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
Even in the third calendar year of the pandemic, it seems we keep failing the test of getting COVID tests in the hands of Americans — but why? NBCLX storyteller Eric Rodriguez looks at how COVID testing infrastructure has changed since March 2020, why omicron created so many challenges and how the testing industry is evolving to meet demand.
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.
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 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.
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