FDA approves COVID-19 vaccines for infants and preschoolers

Pfizer’s COVID-19 vaccine for children under 5 will be manufactured in Puurs, Belgium in May. U.S. regulators on Friday approved the first COVID-19 shots for infants and preschoolers, paving the way for immunizations to begin next week.

Pfizer via AP


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Pfizer via AP


Pfizer’s COVID-19 vaccine for children under 5 will be manufactured in Puurs, Belgium in May. U.S. regulators on Friday approved the first COVID-19 shots for infants and preschoolers, paving the way for immunizations to begin next week.

Pfizer via AP

U.S. regulators on Friday approved the first COVID-19 shots for infants and preschoolers, paving the way for immunizations to begin next week.

The Food and Drug Administration’s action follows the unanimous recommendation of its advisory panel on the Moderna and Pfizer inclusions. That means US children under the age of 5 – some 18 million teenagers – are entitled to the recordings. The nation’s immunization campaign began about 1 1/2 years ago, targeting older adults who have been hit hardest during the coronavirus pandemic.

There is only one step left: The Centers for Disease Control and Prevention recommends the use of vaccines. Its independent advisors began debating Moderna’s two-dose vaccines and Pfizer’s three-dose vaccines on Friday and will make their recommendation on Saturday. Final approval will be given soon after by CDC Director Dr. Rochelle Walensky expected.

At a Senate hearing Thursday, Walensky said her staff was working over the June 16 holiday weekend “because we understand the urgency for American parents.”

She said pediatric deaths from COVID-19 were higher than what’s seen with the flu across the board each year.

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

The FDA also approved Moderna’s vaccines for school-age children and adolescents; CDC’s review is next week. Pfizer’s syringes were the only option for these age groups.

For weeks, the Biden administration has been preparing to roll out the vaccines for young children, with states, tribes, community health centers and pharmacies pre-ordering millions of doses. With the FDA’s emergency clearance, manufacturers can begin shipping the vaccine across the country. Recordings are expected to start early next week, but it’s not clear how popular it will be.

With no protection for their tots, some families had postponed birthday parties, vacations and visits to grandparents.

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

Studies have mostly shown minor side effects

While young children generally don’t get as sick from COVID-19 as older children and adults, their hospitalizations spiked during the Omicron wave, and FDA advisors determined that the benefits of vaccination outweighed the minimal risks. Studies by Moderna and Pfizer showed side effects, including fever and fatigue, were mostly minor.

“As we have seen with older age groups, we expect younger children’s vaccines to provide protection against the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Robert Califf said in a statement.

When tested, the youngest children developed high levels of virus-fighting antibodies comparable to what is seen in young adults, the FDA said. Moderna’s vaccine was about 40% to 50% effective at preventing infection, but there were too few cases during Pfizer’s study to give a reliable, accurate estimate of effectiveness, the agency said.

“Both vaccines were approved with a focus on science and safety,” said Dr. Peter Marks, FDA vaccine chief, at a press conference.

Marks said parents should feel comfortable with either vaccine and get their children vaccinated as soon as possible rather than waiting until the fall when another virus variant may be circulating. He said adjustments were being made to vaccines to take this into account.

“Whatever vaccine your healthcare provider or pediatrician has, I would give that 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 shots are required: the first two three weeks apart and the last at least two months later.

Modernas are two shots, each a quarter of the adult dose, given to children under the age of 6 about four weeks apart. The FDA also approved a third dose, at least a month after the second shot, for children with immune disorders that make them more susceptible to serious illnesses.

Both vaccines are suitable for children from 6 months. Next, Moderna plans to examine its recordings for babies as young as 3 months old. Pfizer has not yet finalized plans for vaccinations in younger infants. A dozen countries, including China, are already vaccinating children under the age of 5 with other brands.

Immediately after dr. Toma Omofoye, a Houston radiologist, upon hearing of the FDA’s decision, made appointments for her 4-year-old daughter and 3-year-old son. Without the shots, her family has missed family reunions, indoor concerts, and even trips to the grocery store, she said. During a recent pharmacy stop, Omofoye said her daughter stared at her and walked around like it was Disneyland, thanking her.

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

But will other parents be equally anxious to get their youngest vaccinated? According to some estimates, three quarters of all US children have already been infected. And only about 30% of children ages 5 to 11 have been vaccinated since Pfizer’s immunizations opened up to them last November.

Acknowledging these low rates, FDA officials said the government is striving to get more older children vaccinated and better outcomes in younger children.

“It’s a real tragedy when you can have something for free with so few side effects that prevents deaths and hospitalizations,” Califf said.

Federal data shows around 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 the tot-sized vaccines would be particularly welcomed by parents with children in day care centers, where outbreaks could keep parents off work and increase the financial burden.

“A lot of people will be happy and a lot of grandparents will be happy too because we missed the babies who grew up when you couldn’t see them,” said Ebel.

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