Why it matters: RSV can be fatal
The US Food and Drug Administration (FDA) estimates that respiratory syncytial virus (RSV) is associated with 6,000 to 10,000 deaths each year in adults 65 and older and at least 60,000 hospitalizations in that age group. It is a major killer of children worldwide.
This winter, respiratory syncytial virus contributed to the “triple pandemic” that also included influenza and Covid cases that flooded children’s hospitals and some intensive care wards.
Announcing the approval, Dr. Peter Marks, the agency’s chief of vaccines, said: “Older adults, particularly those with underlying health conditions, such as heart or lung disease or a weakened immune system, are at increased risk of serious illness from respiratory syncytial virus (RSV). RSV).”
BACKGROUND: Benefits and risks of injections
On March 1, an FDA advisory panel reviewed data from trials of two RSV vaccines targeting the elderly, one from GSK and one from Pfizer. The committee recommended that the agency approve both.
The GSK vaccine was about 83 percent effective in preventing lower respiratory disease in adults 60 and older in a study of nearly 25,000 patients, according to data published in the New England Journal of Medicine. The virus can lead to pneumonia, which is more of a concern for the elderly.
Pfizer’s RSV vaccine for seniors is also expected to win FDA approval this month. In a large study of that shot, it was found to be nearly 67 percent effective in preventing RSV-related illnesses.
The Pfizer and GSK vaccines have been more effective in treating older and sicker patients.
Advisers have learned of some rare side effects from vaccine trials. In the days after the injections were given, two Pfizer vaccine recipients and one GSK recipient developed Guillain-Barré cases, a condition in which the immune system attacks the nervous system, according to data presented to the FDA panel.
Once the footage is available to the public, the agency said it will ask GSK to monitor the occurrence of Guillain-Barré and another rare condition that may have been related to the footage.
Moderna is also developing an RSV vaccine for this age group, and said it expects to get a license in the first half of this year. A trial of 37,000 older adults showed 82 percent efficacy of the shot, the company said, with “no safety concerns identified” although The analyzes were ongoing.
AstraZeneca and Sanofi are seeking FDA approval for a monoclonal antibody treatment to protect infants and young children up to 2 years of age from RSV infection. Results of a major study showed that the treatment reduced confirmed cases of infection by 75 percent after a single dose, according to AstraZeneca.
Pfizer has applied for separate approval for the RSV vaccine to be given in later stages of pregnancy to protect young children.
What’s next: When will the footage be available?
It will still be months before the adult vaccine becomes available to the public in the United States.
The Centers for Disease Control and Prevention is expected to follow through on the FDA’s approval, and is likely to issue its recommendation in June.
GSK said its vaccine will be available in the fall in pharmacies, clinics and other healthcare settings in the United States.
GSK executives said supplies of the vaccine, which is mainly made at a factory in Belgium, should be readily available. Alison Hunt, a spokeswoman for GlaxoSmithKline, said that for Medicare patients with Part D drug coverage, there will be no out-of-pocket expenses. But the company hasn’t released a price, even though insurance companies typically cover much of the cost of many vaccines.
Last week, the European Medicines Agency recommended approval of the GSK vaccine for adults 60 and over. The company said it hopes the footage will be approved at a later date for use in Japan and China.