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 1 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

London Daily
0:00
0:00
Close
CIA and MI6 Chiefs Unite Amid Global Crises
UK Tycoon Mike Lynch's Cause of Death Revealed: Autopsy Report
Mass Protests Erupt Across France Against New Prime Minister Barnier
Iranian Plots to Kill Jews in Europe Unveiled
Huawei Poised for Major AI Chip Unveil at Shenzhen Event
Nvidia’s AI chips are cheaper to rent in China than US
China ends tariffs on all goods exported to China from the poorest countries in the world it has diplomatic ties with, including 33 African nations
Blinken May Not Seek Another Term Due To Family Priorities
Labour Pushes for Special Tribunal Against Russia for Ukraine Invasion
Oil Companies to Contest Judicial Review of North Sea Projects
Ed Balls Urges Keir Starmer and Rachel Reeves to Address Winter Fuel Payments Controversy
British Army Major General Dismissed for Unwanted Advances
Campaigners Urge Bold Actions to Combat Rising Heart Disease in UK
UK Requires One Trillion Pounds Investment for Economic Growth
Plan to House Asylum Seekers at Former Dambusters Home Dropped
UK Drops Indecent Assault Charges Against Harvey Weinstein
Return of Brazilian Artworks to Bahia
UK Signs Landmark International AI Treaty
Demand for Justice After Death of Ugandan Runner Set on Fire
Ukraine's Major Government Reshuffle: Andrii Sybiha Appointed New Foreign Minister
North Korea Executes Officials Over Flood Response
French Woman Testifies in Landmark Rape Trial
Sicily Yacht Disaster: Fatal Asphyxiation Claimed More Lives
Michel Barnier Appointed as Prime Minister of France
The art technique of Grandma Mei Ling, age 82
Mongolia Refuses to Arrest Putin Despite ICC Warrant
UK State Pension to Increase by Over £400 Annually
Amazon Announces 10% Pay Increase for UK Workers
Grenfell Tower Fire Inquiry Demands Swift Justice
French Police Clear Migrant Camp Near Calais
New Law Proposes Jail Time for Covering Up Sewage Dumping in England and Wales
John Swinney's Government Programme Faces Criticism in Scotland
France Pilots Mobile Phone Ban in Schools
Priti Patel Eliminated in First Round of Tory Leadership Race
And Justice for ALL: Elon Musk threatens to go after Brazilian government assets
WHO-Led Study Finds No Link Between Mobile Phones and Brain Cancer
US Charges Hamas Leaders With Terrorism Over October 7 Attack on Israel
Russian Missile Strike Kills 49 in Poltava, Ukraine
Major Cabinet Resignations in Ukraine
Tory Leadership Candidates Criticize Rivals' Promises to Leave ECHR
Campaigners Propose Pay-Per-Mile Charge for UK Electric Cars
Labour Urged to Shift Asylum Policy Rhetoric
Hossein Shamkhani: The Rise of an Oil Tycoon
Putin Defies ICC Arrest Warrant with Mongolia Visit
Frenchman On Trial for Decade-long Abuse of Drugged Wife
The British bus driver explains to usual suspects that they cannot travel without a ticket. Education is important.
Irish Police Arrest Enoch Burke, the teacher who refuses to endorse and affirm transgender ideology
US Soldier Attacked in Turkey
Switzerland Urged to Reconsider Its 500-Year Neutrality
AfD's Historic Victory in Thuringia State Election, Germany
×