FDA advisers move COVID-19 shots closer to children under 5

COVID-19 vaccines for infants, toddlers, and preschoolers in the US got a step closer on Wednesday.

Vaccine consultants from the Food and Drug Administration praised Moderna vaccines and pfizer for the smallest kids.

Outside experts have unanimously voted that the benefits of vaccination outweigh any risks to children under 5 years of age, an estimated 18 million children. This is the last age group in the US without access to COVID-19 vaccines, and many parents have been keen to protect their young children.

If all regulatory steps are met, vaccinations should be available next week.

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

Dr. Peter Marks, the FDA’s head of vaccines, opened the meeting with data suggesting a “highly worrying spike” hospitalization of young children during the omicron wave and noted that 442 children under the age of 4 died during the pandemic. That’s far less than the adult death rate, but the need to vaccinate the youngest children shouldn’t be discounted, he said.

“Every lost child, in fact, destroys the family,” Marks said.

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FDA reviewers said both brands appear safe and effective in children as young as 6 months of age in analyzes released ahead of the one-day meeting. Side effects, including fever and fatigue, were generally minor in both patients and were less common than in adults.

The two vaccines use the same technology, but there are differences. Speaking to reporters earlier this week, vaccine experts noted that vaccines have not been tested against each other, so it’s impossible to tell parents which one is better.

“This is a really big moment,” said Dr. Jesse Goodman of Georgetown University, former head of the FDA’s vaccine division. “You can’t compare vaccines directly.”

If the FDA agrees with its advisors and allows vaccinations, there is one more step left. The Centers for Disease Control and Prevention will decide on a formal recommendation after a meeting of their advisors on Saturday. If the CDC signs off, shots could be available as early as Monday or Tuesday at doctors’ offices, hospitals and pharmacies.

The Pfizer vaccine is for children 6 months to 4 years of age; Art NouveauThe vaccine is valid for 6 months to 5 years.

Moderna’s shots are a quarter of the company’s adult shots. Two doses were found to be strong enough to prevent severe disease, but only 40-50% effective in preventing milder infections. Moderna has added a booster to its research and expects to offer it eventually.

Pfizer shots are only one-tenth of the adult dose. Pfizer and partner BioNTech found that two injections did not provide sufficient protection in testing, so a third was added during the omicron wave.

The data provided by Pfizer showed no safety issues and showed that the three shots were 80% effective in preventing symptomatic coronavirus infections. But this was based on just 10 cases of COVID-19; the calculation may change as more cases emerge in the company’s current research.

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The same FDA panel on Tuesday upheld Moderna’s half shots for ages. 6 to 11 and full size doses for teenagers. If the FDA approves, this will be the second option for these age groups. Currently, the Pfizer vaccine is their only choice.

The national vaccination campaign began in December 2020 with the introduction of adult vaccines from Pfizer and Moderna, with healthcare workers and nursing home residents first in line. Last year, teenagers and children of school age were added to them.

In April, Moderna said it was also looking for regulatory approval outside the US for their little baby shots. According to the World Health Organization, 12 other countries are already vaccinating children under the age of 5 with other brands.

In the US, it remains unclear how many parents want to vaccinate their youngest. Although COVID-19 is generally less dangerous for young children than for older children and adults, there have been serious cases and some deaths. Many parents trying to keep unvaccinated babies safe have postponed family trips or enrolled their children in kindergarten or preschool.

However, by some estimates, three-quarters of all children are already infected. Only about 29% of children aged 5 to 11 have been vaccinated since Pfizer opened vaccinations for them last November, far below what public health authorities think is ideal.

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

“We have those who hesitate, and there are those who are just torn,” she said.

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