USA — The U.S. Centers for Disease Control and Prevention (CDC) has given its endorsement to new vaccines developed by Pfizer and GSK for the prevention of severe respiratory syncytial virus (RSV) infections in older adults.
CDC Director Rochelle Walensky supported the recommendation made by agency advisers, suggesting that individuals aged 60 or older should receive the shots.
However, she stopped short of stating that the entire population in that age group should be vaccinated with these specific vaccines.
These newly approved vaccines mark the first preventive measures against RSV, a virus responsible for approximately 14,000 deaths annually in adults aged 65 and older in the United States, as estimated by the government.
Walensky’s approval represents the final crucial regulatory step before the vaccines can be rolled out.
Both Pfizer and GSK anticipate supplying the vaccines starting in the fall, ahead of the RSV season.
In a statement issued on Thursday, the CDC stated that older adults may receive a single dose of the vaccine after consulting with a healthcare provider to determine if RSV vaccination is appropriate for them.
Health and Human Services Secretary Xavier Becerra commented on the CDC’s recommendation, stating, “With this CDC recommendation, the administration is ensuring that Americans have access to stronger protection against circulating respiratory viruses.”
Becerra further emphasized that the vaccines should safeguard the most vulnerable older adults, including those residing in nursing or long-term care facilities, as well as individuals with compromised immune systems.
During the CDC advisers’ meeting, which took place last week, some committee members advocated for a broader recommendation, while others expressed concerns regarding the limited data on the vaccines’ effectiveness in people over the age of 75 and other high-risk groups.
Although RSV typically causes mild symptoms resembling a cold, it can result in severe illness and hospitalization, particularly among older adults and children.
At the meeting, both Pfizer and GSK presented data suggesting that the vaccines could provide protection for at least two years.
However, the extended protection may result in higher prices due to the additional benefits to the healthcare system.
Medicare beneficiaries aged 65 and older in the United States are not expected to bear the cost of the vaccines.
During the meeting, GSK revealed that it intends to price its vaccine between US$200 and US$295 per dose, while previously announcing a minimum price of US$120 per dose.
Pfizer estimated a price range of US$180 to US$270 per dose, with the final price yet to be determined as negotiations are ongoing.
In May, the U.S. Food and Drug Administration approved GSK’s RSV vaccine, branded as Arexvy, as well as Pfizer’s Abrysvo, for individuals aged 60 and older.
Pfizer is currently awaiting FDA approval for an RSV vaccine designed for pregnant women, aimed at protecting infants.
The regulatory process for this particular vaccine is still in progress, and the CDC’s advisers have not yet evaluated it.
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