The Centers for Disease Control and Prevention Director confirmed Wednesday that the U.S. Food and Drug Administration has approved a vaccine to protect children ages 5 to 11 from hepatitis A.
Dr. Brenda Fitzgerald said during a media call that the FDA decided to approve the vaccine, called Pegasys, as a public health measure to help prevent this type of gastrointestinal illness, which was reported to have afflicted more than 1 million people in the U.S. last year.
“This will continue to protect against the [bacterial] strain of hepatitis A that is now the predominant cause of illness and death in the U.S.,” she said.
Hepatitis A is a viral liver infection spread through direct contact with an infected person’s feces, which can be transmitted through contact with food or water, which can make people unknowingly at risk. According to the National Institutes of Health, the CDC, and the World Health Organization, Americans are among the most at risk of hep-A infections and global outbreaks, according to the US Department of Health and Human Services.
The FDA first approved this vaccine in 2015, for the older population of children 12 to 49 years old. Fitzgerald said Wednesday that since the approval of the vaccine for the older population of children 6 to 23 months, roughly 85,000 children have received the vaccine.
The CDC will continue to monitor how this vaccine is used, the CDC director said.
“This is a vaccine to help protect them against a strain of hepatitis A that’s circulating,” Fitzgerald said. “Obviously, we see with other vaccines that once you have a good immunization or vaccination you tend to see it fade. That’s not necessarily what we want to happen with this one.”
In a press release, Pfizer released a statement saying the approval of the vaccine “ensures that the necessary regulatory approvals and clinical trial data are in place to help protect Americans from a life-threatening disease.”
In January, Pfizer said it was working to register a vaccine for the pediatric population after the FDA gave the company permission to proceed with an early safety study. The company said it estimates that nearly half of those infected with hepatitis A in 2016 were children.
“Pfizer is committed to the research and development of safe and effective immunization programs for infants, children and adolescents,” Michael Rogers, Pfizer’s senior vice president for global vaccines and immunology, said in the statement. “We are actively working to improve upon current vaccines available for children of various ages, and we look forward to reporting additional results and updates in the coming months.”