COVID-19 shots for US infants, toddlers and preschoolers moved a step closer on Wednesday.
The Food and Drug Administration’s external vaccine advisors gave Moderna the thumbs up for two shots for young children. The panel is set to vote later on Wednesday whether to also recommend Pfizer’s three-shot series for those youths.
Outside experts voted unanimously that the benefits of Moderna’s shots outweigh any risks for children under the age of 5 — that is, about 18 million young people.
They are the last remaining group in the US to be vaccinated, and many parents are concerned for the safety of their young children. If all regulatory steps are approved, the shots 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 a lot of parents who are absolutely desperate to get this vaccine, and I think it’s up to us to give them the option to get vaccinated if they want to.”
The FDA’s vaccine chief, Dr. Peter Marks, began the meeting with data showing a “quite troubling surge” in hospitalizations of young children during the omicron wave, and noted that 442 under the age of 4 Children have died during the pandemic. This is much lower than adult deaths. But the youngest children should not be dismissed in considering the need for vaccination, he said.
“Every child that is lost inevitably disintegrates a family,” Marx said.
FDA reviewers noted that both brands appear to be safe and effective for children younger than 6 months of age in posted analyzes prior to the full-day meeting. Side effects, including fever and fatigue, were generally minor in both, and were 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.
“It’s a really important point,” said Georgetown University’s Dr. Jesse Goodman, a former FDA vaccine chief. “You can’t compare vaccines directly.”
If the FDA agrees with its advisors and authorizes the shots, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after Saturday’s meeting of its own advisors. If the CDC signs, the shots may be available Monday or Tuesday at doctor’s offices, hospitals, and pharmacies.
The Pfizer vaccine is for children aged 6 months to 4 years. Moderna vaccines range from 6 months to 5 years.
Moderna’s shots are one-quarter the dose of the company’s adult shots. The two doses appear strong enough to prevent severe disease but are only 40% to 50% effective in preventing mild infections. Moderna has added a booster to its study and hopes to eventually offer one.
Pfizer’s shots are just one-tenth of its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added during the ohmmicron wave.
Data presented by Pfizer found no safety concerns and suggested that the three shots were 80% effective in preventing symptomatic coronavirus infection. But that was based on just 10 COVID-19 cases. The count may change as more cases emerge in the company’s ongoing studies.
The same FDA panel Tuesday endorsed Moderna’s half-size shots for ages 6 to 11 and full-size doses for teens. If authorized by the FDA, it would be a second option for those age groups. Currently, the Pfizer vaccine is his only choice.
The country’s vaccination campaign began in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents being the first in line. Teens and school-age children were added last year.
Moderna said in April that it was also seeking regulatory approval outside the US for shots of its young children. According to the World Health Organization, 12 other countries are already vaccinating children under the age of 5, along with other brands.
In the US, it remains uncertain how many parents want to vaccinate their youngest children. While COVID-19 is generally less dangerous for older children and younger children than adults, severe cases and some deaths have occurred. Many parents trying to keep unvaccinated tots safe have put off family trips or enrolled children in day care or preschool.
Yet, by some estimates, three-quarters of all children have already been infected. Only about 29% of children aged 5 to 11 have been vaccinated since Pfizer opened its shots last November – a rate far lower than public health officials expect to be the norm.
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 eager to leave,” she said.