The US group Pfizer announced on Tuesday positive results from a clinical trial for infants and toddlers of a vaccine against the respiratory syncytial virus (RSV), responsible for bronchiolitis, given to the mother during pregnancy.
The vaccine was about 82% effective in preventing serious cases in a baby’s first three months, and about 69% at six months, according to the results of this Phase 3 test disclosed by the company. The trial, however, did not conclude that the vaccine significantly reduced non-severe cases. “statistically significant”even if the tests show some clinical efficacy, the lab shows.
Based on these results, which have not been reviewed by independent scientists, Pfizer plans to seek approval for the vaccine in pregnant women in the US by the end of the year, and then in other countries.
Bronchiolitis is a common and highly contagious respiratory disease, especially in infants aged 2 to 8 months, where it causes coughing and labored breathing. Most of the time, the disease is mild. But it may require an ambulance or even hospitalization. Pfizer estimates that about 102,000 children worldwide die from RSV each year, half of whom are under six months of age.
Usually, the epidemic of bronchiolitis starts from the end of October to the middle of November, reaches its peak in December, and ends in the end of January or even in the end of February. But in many countries it started earlier than usual this year.
Sanofi and Astrazeneca received a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) in September for nirsevimab, which is designed to protect infants during the virus’s circulating season.
The vaccine, called Beyfortus, differs from vaccines with traditional technologies because it is a monoclonal antibody, that is, an antibody developed in the laboratory, which enables the child to be given so-called passive immunity in a single dose. The European Commission has yet to give the green light for its marketing.
Other pharmaceutical groups are also working on RSV vaccines, including Britain’s GSK and America’s Moderna and Johnson & Johnson. Pfizer already announced positive results of the vaccine for the elderly in August.
Source: Le Figaro
