2023
DOI: 10.1136/bmj.p978
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First RSV vaccine for older adults is approved in Europe

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Cited by 7 publications
(3 citation statements)
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“…It is important to prioritise this population for RSV prevention and vaccination programmes and priority setting. Two RSV vaccines, RSVPreF3-AS01E and RSVpreF, have been approved for use in older adults aged over 60 years by the Food and Drugs Administration (FDA) in the USA and the European Medicines Agency (EMA) [49][50][51]. Post-marketing surveillance to assess the likely impact of the introduction of RSV immunisation on preventing severe infections and hospitalisations in this population will be necessary in the next few years.…”
Section: Discussionmentioning
confidence: 99%
“…It is important to prioritise this population for RSV prevention and vaccination programmes and priority setting. Two RSV vaccines, RSVPreF3-AS01E and RSVpreF, have been approved for use in older adults aged over 60 years by the Food and Drugs Administration (FDA) in the USA and the European Medicines Agency (EMA) [49][50][51]. Post-marketing surveillance to assess the likely impact of the introduction of RSV immunisation on preventing severe infections and hospitalisations in this population will be necessary in the next few years.…”
Section: Discussionmentioning
confidence: 99%
“…On 3 May 2023, the U.S. Food and Drug Administration (FDA) granted approval to the first RSV vaccine in the world (AREXVY from GSK), specifically targeting individuals aged 60 and older, and it was approved by the European Union on 7 June 2023 [ 59 , 61 ]. The vaccine incorporates a stabilized form of the RSV F protein antigen [ 62 ].…”
Section: Discussionmentioning
confidence: 99%
“…The Medicines and Healthcare Products Regulatory Agency has authorised Arexvy, the first vaccine for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in over 60s. The move follows a recommendation for marketing authorisation of the vaccine by the European Medicines Agency in April 2. The UK agency’s decision is supported by data that found 82.6% efficacy against RSV from a phase 3 study published in the New England Journal of Medicine 3.…”
Section: Vaccinesmentioning
confidence: 99%