Moderna seeks FDA clearance for COVID-19 vaccine in young children

For parents of young children, the two-year pandemic has been especially tough. More than a year after vaccinations became routine for adults, they still have no options for their kids.

Meanwhile, the FDA has been trying to speed the process for authorization while maintaining public confidence in vaccines. That’s resulted in missteps, such as the flip-flop on Pfizer’s original two-dose application in February.

Now, the agency is facing criticism for potentially waiting to approve Moderna’s application until Pfizer’s is also ready. Clearing both vaccines at the same time could avoid confusion, National Institute of Allergy and Infectious Diseases director Anthony Fauci told CNN last week. Such “pop psychology” comes at the expense of children’s health, University of North Carolina professor Zeynep Tufekci argued in a New York Times opinion piece on Wednesday.

The FDA’s effort to build confidence in vaccines is complicated by the latest numbers in the kids’ research. The companies were able to deliver astounding results when the original adult doses were being tested, with each shot more than 90% effective against the virus’ original strain at preventing symptomatic COVID-19. However, the latest studies on children were conducted as the more infectious omicron variant spread.

Moderna originally reported that its two-shot vaccine could prevent about 44% of COVID-19 cases in children between 6 months and 2 years old and 38% of cases in children between the ages of 2 and 6. On Thursday, the company said those numbers would be 51% and 37%, respectively, if only cases confirmed by a lab PCR test are considered.

Still, there’s more to vaccines than simply preventing infections. While omicron has also proven able to evade the adult inoculations more often, fully vaccinated people are far less likely to be hospitalized or die if they do contract COVID-19. That’s a critical benefit that should be available for the youngest children as well, according to the advocacy group Protect Their Future.

Pfizer and Moderna chose slightly different age groups in their initial studies. The Pfizer vaccine is currently available for children as young as 5. The company and partner BioNTech also are seeking FDA clearance for a booster dose for children between the ages of 5 and 11.

Published April 28, 2022 By Kristin Jensen

Published original source: https://www.biopharmadive.com/news/moderna-fda-filing-covid-vaccine-children-infants/622844/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-04-28%20BioPharma%20Dive%20%5Bissue:41369%5D&utm_term=BioPharma%20Dive