Europe approves vaccine to protect newborns from RSV winter virus

The vaccine, Abrysvo, is the first RSV vaccine indicated for passive immunisation of babies from birth to six months old, after the mother is vaccinated during pregnancy.

A vaccine to protect newborn babies from the RSV winter virus has been approved for the first time in Europe and could soon be available in Ireland.

The vaccine, Abrysvo, is the first RSV vaccine indicated for passive immunisation of babies from birth to six months old, after the mother is vaccinated during pregnancy. This vaccine, developed by Pfizer, is also indicated for immunising adults aged 60 and older, the European Medicines Agency (EMA) said.

Cases of RSV (respiratory syncytial virus) particularly among children were unusually high this winter, doctors said. During the last two weeks of November alone some 1,341 cases were reported.

RSV is a common respiratory virus and while it usually causes mild symptoms, it can have serious consequences for babies and older people including bronchiolitis and pneumonia.

The EMA said among children RSV is one of the leading causes of children’s hospitalisation in Europe. Among adults over 50, it can lead to acute respiratory infection, influenza-like illness or community-acquired pneumonia.

This bivalent vaccine has "two recombinant RSV fusion surface glycoproteins selected to optimise protection against RSV A and B strains. These proteins are essential for RSV to infect the body and are also the main targets of the antibodies generated to fight the infection,” the EMA said.

Their assessment found when someone is given the vaccine their immune system generates specific antibodies and T cells (immune system cells) that help prevent RSV infection.

“In case of pregnant individuals, the neutralising antibodies cross the placenta, providing infants with protection up to six months after birth,” the EMA said.

Studies

Data from two large-scale studies fed into the final opinion from the EMA’s human medicines committee. Some 3,695 women, at 24-36 weeks pregnant, were given the vaccine while 3,697 received a placebo (a dummy injection).

“Assessment showed that the vaccine was effective in reducing both severe medically attended lower respiratory tract illness and medically attended lower respiratory tract illness occurring within 180 days after birth,” the EMA concluded.

In the other study, 18,488 adults aged 60 years and older were vaccinated, while 18,479 received a placebo.

“The results of the study demonstrated efficacy for Abrysvo in the reduction of RSV-associated lower respiratory tract illness with two (or more) symptoms and with three (or more) symptoms,” the EMA said.

These findings now go to the European Commission. When marketing authorisation has been granted, discussions about price and reimbursement will take place in each member country. In April, the EMA also approved a different vaccine for older people only; Arexvy developed by GSK.