FDA Approves Pfizer's RSV Shot for Older Adults, Abrysvo
01 Jun 2023
VaccineDrug ApprovalClinical ResultClinical StudymRNA
THURSDAY, June 1, 2023 -- Older adults may have a second vaccine option for RSV following the U.S. Food and Drug Administration's approval of a Pfizer vaccine on Wednesday.
The other shot for adults 60 and up is made by GSK. It was approved May 3.
Both should be available by fall, before the seasonal spread of respiratory syncytial virus (RSV), The New York Times reported.
The Pfizer vaccine, known as Abrysvo, has effectiveness of nearly 67% when a patient has two symptoms of RSV, such as a sore throat and cough. It's 86% effective when three or more symptoms surface.
The study on the Pfizer vaccine did include a concern about autoimmune syndromes. One patient among the 34,000 who received the vaccine in the study developed a life-threatening case of Guillain-Barré syndrome a week after receiving the shot. Another developed Miller Fisher syndrome, which is a subtype of that condition.
That means the incidence rate for these syndromes is 1 in 9,000, higher than the 1 in 100,000 seen in the general population.
FDA advisors voted 7 to 4 in favor of the vaccine’s safety and efficacy. It had voted 10 to 2 for the GSK vaccine, which was linked to similar cases.
Advisers for the U.S. Centers for Disease Control and Prevention will meet this month to talk about their recommendations for health care providers. They have suggested that the vaccines may be recommended for those aged 65 and older, according to the Times.
The vaccines come after a winter season in which COVID-19, the flu and RSV all spread. While RSV infection is generally mild and cold-like in healthy people, it can be fatal in infants and the elderly. In the United States, about 60,000 adults aged 65 and up are hospitalized with RSV, and 6,000 to 10,000 die each year, the FDA estimated.
To prevent one of these deaths, about 21,000 to 25,000 older adults would have to be vaccinated against RSV, depending on the vaccine.
Seniors on Medicaid and Medicare will not have a co-pay for a vaccine deemed medically necessary, a Pfizer spokeswoman said.
Sources
The New York Times
Posted June 2023
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