US urges Pfizer to apply for under-5 COVID shots

U.S. regulators are urging drug maker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February, a person familiar with the matter told The Associated Press.

The company’s application is expected to be submitted as soon as Tuesday.

Early Pfizer data has shown the vaccine — which is administered to younger kids at one-tenth the strength of the adult shot — is safe and produces an immune response. But last year Pfizer announced the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5, and regulators encouraged the company to add a third dose to the study on the belief that another dose would boost the vaccine’s effectiveness much like booster doses do in adults.

Zeke Miller, a White House reporter for the Associated Press, said parents are anxious to start their youngest children on a vaccine regiment, and any third doses with have come after the first two shots are administered.

"That’s why, according to a source familiar with the matter, the US government has gone to Pfizer and said, submit your data for the first two doses, prove it, prove that those vaccines are safe and that they help produce some sort of immune response and then come back later once you have the data showing the third dose prevents against serious illness and disease as expected, so that kids can start getting that vaccine series started earlier as soon as potentially the end of February, assuming regulatory review proceeds on course," Miller said.

Now, the Food and Drug Administration is pushing the company to submit its application based on the two-dose data for potential approval in February and then to return for additional authorization once it has the data from the third dose study, which is expected in March, the person familiar with the matter said. The two-step authorization process could mean that young children could be vaccinated more than a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention greenlight the shots.

The person spoke on the condition of anonymity to discuss sensitive regulatory issues. The person said the decreased effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible omicron variant of COVID-19. Allowing young kids to be vaccinated with a two-dose shot earlier would ultimately accelerate when they could get the expected stronger protection from a third dose.

That would be welcome news for parents of young children, the last remaining age group without approval of COVID-19 shots.

"From the beginning of COVID 19 through the present, kids are much less likely than adults to be infected and also to suffer serious side effects, serious illness and even potentially death. But it happens. It’s very, very, very small percentage of cases," Miller said. "So one of the things that vaccinating the youngest kids does is it makes it easier for them to stay in school or daycare if they are exposed to a close contact. It provides peace of mind."

Young children are far less likely than adults to develop serious complications or to die from COVID-19, but incidences of illness among the age group have risen amid the nationwide spike in cases from the omicron variant. Most cases and deaths occur among older people, especially those who are unvaccinated.

Speeding the authorization of pediatric vaccines against COVID-19 has been a priority for more than a year of the Biden administration, which believes them critical to reopening and keeping open schools and day care centers — and for freeing up parents occupied by child care responsibilities to return to the workforce.

Vaccines for kids ages 5-12 were approved by U.S. regulators in November, though uptake of shots has been slower than U.S. officials hoped.

Pfizer’s primary series is administered three weeks apart. The third dose for young kids is being studied for administration at least two months after the second dose.