The Food and Drug Administration’s outside vaccine advisors gave a thumbs up to Moderna’s two injections for the smallest children. The panel will vote later Wednesday on whether or not to recommend Pfizer’s three-shot series for those youngsters.
The outside experts unanimously voted that the benefits of Moderna’s shots outweigh the risks for children under 5 – that’s about 18 million young people.
They are the last remaining group in the US to be vaccinated and many parents were concerned to protect their small children. Once all regulatory steps have been completed, the recordings should be available next week.
“This is a highly anticipated vaccine,” said a panelist, 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 owe it to them to give them the choice to get the vaccine if they want to.”
dr. Peter Marks, the FDA chief of vaccines, opened the meeting with data showing a “quite alarming rise” in hospitalizations of young children during the ommicron wave, noting that 442 children under the age of 4 have died during the pandemic. That’s far less than the number of adult deaths, but shouldn’t be dismissed when considering the need to vaccinate the youngest children, he said.
“Any child that is lost essentially breaks a family,” Marks said.
FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyzes posted prior to all-day sitting. 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. Speaking to 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 very important point,” said Dr. Jesse Goodman of Georgetown University, a former chief of FDA vaccines. “You can’t directly compare the vaccines.”
If the FDA agrees with its advisors and approves the injections, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after their own advisers meet on Saturday. If the CDC signs off, admissions could be available at doctors’ offices, hospitals and pharmacies as of Monday or Tuesday.
Pfizer’s vaccine is for children 6 months to 4 years of age; Moderna’s vaccine is from 6 months to 5 years.
Moderna’s shots are a quarter of the dose of the company’s adult shots. Two doses seemed strong enough to prevent serious illness, but only about 40% to 50% effective at preventing milder infections. Moderna has added a booster to its study and expects to offer it in due course.
Pfizer’s injections are only one-tenth the adult dose. Pfizer and partner BioNTech found that two shots did not provide adequate protection during testing, so a third was added during the ommicron wave.
Pfizer’s submitted data raised no safety concerns and suggested that three injections were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 Covid-19 cases; the calculation could change as more cases appear in the company’s ongoing investigations.
The same FDA panel on Tuesday backed Moderna’s half shots for children ages 6 to 11 and large doses for teens. If approved by the FDA, it would be the second option for those age groups. Currently, the Pfizer vaccine is their only choice.
The country’s vaccination campaign began in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health professionals and nursing home residents first in line. Last year, teenagers and school-age children were added.
Moderna said in April it is seeking regulatory approval outside the US for its photos of small children. 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 to have their youngest 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 protect unvaccinated toddlers have postponed family trips or enrolled children in daycare or preschool.
Yet, according to some estimates, three quarters of all children are already infected. Only about 29% of children ages 5 to 11 have been vaccinated since Pfizer’s injections opened for them last November, a rate much lower than public health authorities consider ideal.
dr. Nimmi Rajagopal, a primary care physician at Cook County Health in Chicago, said she has been preparing the parents for months.
“We have some who are hesitant and some are eager to go,” she said.