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Pfizer COVID vaccine is safe for children under 5, FDA review finds

WASHINGTON (AP) — Federal health officials said Sunday that children’s doses of Pfizer’s COVID-19 vaccines appear to be safe and effective for children under 5, a key step toward a long-awaited decision to start to vaccinate America’s youngest children.

The Food and Drug Administration released its analysis of the Pfizer firing ahead of a Wednesday meeting where outside experts will vote on whether the firings are ready for the nation’s 18 million babies, toddlers and preschoolers. Children under 5 are the only group not yet eligible for the COVID-19 vaccination in the United States

Late last week, the FDA released a similar analysis of Moderna’s vaccines for children under 6.

If regulators clear one or both companies, vaccinations could begin as early as next week, with drugmakers ready to ship government-ordered doses quickly. Parents have been lobbying federal officials for months for the ability to protect their youngest children as more adults shed their masks and abandon other public health precautions.

READ MORE: Moderna says new COVID-19 vaccine protects against omicron

While only about 3% of COVID cases in the United States are in the 6 month to 4 year age group, hospitalization and death rates in this group are higher than those of older children, according to FDA analysis – one of the reasons why experts have said protecting this group is important.

The FDA said children who received Pfizer’s vaccines in testing developed high levels of anti-virus antibodies thought to protect them against the coronavirus. This is the basic threshold needed to obtain FDA clearance. But further testing revealed key differences, with stronger results for Pfizer.

Pfizer’s vaccine, given as a series of three injections, appeared to be 80% effective in preventing symptomatic COVID-19, although this calculation is based on only 10 cases diagnosed among study participants. and before the super contagious omicron variant of the virus became dominant. The figure could change as Pfizer’s study continues.

Moderna’s two-dose series was only about 40% to 50% effective in preventing milder infections, although it was tested during the omicron wave. Moderna has started testing a booster for toddlers.

On Wednesday, the FDA will ask an independent panel of vaccine experts to debate data from the two companies before voting. The FDA is not required to follow the panel’s recommendations, but the process is considered a key step in public scrutiny of vaccines.

READ MORE: For children with COVID-19, everyday life can be difficult

The FDA is expected to issue its official decision shortly after Wednesday’s all-day meeting. Next up: The Centers for Disease Control and Prevention, which recommends how to use vaccines, will convene its own panel of experts to discuss which toddlers need vaccinations.

It’s unclear how many requests there will be initially for the shots. A recent survey suggests that only 1 in 5 parents of young children would get their children vaccinated right away. Vaccines have been available since November for older US school children, but less than a third of those aged 5 to 11 have received the recommended two doses, according to government figures.

For younger children, each company offers different dose sizes and number of doses, from 6 months to 4 years for Pfizer and up to 5 years for Moderna.

Pfizer and its partner BioNTech plan to offer two injections three weeks apart, followed by a third at least two months later, each representing one-tenth the dose given to adults. Pfizer is currently the only company to offer a COVID-19 vaccine for older American children.

Moderna is seeking FDA clearance for two injections, each one-quarter of its adult dose, about four weeks apart.

The FDA currently allows Moderna’s vaccine to be used only in adults. But some countries allow full-size doses for teenagers and half-size doses for children ages 6 to 11 — a step the FDA is also considering.

More than 30,000 U.S. children under the age of 5 have been hospitalized with COVID-19 and nearly 500 coronavirus deaths have been reported in that age group, according to U.S. health officials.

The government allowed pharmacies and states to start placing orders for tot-sized doses last week, with 5 million initially available – half made by Pfizer and the other half by Moderna.


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