Why It Matters: R.S.V. can be lethal
The F.D.A. estimates that R.S.V. 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 leading killer of children worldwide.
This winter, R.S.V. contributed to the “tripledemic” also involving flu and Covid cases that swamped children’s hospitals and some I.C.U. wards.
Announcing the approval, Dr. Peter Marks, the agency’s vaccine division chief, said: “Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by R.S.V.”
Background: Benefits and risks of the shots
On March 1, an F.D.A. advisory panel reviewed data from trials for two R.S.V. vaccines aimed at older adults, one from GSK and one from Pfizer. The panel recommended that the agency approve both.
The GSK vaccine was nearly 83 percent effective in preventing lower respiratory tract illness in adults 60 and older in a study of about 25,000 patients, according to data published in The New England Journal of Medicine. The virus can lead to pneumonia, which is far more worrisome for the elderly.
Pfizer’s R.S.V. vaccine for older adults is also expected to receive F.D.A. approval this month. In a large study of that shot, it was found to be nearly 67 percent effective in preventing R.S.V.-related illness.
The Pfizer and GSK vaccines were even more effective in treating older and sicker patients.
The advisers did learn of some rare side effects from the vaccine trials. In the days after the shots were given, two recipients of the Pfizer vaccine and one recipient of the GSK shot developed cases of Guillain-Barré, a condition where the immune system attacks the nervous system, according to data presented to the F.D.A. panel.
Once the shots become available to the public, the agency said it would require GSK to monitor the incidence of Guillain-Barré and another rare condition that was possibly related to the shot.
Moderna is also developing an R.S.V. vaccine for this age group, and said it expected authorization in the first half of this year. A trial of 37,000 older adults showed 82 percent efficacy of its shot, the company said, with “no safety concerns identified” though analyses were continuing.
AstraZeneca and Sanofi are seeking F.D.A. approval of a monoclonal antibody treatment to protect infants and toddlers up to 2 years old from R.S.V. infections. Findings of a major study showed the therapy reduced confirmed illnesses by 75 percent after one shot, according to AstraZeneca.
Pfizer has applied for separate approval of an R.S.V. vaccine to be given in the later stages of pregnancy to protect young infants.
What’s Next: When will the shots be available?
It will still be months before the adult vaccine is publicly available in the United States.
The Centers for Disease Control and Prevention is expected to follow the F.D.A.’s approval, most likely issuing its recommendation in June.
GSK said its vaccine would then be available in the fall at U.S. pharmacies, clinics and other health care settings.
GSK executives have said that supplies of the vaccine, which is manufactured mainly at a plant in Belgium, should be readily available. For Medicare patients with Part D drug coverage, there would be no out-of-pocket expense, Alison Hunt, a GSK spokeswoman, said. But the company has not released a price, although insurers typically cover much of the cost of many vaccines.
Last week, the European Medicines Agency recommended approval of GSK’s vaccine for adults 60 and older. The company said it hoped the shots would also be approved later for use in Japan and China.
