FDA, GSK and RSV

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
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

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.
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 ...
Is RSV on the rise in Mississippi? Warning signs to look for in children, adults
Doctor visits for RSV are at a "very high" level in Mississippi. Health officials provide warning signs of RSV to look for in ...
Georgia has high levels of RSV in wastewater, CDC says: What to do if you contract RSV
Georgia was one of 18 states with "high" or "very high" levels in wastewater, according to CDC monitoring. Here's what to ...
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 ...
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 ...
More Children Are Being Hospitalized With RSV — A New Vaccine Can Help
Respiratory syncytial virus is the leading cause of hospitalization among U.S. infants. A vaccine, nirsevimab, can reduce the ...
Flu and RSV numbers climbing in B.C., BCCDC data shows
Positive tests for respiratory illnesses have been steadily climbing for weeks in British Columbia, especially for flu and ...