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FDA Approves Pfizer RSV Vaccine for Older Adults

CDC expected to meet later in the month to adopt vaccine recommendations for older Americans

THURSDAY, June 1, 2023 (HealthDay News) -- Older adults have a second vaccine option for respiratory syncytial virus (RSV) following the U.S. Food and Drug Administration approval of a Pfizer vaccine on Wednesday.

The other shot for adults 60 years and older is made by GlaxoSmithKline. It was approved May 3. Both should be available by fall, before the seasonal spread of RSV, The New York Times reported.

The Pfizer vaccine, known as Abrysvo, has effectiveness of nearly 67 percent when a patient has two symptoms of RSV, such as a sore throat and cough. It is 86 percent effective when three or more symptoms surface. Its GSK competitor -- named Arexvy -- was about 83 percent effective against severe RSV, The Times reported.

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, a subtype of Guillain-Barré. That means the incidence rate for these syndromes is one in 9,000, higher than the one in 100,000 seen in the general population.

FDA advisers voted 7 to 4 in favor of the vaccine's safety and efficacy. The panel 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 years and older, according to The Times.

The New York Times Article

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