Giving pregnant mothers a “game-changing” vaccine can significantly reduce the risk of a life-threatening respiratory disease in babies, according to new results from a late-stage clinical trial.
The vaccine, code-named RSVpreF, reduced the chance of severe illness from respiratory syncytial virus (RSV) by 82% in the first 90 days of life and by 69% in the first six months.
RSV kills 100,000 children under 5 years of age worldwide each year, 45,000 of whom are less than 6 months old.
PfizerThe company making the vaccine plans to apply for the first regulatory approval by the end of 2022.
Annaliesa Anderson, the company’s senior vice president and chief scientific officer for vaccine development, said: “We are excited about these data because this is the first study shown to help protect newborns immediately from severe RSV-related respiratory disease. Sex vaccine. At birth.”
About 7,400 women from 18 countries participated in the Phase 3 clinical trial, who received the vaccine or sham needles in the second or third trimester.
The mothers will pass the vaccine to the baby in the womb. There is no evidence of a safety issue.
Most deaths from RSV occur in low- and middle-income countries.
In the UK, an average of 83 children die each year and another 29,000 are admitted to hospital.Incidence rates are rising this fall as the virus bounces back from a lull due to reduced social activity coronavirus disease Pandemic.
Dr Chrissie Jones, Associate Professor of Paediatric Infectious Diseases at the University of Southampton, said: “This is an absolute game changer and is of high global importance.
“If this vaccine is approved by regulators, it will have a significant impact on hospital admissions for RSV disease. This is very important for the UK, but crucial for low- and middle-income countries.”
RSV is a common childhood virus that causes symptoms similar to a severe cold. In babies under six months, it often causes bronchiolitis, an infection of the small airways in the lungs that makes breathing more difficult.
Professor Jonathan Ball, from the University of Nottingham, said: “RSV can cause infections that can lead to pneumonia, which is especially problematic in young children.
“Previous attempts to protect them with vaccines, especially in the first year of life, have proven difficult, so Pfizer’s source says their early clinical trial data suggest good protection against lung infections… good news.”
Pfizer announced the results in a press release. It said it would submit the full data for publication in a medical journal.