Meningitis B Vaccines To Receive FDA Review As Breakthrough Therapy Drugs

meningitis
Two meningitis B vaccines were granted breakthrough therapy status earlier this year after outbreaks on several college campuses. WHO, CC BY 2.0

Two breakthrough therapy drugs, from manufacturers Novartis and Pfizer, are being sent for review to the Food and Drug Administration (FDA), in the hopes the agency will approve the drugs as meningitis B vaccines.

After two decades of development on a meningitis B vaccine, a drug that could potentially save 20 percent of annual deaths from the bacterial infection, Novartis and Pfizer’s latest introductions are slated to round out a meningitis vaccine panel that currently excludes Group B drugs. One of the largest obstacles in safely getting young people vaccinated is the sheer absence of a vaccine, which famously led to outbreaks at four U.S. universities last year. The scare sent state and federal health officials scrambling, trying to find an emergency supply of the unapproved vaccine.

“It’s clearly the vaccine that makes the most sense,” Dr. Andrin Oswald, head of Novartis’ vaccine division, told NBC News, regarding a combination drug Novartis is developing that would deliver each meningitis strain in one fell swoop. “For most parents, they want to protect their children and teenagers with one shot.”

Meningitis comes in a variety of flavors, originating with viruses, fungi, parasites, noninfectious varieties, and of course, bacteria. These bacteria also range in pathogens (types of germs) that can cause the infection. Three main strains, or serogroups, cause all of the outbreaks that occur in the U.S.: B, C, and Y. In other parts of the world, strains A and W also circulate.

Novartis’drug, Bexsero, currently only treats meningitis B. However, the drug company said a multi-group vaccine was in development. It, along with Pfizer’s bivalent rLP2086, received breakthrough therapy status earlier this year. This designation expedites the path toward full approval. If granted, consumers could feasibly begin purchasing the vaccine within several months.

Meningitis, while rare, is often severe. In the U.S. alone, roughly 4,100 cases occurred each year between 2003 and 2007. Of those, approximately 500 people died. Other non-fatal complications can include brain damage, hearing loss, and learning disabilities, according to the Centers for Disease Control and Prevention. The bacteria spreads mainly through community settings — such was the case on the four college campuses — certain medical settings, and foreign countries. Infants are naturally at greater risk for Group B infections.

Still, as Alicia Stillman of West Bloomfield, Mich., tells NBC News, the bacteria presents a deadly risk to people of all ages. Stillman’s 19-year-old daughter died last year from a fast-moving meningitis B infection. Stillman has since begun making the trip to Canada to help others stay protected. “I am excited,” she told NBC News of the recent move, “but still cautious as I know nothing happens fast in that world.”

Correction: This story has been updated to reflect the fact Dr. Andrin Oswald believes a combination vaccine, not a single Group B vaccine, "makes the most sense."

Loading...
Join the Discussion