FDA clears first shots of COVID-19 for infants, preschoolers

US regulators cleared the first COVID-19 vaccines for infants and preschoolers on Friday, paving the way for vaccinations to begin next week.

The Food and Drug Administration’s action follows the unanimous recommendation of its advisory committee for the shots of Moderna and Pfizer. This means that US children under the age of 5 – about 18 million young people – can benefit from the shoot. The nation’s vaccination campaign began about 1 1/2 years ago with the elderly, most affected during the coronavirus pandemic.

One step is missing: the Centers for Disease Control and Prevention recommend how to use vaccines. His independent consultants began discussing the Moderna two-dose and Pfizer three-dose vaccines on Friday and will make their recommendation on Saturday. A final approval is expected shortly after by the director of the CDC, Dr. Rochelle Walensky.

In a Senate hearing Thursday, Walensky said his staff were working over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.”

He said pediatric deaths from COVID-19 were higher than those typically seen each year from the flu.

“So I think we have to protect young children, as well as protect everyone with the vaccine and especially protect the elderly,” he said.

The FDA has also cleared Moderna’s vaccines for school-age children and adolescents; The CDC review is next week. Pfizer’s shots had been the only option for those age groups.

For weeks, the Biden administration has been preparing to launch vaccines for toddlers, with states, tribes, community health centers and pharmacies pre-ordering millions of doses.. With the FDA’s emergency use authorization, manufacturers can begin shipping the vaccine across the country. Filming is expected to begin early next week, but it’s unclear how popular they will be.

With no protection for their little ones, some families had postponed birthday parties, vacations and visits with grandparents.

“Today is a day of tremendous relief for parents and families across America,” President Joe Biden said in a statement.

While young children generally don’t get COVID-19 like older children and adults, their hospitalizations increased during the omicron surge, and FDA consultants determined that the benefits of vaccination outweighed minimal risks. Studies by Moderna and Pfizer showed that side effects, including fever and fatigue, were mostly mild.

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White House coordinator for COVID-19, Dr. Ashish Jha, predicted that the pace of vaccinations for children under 5 will be much slower than that of older populations, and said the administration has no goals. internal for the pace of vaccinations.

“At the end of the day, our goal is very clear: we want as many children as possible vaccinated,” Jha told The Associated Press.

During testing, younger children developed high levels of anti-virus antibodies, comparable to those seen in young adults, the FDA said. Moderna’s vaccine was about 40% to 50% effective in preventing infections, but there were too few cases in Pfizer’s study to provide a reliable and accurate estimate of effectiveness, the agency said.

“Both of these vaccines have been licensed with science and safety at the forefront of our minds,” FDA chief of vaccines Dr Peter Marks said at a news conference.

Marks said parents should be comfortable with both vaccines and vaccinating their children as soon as possible, rather than waiting until the fall when a different variant of the virus may circulate. She said adjustments would be made to vaccines to take this into account.

“Whatever vaccine your doctor, the pediatrician has, is what I would give to my child,” Marks said.

The two brands use the same technology but there are differences.

Pfizer’s vaccine for children under the age of 5 is one-tenth the adult dose. Three injections are needed: the first two three weeks apart and the last at least two months later.

Moderna’s is two doses, each a quarter of its adult dose, given approximately four weeks apart for children under 6. The FDA has also cleared a third dose, at least one month after the second dose, for children who have immune conditions that make them more vulnerable to serious illness.

Both vaccines are for babies as young as 6 months. Moderna then plans to study her shots for babies as young as 3 months. Pfizer hasn’t finalized plans for shots in younger children. A dozen countries, including China, already vaccinate children under 5, under other brands.

Immediately upon learning of the FDA’s decision, Dr. Toma Omofoye, a radiologist from Houston, made appointments for her 4-year-old daughter and 3-year-old son. Without filming, her family missed family reunions, indoor concerts, and even trips to the supermarket, she said. During a recent stop at the pharmacy, Omofoye said her daughter stared at her and walked around like she was Disneyland, and thanked her.

“My heart broke in that moment, which is why my heart is so elated now,” said Omofoye.

But will other parents be so eager to vaccinate the little ones? According to some estimates, three quarters of all US children have already been infected. And only about 30 percent of children between the ages of 5 and 11 have been vaccinated since Pfizer’s vaccines opened them last November.

FDA officials acknowledged those low rates and said the government is committed to vaccinating more older children and having better success with younger children.

“It’s a real tragedy when you have something free with so few side effects that prevents deaths and hospitalization,” said FDA Commissioner Robert Califf.

According to federal data, about 440 children under the age of 5 have died from COVID-19.

Dr Beth Ebel of the University of Washington School of Medicine in Seattle said small vaccines would be especially popular with parents with children in daycare centers, where outbreaks can put parents off work, increasing tension. financial.

“Many people will be happy and many grandparents will be happy too, because we missed those children who grew up when you couldn’t see them,” Ebel said.

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AP reporters Laura Ungar, Carla K. Johnson and Zeke Miller contributed.

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Follow AP medical writer Lindsey Tanner: @LindseyTanner

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