FDA approves first RSV vaccine for at-risk adults in their 50s

The Food and Drug Administration has approved the administration of GSK’s respiratory syncytial virus vaccine through age 50 to those at highest risk for severe RSV, the company said. said Fridaymaking it the first shot given the green light for use in this age group to protect against RSV.

GSK Global and Pharmaceutical Vaccine asked the FDA in February to expand approval beyond adults 60 and older, citing data show that the immune response in vaccinated adults in this younger age group was similar. More trials are planned in adults aged 18 to 49, GSK said, with results expected in the second half of this year.

Two other companies – Pfizer and Moderna – also make RSV vaccines approved for adults 60 and older and are testing their vaccines in younger adults. Pfizer told investors last month, it was preparing to present “positive” data from its own studies carried out up to the age of 18.

Next, GSK’s vaccine will need to be recommended for adults ages 50 to 59 by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Your support in the coming Dating in June or October, it would increase insurance coverage.

Vaccinating adults in their 50s against RSV likely has an effect public health benefita working group within the CDC committee concluded last year before approval, although it is narrower than for older adults who are at greater risk simply due to age.

Under the age of 60, pre-existing medical problems play a greater role in the risk of RSV infections taking a dangerous turn.

“Many diseases arise because the virus is triggering underlying medical conditions, be it COPD, heart failure, etc. So the virus is more of a trigger for exacerbation,” said Dr. Phil Dormitzer, senior vice president and global head of vaccine research and development at GSK.

Dormitzer said GSK achieved “relatively comparable” safety results from its vaccine in this group, compared with when it was given to people aged 60 and over. Some of the vaccine’s side effects appeared to be a little stronger, likely as a result of better immune responses in this age group.

The CDC panel has also faced rare but serious cases of a neurological disorder called Guillain-Barré syndrome seen after using RSV injections.

About 1.5 cases of the syndrome have been reported per million doses of the GSK vaccine administered, the CDC said. he said last week. The agency search data found that nearly a quarter of adults ages 60 and older have received an RSV vaccine since it was approved last year.

GSK’s testing did not reveal any “concerning” trends in GBS cases in the 50-59 age group, Dormitzer said.

“The risk of GBS tends to increase, it is another one of those risks that tends to increase with age. But there is nothing to indicate that there is any specific risk of GBS,” he said.

The CDC panel is also expected to weigh in on whether and when adults will need to start receiving RSV booster shots.
Dormitzer said GSK is planning to present more test results to the CDC committee in June, looking at boosters spaced up to three years after the initial dose.

“This is a really fundamental issue. People initially predicted that it might have to be an annual immunization. But then we discovered that the duration of protection actually lasts longer than one season, clearly,” he said.