The Food and Drug Administration has approved giving GSK's vaccine for respiratory syncytial virus down to age 50 years old, to those who are at higher risk of severe RSV, the companysaid Friday, making it the first shot greenlit for use in this age group to guard against RSV. Global va...
"Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, ...
10,11,14-17 On May 3, 2023, GSK’s adjuvanted RSV vaccine (Arexvy) became the first RSV vaccine to receive FDA approval for use in this age group.12 And, on May 31, 2023, Pfizer's bivalent, RSV prefusion F protein-based (RSVpreF) candidate (Abrysvo) became the second vaccine to...
"Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA's continued commitment to facilitating the development of safe and effective vaccines for use in the United States," Dr. Peter Marks, dir...
director of the FDA's Center for Biologics Evaluation and Research. "Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effe...
The FDA has OK'd FluMist, a nasal spray flu vaccine that you can give and get at home – no health care provider needed. It’s the first flu vaccine of its kind, offering a simple, convenient, needle-free option that its maker hopes will improve access a
The FDA has announced the approval of Ixchiq, the first licensed vaccine for chikungunya virus, for use in adults aged 18 years and older who are at increased risk of exposure.1,2 “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for olde...
GSK’s RSV older adult vaccine is not currently approved anywhere outside the US. The proposed trade name remains subject to regulatory approval outside the US. A clinical trial that aims to expand the population who may benefit from RSV vaccination into a...
Pandemic Preparedness Picks Up Pace with First Flu Vaccine Approval
Doctors and vaccine makers are generally not required to follow the CDC's recommendations on how to use approved vaccines. However, so-called "off-label" use — such as vaccinating those under 60 years old with the RSV shots — may not be covered by insurance. ...