FDA advisers back GlaxoSmithKline RSV vaccine for older adults

A Food and Drug Administration (FDA) advisory panel on Wednesday recommended the second vaccine for respiratory syncytial virus (RSV) in older adults in as many days, setting up a race between manufacturers looking to bring the first-of-its-kind shot to market.

The 12-member panel voted 10-2 that the vaccine developed by GlaxoSmithKline is safe and separately voted unanimously that data show the shot is effective.

Similar to data presented Tuesday for a vaccine manufactured by Pfizer, some panel members had concerns about nervous system disorders like Guillain-Barré syndrome that may be tied to the shot.

“For a vaccine that could be potentially recommended every year for everyone 60 or 65 and older, we should have more safety data. There are some big safety concerns that I have,” said panelist Marie Griffin, a professor at Vanderbilt University Medical Center.

Griffin said she did not see the need to rush ahead with FDA approval. The panel’s recommendation is not binding but the FDA usually follows it.

“This is our chance to get more information on these vaccines before their license,” Griffin said.

In healthy adults and older children, RSV typically causes mild, cold-like symptoms that go away with moderate rest and self care. But it can result in severe illness in infants and older adults.

RSV causes between 60,000 and 160,000 hospitalizations annually for adults older than 65 in the U.S. and 6,000 to 13,000 deaths, according to federal statistics.

There is currently no vaccine for RSV in either adults or children.

Both GSK and Pfizer showed strong data showing the vaccines are effective in adults 60 and older, although there was not much evidence on the extent to which the vaccines can reduce hospitalizations from RSV.

GSK said the benefit in preventing disease would outweigh any potential risks.

“We’re delighted that the Advisory Committee recognized the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine,” GSK’s Global Head of Vaccines Phil Dormitzer said in a statement.

Tuesday’s vote on Pfizer’s vaccine was narrower; the panel voted 7-4 with one abstention that current data support the vaccine’s safety and 7-4 with one abstention in favor of its efficacy, saying that the vaccine adequately protects older adults from lower respiratory tract disease related to RSV.

GSK’s vaccine was about 83 percent effective in preventing lower respiratory tract disease in people aged 60 and older, and it was 94 percent effective in preventing severe disease.

Disease was defined as two more symptoms such as shortness of breath, wheezing, cough, low oxygen saturation or need of oxygen supplementation.

Both GSK and Pfizer were granted priority review by the FDA, which reduces the approval timeline by four months. The end of the review period is expected to be May 2023 for both shots.

If the FDA approves the vaccines, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to issue recommendations on how and when the vaccines are used.

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