European drug manufacturers Sanofi and GlaxoSmithKline or GSK announced yesterday that they are launching large-scale clinical trials for their new COVID-19 vaccines.
Forbes reported that the kickoff of Phase 3 clinical trials is taking place, following promising results from previous trials that specified strong immune response, as well as the potential for the vaccine to be used as a booster shot, regardless of what particular vaccine a participant may have been injected in the first intention. This means that later this year, another COVID-19 vaccine will be available.
Essentially the companies said in a statement they issued, the Phase 3 trial will involve over 35,000 adult participants in the United States, Latin America, and Asia.
To be conducted as a two-part trial, the Phase 3 clinical trial aims to examine the efficacy of the vaccine against the original variant of COVID-19 and the B.1.251 variant originally detected in South Africa.
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Sanofi announced the conduct of a separate trial that will explore the potential of the vaccine as a booster shot is due to begin in the weeks ahead to complement the Phase 3 trial.
A Potential 'Booster' Shot
According to Sanofi, there is recent evidence that suggests protection from the South African variant possibly contributes to protection from other strains of the virus, as well.
The company added that, assuming favorable trials and regulatory review, this jab could obtain approval in the last quarter of this year.
On top of the more extensive vaccine trial, Sanofi also announced the conduct of a separate trial that will explore the potential of the vaccine as a booster shot is due to begin in the weeks ahead to complement the Phase 3 trial.
The large trial, Medical Xpress specified in a similar report, marks a change in fortunes following disappointing outcomes that prevented the firms from joining the initial coterie of vaccines against COVID-19.
In December 2020, the two drug manufacturing firms were obliged to restart their clinical trial when their COVID-19 vaccine showed a low immune reaction in older adults, as an outcome of a weak antigen formulation.
For Post-Pandemic Setting
The vaccine has been developed, said Thomas Triomphe, Sanofi's vaccine unit head, based on "forward-looking considerations" as the COVID-19 virus continues evolving.
The company head added, the firms were anticipating what may be needed in a post-pandemic situation, referring to the simultaneous booster shot trial.
The two European companies did not manage to bring a COVID-19 vaccine to market for the first wave of injections following disappointment over early trials, which, a related EuroNews report said is a source of environment for one of the most lauded firms of France, and a major setback not just to the European, but Global vaccine drive, too.
Sanofi and GSK were expecting to be major suppliers and had arrangements ready for hundreds of millions of doses in the US, the United Kingdom, and the European Union. While the shot is being developed, Sanofi agreed to help other drug manufacturers produce approved vaccines.
1 Billion Doses
Quite a big number, but earlier estimates by Sanofi and GSK expected that one billion doses of vaccine could be produced every year.
It remains unclear if the said figure is accurate in the light of the assistance each is providing to other companies that produce COVID-19 vaccines.
A related report on Sanofi and GSK's clinical trials of their COVID-19 vaccine is shown on CNBC International TV's YouTube video below:
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