Spring is not yet here but the pharmaceutical industry is already preparing for next winter. Last year, Sanofi launched a new vaccine on the French market to protect babies from the respiratory syncytial virus (RSV) which causes bronchiolitis. Designed in partnership with the British AstraZeneca, Beyfortus immunized 250,000 babies this winter, thanks to exceptional mobilization from the Ministry of Health, which made it possible to make this vaccine accessible even before the opening of negotiations on its marketing and distribution conditions. refund.
Each winter, nearly 30% of babies under the age of two, or 480,000 infants, contract bronchiolitis, according to the High Authority for Health. In 2% to 3% of cases, the disease is so severe that it requires hospitalization. In 2022-2023, the triple epidemic of bronchiolitis, flu and covid caused severe congestion in emergency services, which the government wanted to prevent at all costs the following year.
Given the success experienced this winter, the next vaccination campaign against the respiratory syncytial virus (RSV) which causes bronchiolitis should be on a completely different scale, and is being prepared now. The parental support rate has exceeded 80% in 2023-2024, compared to 30% anticipated, so that France will need 600,000 doses rather than 250,000 at the end of the year, according to the general management of health.
Sanofi and its partner AstraZeneca, responsible for producing the vaccine, are gearing up to meet demand. Production of doses at the British laboratory’s American factories has increased more than threefold from 1.5 million doses in 2023. More than 5 million are expected to be produced this year.
At Sanofi, we are pleased that 17 countries around the world have already made recommendations in favor of its vaccine for next season. France, on the other hand, is lagging behind. If the discussions with the economic committee for health products (CEPS) are progressing, and even a little faster than usual when a new drug must be placed on the market, they are still too slow in the eyes of the laboratory, which regrets the speed of last year. “We need to know very soon the quantity of vaccine doses that France will need this winter to prepare the campaign in good conditions,” explains Audrey Derveloy, the president of Sanofi France. The forecasts of the General Directorate of Health must turn into firm commitments. Other countries are in the running, and the minimum production period is six months.
This winter, Sanofi should also face a new competitor. Pfizer also hopes to be able to market its own RSV vaccine, Abrysvo, for the next campaign. Abrysvo protects infants by vaccinating mothers during pregnancy rather than babies – a protocol parents are still unfamiliar with. The vaccine should be administered between the 24th and 36th weeks of pregnancy and provides immunity to the newborn from birth.
Abrysvo obtained its European marketing authorization last August. Pfizer says it is ready to deliver to France. It produces this vaccine at its factory in Puurs, Belgium, which is also responsible for manufacturing doses of the covid vaccine. 13 European countries have already received their doses of Abrysvo. But in France, the American laboratory has not finished its regulatory journey either. It is still waiting for the publication of the recommendations of the technical commission for vaccines (CTV) next May to determine the volume that it will allocate to France, before negotiating the price at which it will be sold.
In the United Kingdom, the authority responsible for these recommendations, the JCVI, did not favor the Sanofi-AstraZeneca vaccine, or that of Pfizer. “These two strategies were both judged to be cost-efficient,” reports HAS. The JCVI does not preferentially recommend one of these two strategies but advises implementing a single strategy throughout the year in order to guarantee a high membership rate. It remains to be seen what recommendations France will make and which of the two vaccines health professionals and parents will favor.