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FDA advisers review Moderna, Pfizer COVID-19 Shots for children as young as 6 months – NBC Chicago

By on June 15, 2022 0

U.S. government advisers met on Wednesday to decide whether to approve COVID-19 shots for babies, toddlers and preschoolers, bringing the country one step closer to vaccinations for all ages.

Children under 5 are the last remaining age group in the United States to get vaccinated, and many parents are eagerly awaiting action from the Food and Drug Administration to protect their little ones. If all the regulatory hurdles are cleared, the shots should be available next week.

The independent advisory board is considering doses the size of a tot from two coronavirus vaccine makers – Pfizer and Moderna.

Dr. Peter Marks, the FDA’s vaccine chief, opened the meeting with data showing a “pretty disturbing increase” in hospitalizations of young children during the omicron wave, and noted that 442 children under the age of 4 died during the pandemic. That’s far fewer than adult deaths, but the need to vaccinate younger children shouldn’t be discounted, he said.

“Each child that is lost essentially fractures a family,” Marks said.

FDA reviewers said both brands appeared to be safe and effective for children as young as 6 months old in reviews released ahead of the one-day meeting. Side effects, including fever and fatigue, were generally minor in both cases and less common than in adults.

Both vaccines use the same technology but there are differences. In a call with 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 one is superior.

“That’s a really important point,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. “You can’t compare vaccines directly.”

U.S. Food and Drug Administration analysis says child-friendly doses of Pfizer’s COVID-19 vaccine appear safe and effective for children under five, which would be a big step towards vaccination of the youngest children in the country who were previously unprotected.

If the FDA clears the shots, 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 approves, the injections could be available as early as Monday or Tuesday at doctor’s offices, hospitals and pharmacies. About 18 million young people would be eligible.

Pfizer’s vaccine is for children 6 months to 4 years old; Moderna is 6 months to 5 years old.

Moderna’s plans are a quarter of the dose of the company’s adult plans. Two doses seemed strong enough to prevent serious infections, but only about 40-50% effective in preventing milder infections. Moderna added a booster to their study.

“I think we can all agree that these children will need a third dose at some point,” Moderna’s Dr. Jacqueline Miller told the panel.

Pfizer’s injections are only a tenth of his adult dose. Pfizer and partner BioNTech found that two injections did not provide enough protection in testing, so a third was added during the omicron wave.

Data submitted by Pfizer revealed no safety concerns and suggested that three injections were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 cases of COVID-19; the calculation could change as more cases occur in the company’s ongoing studies.

The same FDA panel on Tuesday backed half doses of Moderna for ages 6 to 11 and full doses for teens. If cleared by the FDA, this would be the second option for these age groups. Currently, the Pfizer vaccine is their only choice.

Moderna has submitted data to the Food and Drug Administration that it hopes will prove that two low-dose injections can protect children under the age of 6.

The nationwide vaccination campaign began in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with healthcare workers and nursing home residents on the front lines. 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 photos of small children. According to the World Health Organization, 12 other countries already vaccinate children under 5, along with other brands.

In the United States, it is still unclear how many parents want their youngest to be vaccinated. Although COVID-19 is generally less dangerous for young children than for older children and adults, there have been severe cases and 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 have already been infected. Only about 29% of children ages 5 to 11 have been vaccinated since Pfizer’s vaccines were opened to them last November, a rate far below what public health authorities consider ideal.

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

“We have some who are hesitant, and others who are eager to leave,” she said.

With coronavirus vaccines soon to be available for children ages 5 to 11, children may not be as keen as their parents to get vaccinated. Whether it’s their COVID-19 shot or their other routine vaccinations, here’s how to help your child deal with the stress of getting the shot.