Following the favourable opinion issued for the vaccine product Abrysvo from Pfizer Europe MA EEIG by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) on 21 July 2023, the EU Commission followed the committee's recommendation and granted a marketing authorisation on 24 August 2023. Abrysvo is the first RSV vaccine to passively immunise infants from birth to six months of age. The mother is vaccinated during pregnancy so that protective antibodies are transferred to the infant via the placenta. The vaccine is also authorised for active immunisation of individuals 60 years of age and older to protect them from lower respiratory tract disease caused by RSV infection.
Abrysvo is a bivalent vaccine containing recombinantly produced fusion glycoproteins from the viral envelope of the A and B RSV strains. This ensures optimal protection against both strains of RSV. These proteins are essential for an RSV infection and are also the main targets (antigens) of the antibodies produced to fight viral infection.
The CHMP recommendation was based on data from two randomised, placebo-controlled authorisation studies.
In one study, Abrysvo was given to 3,695 people at weeks 24 to 36 of pregnancy, while 3,697 people received a placebo. The assessment showed that the vaccine was effective in reducing both the number of RSV-induced lower respiratory tract diseases and the number of severe lower respiratory tract diseases in infants within 180 days of birth.
In the second study, 18,488 adults aged 60 years and older were given the vaccine, while 18,479 received a placebo. The results of the study demonstrated the efficacy of Abrysvo in reducing RSV-associated lower respiratory tract disease with two (or more) symptoms and with three (or more) symptoms.
The most common side effects in vaccinated persons between the 24th and 36th weeks of pregnancy were pain at the injection site, headache, and muscle pain. In people aged 60 years and older, the most commonly reported side effect was pain at the injection site.
RSV is a common respiratory virus that usually causes only mild, cold-like symptoms, but it can lead to more severe symptoms in infected children and older adults. RSV is the most common cause of hospitalisation among children in Europe. Infection with RSV can cause bronchiolitis, a lower respiratory tract infection, and pneumonia, and can lead to fatal respiratory distress.
Even adults aged 50 and over can experience a severe disease course following RSV infection, including acute respiratory infection, flu-like illness, and pneumonia.
Updated: 29.08.2023
