Pharmaceutical Debrief: Merck PCV Phase 3 Data, Novavax COVID Results, Vaccine Trial Stoppage

The following is a quick review of the week’s top FDA approvals, FDA authorizations, or other infectious disease pipeline developments from the past week.

Merck Announces Results from 2 Phase 3 Studies on its Pneumococcal Conjugate Vaccine

Merck announced yesterday that V114, its investigational 15-valent pneumococcal conjugate vaccine, met its primary objectives. These results come from 2 phase 3 studies, which evaluated the safety, tolerability, and immunogenicity of the vaccine.

“Continued scientific innovation in pneumococcal disease prevention is needed to target the serotypes that pose the greatest risk to specific populations while maintaining immune response as new serotypes are added. These Phase 3 data demonstrated that V114 generated a robust immune response to all 15 serotypes included in the vaccine and reinforce the potential for this investigational vaccine to help protect adults against pneumococcal disease,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said.

Read more.

AstraZeneca, Oxford COVID-19 Vaccine Trial Put on Hold for Safety Concern

Clinical assessment of the coronavirus 2019 (COVID-19) vaccine candidate developed by AstraZeneca and the University of Oxford has been put on hold due to a suspected serious adverse event reaction in a UK-based participant, according to a new report from STAT News.

The report comes one week into the launch of a phase 3 trial gauging AZD1222 in up to 30,000 US adults. The federally-backed program Operation Warp Speed is contributing funds toward the phase 3 program. Another series of countries—including Mexico, Argentina, and Australia—have entered agreements with the company for the mass production of AZD1222 doses for its residents.

Read more.

Positive Phase 1 Results for the Novavax COVID-19 Vaccine

Development of Novavax’s adjuvanted, recombinant, full-length spike protein nanoparticle vaccine NVX-CoV2373 for coronavirus 2019 (COVID-19) is moving forward after positive results were published from its phase 1 trial.

The results were detailed in the New England Journal of Medicine, following an earlier announcement from the company, showing the vaccine appeared safe and elicited strong immune responses at day 35 of the randomized, observer-blinded, and placebo-controlled trial.

Read more.