As anticipated by the companies the first results will be coming in early December 2020 and will hopefully support the initiation of a Phase 3 trial in that same month. If the data is sufficient for licensure application the plan is to request regulatory approval in the first half of 2021. Sanofi is leading the clinical development and registration of the COVID-19 vaccine.
Preclinical data demonstrate an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralizing antibodies that are comparable to levels in humans who recovered from the COVID-19 infection.
The Preclinical results will be published later this year. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the goal of producing up to one billion doses in 2021.
Utilizing Established Technology from Both Sanofi & GlaxoSmithKline
Roger Connor, President of GSK Vaccines, stated, “Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing. This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilizes established technology from both companies and can be produced at scale by two of the leading vaccine manufacturers globally. We now look forward to the data from the study, and if positive, beginning Phase 3 by the end of the year.”
The development of the adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
A Commitment to Making the Vaccine Available Globally
In July 2020 Sanofi and GSK announced a collaborative effort with the U.S. government to supply up to 100 million doses of their COVID-19 recombinant protein-based vaccine to meet the U.S. government’s Operation Warp Speed goal. This goal involves making hundreds of millions of doses of safe and effective COVID-19 vaccines available in the United States as quickly as possible.
The U.S. government has a further option to discuss the purchase of up to 500 million doses longer term. Both companies agreed (subject to final contract) with the UK government to supply up to 60 million doses of recombinant protein-based COVID-19 vaccine.
The partners plan to supply a significant portion of total worldwide available supply in 2021/2022 to COVAX, the vaccines pillar of the ACT-Accelerator (Access to COVID‐19 Tools), a global collaboration of leaders of governments, global health organizations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments and vaccines.
More Than One Technology
In addition to the recombinant protein-based vaccine, which Sanofi is developing in collaboration with GSK, Sanofi is working on a messenger RNA (mRNA) vaccine in collaboration with Translate Bio (TBIO).
With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising. Preclinical data shows that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans.
Sanofi expects the Phase 1/2 study to start in November, with the earliest potential approval in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply an annual capacity of 90 to 360 million doses.
Prohost Observations
Sanofi and GlaxoSmithKline must not be underestimated when they use both vaccine expertise and technologies to create innovative safe, effective and durable vaccines.
With today’s news we can feel and understand the world’s need for these two firms’ capabilities to defeat the unseen coronavirus behind the pandemic that has already killed over a million and a half people in the past 8 months.
We love these two firms.
We believe that Sanofi is climbing a mountain to a summit that hosts only the geniuses and the creators.
We can say the same about Inovio’s (INO) COVID-19 vaccine too.
To read more about these firms or COVID-19 please use the search engine at our website.
Sanofi and GlaxoSmithKLine COVID-19 Vaccines are Advancing in Clinical Trial
Sanofi and GlaxoSmithKline Have COVID-19 Vaccines Advancing in Clinical Trial
Sanofi (SNY) and GlaxoSmithKline (GSK) started Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate developed by both firms uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines, with GSK’s established pandemic adjuvant technology.
The Phase 1/2 clinical trial is a randomized, double-blind and placebo-controlled trial. It is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate.
A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States.
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