- People who get Pfizer’s RSV vaccine for the elderly should be monitored for Guillain-Barré syndrome, scientists said in an article published in the New England Journal of Medicine.
- Two people who received injections during the vaccine trial developed nervous system disorders.
- Scientists say there are other possible explanations for the case, but the FDA believes they could be related to vaccines.
- Pfizer has agreed to conduct safety studies after approval.
- Overall, the scientists concluded that the vaccine was effective and had no obvious safety concerns.
A healthcare worker prepares a flu vaccine before administering it to a local population in Los Angeles, USA, December 17, 2022.
Xinhua News Agency | Getty Images
recipient Scientists found in a clinical trial published in the New England Journal of Medicine that Pfizer’s RSV vaccine for the elderly developed neurological disorders in two people after vaccination, requiring surveillance for Guillain-Barré syndrome. says there is.
The scientists concluded that the vaccine was effective in preventing lower respiratory tract disease in adults over the age of 60, with no apparent safety concerns. I warned you that it is a potential cause for concern.
“If the RSVpreF vaccine is approved and recommended, these adverse events will need to be closely monitored with real-world data and post-marketing surveillance in future studies,” the scientist wrote Wednesday. This study, published in , was supported by Pfizer.
Guillain-Barre syndrome is a rare disorder in which the body’s immune system mistakenly attacks nerves. Symptoms range from temporary weakness to paralysis. According to the National Institutes of HealthMost people recover, even in severe cases.
The scientist’s call to closely monitor possible links between vaccines and Guillain-Barré reflects the position of the Food and Drug Administration.
The agency asked Pfizer to include Guillain-Barré as a “significant potential risk” to the vaccine and to develop a safety study to monitor potential cases if the shot is approved in May.Pfizer agreed to conduct a safety study.
The FDA’s independent advisers approved the vaccine in February, but there was considerable dissent at that meeting. Seven advisors said the safety data were sufficient for approval, four said otherwise and one abstained.
In an article in the New England Journal of Medicine, scientists said two cases occurred in patients in an age group at high risk of developing Guillain-Barré. It may have caused the individual to develop the syndrome, they added.
However, the FDA said the Guillain-Barré case may be related to the vaccine because the Guillain-Barré patient developed the syndrome soon after vaccination, according to a briefing document released in February. Pfizer concluded that the cases were unrelated, and the clinical trial’s data oversight board did not identify any vaccine safety concerns.
Pfizer’s shot is expected to be the first RSV vaccine approved for older adults. According to the Centers for Disease Control and Prevention, 6,000 to 10,000 older people die from her RSV each year. It also causes 60,000 to 160,000 hospitalizations annually in the age group.
Results published in the New England Journal of Medicine show that the vaccine is 86% effective in preventing lower respiratory tract disease with 3 or more symptoms and 66% in preventing disease with 2 or more symptoms. had a % effect. Shots are administered as a single 120 microgram dose.
The injection promises to reduce hospitalizations and deaths from RSV in the elderly, but FDA advisers were concerned about the Guillain-Barré incident at a February meeting.
Dr. Hana El Sahly, chairman of the FDA committee, said Guillain-Barre has an incidence of about 1 in 100,000 among people over the age of 60. was about 1 in 9,000.
“So if you take it at this level, this is important,” said El-Saari. She acknowledged that there is still uncertainty about what the true rate of the disease will be among those vaccinated.
“But it’s nonetheless important when it comes to incidence,” she said of the two cases. also said.
A 66-year-old man in the United States developed Guillain-Barre and a woman of the same age in Japan was diagnosed with a variant of the syndrome called Miller-Fischer. Patients developed symptoms 7 and 8 days after vaccination, respectively. I got sick.
The man had a history of high blood pressure and had a heart attack shortly before being diagnosed with Guillain-Barré, and the woman had a history of diabetes.
The man’s symptoms resolved 6 months after onset, and the woman’s symptoms fully resolved 3 months after onset.
