Meningococcal group B vaccine receives Philippine FDA approval
The Philippine Food and Drug Administration (FDA) approved on October 15 the Meningococcal Group B Vaccine of GlaxoSmithKline (GSK) Philippines, a global biopharma company.
The vaccine is for the prevention of meningococcal disease caused by the Neisseria meningitidis serogroup B in individuals aged two months or older.
Prior this FDA approval, there was no vaccine available for serogroup B.
Meningococcal disease is an “uncommon infection associated with high case fatality rates, especially in some low resource countries,” according to a November 2021 paper published in Microbiology Australia.
Serogroup B is predominant in the Philippines, causing 68% of invasive meningococcal disease (IMD) cases in the country between 2017-2018, the paper said.
IMD can lead to meningitis, an inflammation of the membranes surrounding the brain and spinal cord. It can also lead to meningococcal sepsis, where the bacteria enter the bloodstream, thus spreading the infection. Both conditions require urgent medical attention to prevent irreversible consequences such as permanent hearing loss, vision impairment, and cognitive difficulties.
Infants and children are most vulnerable to the disease.
“IMD can lead to severe illness, long-term complications, or even death, often affecting patients in ways that can alter their lives forever,” said Dr. Giovell P. Barangan, country medical director of GSK Philippines, in an October 15 press statement.
“The availability of this vaccine in the Philippines represents a significant step in protecting families and their loved ones from the life-threatening outcomes of IMD,” he said.
GSK’s Meningococcal Group B Vaccine has been licensed in over 40 countries, including in the member states of the European Union, Australia, Canada, New Zealand, and the United States. – Patricia B. Mirasol