2023-07-21 17:00:02
OK from the European Medicines Agency Ema to the first vaccine against syncytial virus (RSV) for children up to 6 months of life and adults aged 60 and over. The EU regulatory body has recommended granting marketing authorization in the European Union for Abrysvo*, a vaccine for protection against the disease caused by RSV, reads a note in which the EMA also explains the characteristics of the product that will be available in the EU: “Abrysvo is the first RSV vaccine indicated for the passive immunization of infants from birth to 6 months of age, through the administration of the vaccine to mothers during pregnancy”, and is also indicated “for the ‘active immunization of adults 60 years of age and older’.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can cause serious consequences for children and the elderly. In fact, in the youngest, this pathogen is one of the main causes of pediatric hospitalization in Europe. It can cause bronchiolitis and pneumonia and can lead to fatal respiratory distress. RSV infection can also be serious for adults over 50, as it can cause acute respiratory infections, flu-like illnesses, or pneumonia.
Abrysvo is a bivalent vaccine, composed of two glycoproteins selected to optimize protection against Rsv A and B strains. These proteins are essential for the virus to infect the body and are also the main targets for antibodies generated to fight the infection. The new vaccine, highlights the EMA, “has been evaluated under the agency’s accelerated evaluation mechanism, because the prevention of RSV disease is considered of great public health interest”.
When the vaccine is administered – describes the EMA – the recipient’s immune system generates specific antibodies and T cells (immune system cells) which help prevent RSV infection. In the case of pregnant women, neutralizing antibodies cross the placenta, providing protection for babies for up to 6 months after birth.
The positive opinion expressed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is based on data from two randomised, placebo-controlled studies. In one, 3,695 pregnant women were given the vaccine at 24-36 weeks, while 3,697 were given a placebo. The evaluation showed that the vaccine was effective in reducing both clinically recognized serious lower respiratory tract disease, as well as clinically recognized lower respiratory tract disease occurring within 180 days of birth. In the other study, 18,488 adults 60 years of age and older were given the vaccine, and another 18,479 were given a placebo. The results demonstrated the efficacy of the vaccine in reducing RSV-associated lower respiratory tract disease with two (or more) symptoms and with three (or more) symptoms. The most common side effects reported in pregnant women were vaccination site pain, headache and muscle aches. In the over 60s, the most frequently reported side effect was pain at the vaccination site.
The opinion adopted by the CHMP is an intermediate step on Abrysvo’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once granted, decisions on price and reimbursement will take place at the level of each Member State, taking into account the potential use of the vaccine in the context of the national health system.
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