What’s next after FDA clearance? – NBC Chicago

U.S. regulators authorized the first COVID-19 vaccines for infants and preschoolers on Friday, paving the way for vaccinations to begin next week, but one thing still has to happen first.

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.

The country’s 18 million children under 5 were the only age group not yet eligible for vaccination.

Here’s what we know so far.

Which vaccines are now authorized for children under 5?

On Friday, the Food and Drug Administration cleared injections from Moderna and Pfizer. This means that American children under the age of 5 – about 18 million young people – are eligible for vaccines, about a year and a half after the vaccines were first made available in the United States for adults, which have been the most hard hit during the pandemic.

The vaccines are intended for children from the age of 6 months.

The FDA has also licensed Moderna’s vaccine for school-aged children and adolescents. Pfizer injections were previously the only ones available for these ages.

Previously, Pfizer’s COVID vaccine was the only one approved for emergency use in the United States for children ages 5 to 17.

Moderna then plans to study her shots for babies as young as 3 months old. Pfizer has not finalized plans for injections in young infants. A dozen countries, including China, already vaccinate children under 5.

What else needs to happen before shooting can begin and when are they expected?

One step remains: The Centers for Disease Control and Prevention recommends how vaccines should be used, and its vaccine advisers are expected to discuss vaccines for younger children on Friday and vote on Saturday. Final approval would come from CDC director Dr. Rochelle Walensky.

During a Senate hearing on Thursday, Walensky said his staff were working through the June 19 federal holiday weekend “because we understand the urgency of this for American parents.”

For weeks, the Biden administration has been preparing to roll out the vaccines. States, tribes, community health centers and pharmacies have pre-ordered millions of doses. The FDA’s emergency use authorization allows manufacturers to begin shipping vaccines across the country. Vaccinations could start as early as Monday or Tuesday.

How effective are vaccines in children?

In a study of children aged 6 months to 5 years, two injections of Moderna – each representing a quarter of the usual dose – triggered high levels of anti-virus antibodies, the same amount proven to protect young adults. , Burton said. There were no serious side effects and the injections triggered less fever than other routine vaccinations.

But the vaccine was found to be between about 40% and 50% effective in preventing symptomatic COVID-19 during the trial. Burton blamed the omicron variant’s ability to partially evade vaccine immunity, noting that unboosted adults also showed less efficacy against milder omicron infections. Although no children became seriously ill during the study, he said high antibody levels are an indicator of protection against more serious illnesses – and the company will test a child booster dose.

COVID-19 vaccines aren’t as effective against the super-contagious omicron mutant — in people of any age — and Moderna’s study found the same trend.

Meanwhile, preliminary data suggests that the three-dose series from Pfizer and its partner BioNTech is 80% effective in preventing symptomatic COVID-19, the companies said, but cautioned that the calculation is based on only 10 cases diagnosed among study participants by end. From April. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer has promised an update as soon as more data becomes available.

“The study suggests that a low dose of 3 micrograms of our vaccine, carefully selected based on safety data, provides young children with a high level of protection against recent strains of COVID-19,” he said. he said in a statement.

Federal health officials said Sunday that Pfizer’s doses of COVID-19 vaccines for children appear to be safe and effective for children under age 5. Late last week, the FDA released a similar analysis of Moderna’s vaccines for children under 6.

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.

Why do health officials want children vaccinated?

While young children typically don’t get as sick from COVID-19 as older children and adults, their hospitalizations increased during the omicron wave and FDA advisers determined that the benefits of vaccination outweighed the benefits. minimal risks.

Wallensky said pediatric deaths from COVID-19 are higher than what is typically seen from the flu each year.

“So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect the elderly,” she said.

Would children receive the same dose as adults?

Both brands use the same technology but there are differences.

Pfizer’s vaccine for children under 5 is one-tenth the adult dose. Three injections are needed: the first two given three weeks apart and the last at least two months later.

Moderna is made up of two injections, each one is a quarter of its adult dose, given about four weeks apart for children under 6 years old.

What about side effects?

Studies from Moderna and Pfizer showed that side effects, including fever and fatigue, were mostly minor.

Cardiac inflammation sometimes occurs in adolescents and young adults, mostly men, after receiving Pfizer or Moderna vaccines.

But the CDC recently found that the risk of myocarditis and other inflammatory syndromes was higher after COVID infection than after a Pfizer or Moderna vaccination in men and women ages 5 and older.

Moderna has previously said that, armed with additional evidence, it is updating its FDA app for teens and also seeking a green light for ages 6 to 11. Dr Stephen Hoge, president of Moderna, said he was optimistic the company would be able to offer its vaccine “to all age groups in the United States by summer”.

Moderna says its original adult dose — two 100-microgram injections — is safe and effective in ages 12 to 17. For children of primary school age, it uses half the adult dose.

About 1.5 million teenagers have used the Moderna vaccine in other countries, “and so far we’ve seen very reassuring safety from that experience,” Hoge said.

Cardiac risk also appears to be linked to puberty, and regulators in Canada, Europe and elsewhere have recently extended Moderna vaccinations to children as young as 6 years old.

“This concern has not been observed in young children,” said Muller of Northwestern.

NBC Chicago

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