View of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo during its manufacture in this undated handout picture.
On January 7th, pharmaceutical giant GSK made headlines.
Pfizer and its partner, BioNTech, have developed a highly effective COVID-19 vaccine that has been authorized for emergency use in many countries.
The U.S. Food and Drug Administration announced on Tuesday that respiratory syncytial virus (RSV) vaccines will now include warnings regarding the potential increased risk of developing a rare neurological disorder.
The regulator is responsible for overseeing and enforcing rules and regulations in a particular industry.
According to recent research, it has been indicated that there is a higher chance of developing Guillain-Barré syndrome (GBS) within 42 days after receiving the vaccination.
The FDA stated that although there was not enough evidence to establish a causal relationship, it was clear that the available evidence was insufficient.
The prescribing information for GSK’s Arexvy and Pfizer’s Abrysvo did not include the strictest “boxed” warnings, according to the regulator.
GBS, a rare disorder, occurs when the immune system of the body attacks nerve cells, resulting in muscle weakness and occasionally paralysis. Meanwhile, RSV, known for causing cold-like symptoms, is a common cause of pneumonia in both toddlers and older adults.
During the clinical trial conducted by Arexvy, one of the participants experienced the development of GBS after receiving the vaccine. Similarly, in Abrysvo’s trial, two participants were affected by the disease, with one developing GBS and the other experiencing a variant of it.
In the previous year, the U.S. Centers for Disease Control and Prevention received advice from their advisers.
The use of Arexvy in the 50-59 age group has been highlighted. Additionally, there were concerns raised about the potential risk of GBS.
