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.
Findings from a postmarketing observational study showed an increased risk of GBS during the 42 days following vaccination.
As for GBS itself, this neurological ailment can be severe, attacking nerves and warranting hospitalisation for weeks or ...
Regulators say, however, the benefits of vaccination with Abrysvo and Arexvy in preventing respiratory syncytial virus ...
The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the ...
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An RSV vaccine has been approved for people over 60 in Australia, but what about young children?In older adults, side effects following Arexvy appear to be similar to other ... it is anticipated the RSV vaccine would be a one-off dose, at least at this stage. Younger babies don't tend ...
“When we compared the antibody responses between those study participants who received Arexvy with those who got Abrysvo, we found that the group receiving the adjuvanted vaccine tended to have ...
The respiratory syncytial virus (RSV) vaccine may not protect older adults who are immunocompromised as much as their healthier peers, according to new research.
mResvia’s prescribing information indicates that the vaccine ... side effect seen with both GSK and Pfizer’s products. There’s still one more step before Moderna’s vaccine can take on ...
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