The U.S. Food and Drug Administration (FDA) has ordered two Respiratory Syncytial Virus (RSV) vaccines include a warning about the risk for Guillain-Barré syndrome (GBS).
“FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals,” the FDA stated.
“Specifically, FDA has required each manufacturer to include a new warning about the risk for Guillain-Barré syndrome (GBS) following administration of their Respiratory Syncytial Virus (RSV) vaccine,” it continued.
According to the FDA, the Prescribing Information for each vaccine has been revised to include the following language in the Warnings and Precautions section:
- Abrysvo – The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with Abrysvo.
- Arexvy – The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Arexvy.
FDA Mandates Nerve Damage Warnings For 2 RSV Vaccines https://t.co/oWnQWItjel
— zerohedge (@zerohedge) January 12, 2025
“GBS is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis,” the FDA wrote.
From The Epoch Times:
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.
No one saw that coming…
Oh wait… YES WE DID.
Straight from the FDA
Source: https://t.co/GchySYyTNg pic.twitter.com/5zazIOzioF
— 𝝬𝝤𝝖𝝢𝝖♡Ɍ𝝖𓆃 (@Xoana_Ra) January 10, 2025
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication https://t.co/9Tl3y0Sz6J pic.twitter.com/mXZS1Niaim
— US FDA MedWatch (@FDAMedWatch) January 7, 2025
Per CIDRAP:
Arexvy was approved in May 2023 for use in adults ages 60 and older, and the FDA subsequently approved an expanded indication for adults ages 50 to 59 years old who are at increased risk for lower respiratory tract disease caused by RSV.
The FDA approved Abrysvo a few weeks later for people ages 60 and older and later approved indications for adults ages 18 to 59 years old who are at increased risk of RSV infection and for pregnant women in their final 4 weeks of gestation to help protect infants from RSV.
Read the full FDA announcement HERE.
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This is a Guest Post from our friends over at 100 Percent Fed Up.
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