London Daily

Focus on the big picture.

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.
Comments

Oh ya 2 year ago
Anyone willing to take another jab after what has come out about the deaths and injuries from the covid shot deserves everything they get. You cant fix stupid

Newsletter

Related Articles

0:00
0:00
Close
Prince William to End Feudal Land Restrictions in Duchy of Cornwall, but Controversies Remain
British police appear unprepared to deal with usual suspects
Russia's Ballistic Blitz on Kyiv Sends Shockwaves Through Global Stability
Multiple Tragedies and Tensions Mark Global Events: A Closer Look
Elon Musk's AfD Endorsement Ignites Controversy from neo-Nazis who accuse the AfD of being what they themselves are
Ukraine Claims Unprecedented Russian Losses: The Truth Behind Wartime Statistics
Federal Reserve Chair Powell: "We are prohibited from owning Bitcoin and are not seeking any changes to that law."
A Democratic congresswoman with blue and black hair is having a meltdown over "President Musk."
A sizable group of unauthorized migrants is traveling through Mexico with the aim of reaching the USA before Trump assumes office.
Beatles Reunion Electrifies London: Paul McCartney and Ringo Starr Ignite O2 Arena with Surprise Performance
Starmer's Envoy Engages Trump Team as UK Seeks Strategic U.S. Partnership
Britain's Retail Rebound Falters as Black Friday Splurge Dissipates
Bank of Japan's Bold Reckoning: A Decade of Unconventional Policy Under Scrutiny
Republican Discord Threatens Government Shutdown Amid Holiday Season
French Retiree Dominique Pellico Convicted for Recruiting 72 Men to Assault Wife Over a Decade
Putin Defends War Strategy as Global Tensions Rise
Putin Claims Progress as Tensions Rise: Conflict in Ukraine Intensifies
Putin's Paradox: Claiming Strength Amidst Sanctions and Isolation
Water as a Weapon: The Contentious Struggle for Survival in Gaza
Syria's Future: A Fight for Democracy or Another Cycle of Oppression?
UK Considers Sending Troops to Ukraine: A Strategic Move or Intensifying The Proxy War?
Renewed ISIS Threat Puts Syria’s Cultural Heritage in Peril
Escalation in Moscow: High-Profile Assassination and International Tensions Intensify
North Korean Troops in Ukraine: A New Cold War Frontier?
Ukraine's Bold Move: High-Stakes Assassination of Russian General in Moscow
Dubai's Technological Leap: Brain Chips and AI Board Members by 2025
Tragedy Strikes Wisconsin School as Shooting Claims Lives of Teacher and Student
UK's Calculated Gamble: Balancing Defense Aid to Ukraine and Domestic Demands
UK Intensifies Stranglehold on Russian Oil, but Does It Dampen Putin’s Resolve?
British Voter Endorsement of Reeves's Bold Tax Strategy
Nicola Sturgeon Warns of 'Toxic' Discourse: The Perils of Polarisation in Modern Politics
Levelling Down: How the Conservatives Underspent on Regional Revitalization
Alleged Chinese Espionage: The Entangled Web Beyond Prince Andrew
Starmer Navigates Diplomatic Tightrope Amid Chinese Espionage Revelations Involving Prince Andrew
Balancing Democracy and Disorder: The Trial of a Milkshake Incident
Royal Mail Enters New Chapter Under Czech Ownership
UK Companies Slash Jobs Amid Economic Strain
Kemi Badenoch Rekindles Flat Tax Debate Amid Inheritance Tax Uproar
Rewiring Whitehall: New Cabinet Secretary's Mandate for Change
Legal Battle Revives: Lucy Letby Seeks Fresh Appeal as Expert Evidence Faces Scrutiny
Accusations Fly as UK-China Relations Spark Tension Within British Politics
The Delicate Dance of Devolution: As English Council Elections Face Delays
The Alleged Chinese Spy at the Heart of British Royal Circles: Yang Tengbo Unmasked
Prince Andrew Withdraws from Royal Christmas Amidst Chinese Espionage Scandal
EU Takes Legal Action Against UK Over Allegedly Neglected Rights of EU Citizens
Disaster Strikes: Oil Spill in the Black Sea and Cyclone Devastation in Mayotte
Oil Tanker Disaster in the Kerch Strait: A Confluence of Environmental Catastrophe and Geopolitical Tensions
Olaf Scholz’s Gamble: The Collapse of Germany’s Coalition Government and the Path to Early Elections
Keir Starmer's 'Sycophantic' Tone: Tensions Rise Over UK-China Relations
Trump Recognizes Partial Advances in Ceasefire Attempts in Ukraine Conflict
×