Pfizer to apply for use of COVID-19 shots in children under five in the U.S.: sources

Posted February 1, 2022 5:07 am.

Last Updated February 1, 2022 6:39 am.

U.S. regulators are urging drugmaker 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, according to The Washington Post, which first reported the drugmaker would submit their data earlier than expected.

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.

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

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.

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.

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.

A similar reluctance appears to be happening north of the border as well, and Health Canada recently held a forum aimed at educating parents on the safety of vaccines in hopes of increasing the immunization rates.

As of Jan. 28, 2022, 53 per cent of children five to 11 in Canada had received their first shot. The overall Canadian population is 83 per cent vaccinated, among the highest rates in the world.

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