FDA Grants Priority Review For Pfizer’s RSV Vaccine

The United States Food and Drug Administration has granted a priority review for Pfizer’s respiratory syncytial virus (RSV) vaccine.

Pfizer is seeking approval for its vaccine, RSVpreF, for adults over the age of 60.

The pharmaceutical company said that late-stage clinical trials showed that the vaccine was 85.7% effective at preventing severe lower respiratory tract illness and 66.7% at preventing milder disease.

There is currently no authorized RSV vaccine available in the United States.

An RSV infection usually causes mild cold-like symptoms in most people. However, young children and older adults are more at risk for severe cases that could require hospitalization.

Every year between 60,000 and 120,000 older are hospitalized with RSV, and 6,000 to 10,000 older adults die from the viral infection. This year, officials have been dealing with a major spike in RSV cases after seeing a decline during the coronavirus pandemic.

Hospitalizations among seniors are ten times higher this year than it was in 2018 and 2019, before the start of the pandemic. In addition, children’s hospitals are overwhelmed with the number of patients with RSV and the flu.

“With no RSV vaccines currently available, older adults remain at risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death,” said Annaliesa Anderson, Pfizer’s head of vaccine research and development.

The FDA is expected to make a decision by May 2023.

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