COVID-19 vaccine shots for U.S. infants, toddlers and preschoolers came a step closer on Wednesday.
The Food and Drug Administration’s outside vaccine advisors gave a thumbs up to Moderna’s two-shot vaccine and also Pfizer-BioNTech’s three-shot series for the young age group.
The panel of experts voted unanimously that the benefits of Moderna and Pfizer’s injections outweigh the risks for children under 5 – a group that includes about 18 million young people.
They are the last remaining group in the US to get vaccinated and many parents are eager to protect their children. With all regulatory steps complete, 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’s chief vaccination officer, opened the meeting with data showing a “quite disturbing rise” in hospitalizations of young children during the Omicron wave, noting that 442 children under the age of 4 died during the pandemic. That’s far less than adult deaths, but shouldn’t be discounted 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 head 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, withdrawals 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 Omicron wave.
Pfizer’s submitted data found no security issues and suggested that:in preventing symptomatic coronavirus infections. But that was based on just 10 cases of COVID-19; the calculation could change as more cases appear in the company’s ongoing investigations.
Same FDA panel backed on Tuesdayand large doses for teenagers. If authorized 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.