Beautiful Virgin Islands

Tuesday, Jun 03, 2025

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

Beautiful Virgin Islands
0:00
0:00
Close
China Accuses US of Violating Trade Truce
Panama Port Owner Balances US-China Pressures
France Implements Nationwide Outdoor Smoking Ban to Protect Children
German Chancellor Merz Keeps Putin Guessing on Missile Strategy
Mandelson Criticizes UK's 'Fetish' for Abandoning EU Regulations
British Fishing Boat Owner Fined €30,000 by French Authorities
Dutch government falls as far-right leader Wilders quits coalition
Harvard Urges US to Unfreeze Funds for Public Health Research
Businessman Mauled by Lion at Luxury Namibian Lodge
Researchers Consider New Destinations Beyond the U.S.
53-Year-Old Doctor Claims Biological Age of 23
Trump Struggles to Secure Trade Deals With China and Europe
Russia to Return 6,000 Corpses Under Ukraine Prisoner Swap Deal
Microsoft Lays Off Hundreds More Amid Restructuring
Harvey Weinstein’s Publicist Embraces Notoriety
Macron and Meloni Seek Unity Despite Tensions
Trump Administration Accused of Obstructing Deportation Cases
Newark Mayor Sues Over Arrest at Immigration Facility
Center-Left Candidate Projected to Win South Korean Presidency
Trump’s Tariffs Predicted to Stall Global Economic Growth
South Korea’s President-Elect Expected to Take Softer Line on Trump and North Korea
Trump’s China Strategy Remains a Geopolitical Puzzle
Ukraine Executes Long-Range Drone Strikes on Russian Airbases
Conservative Karol Nawrocki wins Poland’s presidential election
Study Identifies Potential Radicalization Risk Among Over One Million Muslims in Germany
Good news: Annalena Baerbock Elected President of the UN General Assembly
Apple Appeals EU Law Over User Data Sharing Requirements
South Africa: "First Black Bank" Collapses after Being Looted by Owners
Poland will now withdraw from the EU migration pact after pro-Trump nationalist wins Election
"That's Disgusting, Don’t Say It Again": The Trump Joke That Made the President Boil
Trump Cancels NASA Nominee Over Democratic Donations
Paris Saint-Germain's Greatest Triumph Is Football’s Lowest Point
OnlyFans for Sale: From Lockdown Lifeline to Eight-Billion-Dollar Empire
Mayor’s Security Officer Implicated | Shocking New Details Emerge in NYC Kidnapping Case
Hegseth Warns of Potential Chinese Military Action Against Taiwan
OPEC+ Agrees to Increase Oil Output for Third Consecutive Month
Jamie Dimon Warns U.S. Bond Market Faces Pressure from Rising Debt
Turkey Detains Istanbul Officials Amid Anti-Corruption Crackdown
Taylor Swift Gains Ownership of Her First Six Albums
Bangkok Ranked World's Top City for Remote Work in 2025
Satirical Sketch Sparks Political Spouse Feud in South Korea
Indonesia Quarry Collapse Leaves Multiple Dead and Missing
South Korean Election Video Pulled Amid Misogyny Outcry
Asian Economies Shift Away from US Dollar Amid Trade Tensions
Netflix Investigates Allegations of On-Set Mistreatment in K-Drama Production
US Defence Chief Reaffirms Strong Ties with Singapore Amid Regional Tensions
Vietnam Faces Strategic Dilemma Over China's Mekong River Projects
Malaysia's First AI Preacher Sparks Debate on Islamic Principles
White House Press Secretary Criticizes Harvard Funding, Advocates for Vocational Training
France to Implement Nationwide Smoking Ban in Outdoor Spaces Frequented by Children
×