The FDA just authorized an extra Pfizer shot for children aged 5 to 11
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- On Tuesday the FDA authorized a third COVID shot for kids ages 5-11.
- The Pfizer booster is recommended at 5 months after youngsters' primary 2-dose series.
- Emerging studies are suggesting 2 primary doses may not be the best protection against Omicron.
On Tuesday the US Food and Drug Administration OK'd a third shot of Pfizer's COVID-19 vaccine for kids aged 5-11.
In a statement announcing the news, FDA Commissioner Robert Califf said "while it has largely been the case that COVID-19 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalized."
The FDA is authorizing the booster dose to be used in kids 5 and up who received their primary series of two shots at least five months ago.
In April, Pfizer announced that its booster shot could significantly increase the levels of neutralizing antibodies kids had against the Omicron variant. That was according to a small study of 140 children.
However, recent independent studies from the Centers for Disease Control and Prevention have suggested that youngsters' immune response to the 2-shot series is still very decent at shielding kids from severe outcomes. Data from 14 US states that the CDC released in April showed that during the Omicron outbreak, 87% of children aged 5-11 who were hospitalized were completely unvaccinated. Another study published in the New England Journal of Medicine in March found that vaccinated 5 to 11 year olds reduced their risk of COVID hospitalization by two thirds.
"Where they see the difference is between the unvaccinated and vaccinated," epidemiologist Ruth Link-Gelles, who leads the CDC's COVID-19 vaccine effectiveness studies, told Stat.
Still, there have been some worries among disease researchers that the Pfizer dose which is administered to 5-11 year olds (which is 33% of the amount that teens and adults get) may merit either a third dose boost, a longer interval between the first two doses, or both, in order to provide enduring, robust, broad-spectrum disease protection to kids.
The new booster recommendation still does nothing for babies and children under 5 in the US, who have no authorized COVID vaccine to use yet. The FDA has said it may be ready to authorize a COVID-19 vaccine for babies and toddlers 6 months and up from Pfizer or Moderna or both companies by the end of June, but no firm timeline has been set yet, and the FDA is still waiting for completed applications from both companies.
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