The pharmaceutical companies Sanofi and GSK have announced that they are entering the clinical trial phase of the vaccine against Covid-19 on humans and hope for marketing by the end of the first half of 2021.
- Preclinical studies of the vaccine candidate revealed “a promising safety and immunogenicity profile”.
- This vaccine candidate is based on a technology based on recombinant protein that Sanofi used to produce one of these vaccines against seasonal influenza and on an adjuvant developed by GSK.
- The vaccine manufacturing process will be initiated before the final results of the trials.
The race for the vaccine knows no downtime. Eagerly awaited to stem the coronavirus pandemic, the future vaccine is stirring up research. The French and British pharmaceutical groups Sanofi and GSK have announced this Thursday, September 3 the launch of the phase I/II clinical trial of their vaccine candidate against Covid-19. It’s about “of an important step and one more step towards the development of a potential vaccine to help us defeat Covid-19”, welcomes Thomas Triomphe, the executive vice-president of Sanofi.
Phase III expected for the end of the year
The Phase I/II clinical trial marks the start of testing the vaccine candidate in humans after preclinical studies revealed “a promising safety and immunogenicity profile“, specifies the press release. The randomized trial, which will be carried out double-blind with a placebo, will be done on 440 adults. It aims to assess the safety, tolerance and immune response profiles of this candidate vaccine against Covid-19. “Moving this vaccine candidate into clinical development is an important step in efforts to fight the pandemic we are facing”, advances Roger Connor, president of GSK Vaccines, in the press release of the two companies.
This vaccine candidate is based on a technology based on recombinant protein that Sanofi used to produce one of these vaccines against seasonal influenza and on an adjuvant developed by GSK. “We are eagerly awaiting the data from this study which, if positive, will allow us to move into phase III by the end of the year.”, adds Roger Connor. The first results should come in early December and will be followed, if positive, by a move to phase III by the end of the year where the vaccine candidate will be tested on tens of thousands of people.
Production will begin before testing is complete
The researchers hope to be able to submit an application for registration before next July. Without even waiting, the two companies have already increased their production capacity “to be able to ensure the manufacture of one billion doses in 2021.” Sanofi and GSK’s goal is to “make this vaccine available to all”, they assure. “The two partners also plan to make a significant part of their total 2021-2022 production available to Covax”, a device intended to equitably procure and distribute 2 billion doses in 2021. Covax was initiated by the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI) and the organization Gavi, the Vaccine Alliance.
The manufacturing process will be initiated before the final results of the tests. “We are going to do something quite exceptional – we will not be the only ones – it is that we are going to start manufacturing from the start of phase III without waiting for the results of phase III”, revealed Serge Weinberg, chairman of the board of directors of Sanofi, to BFM Business. Before adding that the vaccine candidate, if it proves to be effective and safe, is expected to “mid 2021”. This vaccine candidate is already of interest to many countries that have placed an order. This allows the two companies to share the financial risk in the event that this vaccine candidate proves ineffective. The British government has positioned itself on 60 million doses while the European Commission has reserved 300 million and the United States 100 million with an option for 500 million doses in the longer term.
Covid-19: Serge Weinberg (Chairman of the Board of Sanofi) believes that the vaccine “will be for mid-2021” pic.twitter.com/VxCk8KH67K
— BFM Business (@bfmbusiness) September 3, 2020
In the world, a frantic race
In the vaccine race, Sanofi and GSK are not in the lead. The American vaccine candidate, developed by the Pfizer laboratory in partnership with the biotech Moderna, has already entered phase III of clinical trials, the last before marketing. Donald Trump hopes a vaccine will be ready for the 1er November and the United States would prepare for a large-scale vaccination plan for that date. The same is true for British researchers at Oxford, with the pharmaceutical company AstraZeneca, who hope to obtain the results in the fall in order to be able to offer the vaccine by the end of the year. The candidate vaccine developed by the Chinese laboratory CanSino is also in phase III of clinical trials which are being carried out in Brazil and Indonesia. In addition, at the end of July, the government announced on public television that it had already launched a vaccination campaign for 20,000 people at risk.
Other vaccine candidates are being developed around the world. Vladimir Putin announced on August 11 that Russian researchers have developed a vaccine which should be produced in large quantities during the month of September. Many scientists have warned against this announcement considered too early. Sanofi, in addition to the vaccine candidate developed with GSK, is preparing another with messenger RNA in partnership with Translate Bio.
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