LONDON Nov 16 The first vaccine against
meningitis B has been recommended for approval in Europe in a
boost for its maker Novartis, which has struggled in
the vaccines field against larger rivals.
The European Medicines Agency (EMA) said on Friday that its
experts had given a green light to Bexsero for the prevention of
"MenB". There is currently no approved vaccine offering broad
protection against this particular type of meningitis.
MenB is causes by bacteria, leading to inflammation of the
lining around the brain and spinal cord. It can kill within 24
hours and infants are at highest risk.
Securing European backing for Bexsero is a vindication of
the Swiss drugmaker's research in vaccines, where it lags behind
market leaders GlaxoSmithKline, Sanofi and
The company is pinning high hopes on Bexsero and the new
product will complement another meningitis vaccine it already
has on the market called Menveo that covers other strains of the
Recommendations from the EMA are normally endorsed by the
European Commission within a couple of months. That will allow
Novartis to launch Bexsero in 2013 - but its commercial success
still depends on whether individual governments then decide to
add it to routine vaccination programmes.
Tim Anderson, an industry analyst at Bernstein, believes
getting Bexsero widely adopted may not be easy because although
MenB is a serious disease with high mortality, its incidence is
"If the disease occurs only rarely, then it may not make
sense to administer the vaccine broadly as a preventive
measure," Anderson said in a research note before the EMA
In the United States, Novartis is still working with
authorities to design U.S.-specific Phase III clinical trials.