Novartis AG (NOVN) said its Bexsero vaccine protected infants against meningococcal B disease when given together with routine childhood inoculations, suggesting the shot could be included in standard vaccination programs.
In a trial involving 1,885 infants in Europe, Bexsero stimulated an immune response against three strains of the meningococcus B bacterium, researchers led by Matthew Snape at the University of Oxford wrote in the Journal of the American Medical Association today. The vaccine was safe and didn’t interfere with the other shots, they wrote.
The result suggests Novartis, Europe’s biggest drugmaker, may have succeeded in developing the first effective shot against the main cause of meningitis, a deadly brain-swelling disease, in developed nations. The company already competes with Sanofi (SAN) and GlaxoSmithKline Plc (GSK) in marketing shots against four other strains of the Neisseria meningitidis bacteria.
The study “represents a major step forward,” Amanda Cohn and Nancy Messonnier from the U.S. Centers for Disease Control and Prevention wrote in an editorial accompanying the study. “The anticipated licensure of this vaccine in Europe and other countries means that for the first time vaccines to prevent all five of the serogroups that cause most meningococcal disease worldwide will be available.”
Novartis, which paid for the trial, applied for marketing approval of Bexsero in the European Union in December 2010, and expects a decision this year, it said in a statement. If approved, the shot may earn the Basel, Switzerland-based drugmaker $1 billion a year in sales by 2015, according to Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston.
Carrying and Transmitting
The vaccine’s design may not stop children from carrying and transmitting the bacterium, Cohn and Messonnier wrote.
“Countries will have to weigh the benefits of serogroup B vaccination against the costs of adding vaccines to the infant schedule,” they said.
Meningococci bacteria can be carried in the throat and transmitted through kissing, sneezing, coughing or sharing food and drink. The bugs mainly affect young children and can cause meningitis, in which the thin lining surrounding the brain and spinal cord becomes inflamed, causing symptoms including stiff neck, high fever, sensitivity to light, confusion, headaches and vomiting.
As many as 10 percent of those infected die within 48 hours after symptoms start, according to the World Health Organization. Brain damage, hearing loss or learning disabilities may affect as many as 20 percent of survivors, the Geneva-based agency said on its website.
Meningococcus A is most common cause of meningitis in Africa, while type B accounts for as many as 40 percent of cases in North America and as many as 80 percent in some European nations, according to the WHO.
Children in the trial received three shots of Bexsero, also known as 4CMenB, at the same time they got routine vaccines made by Glaxo and Pfizer Inc. (PFE), or in alternating months to the standard shots. Another group received only the routine vaccinations.
Among those who received Bexsero with the routine vaccines, 99 percent had a protective immune response to two of the three strains. For the third strain, as many as 82 percent of children getting the shots concurrently had an immune response, compared with 86 percent of those who received Bexsero separately. The response was sufficient for all three strains in the vaccine, the study showed.
“These results also show that Bexsero can fit into various vaccination schedules in the first year of life when the likelihood of contracting this often-deadly disease is greatest,” Novartis said in an e-mailed statement.
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