Respiratory syncytial virus (RSV) activity is currently deemed to be ‘very high’ in many parts of the United States, according to CDC.
The U.S. Food and Drug Administration (FDA) ordered two respiratory syncytial virus (RSV) vaccine manufacturers to include a potentially paralytic side effect warning related to nerve damage on product labels.
The manufacturers, GSK and Pfizer, manufacturing Arexvy and Abrysvo vaccines respectively, must now include a warning stating a risk of Guillain-Barre syndrome (GBS) following vaccination, according to a Jan. 7 statement from the agency.
GBS is a rare disorder in which the immune system ends up damaging nerve cells, which leads to weakness in the muscles and potential near-total paralysis, depending on severity.
RSV is a common respiratory virus that infects the throat, nose, and lungs, and typically spreads during fall and winter seasons. Infected people can experience symptoms similar to that of a common cold such as a runny nose, congestion, sneezing, and coughing.
The FDA said the following statement is to be included in the Warnings and Precautions section of the two vaccines: “The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Abrysvo” or with “Arexvy” for that vaccine.
Arexvy is used by people aged 50 and older to deal with lower respiratory tract disease caused by RSV, while Abrysvo has been approved for use in adults aged 18 and above.
Abrysvo is also used by pregnant women who are at 32 through 36 weeks of gestational age to protect infants from birth through six months of age.
The labeling requirement follows an observational study conducted by the FDA.
In the study, the agency found there was an “increased risk of GBS during the 42 days following vaccination, with an estimated 9 excess cases of GBS per million doses of Abrysvo, and an estimated 7 excess cases of GBS per million doses of Arexvy administered to individuals 65 years of age and older.”
However, despite these results, the FDA determined that “the benefits of vaccination with Abrysvo and Arexvy continue to outweigh their risks.”
