United States – The FDA law has recently accredited the use of an RSV vaccine not only to infants but to at-risk adults over the age of 50 years.
It comes a day after manufacturer GSK stated the approval on Friday — ahead of it becoming the first vaccine endorsed for use in adults between the ages of 50 and 59 against the virus, as reported by The Hills.
Broadening Immunization Benefits
“Today’s approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk,” Tony Wood, GSK’s chief scientific officer, said in a statement. “For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”
Trial Success and Future Steps
The pharmaceutical company asked for an expansion in early February when its trial indicated that it produced an immune response and moderate tolerability in adults in their 50s. Now, GSK requires the vaccine to receive endorsement by the CDC immunization advisory committee for those in that age bracket.
Competing Vaccines
Apart from GSK, Moderna, and Pfizer, there are other companies that have created approved RSV vaccines for people above 60 years. The US health regulator approved Moderna’s RSV vaccine at the end of last month, the third shot for the RSV, other than GSK’s Arexvy and Pfizer’s mRESVIA.
The CDC panel will also have to take into consideration such issues as whether booster shots of RSV will be required.
GSK has also submitted a regulatory application in some European countries, Japan, and others seeking to expand the use of the vaccine in the 50-59 age range with some comorbidities.
Expert Insights
“When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider,” Ann R. Falsey, a professor at the University of Rochester School of Medicine, said in the statement, as reported by The Hills.
“Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions,” Falsey added. “Now there is a vaccine approved that can help protect them.”