Pfizer’s RSV vaccine gets priority review from the FDA, decision expected May 2023

USA — Pfizer, in a statement, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval timeline by four months.

The FDA is expected to make a final decision on whether to approve the vaccine to prevent respiratory syncytial virus (RSV), in adults ages 60 and older by May 2023.

RSV is a common respiratory virus that causes cold-like symptoms in most people, but it can result in severe illness in infants and older adults.

Between 60,000 and 120,000 older adults are hospitalized with RSV every year and 6,000 to 10,000 older adults die from the virus.

Children’s hospitals in parts of the U.S. are seeing a surge in a common respiratory illness that can cause severe breathing problems for babies.

RSV cases fell dramatically two years ago as the pandemic shut down schools, daycares, and businesses. With restrictions easing in the summer of 2021, doctors saw an alarming increase in what is normally a fall and winter virus.

There are currently no prophylactic, therapeutic, or vaccine options for older adults and the medical community is limited to offering only supportive care for adults with the illness.

Pfizer’s vaccine candidate was about 86% effective in preventing severe lower respiratory tract illness, defined as three or more symptoms.

The vaccine was about 67% effective at preventing milder lower respiratory tract illness, defined as two or more symptoms.

Pfizer is also working on a maternal vaccine to protect newborns who are too young to be immunized.

The company announced last month that its bivalent RSV prefusion vaccine candidate was found to be effective in preventing severe infections in infants after being given to expectant mothers, according to an interim analysis.

Meanwhile, in Canada, pediatric hospitals fill up with young children sickened by respiratory syncytial virus (RSV) and doctors are worried that older adults will be the next wave to become seriously ill.

Providing a glimmer of hope, Health Canada in a statement said it had received a submission from GlaxoSmithKline (GSK) on Oct. 25 for an RSV vaccine for adults 60 years of age and older.

In addition, Pfizer has notified Health Canada that it is planning to submit two RSV vaccine candidates for consideration: one for seniors and one for pregnant women, the statement said.

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