Ok from the European Medicines Agency Ema to the first anti vaccine syncytial virus (RSV) for children up to 6 months old and adults aged 60 and over. The EU regulatory body has recommended granting marketing authorization in the European Union for Abrysvo*, a vaccine developed by Pfizer to protect against disease caused by RSV, it reads in a note in which the EMA also explains the characteristics of the product which will be available in the EU: “Abrysvo is the first RSV vaccine indicated for the passive immunization of newborns 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 aged 60 years and over”.
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.
What kind of vaccine is it and how does it work
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 of the 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.
What the supporting studies say
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 the vaccine was administered to3,695 pregnant women at 24-36 weeks, while 3,697 were given a placebo.
Why does vaccinating mothers protect newborns?
The purpose – explained Roberta Villa in a recent contribution to Salute on this vaccine – is to make the mother produce antibodies to be passed on to the unborn child, so as to protect it in the first weeks of life, when the risk of infection is higher. At this stage, the baby is more vulnerable and its immune system, even if it were vaccinated at birth, would not be able to mount a protective response in time.
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 side effects
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 approval process
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.
The final decision from the European Commission is expected in the coming weeks and will apply to all 27 EU member states plus Iceland, Liechtenstein and Norway.
Another vaccine to protect the over 60s
Just over a month ago the European Commission authorized Arexvythe first vaccine (made by GSK) to protect adults 60 years of age and older, against lower respiratory tract disease caused by the virus.
A few days ago the news came that after Ema the FDA also authorized the use of Nirsemivab for preventive purposes, which is added to another monoclonal antibody, Palivizumabwhich has been used for many years to protect infants born prematurely.
At present Nirsemivab, despite having obtained the green light from Ema, is still being evaluated by Aifa.