FDA advisers move closer to COVID-19 vaccines for children under 5

COVID-19 vaccines for US infants, toddlers and preschoolers moved a step closer Wednesday.

Outside vaccine advisors to the Food and Drug Administration approved Moderna’s two shots for younger children. The panel will vote later Wednesday on whether to also recommend Pfizer’s three-shot series for those youngsters.

Outside experts unanimously voted that the benefits of Moderna’s injections outweigh any risks for children under the age of 5, that is, approximately 18 million young people.

They are the last group left in the US to be vaccinated, and many parents have been anxious to protect their young children. If all the regulatory steps are cleared, the vaccines should be available next week.

“This is a long-awaited vaccine,” said panel member Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are so many parents who are absolutely desperate to get this vaccine and I think we owe it to them to give them the option to get vaccinated if they want to.”

Dr. Peter Marks, the FDA’s chief of vaccines, opened the meeting with data showing a “pretty worrying increase” in hospitalizations for young children during the omicron wave, noting that 442 children under the age of 4 have died during the pandemic. That’s far less than adult deaths. but it shouldn’t be discounted when considering the need to vaccinate younger children, he said.

“Every child that is lost essentially fractures a family,” Marks said.

FDA reviewers said both brands appear to be safe and effective for children up to 6 months of age in analyzes published before the all-day meeting. Side effects, including fever and fatigue, were generally minor in both and less common than those seen in adults.

The two vaccines use the same technology but there are differences. In a call with reporters earlier this week, vaccine experts noted that the shots haven’t been tested against each other, so there’s no way to tell parents if one is superior.

“That’s a really important point,” said Dr. Jesse Goodman of Georgetown University, a former FDA chief of vaccines. “You can’t compare the vaccines directly.”

If the FDA agrees with its advisers and authorizes the injections, there is one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers meet on Saturday. If the CDC approves, the vaccines could be available as early as Monday or Tuesday at doctors’ offices, hospitals and pharmacies.

Pfizer’s vaccine is for children ages 6 months to 4 years; Moderna’s vaccine is from 6 months to 5 years.

Moderna’s injections are a quarter of the dose of the company’s adult injections. Two doses seemed strong enough to prevent serious illness, but only 40% to 50% effective in preventing milder infections. Moderna has added a booster to its studio and hopes to offer one eventually.

Pfizer’s injections are only a tenth of the adult dose. Pfizer and its partner BioNTech found that two injections did not provide enough protection in tests, so a third was added during the omicron wave.

The data presented by Pfizer found no safety concerns and suggested that three injections were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 cases of COVID-19; the estimate could change as more cases occur in the company’s ongoing studies.

The same FDA panel on Tuesday endorsed Moderna’s half-size shots for ages 6 to 11 and full-size doses for teens. If approved by the FDA, it would be the second choice for those age groups. Currently, the Pfizer vaccine is his only option.

The nation’s vaccination campaign began in December 2020 with the launch of adult vaccines from Pfizer and Moderna, with healthcare workers and nursing home residents on the front lines. Teens and school-age children were added last year.

Moderna said in April that it is also seeking regulatory approval outside the US for its vaccines for young children. According to the World Health Organization, 12 other countries already vaccinate children under 5 years of age, with other brands.

In the US, it remains uncertain how many parents want their youngest children to be vaccinated. Although COVID-19 is generally less dangerous for young children than it is for older children and adults, there have been severe cases and some deaths. Many parents trying to keep unvaccinated children safe have put off family trips or their child’s enrollment in daycare or preschool.

Still, by some estimates, three-quarters of all children have already been infected. Only about 29% of children ages 5 to 11 have been vaccinated since Pfizer opened up the shots to them last November, a rate far lower than what public health authorities consider ideal.

Dr. Nimmi Rajagopal, a family medicine physician at Cook County Health in Chicago, said she has been preparing parents for months.

“We have some who are hesitant and some who are just itching to get started,” he said.

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