Covid vaccine for children under 5 draws closer to FDA approval after committee supports shots

Covid vaccine for children under 5 draws closer to FDA approval after committee supports shots

A kindergarten student gives her teacher the thumbs up before starting day one of kindergarten Tuesday, August 17, 2021 at Laguna Niguel Elementary School in Laguna Niguel, CA.

Paul Bersebach | MediaNews Group | Getty Images

Moderna’s Covid-19 vaccine for infants to preschoolers is one step closer to approval by the Food and Drug Administration.

The FDA’s committee of independent vaccine experts voted unanimously to recommend the vaccines for use in the youngest children after weighing how safe and effective the vaccines are during a day-long public session.

The committee will also shortly vote on Pfizer’s vaccine for infants through preschoolers.

The FDA will likely accept the committee’s guidance and quickly approve the recordings. The Centers for Disease Control and Prevention must then approve the vaccines before pharmacies and doctor’s offices can start giving them to the children.

Parents will likely be able to have their children vaccinated as early as Tuesday, although Dr. Ashish Jha, who is overseeing the White House’s response to the pandemic, could initially be limited as the vaccination program ramps up.

Covid is generally less severe in children than adults. However, hospitalizations of children under the age of 5 increased during the Omicron wave, reaching the highest level of the pandemic. According to the CDC, the hospitalization rate for these children during omicron was as bad or worse than any recent flu season.

Covid has killed 202 six-month-olds to 5-year-olds since January 2020. Children under the age of 5 are the only age group in the United States that are not eligible for vaccination. Many parents have waited months for the FDA to approve the recordings.

“We have to be careful not to go deaf from the overwhelming number of elderly deaths given the number of pediatric deaths. Every life matters,” said Dr. Peter Marks, chief of the FDA’s Vaccine Division, told the committee.

“For those who have lost children to Covid-19, our hearts go out to them because every lost child essentially breaks a family apart,” Marks said.

Pfizer vs. Moderna vaccines

The Pfizer and Moderna vaccines for the youngest differ in many ways. Based on available data, Pfizer’s three shots appear more effective than Moderna’s two shots. Both vaccines are safe and have side effects similar to those of the common cold, according to FDA presentations.

Pfizer’s vaccine is given in three doses to children aged six months to four years. The shots are dosed at 3 micrograms, a tenth of what adults receive.

Pfizer’s three-dose vaccine was about 80% effective in preventing disease from Omicron, the predominant variant in the US. Subject to change as more data becomes available.

Moderna’s vaccine is given in two doses to children aged six months to five years. The shots are dosed at 25 micrograms, a quarter of what adults get.

Moderna’s two-dose vaccine was about 51% effective in preventing disease caused by Omicron in children ages six months to two years and about 37% in children ages two to five years.

According to Jacqueline Miller, an executive at the company, Moderna plans to release data later this summer on a third dose targeting the Omicron variant in this age group and ask the FDA to review it.

“However, because children under the age of 4 were at greatest risk of hospitalization due to Covid-19 during the Omicron surge, starting this vaccine series now is critical to begin protecting children this summer,” Miller told the committee . Moderna believes two doses will protect against serious illness from Omicron at similar levels seen in adults, she said.

The most common side effects of both vaccines are pain at the injection site, irritability and crying, loss of appetite and sleepiness. Very few children who received either vaccine developed a fever greater than 102 degrees Fahrenheit or 39 degrees Celsius. The children in the Pfizer and Moderna studies had no cases of myocarditis, a type of heart inflammation.

This is an evolving story. Please check again for updates.

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