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FDA Advisory Panel Recommends Approval of RSV Vaccine for Older Adults: May Be First in US

2023-02-28T23:10:21.660Z


Pfizer's vaccine against respiratory syncytial virus reduced the risk of disease by up to 86% in people over the age of 60, according to data from the pharmaceutical company. Each year, RSV kills more than 10,000 adults 65 years and older, and about 300 children under 5 years of age in the country.


By Aria Bendix -

NBC News

An advisory panel of the Food and Drug Administration (FDA, for its acronym in English) recommended to the federal agency on Tuesday that it approve a Pfizer vaccine against RSV for adults from the age of 60, which may become the first in the United States against this virus that kills tens of thousands each year in the country.

The FDA's Advisory Committee on Vaccines and Other Biologicals

voted 7-4 to approve the

respiratory syncytial virus (abbreviated RSV) vaccine based on its efficacy.

One member of the advisory panel abstained.

According to Pfizer data, its single-dose vaccine reduces the risk of RSV disease by up to 86%.

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The FDA generally follows the recommendations of its advisers.

If you do so in this case as well, approval could take several months.

After approval, the Centers for Disease Control and Prevention (CDC) must recommend the vaccine before it is available to the public.

It would be the first respiratory syncytial virus vaccine approved in the United States.

Children and older adults are the most vulnerable to the virus. Alex Kormann / Star Tribune via Getty Images file

The advisory panel will meet again on Wednesday to assess the safety and efficacy of another similar RSV vaccine for older adults, this time from the pharmaceutical company GlaxoSmithKline.

Data from a trial published earlier this month in the New England Journal of Medicine showed that,

in adults older than 60, the injection reduced the risk of symptomatic disease by 83% and severe disease by 94%.

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RSV causes infection in the respiratory tract, although symptoms are mild in most healthy adults.

However, in severe cases,

it can cause bronchiolitis (inflammation of the airways and obstruction by mucus), or pneumonia

.

Older people and babies are especially vulnerable to the consequences of the virus.

Each year, RSV kills more than 10,000 adults 65 years of age or older and about 300 children under 5 years of age in the United States.

RSV cases among children increased dramatically earlier this winter, causing an overflow at some children's hospitals.

Source: telemundo

All news articles on 2023-02-28

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