US regulators have approved a new meningitis vaccine developed by GSK, sparking cautious optimism for the sector in the wake of Donald Trump's election for a second term as President. The Food and Drug Administration (FDA) announced that Penmenvy will be allowed for use in individuals aged 10-to-25 years old following two successful Phase III trials. GSK said safety data from the trials, which had over 4,800 participants, showed the drug's safety profile is compatible with its licensed meningococcal vaccines.
Penmenvy is a combination of Bexsero and Menveo, which contributed approximately £1.4billion to GSK's turnover last year. It targets five major bacteria of Invasive Meningococcal Disease (IMD), a significant cause of meningitis and septicaemia. Up to one in six people who contract IMD die from the condition within 24 hours, even if they receive treatment, according to the World Health Organisation. Thumbs up: US regulators have given the green light for Penmenvy, a new meningitis vaccine developed by pharmaceutical giant GSK.
Around one in five survivors also experience severe long-term consequences, such as hearing loss, brain damage, limb amputations, and nervous system problems. Tony Wood, chief scientific officer at GSK, said: 'We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States. 'Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.'.
While IMD can impact all age ranges, those 16-to-23 years old are more likely to contract the condition due to common behaviours like living in college dormitories and sharing drinks or smoking devices. Matt Britzman, senior equity analyst at Hargreaves Lansdown, said GSK has 'hit a big milestone' with its new meningitis treatment. He added: 'While this approval is a solid win for GSK, it also signals broader optimism for the industry, despite some lingering nerves around pending approvals given the shakeup that's expected under the Trump administration, including layoffs at the FDA.'.
The Associated Press reported on Monday that probationary FDA staff received notices over the weekend telling them that their jobs were being axed. President Donald Trump appointed Robert F Kennedy Jr to run the US Department of Health and Human Services, whose responsibilities include overseeing the FDA and Centers for Disease Control (CDC). Kennedy has proposed banning pharmaceutical companies from advertising directly to consumers and generated considerable controversy for his anti-vaccine advocacy.
GSK's sales rose by 7 per cent to £31.7billion last year, thanks to increasing demand for HIV treatments and oncology medicines, as well as purchases of its meningitis vaccines by the CDC. GSK shares were 1.15 per cent lower at 1,418.5p, taking their losses over the past year to about 15 per cent. Affiliate links: If you take out a product This is Money may earn a commission. These deals are chosen by our editorial team, as we think they are worth highlighting. This does not affect our editorial independence.
