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FDA Approves Pfizer's R.S.V. Vaccine for Older Adults

The price of the vaccine is unknown, but Medicaid and Medicare will cover medically necessary vaccines without a co-pay.

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A recent New York Times article noted that the FDA has approved Pfizer's vaccine for the respiratory syncytial virus (R.S.V.) for adults over the age of 60. This marks the second approval for R.S.V. vaccines this month, following GSK's approval on May 3. The vaccines are expected to be available in the fall, before the winter R.S.V. season. Older adults are particularly at risk from R.S.V., with an estimated 60,000 hospitalizations and 6,000 to 10,000 deaths annually among adults aged 65 and older.

R.S.V. was a significant factor in the winter's "tripledemic" alongside COVID-19 and the flu, placing a heavy burden on hospitals. The virus also poses a significant risk to infants as a leading cause of infant mortality worldwide. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are currently under review by the FDA. During advisory meetings, concerns were raised about safety, especially cases where recipients of the vaccines developed autoimmune syndromes shortly after receiving the shots. However, the FDA's advisory panel ultimately voted in favor of the safety and efficacy of both the Pfizer and GSK vaccines.

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