FDA Mandates Nerve Damage Warnings For 2 RSV Vaccines

Authored by Naveen Athrappully via The Epoch Times (emphasis ours),

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.”

According to the U.S. Centers for Disease Control and Prevention (CDC), early symptoms of GBS can include feelings of weakness and tingling.

“People with GBS usually first feel these symptoms in both legs. Then, they might feel these symptoms in their arms and upper body,” it said. “Symptoms can progress over hours, days, or weeks.” The weakness keeps increasing until people are unable to use certain muscles.

“People with GBS need to be hospitalized,” the agency said. “Most people start to recover 2–3 weeks after symptoms start. Recovery may take as little as a few weeks or as long as a few years. Most people recover fully, but some have permanent nerve damage. Some people have died from GBS.”

The Epoch Times reached out to GSK and Pfizer for comment.

RSV Vaccine Usage and Risks

The RSV vaccine label update comes as the overall respiratory illness activity in the United States is deemed to be at a “high” level, with RSV activity being “very high in many areas of the country, particularly in young children,” according to the CDC.

“Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.”

The agency recommends all babies be protected from RSV by either vaccinating mothers or by giving an antibody to the infant.

Even if the mother is not at high risk for severe RSV, the vaccination is important since the pregnant woman will “pass the protection” to her baby, the CDC said. “It takes two weeks to develop protection (antibodies) and for protection to pass on to your baby.”

This protection lasts for the first six months of the infant’s life “while they are at highest risk of severe RSV.”

Pregnant women who have already taken an RSV vaccine during a previous pregnancy are not recommended to take it again. Instead, the baby should get nirsevimab, an antibody.

CDC recommends antibodies to “all babies younger than eight months of age born to mothers who did not receive a maternal RSV vaccine (Pfizer’s Abrysvo) during pregnancy.”

For older adults, the CDC advises vaccination for 60 to 74-year-olds who are at increased risk of severe RSV and for all individuals aged 75 and above.

However, the agency warns that vaccination could result in certain adverse events. “Side effects such as pain, redness, and swelling where the shot is given, fatigue, fever, headache, nausea, diarrhea, and muscle or joint pain may occur after you get an RSV vaccine.”

“These side effects are usually mild. Patients who have experienced these symptoms when getting other vaccines might be more likely to experience them after getting an RSV vaccine,” it said.