Recently, the European Medicines Authority approved a new and first vaccine of its kind against the RSV virus, which is intended for babies. The vaccine will be given in one dose only. Until today, the vaccine was intended for premature babies and babies at increased risk, and it was given in five doses – one every month.
The new vaccine, called Beyfortus, actually becomes the only option that is given in one dose to babies in order to protect against the RSV virus, which is considered particularly contagious. Almost all children up to the age of two around the world will get RSV. The virus is responsible for a quarter of the hospitalizations of infants and toddlers due to pneumonia, and for almost 75% of the hospitalizations due to bronchiolitis. According to data from the World Health Organization, in 2019 there were approximately 33 million cases of illness as a result of RSV, of which approximately 3 million people required hospitalization. In the same year, 100,000 deaths were also recorded as a result of complications of the virus.
The European approval that was given was based on a study published last year in the most prestigious journal in the medical world – “New England Journal of Medicine”. The study found that the new vaccine, given in just one dose, was able to reduce by 75% the infections in the lower respiratory tract among infants following infection with the RSV virus.
The study was conducted in more than 20 countries around the world, during which the researchers made a comparison between two groups of babies born from the 35th week of pregnancy and above. One group received the new vaccine, given in just one injection, and the other group received a dummy injection (placebo).
The researchers followed 1,490 infants and examined the condition of the vaccinated in a period of 150 days after the administration of the vaccine, with the aim of checking whether they suffered from lower respiratory tract infections following infection with the RSV virus. According to the findings, as mentioned, there was a 75% reduction in lower respiratory tract infections that included diseases such as pneumonia and bronchiolitis among the group that received the vaccine.
The vaccine has also been submitted for approval by the FDA, and is likely to be approved in the coming months. According to estimates, in the next winter season – 2023/24 – it will be available in the USA and probably in Israel as well.