A vaccine given to pregnant women that subsequently protects newborns in their first months against the worst consequences of respiratory syncytial virus, or RSV, is showing promising results in new trial data from the pharmaceutical company Pfizer.
By the end of the year, Pfizer will submit an application for FDA approval, the firm announced in a statement on Tuesday.
Trial results were so encouraging that the business decided to halt taking on additional participants after consulting with government regulators.
The vaccination, specifically, protected severe sickness particularly well during the first 90 days of life, and measurable protection against severe disease persisted until 6 months of age, according to the company. Infants are more vulnerable during those time if they contract RSV.
Anyone can contract RSV, a respiratory illness that typically has no symptoms or symptoms that are comparable to the common cold. However, it can be particularly risky — and even fatal — for infants and seniors 65 and older. The Washington Post claimed that Pfizer and another pharmaceutical company, GSK, are working on potential vaccines for elderly people.
According to the Post, RSV is the main reason why infants are admitted to hospitals.
In 18 nations throughout the world, 7,400 pregnant women participated in the Pfizer study known as MATISSE. The vaccination was administered to those who received it in the late second to third trimester of pregnancy. The remainder of the women’s pregnancies and the first six months following the birth of their children were observed for safety. For safety and effectiveness, infants were followed up on for at least a year; more than half were followed up on for two years.
According to a story in The Washington Post, the Pfizer vaccine functions by transmitting mother antibodies to the foetus during pregnancy. Other vaccinations that are delivered via maternal immunisation include those for influenza, diphtheria, tetanus, and pertussis.
RSV has a devastating effect on young children every year, sending tens of thousands to the hospital and contributing to up to 300 fatalities, according to data.
According to the CDC, one or two of every 100 infants under six months of age who with RSV may require hospitalisation. Infants who are in hospitals may require breathing assistance such as oxygen, intubation, or even mechanical ventilation.
According to the CDC, “most improve with this type of supportive treatment and are discharged in a few days.”
According to vaccine developer Barney Graham, PhD, “I think this is a huge breakthrough towards protecting babies against RSV and boosting general lung health.” “In general, RSV is experiencing interesting times. It’s also a distressing period because you can see how COVID has altered infection patterns, and this year’s season is sooner and bigger than in previous years, which is making a lot of people hospitalised and miserable.
According to CNN, the FDA may receive applications for up to four RSV vaccinations this year. An antibody shot given to children shortly after birth is also in development, according to the news source.
The data, which Pfizer disclosed on Tuesday, has not yet been published or subjected to peer review, but the firm said it is working to have it done.
In a statement, Annaliesa Anderson, PhD, Pfizer’s chief scientific officer for vaccine research and development, stated, “We are excited with these data as this is the first-ever investigational vaccination demonstrated to help protect newborns against severe RSV-related respiratory disease right at delivery.” In order to help protect newborns against severe RSV during their most vulnerable first six months of life, which have the highest prevalence of RSV disease in infants, we look forward to collaborating with the FDA and other regulatory bodies to provide this vaccine candidate to pregnant moms.
