Second RSV Vaccine Candidate Moves Forward On Path To US Approval
A FDA advisory panel voted Wednesday in favor of authorizing GSK's respiratory syncytial virus vaccine for people 60 and over. The advisers had also backed Pfizer's RSV vaccine candidate the day before, setting up a race for the first to earn U.S. regulatory approval.
Reuters:
US Panel Backs GSK Vaccine, Heating Up RSV Vaccine Race
A panel of outside advisers to the U.S. health regulator on Wednesday backed GSK's respiratory syncytial virus (RSV) vaccine, setting it up for a race with rival Pfizer to become the first approved U.S. shot against the disease. The Food and Drug Administration's (FDA) advisory committee voted unanimously in favor of the vaccine's effectiveness in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above, and voted 10 to 2 for its safety. The panelists seemed significantly more confident about the demographic profile used during the GSK study in comparison to Pfizer's RSV vaccine, which was recommended by the FDA panel on Tuesday. (Mandowara and Esunny, 3/1)
CIDRAP:
FDA Panel Recommends GSK's RSV Vaccine For Ages 60 And Up
GSK's vaccine, called RSVPreF3 (Arexvy), is a recombinant product that contains a glycoprotein antigen based on the RSV A subgroup and is given with a proprietary adjuvant—the same one in GSK's Shingrix shingles (herpes zoster) vaccine—designed to boost the immune response. It is administered as a single 0.5-milliliter dose. The group based its efficacy assessment on clinical trials that enrolled nearly 25,000 people, half of whom, as the control group, received a saline injection. Overall efficacy was 82.6% against lower respiratory tract illness, with an efficacy of 94.1% against severe disease. Efficacy was high for both RSV A and RSV B and was even higher, at 93.8%, in the oldest age-group in the study, those ages 70 to 79. (Schnirring, 3/1)
The New York Times:
FDA Panel Recommends 2 RSV Vaccines For Older Adults
In addition to the vaccine candidates reviewed by the panel this week, AstraZeneca and Sanofi are seeking F.D.A. approval of a monoclonal antibody treatment aimed at protecting infants and toddlers up to 2 years old from R.S.V. infections. The companies reported findings from a major study indicating that the therapy reduced “medically attended” illnesses by 75 percent after one infusion, according to AstraZeneca. (Jewett, 3/1)
And a shortage of albuterol, used to treat RSV, may soon get worse —
The Washington Post:
Albuterol For Children's Hospitals Scarce After Illinois Plant Shutdown
Children’s hospitals across the country lost a supplier of a common respiratory medicine with the sudden shutdown of an Illinois manufacturing plant last week, which specialists warned will prolong shortages of an important treatment for kids with RSV and asthma who show up in emergency rooms. Akorn, a company that has struggled under bankruptcy for two years and had been the subject of Food and Drug Administration enforcement actions, shut down its U.S. operations on Thursday, including manufacturing facilities in Illinois, New Jersey and New York. (Rowland, 3/1)
