fda: US FDA advisers move Covid-19 shots closer for kids under 5

Covid-19 shots for US babies, toddlers and preschoolers got one step closer on Wednesday.
The Food and Drug AdministrationOutside vaccine advisors agreed ModernaTwo pictures for the youngest children. The panel is set to vote later on Wednesday on whether to recommend Pfizerthree-bullet series for those young people.
Outside experts voted unanimously that the benefits of Moderna’s shots outweigh any risks for children under 5 – that’s about 18 million teenagers.
They were the last group left in the US to be vaccinated, and many parents were anxious to protect their young children. If all prescribed steps are completed, the injections should be available next week.
“This is the long-awaited vaccine,” said panel member Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are so many parents who are absolutely desperate to get this vaccine and I think we are grateful to them for giving them the option to get vaccinated if they want to.”
Dr. Peter Marks, FDAThe director of vaccines, opened the meeting with data showing a “quite disturbing increase” in hospital admissions of young children during the omicron outbreak, and noted that 442 children under the age of four had died in the pandemic. this translation. This is much less than the number of deaths in adults, but shouldn’t dismiss considering the need to vaccinate the youngest children, he said.
“Every loss of a child essentially tears apart a family,” says Marks.
FDA reviewers said both brands appeared to be safe and effective for infants as young as 6 months of age in analyzes posted before the all-day meeting. 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 have differences. In a call with reporters earlier this week, vaccine experts noted that the shots had not been tested against each other, so there was no way to tell parents if which one was better.
“That’s a really important point,” said Dr. Jesse Goodman of Georgetown University, former director of vaccines for the FDA.
If the FDA agrees with its advisors and allows the injection, there is one more step. The Centers for Disease Control and Prevention will decide on a formal proposal after their own advisors meet on Saturday. If CDC signs off, injections are available as soon as Monday or Tuesday at doctor’s offices, hospitals and pharmacies..
Pfizer vaccine for children 6 months to 4 years old; Moderna’s vaccine is for 6 months to 5 years.
Moderna’s injections are a quarter of the dose of the company’s adult shots. Two doses appear to be strong enough to prevent severe illness but are only about 40% to 50% effective at preventing mild infections. Moderna has added an booster to its research and hopes to eventually deliver one.
Pfizer’s injections are only 1/10 of its adult dose. Pfizer and partner BioNTech found that two shots did not provide enough protection in testing, so a third photo was added in the omicron wave.
The data filed by Pfizer found no safety concerns and suggested that the three shots were 80 percent effective at preventing symptomatic coronavirus infections. But that’s based on just 10 Covid-19 cases; Calculations may change as more cases occur in the company’s ongoing studies.
The same FDA panel on Tuesday endorsed Moderna’s half-size shots for ages 6 to 11 and full-size doses for teenagers. If approved by the FDA, it would be a second choice for those age groups. Currently the Pfizer vaccine is their only option.
The nation’s immunization campaign began in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with healthcare workers and nursing home residents lining up first. Teens and school-age children were added last year.
Moderna said in April that it was also seeking regulatory approval outside of the US for photographs of its young children. According to the World Health Organization, 12 other countries have vaccinated children under 5 with other brands.
In the US, it’s still uncertain how many parents want their kids vaccinated. Although Covid-19 is generally less dangerous for young children than older children and adults, there have been severe cases and some deaths. Many parents trying to keep their unvaccinated kids safe have postponed family trips or signed their kids up for daycare or preschool.
However, by some estimates, three-quarters of children have been infected. Only about 29% of children aged 5 to 11 have been immunized since Pfizer shots were given last November, a rate far below the ideal level of public health authorities.
Dr. Nimmi Rajagopal, a family medicine physician at Cook County Health in Chicago, said she has been preparing parents for months.
“We have some hesitations, and some are just eager to go,” she said.

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