FDA, RSV and Guillain–Barré syndrome

FDA Adds Guillain-Barre Syndrome Warning to Two RSV Vaccines
Before the RSV vaccines were approved, the FDA flagged potential GBS risks with the vaccines. After approval, the CDC continued to monitor for GBS risk. FDA conducted a postmarket
FDA says RSV vaccines must come with Guillain-Barré warning
The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and Pfizer based on data that suggest there may be a link between the shots and the rare disorder.
RSV vaccines from Pfizer, GSK take another hit with new FDA warning mandate
The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning about the risk of developing Guillain-Barré syndrome (GBS), a rare neurological condition that can cause paralysis.
FDA adds warning to RSV shots from GSK, Pfizer
Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.
Pharmalittle: We’re reading about FDA commish’s parting thoughts, a warning on RSV shots, and more
He also articulated a very specific doctrine about the role of an FDA commissioner, one that is limited in its power and leaves many controversial decisions to career government officials. Califf said he would not directly comment on any individual,
GSK, Pfizer RSV vaccines to carry warnings of GBS, Reuters reports
GSK (GSK) and Pfizer (PFE) vaccines for respiratory syncytial virus, or RSV, will carry warnings that they can increase the risk of developing
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing a rare neurological disorder, the U.S. Food Drug Administration said on Tuesday.

RSV, COVID-19 pandemic

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FDA requires Guillain-Barre label warnings for 2 RSV vaccines
The change was prompted by postmarketing observational studies that suggest an increased risk of GBS within 42 days of ...
Flu, COVID-19, RSV: Oneida County Health Department warns of respiratory illnesses
“As of December 28, Oneida County has had 386 flu cases reported since the flu season began,” said Daniel W. Gilmore, Ph.D., ...
RSV emergency department visits remain high in Florida. What to know
The CDC’s overall snapshot of respiratory illness activity in Florida remains very high. The CDC has measured moderate levels ...
Medscape1d
RSV Vaccines and Treatments Face Global Access Hurdles
Vaccines and monoclonal antibodies are reducing RSV hospitalizations, but high costs and limited access in low-income ...
Columbus Dispatch6d
NC has high levels of RSV in wastewater, CDC says: What to do if you contract RSV
The Centers for Disease Control and Prevention measures viral activity levels in wastewater for many illnesses. Included ...
RSV activity is 'increasing' in Wisconsin, DHS says. Here's what you should know
For RSV in particular, nearly two dozen states are currently reporting high levels, according to the U.S. Centers for Disease ...
What is RSV? Respiratory illnesses for children, others on rise in Florida. What to do
For most people RSV is like a cold, but for infants and older people it can lead to serious infections. Here's what to know.