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FDA advisers back Pfizer shot for ages 5-11, paving way for Israel to follow

Vaccine for young children still requires approval from FDA itself, as well as the CDC; experts believe vaccine’s benefits for age group outweigh any potential risks

This October 2021 photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. (Pfizer via AP)
This October 2021 photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. (Pfizer via AP)

WASHINGTON — A panel of United States health advisers on Tuesday endorsed kid-size doses of Pfizer’s COVID-19 vaccine, moving the US closer to beginning vaccinations in children ages 5 to 11.

A US Food and Drug Administration advisory panel voted unanimously with one abstention that the vaccine’s benefits in preventing COVID-19 in that age group outweigh any potential risks — including a heart-related side effect that’s been very rare in teens and young adults who get a much higher dose.

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days, though it is widely expected to okay the move.

If the FDA authorizes the kid-size doses, there’s still another step: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots and which youngsters should get them.

While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness — including over 8,300 hospitalizations reported, about a third requiring intensive care, and nearly 100 deaths.

The dose for young children is just one-third of the Pfizer shot already recommended for everyone 12 and older. Moderna also is studying its vaccine for young children.

An Israeli child receives a COVID-19 vaccine at a Clalit vaccination center in Petah Tikvah, on June 6, 2021. (Flash90)

A study of elementary schoolchildren found the Pfizer shots are nearly 91 percent effective at preventing symptomatic infection — even though the youngsters received just a third of the dose given to teens and adults.

While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness — including over 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths, FDA vaccine chief Dr. Peter Marks told the advisory panel.

Meanwhile on Tuesday, Prime Minister Naftali Bennett was scheduled to meet with health officials to discuss the potential approval as well.

An emergency authorization in Israel could follow within weeks of approval by the FDA. Health Ministry officials said earlier this week that shots for children under the age of 12 in Israel could begin in mid-November.

Israel’s policy has been to closely follow FDA guidelines on COVID-19 vaccine usage, though it has also broken with US regulators in offering booster shots to the general population before America.

In Israel, full-strength Pfizer shots are already recommended for anyone 12 or older, but pediatricians and parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious Delta variant and to help keep kids out of quarantine and in school.

Israel appears to be at the tail end of its fourth coronavirus wave, as new infections and serious cases have ticked down over the past few weeks.

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