London Daily

Focus on the big picture.
Saturday, Oct 10, 2026

US Becomes 1st Country To Approve Respiratory Syncytial Virus Vaccine

US Becomes 1st Country To Approve Respiratory Syncytial Virus Vaccine

Drugmaker GSK's Arexvy was green-lighted for adults aged 60 and older, with similar shots from other makers including Pfizer and Moderna expected to follow soon.
The United States on Wednesday approved the world's first vaccine for the Respiratory Syncytial Virus (RSV), the culmination of a decades-long hunt to protect vulnerable people from the common illness.

Drugmaker GSK's Arexvy was green-lighted for adults aged 60 and older, with similar shots from other makers including Pfizer and Moderna expected to follow soon.

"Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening," said senior US Food and Drug Administration (FDA) official Peter Marks in a statement.

The decision "marks a turning point in our effort to reduce the significant burden of RSV," added Tony Wood, GSK's chief scientific officer.

RSV is a common virus that normally causes mild, cold-like symptoms, but can be serious for infants and the elderly, as well as those with weak immune systems and underlying conditions.

In severe cases it can cause pneumonia and bronchiolitis, an inflammation of the small airways deep inside the lungs.

According to the US Centers for Disease Control and Prevention, RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older.

Awareness of the disease has increased in recent years, in part because of the strain it has placed on hospital systems over the last two winters.

Rates of RSV and flu fell during Covid-19 lockdowns, but surged when restrictions were lifted, with young children hit hard.

Pharmaceutical companies have been chasing an RSV vaccine for years. Given recent successful breakthroughs in the sector, analysts predict the market could be worth over $10 billion in the next decade, according to reports.

More vaccines on way

GSK's vaccine contains a "subunit" or part of the virus to help train the immune system should it encounter the real thing.

It was approved based on a study of 25,000 people aged 60 and older that showed a single dose was 83 percent effective against disease caused by RSV, and more than 94 percent effective against severe disease.

Researchers will continue to follow volunteers in the study to assess the duration of protection as well as the safety and efficacy of more doses.

The most common side effects included injection site pain, fatigue, muscle pain, headaches and joint stiffness.

An irregular heartbeat was a less common side effect, occurring in 10 participants who received Arexvy and four participants who received placebo.

Safety issues were also found in two other studies of the drug involving approximately 2,500 people aged 60 and up. In one of these studies, two volunteers developed a rare type of inflammation that affects the brain and spinal cord, and one of them died.

In the other study, one participant developed Guillain-Barre syndrome, in which the immune system damages nerve cells, causing muscle weakness and sometimes paralysis.

GSK's Arexvy was recommended for approval last week by the European Union's drug watchdog, the European Medicines Agency, whose positive opinions are normally formally followed by approval from the European Commission.

Pfizer has said that it expects a decision from the FDA in May for its own RSV vaccine, also for those over 60 years old.

In January, Moderna said it hopes its RSV vaccine will be approved and available in time for the Northern Hemisphere's winter later this year.

Several other companies are also developing RSV vaccines.

Last year, the EU approved a preventative antibody treatment against RSV, developed by British-Swedish pharmaceutical firm AstraZeneca and France's Sanofi, which confers temporary protection.
Newsletter

Related Articles

0:00
0:00
Close
British Prime Minister Burnham Pledges Closer EU Ties During Visit to Germany
UK Announces New Sanctions on 17 Russia-Linked Entities During Foreign Secretary's Ukraine Visit
UK and Germany Finalize Kensington Treaty to Strengthen Defense and Technology Cooperation
Britain Maintains Diplomatic Mission in East Jerusalem Despite Israeli Closure Deadline
English Councils Push Government to Rethink Proposed Funding Cuts
Scottish Homebuilding Falls to Lowest Level in 11 Years
BBC Chief Matt Brittin Defends Restructuring as Staff Challenge Job Cuts
UK Finance Warns High Energy Costs and Bond Yields Are Complicating Fiscal Outlook
UK Adopts All 44 Recommendations on Regulating AI in Healthcare
Chancellor John Healey Prepares Autumn Budget as Borrowing Costs Strain Public Finances
UK Investigators See Strong Indications of Iranian Link After RAF Fairford Security Operation
Laura Trott Pledges Tighter Controls on Political Activism in UK Classrooms
Welsh Ministers Launch Long-Term Review of North Wales and Anglesey Crossings
Welsh Government Orders 18-Month Study of Road Solutions Around Newport
Reform UK MP Sarah Pochin Faces Scrutiny Over £800,000 Second Home Purchase
British Households Grow More Concerned About Fuel and Energy Prices
NHS Leaders Warn of Rising Winter Pressure on Emergency Departments
Kemi Badenoch Proposes £2.3 Billion Employer National Insurance Cut for Young Workers
Middle East Conflict Could Erase UK Fiscal Headroom, Economists Warn
Manchester City Found Guilty of Multiple Premier League Financial Rule Breaches
UK Security Services Find Strong Indications of Iranian Role in RAF Fairford Incident
Costa Coffee Returns to Operating Profit on Iced Drinks and Menu Changes
Asos Warns Customers After Unauthorized Access to Retail App and Data
Kemi Badenoch Puts Growth and Deregulation at Center of Conservative Conference
Campaigners Warn of Deepening Social Care Crisis for Disabled Adults
Study Finds Rising Early-Onset Cancer Rates Among Adults Under 50 in Britain
UK Coach Operators Warn High Diesel Prices Could Force Route Cuts
FCA Opens Independent Review Into Handling of Epstein-Linked Whistleblower Case
Argentina Vows to Block Falkland Islands Offshore Oil Development
UK Chancellor Prepares Fiscal Measures and Welfare Reforms Ahead of Autumn Budget
Sainsbury’s and Morrisons Explore Potential Multi-Billion-Pound Merger
UK Weighs Tariffs on Chinese Electric Vehicles to Align With European Union
UK Threatens Diplomatic Expulsions Over Planned Closure of East Jerusalem Consulate
UK Energy Price Cap Hits Three-Year High as Middle East Conflict Raises Costs
Seventh Arrest Made in Suspected Terror Plot at RAF Fairford
Systemic Education Collapse Sparks Mass Student Uprisings in France
Green Party Faces Backlash Over Resolution Equating Zionism With Racism
Conservatives Debate Scrapping Environmental Rules for New Homes
Cornwall Insight Warns UK Energy Bills Could Approach £2,000 This Winter
UK Coach Operators Warn of Service Cuts as Diesel Prices Exceed £2
Scottish Parliament Approves £68 Billion Budget With New Tax and Property Measures
FCA Opens Independent Review Into Handling of Epstein Whistleblower
UK Government Drops Plan to Suspend Jury Trials in England and Wales
Bank of England Holds Interest Rate at 3.75% as Markets Watch November
Two Iranian Nationals Charged Over Alleged Plot Targeting Manchester Jewish Community
UK Fiscal Headroom Halves to £11 Billion Ahead of Budget, EY Warns
US Bomber Withdrawal From RAF Fairford Prompts UK Security Review
Sarah Wakfer Appointed Chair of Northern Ireland’s Health and Care Regulator
Scotland Housing Completions Fall to 11-Year Low Amid National Shortage
UK Water Companies Face Tougher Oversight and Unannounced Regulatory Inspections
×