FDA Approves GSK’s RSV Vaccine for Adults 50+, Expanding Protection

The FDA has authorized GlaxoSmithKline’s (GSK) vaccine for respiratory syncytial virus (RSV) for use in individuals as young as 50 years old, specifically targeting those with a heightened susceptibility to severe RSV infections. This approval signifies the first instance of a vaccine being greenlit for this age bracket to address RSV.

In February, GSK requested the FDA to expand approval beyond adults aged 60 and older, presenting data indicating that the immune response in younger adults vaccinated with the vaccine was comparable. Further trials are underway, focusing on adults aged 18 to 49, with results expected later in the year.

Other companies such as Pfizer and Moderna also manufacture RSV vaccines approved for adults aged 60 and older and are currently testing their vaccines in younger age groups. Pfizer recently announced its intention to submit positive data from studies of its vaccine for individuals as young as 18 years old.

FDA Approves GSK's RSV Vaccine for Adults 50 and Older
Pfizer, Moderna expand RSV vaccine testing to younger age groups, including 18-year-olds.

For GSK’s vaccine to be recommended for adults aged 50 to 59, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will need to provide their endorsement, which is anticipated to occur in upcoming meetings scheduled for June or October. This recommendation would facilitate insurance coverage for this age group.

The decision to vaccinate adults in their 50s against RSV is supported by public health considerations, as outlined by a CDC committee work group’s conclusions from last year. However, the benefit is narrower compared to older adults who face higher risks due to age alone. Pre-existing medical conditions play a significant role in the risk of severe RSV infections for individuals under 60 years old.

GSK’s vaccine has shown similar safety profiles in individuals aged 50 to 59 as in those aged 60 and above. However, some vaccine side effects were slightly more pronounced in the younger age group, likely due to their stronger immune responses.

Concerns regarding rare but severe cases of Guillain-Barr√© syndrome (GBS) linked to RSV vaccines have been addressed in GSK’s trials, which found no worrisome trends of GBS cases among those aged 50 to 59. The CDC panel is anticipated to assess the necessity of booster shots for RSV. GSK intends to present additional trial data in June to evaluate the effectiveness of boosters administered up to three years post-initial vaccination.

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