- GSK, Sanofi launched the final phase III trials of their delayed Covid vaccine.
- The phase III trial for the vaccine have 35,000 people enrolled, who are 18 years and above from different countries.
- The trial would study the efficiency of the vaccine against both the original strain as well as the B.1.351 variant, detected first in South Africa.
British pharmaceutical company GSK Plc (LON: GSK) and France’s Sanofi on Thursday said that they had launched the final trials of their delayed Covid vaccine.
The phase III trail for the vaccine have 35,000 people enrolled, who are 18 years and above from different countries like Latin America, Africa, Asia, and the USA. The trial would study the efficiency of the vaccine against both the original strain as well as the B.1.351 variant, detected first in South Africa.
What is planned
As of December, Britain has pre-ordered about 60 million doses of the vaccine. The GSK vaccine was supposed to have got the necessary regulatory approvals by the first half of the year but got delayed in December after failing to get a credible immune response in older people.
The announcement came after the approval of sotrovimab, an antibody treatment, by the US Food and Drug Administration (FDA) for the therapy of mild-to-moderate coronavirus patients in the age group of 12 years or above.
GSK’s shares were down 1.05 per cent and were trading at GBX 1,339 on 27 May at 13:09 GMT+1. The FTSE 100 was down 0.19 per cent at 7,013.89.
The clinical studies that would begin in the coming weeks would focus on the efficiency of the vaccine as a second dose if the first was a different jab. It would also study the efficiency of the vaccine on the original coronavirus strain and then look at the efficacy of the variant that originated in South Africa.
Sanofi’s global head Thomas Triomphe said that it was encouraging to see the first vaccination beginning at such a pivotal Phase 3 study. He said that the company believed that its technology platform would help to provide a vaccine option that would be clinically relevant.
The companies would also focus on studying the efficacy of the vaccine as a booster dose in people already vaccinated with other vaccines.
After the initial setback, the company announced earlier this month that its protein-based vaccine was able to produce antibodies in 95 to 100 per cent of the cases after they could successfully adapt their formula.
Their phase 2 trials had been successful in showing a strong immune response post a single shot in those who had been previously infected by the virus.
Triomphe said that the company adopted a forward-looking vaccine development strategy as the virus situation was a fast evolving one and was also anticipating what could be required in a post-pandemic setting.
The EU has so far approved four vaccines, namely, AstraZeneca/Oxford University, Pfizer/BioNTech, Moderna and Johnson & Johnson, the last being a single-dose.
Sanofi and GSK said that the vaccine was on track to being approved in the last quarter of this year. Most of the adult population of the UK, US and the EU are expected to have been fully vaccinated by then.