Pfizer asks FDA to approve updated COVID-19 shot for young children

Dec. 5 (UPI) -- Pharmaceutical giant Pfizer on Monday announced the company and its partner BioNTech have asked the U.S. Food and Drug Administration to approve an updated COVID-19 vaccine regimen for young children.

Pfizer has asked the FDA to authorize a substitution for the third shot of the regimen, replacing an extra-small dose of the vaccine with the company's bivalent vaccine that targets the Omicron variant of the virus for children under age 5.

As of now, children between the ages of 6 months and 4 years are approved to receive three doses with each containing a tenth of the amount adults receive.

"With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization," the company said in a statement.

The bivalent vaccine is currently authorized as a booster for children over age 5 in the United States and Europe but has not yet been approved for younger children.

If approved as part of Monday's request, it would be considered a part of the initial vaccine regimen for young children and not as a booster.

Data from the Centers for Disease Control and Prevention shows that just 1.61 million of the youngest Americans have received at least one dose of the vaccine since June, when the regimen was approved.

Market data published by MarketWatch on Monday shows that Pfizer's stock is down 14.3%, while BioNTech shares have dropped 35.1% in 2022.