Pioneer of World's First RSV Vaccine: FDA Advisor Endorses Pfizer Syringe
Study Shows Pfizer's RSV Syringe Reduced Risk of Disease in Older Adults. An FDA advisory panel will review a similar shot by GlaxoSmithKline on Wednesday.
High magnification transmission electron micrograph of human respiratory syncytial virus. Palmer/CD
In Tuesday's narrow vote, a Food and Drug Administration adviser said officials would approve his RSV vaccine, the nation's first for the elderly, Pfizer's shot for people over 60. recommended.
The FDA's independent Vaccines and Related Biologics Advisory Committee voted 7 to 4, with one abstaining, to recommend the vaccine based on its efficacy. A single-dose injection reduced the risk of respiratory syncytial virus disease by up to 86%, according to Pfizer.
The FDA's next step is to approve the vaccine. FDA usually follows advisory committee recommendations, but it may take several months. After FDA approval, the Centers for Disease Control and Prevention must recommend immunizations before they are released to the public. All of this, if realized, would be the first RSV vaccine licensed in the Guillain-Barré.
The second may be hot in his heels. An advisory panel will meet again on Wednesday to evaluate the safety and efficacy of a similar RSV vaccine for older adults. This vaccine is from his GlaxoSmithKline. In people over the age of 60, injections reduced the risk of symptomatic disease by 83% and the risk of serious disease by 94%, according to study data published this month in the New England Journal of Medicine. RSV causes lower respiratory tract disease, but most healthy adults have mild symptoms. However, in severe cases, RSV can cause bronchiolitis, which causes airways to become inflamed and clogged with mucus and pneumonia.
Elderly people and young children are particularly vulnerable to such consequences. More than 10,000 of her over the age of 65 and about 300 of her children under the age of 5 die from her RSV each year in the United States. Infant cases have risen dramatically this winter, overwhelming children's hospitals. This reminds me of the virus threat. At Tuesday's advisory board meeting, Pfizer voted 7 in favor, 7 in favor, 7 in favor, 7 in favor, 4 against, 1 abstained, in another vote to assess the safety of his vaccine. Some of the experts who did not vote in favor of the vaccine based on its efficacy expressed concern that there were not enough participants in her RSV infection study to adequately assess vaccination. Those who voted "no" based on the vaccine's safety profile have been linked to Guillain-Barré syndrome (GBS), a rare neurological condition that damages nerve cells and causes muscle weakness or paralysis. I was very concerned about the possibility.
“It was a 1 in 9,000 GBS risk.
Pfizer has tested the RSV vaccine in pregnant women to see if it can extend protection to babies in the womb. The company says its data suggest that the vaccine reduces the risk of serious illness in infants by 82% in the first 90 days and 69% in the first six months.
But her FDA panel vote on Tuesday limited the vaccine's use to the elderly. The agency is still reviewing Pfizer's pregnancy data, and a decision is expected in August.
According to an FDA briefing document released prior to the conference, the most common side effects in older adults were fatigue, headache, injection site pain, and muscle aches. The document also highlights the potential risk of Guillain-Barré syndrome.
In a Pfizer study, men developed Guillain-Barré after vaccination and women developed Miller-Fischer syndrome, a rare neurological disorder associated with Guillain-Barré.
The most common side effects of the GlaxoSmithKline vaccine were similar, including pain at the injection site, fatigue, and muscle aches, but participants in this study reported more side effects than the Pfizer vaccine. .
Competition for RSV Vaccine
Several companies are competing for FDA approval of an RSV vaccine.
According to data from PATH, a non-profit global health organization, 11 RSV vaccines are actively being investigated in US research.
Moderna says his RSV injection in development for the elderly could be submitted to the FDA by his July. The Bavarian Nordic expects to have late-stage data from an RSV vaccine targeting the same population by midyear.
FDA is also reviewing clinical trial data for a vaccine-like monoclonal antibody injection designed to protect an infant from her RSV. Sanofi and AstraZeneca shots are already approved in Europe.
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