Pfizer asks FDA to clear its updated COVID shot for kids under 5 years

USA — Pfizer and BioNTech have submitted an application to the US Food and Drug Administration (FDA) for their updated Covid-19 vaccine to be used as the third shot in the three-dose primary vaccine series for children ages 6 months through 4 years.

In the application, Pfizer is asking U.S. regulators to authorize its updated COVID-19 vaccine for children under age 5, not as a booster but as part of their initial shots.

The request for emergency authorization comes as the highly contagious Omicron variant has led to record numbers of infections.

The under-5 group includes more than 19 million children, the only Americans not yet eligible for vaccination.

Children ages 6 months through 4 years already are supposed to get three extra-small doses of the original Pfizer COVID-19 vaccine, each a tenth of the amount adults receive as their primary series.

If the Food and Drug Administration agrees, a dose of Pfizer’s bivalent omicron-targeting vaccine would be substituted for their third shot.

Pfizer and its partner BioNTech said that may help prevent severe illness and hospitalization from COVID-19 in little kids, at a time when children’s hospitals already are packed with youngsters hit by other respiratory illnesses.

Few of the nation’s youngest children have gotten their COVID-19 vaccinations since the shots were approved in June.

In general, Covid-19 vaccinations have been slow among young children. According to data from the US Centers for Disease Control and Prevention, less than 5% of children younger than 5 are fully vaccinated against the coronavirus, having completed their primary series of vaccinations.

Among people ages 5 and older, 73% are vaccinated, and 13% are vaccinated and boosted.

The FDA has authorized the new bivalent COVID-19 shots, versions made by Pfizer and rival Moderna as a booster for everyone ages 5 and older.

Those combination shots contain half the original vaccine and half tweaked to match the BA.4 and BA.5 omicron strains that until recently were dominant. Now BA.5 descendants are responsible for most COVID-19 cases.

The CDC last month released the first real-world data showing that an updated booster, using either company’s version, does offer added protection to adults.

The analysis found the greatest benefit was in people who had never had a prior booster, just two doses of the original COVID-19 vaccine, but that even those who had a summertime dose were more protected than if they had skipped the newest shot.