FDA authorizes Pfizer, Moderna vaccines for children as young as 6 months

On Friday, the Food and Drug Administration authorized Moderna and Pfizer’s Covid-19 vaccines for children as young as 6 months old, which now makes nearly every person in the United States eligible for vaccination.

The FDA’s decision comes after its committee of independent vaccine experts voted unanimously to recommend the vaccines after evaluating their safety and effectiveness in an all-day meeting open to the public on Wednesday.

The FDA has cleared Pfizer’s three-dose vaccine for children 6 months to 4 years old and Moderna’s two-dose vaccine for children 6 months to 5 years old. Children under the age of 5 were the only remaining people in the United States not eligible for vaccination. Many parents have been waiting months for the FDA to authorize vaccines for their children.

On Friday, the FDA also cleared Moderna’s vaccines for children in kindergarten through high school. Previously, Pfizer’s vaccine was the only Covid vaccine available for this age group.

However, there is still one step before vaccination of children under 5 can begin. The Centers for Disease Control and Prevention committee will meet on Saturday to vote on guidelines for pharmacies and doctor’s offices. CDC director Dr. Rochelle Walensky must then sign off on those guidelines before children can begin receiving the injections.

The White House expects vaccinations to begin as early as Tuesday. Appointments may be limited initially, but every parent who wants to have their child vaccinated should be able to do so within weeks, according to Dr Ashish Jha, who oversees the Biden administration’s Covid response.

The federal government has made 10 million Pfizer and Moderna doses available to state and local authorities.

Dr. Arnold Monto, acting chairman of the FDA committee, said it took the agency longer to clear injections for infants through preschoolers than for other ages because this is a vulnerable group that requires special attention to ensure that the injections were safe and effective. .

Although Covid is generally less severe in children than in adults, hospitalizations of children under 5 increased during the winter wave of omicron, reaching the highest level of the pandemic. Covid has killed more than 200 children six months to 5 years old since January 2020, according to the CDC.

Pfizer shots against Moderna

Pfizer’s and Moderna’s vaccines for infants through preschoolers differ in the number of injections they use, the dosage level, and the age of eligibility to receive them. Pfizer’s vaccine also appeared more effective than Moderna shots in children under 5, although the data is preliminary.

Pfizer’s vaccine is given in three doses for children 6 months to 4 years old. The shots are dosed at 3 micrograms, one-tenth the level of what adults get. Three injections were about 75% effective in preventing omicron infection in children 6 months to 2 years old and 82% effective in children 2 to 4 years old.

However, it is crucial that parents opting for Pfizer ensure their children receive the third vaccine to be protected against the virus. Two doses were only about 14% effective in preventing infection in children under 2 years old and 33% effective in children 2 to 4 years old.

Moderna’s vaccine is given in two doses for children 6 months to 5 years old. The shots are dosed at 25 micrograms, a quarter of the level that adults receive.

Moderna’s vaccine was about 51% effective in preventing omicron infection in children 6 months to 2 years old and about 37% effective in children 2 to 5 years old. However, the company expects the vaccine to provide strong protection against serious disease, as children had higher antibody levels than adults who received two doses.

According to the FDA, the most common side effects of vaccines were pain at the injection site, irritability and crying, loss of appetite and drowsiness. Very few children who received either vaccine developed a fever above 102 degrees Fahrenheit, and there were no cases of myocarditis, a type of heart inflammation, in trials. Pfizer or Moderna.

CNBC Health and Science

Read CNBC’s latest global coverage of the Covid pandemic:

Leave a Comment