Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial

▴ companies-continue-expect-conclusive-efficacy-readout-october
The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing

Pfizer Inc. and BioNTech SE announced that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.

Enrollment in the trial has been proceeding as planned and the company expects to reach its initial target of up to 30,000 participants next week. The proposed expansion would allow the companies to further increase trial population diversity and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.

The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.

At Pfizer, they apply science and global resources to bring therapies to people that extend and significantly improve their lives. The company strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of the time. Consistent with the responsibility as one of the world's premier innovative biopharmaceutical companies, they collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

Biopharmaceutical New Technologies is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

Tags : #Pfizer #BioNTech #OncologyProduct #immunotherapy

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Sexual wellness superstore, Love Depot launches digital campaign to deliver every desireMarch 28, 2024
Recharge Your Life: Simple Ways to Boost Your Physical and Mental EnergyMarch 28, 2024
The Neurological Toll of Common Household Chemicals: Insights from Recent ResearchMarch 28, 2024
The Aging Puzzle: Decoding the Mechanisms of AgingMarch 28, 2024
The Double-Edged Sword of Kala-azar Treatment: Shedding Light on Eye ComplicationsMarch 28, 2024
FTCCI Launches Industry-Academia Connect to improve the employability of Engineering Graduates and address the growing demand for Talent in Emerging TechMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
2nd Edition of IIFL JITO Ahimsa Run for peace & for non-violence to be held on 31st MarchMarch 27, 2024
Brij Hotels Announced 4 Million in Series A Funding March 27, 2024
Combatting Childhood Sedentariness: The Key to Preventing Premature Vascular DamageMarch 27, 2024
Crucial Findings: Unlocking Paths to Combat Ebola's DevastationMarch 27, 2024
Guarding Against Disease: The Crucial Role of Oral Hygiene in Preventive HealthcareMarch 27, 2024
Sanofi & Cipla announce exclusive distribution partnership to expand reach of CNS portfolio in IndiaMarch 26, 2024
Surmandal's Tribute to the Legends of Hindustani Classical MusicMarch 26, 2024
In Moscow, over 350,000 mammograms have been analyzed using artificial intelligence as part of the compulsory health insurance programMarch 26, 2024
Embark on a Creative Journey: "Kala For A Cause" Unveils Pottery Workshop Series March 26, 2024
Healthtech pioneer Aurora Innovation appoints new CEO – expands in Europe with service that streamlines patient-healthcare interactionMarch 26, 2024
In A Rare Feat, 45 YO Woman Walks Within 6 Hrs. Of Dual Robotic Surgery In A Single Operation At HCGMCCMarch 26, 2024
Improve Cancer Care through Automated CT Analysis: Oncoshield – CTMarch 26, 2024