CHMP, the European Medicines Agency’s Committee for Medicinal Products for Human Use has positively evaluated Pfizer Inc. (NYSE:PFE)’s TRUMENBA and given the go-ahead that is necessary for the drug to be marketed in the countries that make up the European Union. The final decision will be made by the European Commission once the opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use has been forwarded to the body.
Meningitis vaccine
Pfizer’s chief of Vaccine R&D and senior vice president, Kathrin Jansen, said the positive opinion given by the CHMP was a vote of confidence in TRUMENBA, a vaccine that is designed for individuals aged above 9 years for the prevention of invasive meningococcal disease which is brought about by MenB or Neisseria meningitidis serogroup B, and is often fatal.
“This positive opinion by the CHMP to recommend marketing authorization of TRUMENBA in the EU is an additional step toward the fight to help protect individuals over 10 years of age from meningococcal disease…,” said Jansen.
Pfizer’s program to clinically evaluate TRUMENBA was conducted on adults and adolescents numbering over 20,000 of which about 15,000 received the drug. TRUMENBA was found not only to be effective vaccine but also well-tolerated.
Serious life-threatening disease
Though uncommon, meningococcal disease can occur at any time to anyone and with devastating effects. It can occur either as mengingococcemia which is a bloodstream infection or as meningitis. About 10% of those who get the disease eventually succumb to it while about 20% of the survivors may suffer from significant disabilities such as motor skill impairment, mental impairment, hearing or visual impairment and even limb amputation.
Young adults and adolescents are at especially higher risk of getting meningococcal disease owing to behavioral and environmental factors that are particular to this group such as the sharing of utensils, cups or drinks or even sharing rooms or living quarters.
Globally, most of the cases of meningococcal disease are as a result of 6 Neisseria meningitidis serogroups including serogroup A, serogroup B, serogroup C, serogroup W, serogroup X and serogroup Y. In Europe, serogroup B is the most common cause of the meningococcal disease.
On Friday shares of Pfizer Inc edged downwards by 0.85% to close the day at $34.00.
