Pfizer and BioNTech Submit Data to EMA for Omicron BA.1 Adapted Bivalent Vaccine Candidate
Potential COVID-19 jab would apply to individuals age 12 and older
Pfizer and BioNTech have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older.
The companies previously announced safety, tolerability, and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate produced a superior immune response against Omicron BA.1, as compared to the companies’ current COVID shot. The bivalent vaccine candidate was well-tolerated with a favorable safety profile.
The involved parties previously shared these data with FDA to support a potential variant-adapted vaccine, and they continue to submit additional data as advised by the agency.
Protecting Temperature-Sensitive Pharmaceuticals, Without Unnecessary Plastic Waste
March 24th 2025Advances in the life sciences are driving a significant increase in the number of temperature-sensitive pharmaceuticals. The packaging industry is meeting the moment with advances of its own, including high-performance, environmentally-friendly materials that allow life science companies meet stringent thermal requirements and ambitious CO2e reduction goals. In this episode, TemperPack’s CEO Peter Wells shares insights from working with life sciences to move to certified biobased, home compostable, and curbside recyclable shipping solutions.
