The bronchiolitis virus or RSV causes a winter epidemic every year and is one of the leading causes of pediatric hospitalization in Europe. But the situation could soon improve as the European Medicines Agency has already approved several vaccines to prevent this virus.
Several vaccines against bronchiolitis approved in Europe.
The bronchiolitis virus is a common respiratory virus in babies and the elderly. It affects 90% of young children before the age of 24 months and can lead to hospitalizations and even deaths.
The development of a vaccine against this virus, called respiratory syncytial virus (RSV), is an old dream about to come true.
After approving Beyfortus or Nirsevimab, a preventive treatment for bronchiolitis developed by Sanofi and AstraZeneca, the European Medicines Agency or EMA has just given the green light to a vaccine developed by the American laboratory Pfizer on July 21, 2023.
This vaccine, named Abrysvo, will be the first to protect babies and seniors against RSV. It will allow passive immunization of infants from birth to 6 months of age through vaccination of the mother during pregnancy. This vaccine can also be used to immunize individuals aged 60 years and older.
Individuals over 60 years old are part of the at-risk population. That is why the Pfizer vaccine is also intended for them. At the same time, the European Medicines Agency authorized a vaccine from the British laboratory GSK for this age group in June 2023.
On the other hand, the American laboratory Moderna dreams of combining a vaccine against bronchiolitis with its flu vaccine and its existing anti-Covid vaccine, in order to develop a 3-in-1 respiratory vaccine...
A major breakthrough for public health.
The development of these new vaccines against bronchiolitis is excellent news because RSV is a highly contagious virus that can have serious consequences for the health of young children and the elderly.
In its most severe forms, it can cause pneumonia and lung complications that are responsible for thousands of deaths and hundreds of thousands of hospitalizations worldwide. It is estimated that this virus causes 60,000 deaths worldwide each year.
Each year, nearly 500,000 infants (about 30% of children under 2 years old) are affected by this seasonal viral infection. In France alone, it is estimated that this virus is responsible for 50,000 hospitalizations every winter.
These vaccines, on track to be authorized in France, would represent a significant progress in public health by preventing the winter epidemic and relieving hospitals during a time of year when they are already overwhelmed.
Expected release for autumn 2023.
After receiving the green light from Brussels, Pfizer still needs to obtain authorization from the French High Health Authority to market its bronchiolitis vaccine in France.
The Sanofi vaccine, which was authorized by European authorities last November, has not yet received market authorization in France. However, this French laboratory, which worked in partnership with AstraZeneca, unveiled a large-scale study with very encouraging results in May.
Their injectable product, which is not a vaccine in the strict sense, was tested on 8,000 infants and reduced hospitalizations by 83%. It is a monoclonal antibody that is injected into the baby to compensate for the immaturity of their immune system and protect them against RSV (Respiratory Syncytial Virus) throughout the bronchiolitis season in autumn and winter.
The Franco-British duo Sanofi-AstraZeneca hopes to obtain market authorization for Nirsevimab in France in time for the next epidemic season, which will extend from October 2023 to March 2024. Such authorization would be a major medical breakthrough, addressing a massive need.
According to figures provided by Sanofi in 2017, direct medical expenses related to RSV for babies worldwide were estimated at €4.82 billion. Administering a vaccine would lead to cost savings by relieving hospitals during winter and reducing antibiotic consumption.
A vaccine fully covered in 2023.
On August 1, 2023, the High Health Authority (HAS) issued a favorable opinion on the Beyfortus vaccine against bronchiolitis from Sanofi and AstraZeneca laboratories.
This decision opens the door to reimbursement of this vaccine for all babies under one year old. Infants can be vaccinated as early as the day they are born.
With Santé Publique France having purchased a stock, France is the first country in the world to be ready for a vaccination campaign starting in September 2023. This year, there will be no out-of-pocket expenses for parents.
The vaccination of babies will be completely free, with no upfront costs: a compelling reason for parents to have this protective injection administered! As a reminder, a single dose of Beyfortus provides immediate protection that lasts approximately six months. It therefore protects the baby throughout the epidemic season, which lasts from October to March.
Next year, vaccination against bronchiolitis will continue, but the details, including the financial aspects, are yet to be determined.