FDA表示，分析发现，在65岁及以上人群中，每100万剂abysvo中，就有9例身患吉兰-巴雷综合征，每100万剂Arexvy中，估计有7例Arexvy综合征。该机构说，虽然数据表明接种疫苗的风险增加，但没有足够的证据表明疫苗是导致这种情况的原因。The FDA stated that a vaccine produced by GlaxoSmithKline (GSK.US) and Pfizer (PFE.US) must include a warning about the potential increased risk of a rare neurological side effect.
According to the Zhitong Finance APP, the USA Food and Drug Administration (FDA) stated that a common respiratory virus vaccine produced by GlaxoSmithKline (GSK.US) and Pfizer (PFE.US) must carry a warning indicating that these vaccines may increase the risk of a rare neurological side effect that could lead to paralysis.
In a safety communication released on Tuesday, the Institutions said that a study conducted after the approval of the respiratory syncytial virus vaccine indicated that individuals vaccinated with GlaxoSmithKline's Arexvy and Pfizer's Abrysvo might have an increased risk of developing Guillain-Barré syndrome within 42 days after vaccination.
The FDA stated that analysis found that among the population aged 65 and older, there are 9 cases of Guillain-Barré syndrome for every 1 million doses of Abrysvo, and an estimated 7 cases for every 1 million doses of Arexvy. The Institutions said that although the data indicates an increased risk with vaccination, there is not enough evidence to suggest that the vaccine is the cause of this condition.
GlaxoSmithKline and Pfizer did not immediately respond to requests for comment from reporters.
According to the FDA, this disease refers to the body’s immune system attacking the patient's own nerves, leading to muscle weakness and potentially causing paralysis. It usually occurs prior to an infection, and there is currently no known treatment.
The potential risks associated with the respiratory syncytial virus injection are already known, and the vaccine advisory panel of the Centers for Disease Control and Prevention discussed these dangers last year. However, the data at that time was mixed, and FDA post-marketing research is ongoing to clarify this issue.
This is not the first time the FDA has issued a warning about people vaccinated developing Guillain-Barré syndrome. In 2021, the federal regulator amended the product label for Johnson & Johnson's (JNJ.US) COVID-19 vaccine, warning that there is a "possibly small risk" of this disease.
Before the pandemic, Guillain-Barré syndrome was associated with the flu vaccine, prompting some individuals to question the safety of vaccinations and exacerbating vaccine hesitancy. Other controversial vaccinations include those for human papillomavirus and meningococcal disease, although evidence regarding their safety is limited.
