Moderna and Pfizer’s Covid-19 vaccines for infants to preschoolers have gone through Food and Drug Administration approval.
The FDA’s Committee of Independent Expert On Vaccines voted unanimously to introduce vaccines for use in younger children after comparing their protection and efficacy at a one-day public meeting.
Most likely, the FDA will accept the committee’s recommendation and immediately authorize the injections. The Centers for Disease Control and Prevention will have to approve vaccines before pharmacies and doctors’ offices can begin administering them to children.
Parents will most likely vaccinate their children on Tuesday, though appointments could be limited at first as the vaccination program intensifies, according to Dr. Ashish Jha, who oversees the White House’s response to the pandemic.
Covid is sometimes less severe in young people than in adults. However, hospitalizations of children under five surpass the omicron wave, reaching the highest point of the pandemic. The omicron hospitalization rate was as bad or worse for those young people than any recent flu. season, according to the CDC.
Covid has killed 202 children aged six months to five years since January 2020. Children under the age of five are the only remaining age organization in the United States that is vaccinated. Many parents have been waiting for months for the FDA to authorize the injections. .
“We want to be careful not to be insensitive to the number of pediatric deaths because of the overwhelming number of deaths of older people. Every life matters,” Dr. Peter Marks, chief of the FDA’s vaccine division, told the committee.
“For those who have lost young people to covid-19, our mind is with them because each and every child lost necessarily fractures a family,” Marks said.
Pfizer and Moderna’s vaccines for younger youth differ in several ways, adding the number of shots they use, the dose level, and the age of eligibility.
The Pfizer vaccine is given in 3 doses for children older than six months to four years. Injections are dosed at 3 micrograms, which is one-tenth of what adults receive.
Pfizer’s three-dose vaccine is approximately 75% effective in preventing omicron disease in children 6 months to 2 years of age, and 82% efficacy compared to omicron in children 2 to 4 years of age.
Dr. Doran Fink, a senior official in the FDA’s vaccine division, said the efficacy of Pfizer’s vaccine after the third dose is a vague estimate that is likely to be replaced as more knowledge becomes available.
The third vaccine is very important for the Pfizer vaccine because two doses had little protection. First, the FDA sought to speed up the first two doses in February, but Pfizer postponed its submission because the knowledge wasn’t smart enough. Two doses were approximately 14% effective for children under 2 years and 33% effective for children aged 2 to 4 years.
Dr. Paul Offit, a member of the FDA committee, said Pfizer’s 3-microgram doses could be too low. Offit said it’s important for parents to know that their children aren’t looking for two doses and deserve to get the third Pfizer vaccine.
“I’m concerned that parents don’t necessarily know that after two doses, they may no longer be and have interaction in the kind of activity that would put their child at risk,” said Offit, a pediatrician at Creme Philadelphia. Children’s Hospital.
The Moderna vaccine is given in two doses for children six months to five years of age. The injections are dosed at 25 micrograms, a quarter of what adults receive.
Moderna’s two-dose vaccine is approximately 51% effective in preventing omicron disease in children six months to 2 years of age and approximately 37% effective in children aged 2 to 5 years. Moderna expects two doses to protect against severe omicron disease at similar levels seen in adults, said Jacqueline Miller, a company executive.
Moderna plans to learn about a third dose targeting the omicron variant at this age organization over the summer and ask the FDA to review that information as soon as possible, Miller said.
“However, given that children under the age of four experienced the greatest threat of hospitalization due to the surge of omicron from COVID-19, it is now important to launch this series of vaccines to begin protecting children this summer,” Miller told the committee.
Panel member Dr Jay Portnoy said he was disappointed that Moderna’s vaccine has not done a better job of saving those infected with covid. However, Portnoy said the injections would prevent children from becoming seriously ill.
“The evidence is transparent enough to prevent serious illness, hospitalizations and emergency visits,” said Portnoy, a professor of pediatrics at the University of Missouri-Kansas City. “This vaccine is very effective. It’s also very useful,” he said. Said.
The most common side effects of either vaccine are pain at the injection site, irritability and crying, loss of appetite and drowsiness, according to FDA filings. Very few children who received either vaccine developed a fever above 102 degrees Fahrenheit or 39 degrees Celsius. There have been no cases of myocarditis, a type of cardiac inflammation, among young people in the Pfizer and Moderna trials.
However, committee member Dr. Cody Meissner said the protective profile of vaccines in children under five is not as well established as in adolescents and adults. Meissner, a professor of pediatrics at Tufts University, said injections are an option for parents. it is not a requirement. He said the FDA and CDC continue to closely monitor vaccine protection.
Marks, chief of the FDA’s vaccine division, said the agency’s experts are working around the vaccine protection profile day and night and will continue to do so. He said the FDA will alert the public to any rare side effects, as it did with myocarditis. in adolescents.
“We at the FDA care a lot about the protection and efficacy of those vaccines and will continue to monitor those vaccines as they are rolled out,” Marks said.
Marks also warned the public about the findings on vaccine protection from the FDA and CDC knowledge base, known as VAERS. there is a relationship between an adverse event and vaccines, he said.
“For rare adverse events, we will make the public aware of them,” Marks said.
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