US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
Moderna's RSV shot, mRESVIA, was the first non-Covid-19 messenger RNA-based vaccine to be approved in the United States. PHOTO: REUTERS
US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
MARYLAND - The US Food and Drug Administration on June 12 expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59 years at increased risk for disease.
Moderna's RSV shot, mRESVIA, was the first non-Covid-19 messenger RNA-based (mRNA) vaccine to be approved in the United States.
The shot, the company's second product, is already approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older.
While the FDA approval is a necessary step, the US Centres for Disease Control and Prevention (CDC) still has to recommend the shots before they are available for the age group.
The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection.
In April, the CDC's panel of outside experts recommended the use of approved RSV vaccines in at-risk adults aged 50 to 59.
Health Secretary Robert F. Kennedy Jr. on June 11 named eight new members to serve on the key panel of vaccine advisers, known as the Advisory Committee on Immunisation Practices, after previously firing all 17 of its members, saying it would 're-establish public confidence in vaccine science'.
However, public health experts warn that this could undermine public confidence in available vaccines.
Some of the new appointees have openly expressed anti-vaccine views, including against the mRNA vaccine technology.
The panel, which provides guidance to the CDC on which groups of people would most benefit from an already-approved vaccine, is scheduled to meet later this month.
RSV typically causes cold-like symptoms, but is also a leading cause of pneumonia in toddlers and older adults. The CDC estimates 15,000 to 20,000 annual RSV-associated hospitalisations in the US in adults aged 50 to 59.
The FDA's approval for mRESVIA was based on results from a late-stage trial where the shot helped initiate significant immune responses in adults aged 18 to 59 years with underlying health conditions.
The vaccine was well-tolerated with no safety concerns, the company said.
The FDA approved mRESVIA in adults aged 60 or older in 2024 , but with a lower efficacy label indicating the shot was 79 per cent effective at preventing at least two symptoms of RSV, such as cough and fever.
Moderna had said the shot was shown to be 83.7 per cent effective in a late-stage trial.
All currently approved shots against RSV, including Pfizer's Abrysvo and GSK's Arexvy, are for adults aged 60 years and above.
Arexvy and Abrysvo are also approved to prevent RSV-associated disease in at-risk adults aged 50 to 59 and 18 to 59, respectively. REUTERS
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US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
Moderna's RSV shot, mRESVIA, was the first non-Covid-19 messenger RNA-based vaccine to be approved in the United States. PHOTO: REUTERS US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults MARYLAND - The US Food and Drug Administration on June 12 expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59 years at increased risk for disease. Moderna's RSV shot, mRESVIA, was the first non-Covid-19 messenger RNA-based (mRNA) vaccine to be approved in the United States. The shot, the company's second product, is already approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older. While the FDA approval is a necessary step, the US Centres for Disease Control and Prevention (CDC) still has to recommend the shots before they are available for the age group. The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection. In April, the CDC's panel of outside experts recommended the use of approved RSV vaccines in at-risk adults aged 50 to 59. Health Secretary Robert F. Kennedy Jr. on June 11 named eight new members to serve on the key panel of vaccine advisers, known as the Advisory Committee on Immunisation Practices, after previously firing all 17 of its members, saying it would 're-establish public confidence in vaccine science'. However, public health experts warn that this could undermine public confidence in available vaccines. Some of the new appointees have openly expressed anti-vaccine views, including against the mRNA vaccine technology. The panel, which provides guidance to the CDC on which groups of people would most benefit from an already-approved vaccine, is scheduled to meet later this month. RSV typically causes cold-like symptoms, but is also a leading cause of pneumonia in toddlers and older adults. The CDC estimates 15,000 to 20,000 annual RSV-associated hospitalisations in the US in adults aged 50 to 59. The FDA's approval for mRESVIA was based on results from a late-stage trial where the shot helped initiate significant immune responses in adults aged 18 to 59 years with underlying health conditions. The vaccine was well-tolerated with no safety concerns, the company said. The FDA approved mRESVIA in adults aged 60 or older in 2024 , but with a lower efficacy label indicating the shot was 79 per cent effective at preventing at least two symptoms of RSV, such as cough and fever. Moderna had said the shot was shown to be 83.7 per cent effective in a late-stage trial. All currently approved shots against RSV, including Pfizer's Abrysvo and GSK's Arexvy, are for adults aged 60 years and above. Arexvy and Abrysvo are also approved to prevent RSV-associated disease in at-risk adults aged 50 to 59 and 18 to 59, respectively. REUTERS Join ST's Telegram channel and get the latest breaking news delivered to you.
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Kennedy's ouster of US vaccine advisers puts pharma ties under scrutiny
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Seven other panel members received between $4,000 and $55,000 from drugmakers for consulting, speaking fees, travel or meals over the period 2017 to 2023. Two of those experts had also worked with other scientists in industry-funded research projects worth several millions of dollars. Brooks, retired chief medical officer at Watts Healthcare in Los Angeles and former president of the National Medical Association, received nearly $44,000 in general payments from Sanofi, according to the government records. Most of the payments occurred in 2017 and 2018, with nothing after 2020. Brooks became a vaccine adviser in 2021, and did not disclose any conflicts that would preclude him from voting. He said the panel's sole aim is "to prevent vaccine-preventable illness." Sanofi declined to comment. At least three vaccine advisers were not health professionals tracked by mandatory Open Payments reporting. 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REUTERS Join ST's Telegram channel and get the latest breaking news delivered to you.
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Forum: Singapore's outsized influence in healthcare, even as a colony
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