U.S. Food and Drug Administration (FDA), is for a 3-microgram dose. The dose would be the third in what is described as a three-dose primary series. Pfizer added a third dose to its primary regimen for young children after two doses failed to trigger an adequate immune response. The primary series for all ages above 5 is two doses, with additional doses being called booster doses….