Modern announced Wednesday it aims to report data of the efficacy of its Covid-19 vaccine in children ages 2-5 by March, and hopes to evaluate its booster shot for those ages 12-17 as Covid-related hospitalizations for children have reached record levels.
If data from the 2 to 5 age group trials is promising, the company says it will proceed with regulatory filings to seek approval from the U.S. Food and Drug Administration.
The FDA has yet to approve any Covid-19 vaccine for those ages 2 to 5, with only Pfizer’s vaccine authorized for those ages 5 to 11.
Despite not yet having its initial two-dose vaccine approved for those ages 12 to 17, Moderna said it has been evaluating a booster dose for the age group.
Pfizer’s is also the only Covid-19 vaccine approved for those ages 12 to 17 in the U.S., though Moderna’s has received authorizations in Europe, Australia and Canada.
The FDA told Moderna in October the agency needed more time to assess the company’s vaccine before approving it for the adolescent age group, with an update possibly coming later this month.
Moderna says it began evaluating a lower dosage for the 6-to-11 and 12-to-17 age groups in order to meet regulatory guidance.
Pfizer has also been conducting trials on the efficacy of its Covid-19 vaccine for those ages 2 to 5, as well as babies ages 6 months to 2 years. In December, it announced initial trials showed the vaccine was not providing the same level of immunity in those ages 2 to 5 as it does in older age groups, though it proved effective for the 6- to 24-month group. The company said it would evaluate the efficacy of a third dose in an attempt to reach the desired immunity in this group, as well as a third dose for children ages 5 to 12.
7 million. That’s how many children ages 5 to 11 have received at least one dose of the Covid-19 vaccine as of January 5, according to the CDC, representing a quarter of all 5- to 11-year-olds in the U.S. Experts fear this figure is not nearly high enough as children return to school in the new year. Hospitals averaged 870 new Covid-related pediatric admissions per day last week—the highest rate since the pandemic began.
Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine, told the Associated Press Wednesday the age group’s low vaccination rates are “very disturbing.” Murphy pointed to hesitation by some parents, who believe their children are not at risk for a severe reaction to the virus, stating they are “taking an enormous risk and continuing to fuel the pandemic.”
By Mason Bissada, Forbes Africa