Pfizer COVID-19 vaccine appears effective for kids under 5: U.S. health officials

Federal health officials said Sunday that kid-sized doses of Pfizer's COVID-19 vaccines appear to be safe and effective for kids under five.

Federal health officials said Sunday that kid-sized doses of Pfizer’s COVID-19 vaccines appear to be safe and effective for kids under five, a key step toward a long-awaited decision to begin vaccinating the youngest American children.

The Food and Drug Administration posted its analysis of the Pfizer shot ahead of a Wednesday meeting where outside experts will vote on whether the shots are ready for the nation’s 18 million babies, toddlers and preschoolers. Kids under five are the only group not yet eligible for COVID-19 vaccination in the U.S.

Late last week the FDA posted a similar analysis of Moderna’s shots for children under six.

If regulators clear the shots by one or both companies, vaccinations could begin as soon as next week with the drugmakers ready to rapidly ship doses ordered by the government. Parents have been pressing federal officials for months for the opportunity to protect their smallest children as more adults shed masks and abandon other public health precautions.

While only about 3% of U.S. COVID cases are in the age group six months to four years, hospitalization and death rates in that group are higher than those for older children, according to the FDA’s analysis – one reason experts have said protecting this group is important.

The FDA said children who received Pfizer’s shots during testing developed high levels of virus-fighting antibodies expected to protect them against coronavirus. That’s the basic threshold needed to win FDA authorization. But additional testing turned up key differences, with stronger results for Pfizer.

Pfizer’s vaccine, given as a three-shot series, appeared 80% effective in preventing symptomatic COVID-19, although that calculation was based on just 10 cases diagnosed among study participants. The figure could change as Pfizer’s study continues.

Moderna’s two-dose series was only about 40% to 50% effective at preventing milder infections, though the two companies’ shots were tested at different times during the pandemic, when different variants were circulating. Moderna has begun testing a booster for tots.