Sanofi and GlaxoSmithKline (GSK) announced Thursday that they have launched large-scale trials of their COVID-19 vaccine.
The phase 3 clinical trial will involve 35,000 people aged 18 or over from several countries and will investigate the vaccine’s efficacy against the original strain of the virus as well as the B.1.351 variant, first discovered in South Africa.
“Recent scientific evidence shows that antibodies generated against the B.1.351 variant may provide comprehensive protection against other, more transmissible variants,” the companies said in a statement.
In the meantime, clinical studies to be launched in the coming weeks will look at the protection afforded by the vaccine when given as a second dose after the first injection with another dose.
“We encourage the start of the first vaccines in such an important and pivotal Phase III study, as we believe our unique technology platform will provide a clinically appropriate vaccine option,” said Thomas Triumph, global president of Sanofi Pasteur. .
“We have adapted our vaccine strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipate what may be required in a post-pandemic environment. This trial is evidence of the urgency and agility in our approach to help weather and continue the impact of this pandemic.”
Sanofi/GSK vaccine development suffered an initial setback as companies announced in December that their vaccination “caused an inadequate response in the elderly”.
They have since adapted the formula and announced earlier this month that their protein-based vaccine produces antibodies in 95 percent to 100 percent of cases after a second dose.
Sanofi and GlaxoSmithKline said the vaccine was still on track for approval in the last quarter of the year. By that time, it is expected that most of the adult population in the United States, the United Kingdom, and the European Union will have been fully vaccinated.
In the European Union, four vaccines have so far been approved: Pfizer / BioNTech, AstraZeneca / Oxford University, Moderna and Johnson & Johnson, the latest of which is a single dose.
However, some experts, including Pfizer CEO Albert Burla, said a third booster dose may be needed within 12 months after the second one.
Sanofi is also developing an mRNA vaccine — technology used by Pfizer/BioNTech and Moderna — with US therapeutics company Translate Bio.
It also struck deals to produce tens of millions of doses of Pfizer and Johnson & Johnson doses.