The Food and Drug Administration has approved GSK’s respiratory syncytial virus vaccine for use up to age 50, to those at higher risk for severe RSV, the company announced. said Fridaymaking it the first vaccine to be used in this age group to protect against RSV.
GSK, global manufacturer of vaccines and drugs request the FDA in February to expand approval beyond adults 60 and older, citing data showing that the immune response in vaccinated adults in this younger age group appeared similar. Further 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, he was preparing to submit “positive” data from his own studies conducted up to the age of 18.
GSK’s vaccine will then need to be recommended for adults ages 50 to 59 by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Their support, to come meetings in June or October, insurance coverage would increase.
Vaccination of adults in their 50s against RSV probably has a public health benefita working group within the CDC committee concluded last year before approval, although it is more restricted than for older people who are at higher risk due to their age alone.
Among those under 60, pre-existing medical conditions play a greater role in the risk of RSV infections becoming dangerous.
“Many illnesses occur because the virus triggers underlying health conditions, whether it’s 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 saw “relatively comparable” safety results with its vaccine in this group, compared to when it was given to people 60 and older. Some of the side effects of the vaccine appear to be a little stronger, likely due to better immune responses in this age group.
The CDC panel has also previously grappled with rare but serious cases of a neurological disorder called Guillain Barre syndrome seen after using RSV shots.
Approximately 1.5 cases of the syndrome per million administered doses of the GSK vaccine have been reported, according to the CDC. said last week. The agency Survey data found that nearly a quarter of adults aged 60 and older had received an RSV shot since it was approved last year.
GSK’s trials found no “concerning” trend in GBS cases in the 50 to 59 age group, Dormitzer said.
“The risk of GBS tends to increase, it’s another one of those risks that tends to increase with age. But there is no indication that there is a particular risk of GBS,” he said .
The CDC panel is also expected to assess whether and when adults will…
