Why it matters: RSV can be fatal
FDA Estimate RSV causes 6,000 to 10,000 deaths in adults over the age of 65 each year and at least 60,000 hospitalizations in that age group.that is child killer World wide.
this winter, RSV contributed to the ‘Triple Demic’It also includes flu and Covid cases that hit children’s hospitals and some ICU wards.
announcement Commenting on the approval, Dr. Peter Marks, director of the FDA’s Vaccines Division, said:
Background: Benefits and Risks of Shots
March 1, FDA Advisory panel review Data from two RSV vaccine trials in the elderly. One from GSK and one from Pfizer. The committee recommended that agencies approve both.
According to data published in , in a study of approximately 25,000 patients, the GSK vaccine was nearly 83% effective in preventing lower respiratory tract disease in adults over the age of 60. New England Journal of MedicineThe virus can cause pneumonia, which is much more worrying for older people.
Pfizer’s RSV vaccine for the elderly is also expected to receive FDA approval this month. A large study of the shot found him nearly 67% effective in preventing RSV-related illness.
The Pfizer and GSK vaccines were more effective in treating older and sicker patients.
Advisors learned about some rare side effects from clinical trials of vaccines. A few days after the injections were given, two who received the Pfizer vaccine and one who received her GSK, the immune system attacked the nervous system, according to data presented to the FDA committee. A case of Guillain-Barré, a condition that causes
Upon revealing the shots to the public, the agency said: I neede GSK monitors the incidence of Guillain-Barre and another rare condition that may be shot-related.
moderna is also under development It is an RSV vaccine for this age group and is expected to be approved in the first half of this year. A trial in 37,000 seniors showed the shot to be 82% effective, but “no safety concerns were identified,” the company said. I continued to analyze.
AstraZeneca and Sanofi demand FDA approval of monoclonal antibody therapy to protect infants up to 2 years of age from RSV infection.Key Findings study According to AstraZeneca, the treatment was shown to reduce confirmed disease by 75% after a single injection.
Pfizer has filed a separate application for approval of an RSV vaccine administered late in pregnancy to protect infants.
Up next: When will Shots be available?
It will be months before an adult vaccine is generally available in the United States.
The Centers for Disease Control and Prevention is expected to follow the FDA’s approval, most likely to issue a recommendation in June.
GSK said its vaccine will be available in US pharmacies, clinics and other medical institutions in the fall.
GSK Officer vaccine supplyMainly made in the Belgian factory, should be available soon. GSK spokeswoman Alison Hunt said there will be no out-of-pocket costs for Medicare patients covered by Part D drugs. However, insurance companies typically cover most of the costs of many vaccines, though the company has not announced prices.
Last week, the European Medicines Agency Recommended Approval of GSK Vaccines for Adults Over 60The company said it hopes it will be approved for use in Japan and China later.
