The Food and Drug Administration has approved giving GSK's vaccine for respiratory syncytial virus down to age 50 years old, to those who are at higher risk of severe RSV, the company said Friday , making it the first shot greenlit for use in this age group to guard against RSV. Global vaccine and drugmaker GSK asked the FDA in February to expand approval beyond adults 60 and older, citing data showing the immune response in adults vaccinated from this younger age group looked similar. Further trials are planned looking at adults between 18 and 49 years old, GSK said, with results expected in the second half of this year.
Two other companies – Pfizer and Moderna – also manufacture RSV vaccines approved for adults 60 and older, and are testing their shots in younger adults. Pfizer told investors last month it was getting ready to submit "positive" data from studies of its own shot down to age 18. GSK's vaccine will next need to be recommended for adults between 50 and 59 years old by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
Their backing, at upcoming meetings in June or October, would tee up insurance coverage. Vaccinating adults in their 50s for RSV likely has a public health benefit , a work group within the CDC's committee concluded last year ahead of the approval, though it is narrower than for older adults who are at higher risk from their age alone. Under 60 years old, pre-existing medical issues play larger roles.