USA — The U.S. Food and Drug Administration (FDA) has granted GlaxoSmithKline (GSK) approval for their respiratory syncytial virus (RSV) vaccine for adults aged 60 and older.

This makes GSK the first to gain regulatory approval globally for an RSV vaccine, putting them ahead of Pfizer and Moderna in the race to develop a vaccine for the virus.

The approval is a significant milestone in GSK’s efforts to reduce the “significant burden” of RSV, according to Tony Wood, the company’s Chief Scientific Officer.

GSK now plans to ensure that eligible older adults in the US can quickly access the vaccine while simultaneously working towards regulatory approval in other countries.

The company claims to have “millions” of vaccine doses ready for shipment, with plans to meet with the Centers for Disease Control and Prevention’s vaccine advisory committee in June to discuss potential vaccination schedules for the U.S.

The RSV vaccine is also close to gaining approval in the European Union. The European Medicines Agency recently recommended approval of GSK’s vaccine for older adults in the EU.

This comes as the U.S. prepares for the next RSV season in the fall, having experienced an unusually severe season last year.

Hospital systems were overwhelmed with cases of the virus, primarily because the public stopped adhering to Covid pandemic health measures that had kept RSV spread low.

RSV typically causes mild, cold-like symptoms, but it can be deadly for older adults and young children.

The CDC reports that each year, RSV kills between 6,000 to 10,000 seniors and several hundred children younger than 5 years old.

GSK’s RSV vaccine is 94% effective in preventing severe disease in seniors, which is defined as the need for supplemental oxygen or mechanical breathing assistance, such as a ventilator.

The vaccine works by using a small piece of the virus’s surface protein, called the fusion or F protein, to build immunity.

The protein pieces in the vaccine are made in a lab using specially programmed cells to manufacture them.

Aside from GSK, three other RSV vaccines for older adults are in the final phases of testing.

Pfizer’s RSV vaccine for older adults is expected to receive FDA approval by the end of May. The agency is also reviewing Pfizer’s maternal vaccine to protect infants, which it plans to decide on by the end of August.

Moderna is also finishing its Phase 3 trial of an mRNA vaccine for RSV in older adults and expects to submit the results to the FDA for approval within the next few months.

Lastly, Bavarian Nordic, maker of the Jynneos mpox vaccine, is set to report results from a Phase 3 trial of its RSV vaccine for older adults this year.

According to Paul Chaplin, the CEO of Bavarian Nordic, the race to develop an RSV vaccine has been a long time coming, with numerous attempts that have failed.

However, now there is hope that one of these vaccines will be successful in the fight against RSV.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.