Syncytial virus, the first European yes to the vaccine for the elderly and pregnant women

Syncytial virus, the first European yes to the vaccine for the elderly and pregnant women

If approved, the syncytial virus RSVpreF vaccine candidate would be the first and only vaccine intended for both the elderly and for administration to pregnant women to protect newborns. The final European go-ahead could be a few weeks away given that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has expressed a positive opinion, recommending the granting of the authorization for its marketing with the dual indication. Now the ball passes to the European Commission, whose final decision will apply in all 27 EU member states plus Iceland, Liechtenstein and Norway.

Data on the two populations

The positive opinion of the CHMP is the result of the analysis of two phase 3 clinical studies. The first evaluated the efficacy, the ability to produce an immune response and the safety of the vaccine candidate in people over 60 years of age. Some results - relating to efficacy and safety - were published in the New England Journal of Medicine. The second, however, evaluated the three parameters but in combating lower respiratory tract diseases due to the syncytial virus in infants born to healthy women vaccinated during pregnancy. The efficacy and safety results were recently published in the New England Journal of Medicine.

For seniors, and more

In the United States, RSVpreF obtained approval from the Food and Drug Administration (FDA) for the prevention of lower respiratory tract diseases caused by RSV in the over 60s in May. Furthermore, at the beginning of this year, the same Agency began to evaluate extending the indication also to the active immunization of pregnant women for the prevention of diseases, even serious ones, of the lower respiratory tract caused by RSV in newborns from birth up to six months of age. Another vaccine against RSV is already authorized in both the United States and Europe, but only in the elderly population. RSVpreF is therefore the first and only RSV vaccine that could gain indication for two distinct patient populations.

Syncytial virus, FDA-approved vaccine for the elderly in the United States

The vaccine candidate is also currently being studied in other populations: in healthy children aged 2 to 5 years, children aged 5 to 18 years with pre-existing medical conditions, adults aged 18 to 60 years at high risk of syncytial virus disease due to underlying medical conditions, and adults aged 18 years and older who are immunocompromised and at high risk of developing disease from this virus.

Vaccines and monoclonal antibodies are on the way. So we will fight the respiratory syncytial virus

by Valentina Guglielmo, Tiziana Moriconi

The virus

RSV is a highly contagious virus that causes lung and respiratory tract infections in people of all ages. Its circulation is seasonal, typically starting during the fall and peaking in the winter. It is a respiratory virus which in people who are frail due to age – the elderly or newborns – or due to illness can cause even serious complications. For example, it is estimated that every year in Europe it causes about 250,000 hospitalizations and 17,000 deaths in hospital among the over 65s.

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