NETHERLANDS — The European Medicines Agency (EMA) has put GSK in a leading position in the respiratory syncytial virus (RSV) vaccine market, following its recent recommendation to authorize the use of the Arexvy vaccine for adults aged 60 and over.

This vaccine, which has been found to be 82.6% effective in preventing lower respiratory tract disease and 94.1% effective in preventing severe lower respiratory tract disease associated with RSV infection, is the world’s first vaccine of its kind.

RSV produces flu-like symptoms, but it can be fatal for young children and older adults. The disease surged in the US and Europe in the fall of 2022, alongside the flu and COVID-19.

The disease surged in the US and Europe in the fall of 2022, alongside the flu and COVID-19. Hence, the approval of the Arexvy vaccine comes as a much-needed relief for the elderly population in Europe.

With RSV estimated to cause 250,000 hospitalizations and 17,000 in-hospital deaths every year in people aged 65 and older in Europe alone, the approval of this vaccine is a significant milestone in the fight against this common virus.

According to analysts, the RSV vaccine market is estimated to exceed US$5 billion and could surpass US$10 billion by 2030, making it a lucrative area for drugmakers to tap into.

GSK’s approval puts them ahead of their rival Pfizer Inc., which is also awaiting approval from the US Food and Drug Administration (FDA) to use their RSV vaccine in the United States.

Both Pfizer and GSK had gained the backing of a panel of FDA advisers in late February and early March, bringing them a step closer to final US approval.

However, US biotech Moderna, another RSV vaccine developer, has announced plans to submit its mRNA-1345 for approval globally in the first half of 2023.

GSK is relying on its potential blockbuster RSV vaccine to drive long-term growth, as it faces the pending loss of patent protection for its HIV compounds and setbacks in its marketed oncology portfolio.

The EMA’s accelerated assessment route for its committee to recommend authorization of drugs reviewed Arexvy, and EMA recommendations are typically followed by the European Commission in final decisions on drug approvals.

GSK is also making strides in the development of other vaccines, such as its five-in-one meningococcal vaccine candidate, MenABCWY.

This vaccine has shown promising phase 3 results in healthy individuals aged ten to 25 years and targets all five Neisseria meningitidis serogroups responsible for nearly all cases of invasive meningococcal disease.

If approved, the vaccine could provide the widest possible protection against the disease and lead to higher vaccine uptake.

Moreover, GSK’s acquisition of Canadian biotech Bellus Health for a US$2bn deal is set to add a specialty medicine aimed at the 10 million people who suffer from a debilitating and persistent cough.

This deal follows GSK’s acquisition of Sierra Oncology for US$1.9bn and their deal worth up to US$3.3bn for vaccine maker Affinivax in 2021.

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