FDA Approves GSK’s RSV Vaccine for Adults 50 and Older

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Written By Lori Walker

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The Food and Drug Administration (FDA) has approved GSK’s vaccine for respiratory syncytial virus (RSV) for people as young as 50 years old who are at higher risk of severe RSV. This makes it the first shot approved for use in this age group to protect against RSV.

GSK, a global vaccine and drugmaker, requested FDA approval in February to expand the use of its vaccine beyond adults 60 and older. They cited data showing that the immune response in adults vaccinated from this younger age group was similar. Further trials are planned to study adults between 18 and 49 years old, with results expected later this year.

Two other companies, Pfizer and Moderna, also make RSV vaccines approved for adults 60 and older, and are testing their shots in younger adults. Pfizer has said it plans to submit positive data from studies of its own shot for approval down to age 18.

For GSK’s vaccine to be recommended for adults between 50 and 59 years old, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices needs to approve it. This is expected to happen at upcoming meetings in June or October, which would then allow for insurance coverage.

Vaccinating adults in their 50s for RSV is likely to have a public health benefit, according to a work group within the CDC’s committee. However, the benefit is narrower than for older adults who are at higher risk due to their age alone.

Pre-existing medical issues play a larger role in the risk of RSV infections becoming dangerous in people under 60 years old.

Dr. Phil Dormitzer, from GSK, said the vaccine had shown “relatively comparable” safety results in the 50 to 59 age group compared to those 60 and over. Some side effects of the vaccine appeared to be slightly stronger, likely due to better immune responses in this age group.

The CDC panel has previously discussed rare but serious cases of a neurological disorder called Guillain-BarrĂ© syndrome (GBS) seen after the use of RSV shots. Around 1.5 cases of GBS per million doses of GSK’s vaccine have been reported. The risk of GBS tends to increase with age, but there’s no indication of any particular risk of GBS from the vaccine.

The CDC panel is also expected to consider whether and when adults will need booster shots for RSV. GSK plans to present more trial results to the CDC committee in June, looking at boosters given as much as three years after the initial shot.

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