The US group Pfizer announced on Tuesday positive results in newborns and infants from a clinical trial of a vaccine against respiratory syncytial virus (RSV), responsible for bronchiolitis, administered to the mother during pregnancy.
According to the results of this phase 3 trial released by the company, the vaccine was found to be about 82% effective in preventing severe cases in a baby’s first three months, and about 69% within next six months.
The trial, however, did not conclude that the vaccine reduced non-severe cases in a “statistically significant” way, although the tests show some clinical efficacy, the laboratory indicates.
Thousands of children die from the disease each year.
Based on these results, which have not been reviewed by independent scientists, Pfizer plans to seek authorization of the vaccine in pregnant women by the end of the year in the United States and then in other countries.
Bronchiolitis is a common and highly contagious respiratory illness, especially in infants 2 to 8 months of age, where it causes coughing and shortness of breath.
Most of the time, the disease is mild. But it may require a visit to the emergency room or even a hospital stay. Pfizer estimates that around 102,000 children die from RSV each year worldwide, half of them under six months of age.
Not yet marketed
Sanofi and Astrazeneca obtained a favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in September for nirsevimab, intended to protect infants during the virus’ circulation season.
Called Beyfortus, it differs from vaccines that use traditional technologies because it is a monoclonal antibody, that is, an antibody developed in the laboratory, which allows the so-called passive immunity to be conferred on the infant, with a single dose.
The European Commission has not yet given the green light for its commercialization. Other pharmaceutical groups are also working on RSV vaccines, including the UK’s GSK and the US’s Moderna and Johnson & Johnson.
Source: BFM TV
