Pfizer and BioNTech Request EUA for Omicron BA.4/BA.5 Adapted Bivalent Vaccine
If authorized by FDA, will arrive in time for possible fall and winter surges
Pfizer and BioNTech have completed a submission to FDA requesting emergency use authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for people 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine—alongside pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine—to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 vaccine, has allowed us to develop, test, and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” says Albert Bourla, Pfizer’s chairman and CEO. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges."
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is found in the original Pfizer-BioNTech COVID vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.
LogiPharma Unpacked: Highlights, Key Insights, and the Road to 2025
October 16th 2024In this special post-show episode, we sit down with Ryan Portela, Head of Production for LogiPharma, to reflect on the highlights and key takeaways from this year’s event. From attendee feedback to the most impactful sessions, Ryan shares insider insights and discusses how the momentum from 2024 will continue to shape the future of pharma supply chains. Plus, get a sneak peek into the exciting plans for LogiPharma's 20th Anniversary in 2025.
Reimagining Closed-Loop Marketing Strategies for Pharma Companies
November 21st 2024The pharmaceutical industry is evolving, and so are the strategies needed to connect with healthcare professionals. Closed-loop marketing (CLM) has become essential in delivering personalized, data-driven engagement that resonates with physicians and improves key outcomes, such as enhancing patient care, increasing
Maximize Pharma’s Potential with AI-Ready Data for Commercial Excellence
November 21st 2024As the pharmaceutical industry embraces the power of AI, having data that’s large, diverse, and well-structured is critical for driving innovation and improving outcomes. Ensuring your data is AI-ready and can be used with more advanced solutions enables your teams to make informed strategic decisions, predict trends, enhance customer engagements and drive overall strategy.
