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. It is the leading killer of children around the world.
This winter, RSV contributed to a “triple infection” that included flu and Covid cases that overwhelmed children’s hospitals and some ICU wards.
Background: Benefits and Risks of Shots
On March 1, an FDA advisory panel reviewed data from two 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, especially those with underlying medical conditions such as heart and lung disease and diabetes.
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 recipients of the Pfizer vaccine and one recipient of the GSK injection developed Guillain-Barré cases. Data Submitted to FDA Panel.
moderna is also under development It is a vaccine for RSV in the elderly and is expected to be approved in the first half of this year. According to the company, a trial involving 37,000 seniors showed his 82% efficacy of this injection. A Moderna news release said the study ended with “no identified safety concerns,” but added that safety analysis was ongoing.
AstraZeneca and Sanofi demand FDA approval of monoclonal antibody therapy to protect infants up to 2 years of age from RSV infection. Companies reported key findings. study According to AstraZeneca, the treatment was shown to reduce confirmed disease by 75% after a single injection.
Pfizer is seeking separate approval for an RSV vaccine given late in pregnancy to protect young infants.
What’s next: When will a vaccine be available?
The Centers for Disease Control and Prevention is expected to follow FDA approval recommending the use of the RSV vaccine for older adults, possibly in June. The vaccine is expected to be available in the fall at local pharmacies, clinics and other health care providers.
GSK officials have said supplies of the vaccine, which is primarily manufactured in factories in Belgium, should be available as soon as it is approved for use. For Medicare patients covered by Part D drugs, the vaccine will be available at no out-of-pocket cost, it said. Insurance companies, however, typically cover vaccines, though the company has not announced prices.
The company has told investors this year that it hopes to obtain approval for its RSV vaccine from the European Union, followed by approval in China.Last week, the European Medicines Agency recommended approval of GSK’s vaccine for adults over 60 years of age.
