FDA panel recommends Covid vaccine for youngest children. Shots could begin next week.

Food and Drug Administration advisers voted Wednesday to recommend authorizing Moderna’s Covid-19 vaccine for children ages 6 months to 5 years, clearing one of the final hurdles to getting the youngest Americans vaccinated.

The unanimous recommendation was the first of two votes called by the Vaccine and Related Biological Products Advisory Committee during its Wednesday meeting.

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Later this afternoon, the advisory committee will also consider the Pfizer-BioNTech Covid vaccine for children ages 6 months to 4 years.

The committee’s recommendations are not the final signoff needed to administer the shots, but the votes will now set in motion a fast-moving process expected to be completed by Tuesday — a great relief to parents who have waited more than a year-and-a-half to vaccinate their youngest.

The decision will now go to the FDA, which is expected to grant emergency use authorization to the vaccines in the coming days. On Friday and Saturday, an advisory panel to the Centers for Disease Control and Prevention is expected to vote on whether to endorse the shots. The final step is signoff from CDC Director Dr. Rochelle Walensky — then, shots in arms (or thighs).

Though younger children are usually spared the worst effects of Covid, severe cases and deaths can still occur. This was particularly apparent this past winter, when the omicron wave sent the hospitalization rate of children under 5 higher than any previous point in the pandemic, according to CDC data.

As of May 28, at least 442 children under 5 have died due to Covid, Dr. Peter Marks, the FDA’s top vaccine regulator, told the committee. That number of deaths, over the course of just over two years, is far higher than what’s typically seen over the same time period for other dangerous respiratory viruses, such as influenza, he said.

Children are also susceptible to a rare complication of Covid called MIS-C, or multi-system inflammatory syndrome in children, which causes severe inflammation throughout the body.

Clinical trial data presented by both Moderna and Pfizer representatives at Wednesday’s meeting showed the vaccines were safe and effective in the youngest kids.

Moderna’s vaccine consists of two shots, given four weeks apart. The tot-size doses are 25 micrograms — a quarter of the dosage given to adults. The shots were around 40 to 50 percent effective at preventing milder omicron infections in young children.

Acknowledging the lower efficacy, Moderna said it expects children in the age group to be offered a booster dose of the vaccine “at some point in time.”

Pfizer experienced similar problems to Moderna earlier this year when clinical trials found its two-dose regimen provided only limited protection against infection.

At Wednesday's meeting, Pfizer presented data on three doses of the vaccine, which were shown to be 80 percent effective in preventing symptomatic Covid. In what might be seen as a drawback to some parents, however, the shots must be given over 11 weeks: the first shots are given three weeks apart, followed by the third shot, eight weeks later.

Pfizer's shot for children under 5 is also a lower dosage than its version for adults: 3 micrograms versus 30 micrograms.

This is a developing story. Please check back for updates.

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