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UK approves first RSV vaccine for both infants and older adults

The first vaccine against respiratory syncytial virus (RSV) suitable for both babies and older adults has been approved by UK regulators.

A bivalent recombinant vaccine developed by Pfizer called Abrysvo has been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) based on results from two separate trials published on this early year.

It comes after the Joint Committee on Vaccination and Immunization (JCVI) recommended in June that the UK should roll out routine RSV vaccination for both newborns and people over 75 years of age.

The committee reviewed several vaccines in development, including Abrysvo, as it and others are expected to be approved this year or in 2024.

They said they made the recommendations early to allow the Government enough time to implement policies and programs.

But JCVI does not care whether to choose a maternal vaccination program or a passive vaccination program to protect newborns. It also said three potential products for people over 75 should all be considered.

It also did not specify a timeline for implementation and DHSC said it was considering options with UKHSA.

RSV causes up to 15,000 babies under 6 months of age to be admitted to hospital in the UK each year and in winter, up to a sixth of all babies and young children admitted to hospital in the UK are due to bronchiolitis with 80% of cases. RSV-related cases.

For older people in the UK, it is estimated that RSV leads to 175,000 GP visits and 14,000 hospital admissions annually.

In a trial published in the New England Journal of Medicine in April, Pfizer RSV vaccine is given during pregnancy has been shown to be effective against severe lower respiratory tract illness associated with RSV in infants up to six months of age.

And in one The second trial is underway, This vaccine prevents RSV-associated lower respiratory illness and RSV-associated acute respiratory illness in adults over 60 years of age.

Julian Beach, interim chief executive for healthcare quality and access at the MHRA, said: ‘We are pleased to confirm that we have authorized the Abrysvo vaccine to protect against the disease. lower respiratory tract caused by respiratory syncytial virus (RSV) through our trusted protocol.

‘Abrysvo has been licensed for use in infants from birth to 6 months of age following maternal vaccination during pregnancy and in adults 60 years of age and older.

‘No drug is approved unless it meets our expected standards of safety, quality and effectiveness.’

A spokesperson for the Department of Health and Social Care said: ‘The NHS has provided monoclonal antibodies that help protect against RSV to very high-risk babies.

‘We are developing options to deliver wider RSV programs for babies and adults, in collaboration with the UK Health Security Agency, NHS England and manufacturers. We will update at the appropriate time.’

Professor Beate Kampmann, professor of pediatric infection and immunity at the London School of Hygiene and Tropical Medicine, who is leading the trial in pregnancy, said: “The availability of vaccines is an opportunity to reduce serious complications of virus-related respiratory illness.” .

‘This could save countless parents and family members from the ordeal of watching their children and loved ones battle complications of the virus in hospital – while also easing the pressure on health services at the most stressful time of the year.’

Dr Ronnie Cheung, consultant general paediatrician at Evelina London Children’s Hospital said: ‘The number of babies seeing their GP or being admitted to hospital with RSV infection has been increasing every week.

‘The recent arrival of an RSV vaccine will herald a new dawn for tackling this common disease, however, clinicians and parents continue to be frustrated by delays in implementation. current national RSV vaccination program.

‘It is imperative that the advice of experts and NHS staff is listened to and that the national RSV vaccination program is rolled out promptly.’


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