3.1.23 – Effective March 1st, Rotarix Liquid (No Mixing Required) is Available on GSK Direct
On Nov. 4, 2022, the FDA approved an oral-dosing applicator-only presentation (liquid formulation) of ROTARIX. This new formulation does not require reconstitution and is available for ordering now. There will be two ROTARIX presentations available until early 2025 when the lyophilized formulation (that requires reconstitution) will retire.
2.24.23 – Pfizers Maternal RSV Vaccine Gets Priority Review, Setting Up Showdown With AstraZeneca, Sanofi
Pfizer is ready to ram home its advantage in the respiratory syncytial virus (RSV) maternal vaccine race. With onetime close rival GSK still stalled, the Big Pharma has put itself on course to receive a landmark approval by August and go on to challenge AstraZeneca and Sanofi’s long-acting antibody for the market. In November, Pfizer stopped a pivotal trial of its bivalent RSV prefusion vaccine candidate RSVpreF early after an interim analysis. The study linked administration of RSVpreF during pregnancy to 81.8% efficacy against severe medically attended lower respiratory tract illness over the first 90 days of the baby’s life. And, while the study missed a co-primary endpoint, Pfizer had seen enough to race to regulators.
2.9.23 – CDC Flu Season Overview
While seasonal influenza (flu) viruses are detected year-round in the United States, flu viruses typically circulate during the fall and winter during what’s known as the flu season. The exact timing and duration of flu seasons varies, but flu activity often begins to increase in October. Most of the time flu activity peaks between December and February, although significant activity can last as late as May. Since the start of the COVID pandemic, the timing and duration of flu activity has been less predictable.
1.17.23 – Updates from Luke Miels on RSV and MRNA Vaccines
COVID -19 Background: After an initial setback with their mRNA COVID vaccine, GSK and partner CureVac came back a few days ago with positive preliminary data for their modified COVID and flu shots. But the question is, with entrenched mRNA players Pfizer-BioNTech and Moderna, is there any room left for another COVID shot?
RSV Vaccine Competition Background: GSK’s application for an RSV vaccine for adults 60 years and older is under FDA priority review, with a decision expected by May 3. Pfizer has a candidate targeting the same population also under priority review for a verdict in May. Furthermore, Pfizer touted positive data for its maternal vaccine to protect newborns, but GSK’s maternal effort hit a safety hiccup.