FDA advisers approach COVID-19 shots for children under 5 years old

COVID-19 shots for infants, toddlers and preschoolers in the US came one step closer on Wednesday.

The Food and Drug Administration’s outpatient vaccine consultants applauded Moderna’s two shots for younger children. The committee is due to vote later Wednesday on whether it would also propose Pfizer’s three-shot series for these youngsters.

External experts unanimously voted that the benefits of Moderna shots outweigh the risks to children under 5 – that is, about 18 million young people.

It is the last group left in the US to be vaccinated and many parents are anxious to protect their young children. If all the regulatory steps are deleted, the downloads should be available next week.

“This is a long-awaited vaccine,” said one committee 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 have to give them the option to get the vaccine if they want to.”

Dr. Peter Marks, head of vaccination at the FDA, opened the meeting with data showing a “rather alarming increase” in infant hospitalization during the Omicron wave and noted that 442 children under the age of 4 had died during the pandemic. That’s a lot less than adult deaths, but it should not be overlooked given the need to vaccinate younger children, he said.

“Every child who goes missing breaks a family,” Marks said.

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

The two vaccines use the same technology but there are differences. In a call to reporters earlier this week, vaccine experts noted that the vaccines have not been tested against each other, so there is no way to tell parents if someone is superior.

“This is a really important point,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine director. “You can not compare vaccines directly.”

If the FDA agrees with its advisers and approves the shots, there is one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after their own advisors meet on Saturday. If the CDC signs, the downloads could be available Monday or Tuesday at clinics, hospitals and pharmacies.

The Pfizer vaccine is for children 6 months to 4 years old. The Moderna vaccine is for 6 months to 5 years.

Moderna’s downloads are a quarter of the company’s adult downloads. Two doses seemed strong enough to prevent serious illness, but only about 40% to 50% effective in preventing milder infections. Moderna has added a booster to its study and expects to finally offer one.

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

The data provided by Pfizer did not identify safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But this was based on just 10 cases of COVID-19. the calculation could change as more cases appear in the company’s ongoing studies.

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

The nation’s vaccination campaign began in December 2020 with the release of adult vaccines by Pfizer and Moderna, with health workers and nursing home residents at the forefront. Teenagers and school-age children were added last year.

Moderna said in April that it was also seeking regulatory approval outside the United States for its infant downloads. 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 uncertain how many parents want their youngest to be vaccinated. While COVID-19 is generally less dangerous for young children than 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 enrolling children in daycare or kindergarten.

However, according to some estimates, three quarters of all children are already infected. Only about 29% of children aged 5 to 11 have been vaccinated since the Pfizer vaccine was given to them last November, a much lower rate than what public health authorities consider ideal.

Dr. Nimmi Rajagopal, family medicine at Cook County Health in Chicago, said she prepares parents for months.

“We have some who hesitate and some who rarely go,” he said.


Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.


The Associated Press Department of Health and Science receives support from the Department of Education Sciences of the Howard Hughes Medical Institute. The AP is solely responsible for all content.

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