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First RSV vaccine approved in US


Jolyon Attwooll


9/05/2023 4:26:36 PM

The US drugs regulator has given the green light to a new vaccine, which is also under consideration by the TGA in Australia.

Child with RSV
RSV is one of the main causes of hospitalisation among young children.

The first approval for a vaccine offering protection against respiratory syncytial virus (RSV) has been given by the US Food and Drug Administration (FDA).
 
The medicine regulator this month confirmed a preliminary decision to give the green light to Arexvy, a vaccine developed by UK pharmaceutical company GlaxoSmithKline, for use among people aged 60 and older.
 
An application to approve the same protein-based vaccine in Australia is also currently under consideration by the Therapeutic Goods Administration (TGA).
 
According to the FDA, RSV causes between 6000–10,000 deaths among over-65s in the US each year.
 
The FDA said its decision is based on data from an ongoing randomised controlled clinical trial, involving around 25,000 participants, with half receiving the vaccine and the remainder receiving a placebo.
 
Injection site pain, fatigue, muscle pain, headache and joint stiffness or pain are the most commonly cited side effects of the vaccination.
 
According to the results, the vaccine cut the risk of RSV-associated lower respiratory tract disease significantly by 82.6%, with the chances of severe disease reduced further still by 94.1% compared to a placebo group.
 
The results were published in the New England Journal of Medicine (NEJM) in February.
 
‘A single dose of the … vaccine had an acceptable safety profile and prevented RSV-related acute respiratory infection and lower respiratory tract disease and severe RSV-related lower respiratory tract disease in adults 60 years of age or older, regardless of RSV subtype and the presence of underlying coexisting conditions,’ the NEJM article stated.
 
The trial is due to continue to track the impact of the vaccine across three RSV seasons.
 
Reuters reports that the vaccine will be available in the US before the onset of next year’s RSV season.
 
Other organisations are also vying for official approval of an RSV vaccine, including Pfizer, with its vaccine reportedly 81.8% effective in preventing severe infections in infants from birth to six months after being given to women in the second half of pregnancy.
 
The same vaccine is also under consideration by the TGA for use in Australia.
 
Moderna, in the meantime, has reported an efficacy rate of 83.7% in preventing RSV symptoms among the over-60s for its own mRNA-based vaccine.
 
A monoclonal antibody, nirsevimab, developed by AstraZeneca and French pharmaceutical company Sanofi, has a 74.5% efficacy rate in preventing severe infection among babies, according to data that was also published in the NEJM. That treatment is again under TGA evaluation.
 
According to the World Health Organization, RSV vaccine development has been underway since the 1960s.
 
The disease is one of the main causes of hospitalisation among very young children, while a study published last year in The Lancet suggests the overall mortality for RSV could be as high as 118,200 deaths annually.
 
The Chair of RACGP Specific Interests Respiratory Medicine, Dr Kerry Hancock, has welcomed the recent progress in vaccine development.
 
‘We look forward to an effective and safe vaccine to reduce the burden of RSV infection in the very young, but also in older adults where the greatest morbidity and mortality exists and can have the most impact,’ she told newsGP.  
 
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