One year after GlaxoSmithKline's meningitis vaccine (Bexsero) became commercially available in the United Kingdom, the number of cases of meningococcal B meningitis and septicemia in infants has decreased by nearly half, according to data from Public Health England (PHE), an organization affiliated with the UK Department of Health.
These data, which have not yet been published, were presented at the International Pathogenic Neisseria Conference in Manchester on September 5.
"These data are interesting because they're the first real-world efficacy data on vaccination with Bexsero. Until now, there were no efficacy studies. Registration of the vaccine was obtained solely on the basis of immunogenicity studies," Professor Daniel Floret, a pediatrician and chair of the High Council for Public Health's Technical Committee on Vaccines in Lyon, France, told Medscape.
Currently, only two countries recommend this vaccine for the general population: Australia and England.
All newborns in the United Kingdom are given the vaccine against serogroup B meningococcal disease in the first program of its kind in the world for infants. They receive three injections: the first at 2 months, the second at 4 months, and the last at 12 months. The European marketing authorization recommends one additional dose: three initial injections and a booster dose.
Infections Nearly Halved
According to PHE researchers, the infection rate in vaccinated infants was less than 20% of that observed in nonvaccinated infants.
Furthermore, the number of laboratory-confirmed cases in infants younger than 1 year, the age group at greatest risk for infection, has decreased by 42% since the vaccine's arrival. Expressing this in numbers, only 37 cases of infection have been recorded since the program started compared with an average of 74 cases for the same period during the previous 4 years.
The key to success appears to be close adherence to the vaccination program. According to the PHE, at age 6 months, more than 95% of infants had received the first dose of the vaccine, and close to 90% had received the second dose.
According to Dr Mary Ramsay, head of immunization at the PHE, "This is definitely great news. Meningitis B is a rare but terrible disease…. We now know that the vaccine can and will be able to save lives and prevent long-term disabilities."
The researcher adds that the program is only in its infancy. The vaccine's long-term impact will need to be assessed by means of a surveillance program, but "the benefit is clear," she said. "We hope that countries around the world that are aware of these results will consider setting up similar vaccination programs to save the lives of a great many children."
Should Indications Be Broadened?
In many countries, including France and the United States, Bexsero is still reserved for individuals at high risk for contracting invasive meningococcal disease and for very specific circumstances, such as epidemics.
Should these new UK data change the rules of the game?
"These results are very preliminary. One important question about this vaccine is the duration of immunity. It's still too early to say that this vaccination strategy is actually effective," admitted Professor Floret.
Furthermore, the pediatrician points out that in England, the incidence of meningococcal B disease is especially high.
Vaccination strategies should be tailored to the particular circumstances in each country, he said.
"The vaccination regimen of three doses and a booster does not seem possible to me in France, where the vaccination schedule is already considered overloaded and with the pressure, in terms of the number of cases, being totally unlike that in England. Also, for a little over 2 years, the incidence of meningococcal B disease has been decreasing significantly in France and elsewhere," says Professor Floret.
For the US perspective on the UK experience with infant immunization with Bexsero, Medscape spoke with Kwang Sik Kim, MD, director of pediatric infectious diseases at Johns Hopkins University School of Medicine in Baltimore, Maryland.
"This is a great story for the UK. The vaccine was highly successful in reducing cases [of meningitis in infants], but there are differences between the United States and the UK," Dr Kim said.
"In the UK, this infection is prevalent but the rate is very much lower in the United States. No one really knows why our rate of meningococcal disease is lower compared to the UK and other countries. There are many speculations, but basically we don't know. We tend to pay attention to this disease when it occurs in outbreak settings, like in Princeton, for example, when it makes headlines," Dr Kim noted.
"Because the rate is so much lower here, there is no way one is able to do efficacy studies for this vaccine [in infants], so licensure would be entirely based on immunogenicity, that is, in vitro testing," he added. "It's not high priority at this time."
This article was originally published on the French edition of Medscape.
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Cite this: Infections Nearly Halved After Intro of Meningococcal Vaccine in UK - Medscape - Sep 12, 2016.