A new COVID-19 vaccine developed by GSK (GlaxoSmithKline) and Sanofi has reportedly showed strong immune response in initial-stage clinical trial outcomes, allowing the two drug manufacturers to move towards a late-stage study for the same, as per an official statement by Sanofi.
GSK and Sanofi stated that a Phase III trial will soon start in the next few weeks and will involve up to 35,000 adults, with a plan of seeing COVID-19 vaccine approved by Q4, after having originally targeted the first half of 2021 before facing a major setback.
Last December, both the firms were forced to reboot their clinical trial when the vaccine exhibited a low immune response in senior adults because of weak antigen formulation.
Sanofi stated that the interim results of the Phase II showed nearly 95% to 100% seroconversion after a second injection in all age types and across all dosages, with bearable tolerability as well as zero safety concerns.
Global head of medical for vaccines, Sanofi, Su-Peing Ng, stated that the vaccine has not been tested against the so-named variants in the Phase II trial, but the Phase III study will be evaluating it against strains which includes a virus lineage referred as B.1.351, which was first discovered in South Africa.
But the French drug maker, Ng added, has conducted parallel studies assessing its vaccines against numerous variants, with outcomes expected to be published soon.
The French drug maker’s shot, however, even if accepted, would come to the market much after those of Moderna and Pfizer/BioNTech, which have known to produced efficacy results of above 90%.
To date, the French drug maker has purchasing agreements with Canada, Britain, the EU, the US and with WHO-backed COVAX facility. The firm has promised to aid other drug makers this year, hitting “fill & finish” new deals for vaccines made by Johnson & Johnson, Moderna, and Pfizer/BioNTech.
Along with its vaccine project in partnership with GlaxoSmithKline, Sanofi is also working on a mRNA candidate with Translate Bio, a US-based firm, for which it has begun clinical trials.