Pfizer’s bivalent respiratory syncytial virus (RSV) vaccine candidate was 81.8% (CI: 40.6%, 96.3%) effective against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life in the phase 3 MATISSE (MATernal Immunization Study for Safety and Efficacy) trial, the company reported yesterday. In an interim analysis of this randomized, double-blinded, placebo-controlled trial, 7,400 healthy women aged 49 years or younger have been vaccinated during the late second to third trimester of pregnancy. Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the 6-month follow-up period. The product, RSVpreF or PF-069283, was well tolerated with no safety concerns for both vaccinated individuals and their newborns, according to these top-line results. Pfizer has stopped enrollment in the study based on recommendations of the trial’s data monitoring committee and in consultation with the FDA; it plans to submit a Biologics License Application to the FDA by the end of 2022.
Telehealth is providing a path for pharmaceutical companies to make “prescription drugs about as available as over-the-counter drugs,” Georgetown University Medical Center professor Adriane Fugh-Berman told Stat. “This is pharma’s dream.” It’s not just the sales, though — the data are also important. Traditional pharmaceutical marketing relies on patients to see ads, remember them until they see a prescriber, and get a prescription and have it filled — and the company gets no direct insight into the transactions or what role the advertising played in it. “Today, companies like Populus, UpScriptHealth, and Prescribery aim to improve those odds by building digital front doors to clinics right on those marketing pages,” the Stat article reports. “Teleproviders are prohibited from sharing protected health information, but there’s plenty of data that is still shared with manufacturers — a middle ground of ‘consumer health information’ that can include fields like age, other medications, allergies, and ZIP code. That can help pharma companies negotiate better with payers, or more precisely target their ads. More and more, companies selling the drugs can control how and when they’re used.”