GSK and Sanofi Proceed With Human Trials of Potential Covid-19 Vaccine

September 05, 2020 09:01 PM BST | By Kunal Sawhney
 GSK and Sanofi Proceed With Human Trials of Potential Covid-19 Vaccine

Summary

  • Drug companies GSK and Sanofi have started their clinical trials for the development of their coronavirus vaccine
  • The partner drug-makers will be studying the vaccine candidate in 440 healthy adults having being enrolled in the trial across 11 investigational sites in the US
  • The first results are anticipated to be out in early December 2020 so as to support the initiation of a Phase 3 trial in December 2020
  • Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021

In the light of the ongoing disruption spurred by the Covid-19 pandemic, most of the companies are adopting new business models and philosophies for better management of potential outbreaks in the future. Nations with colossal healthcare spending are expected to profit from this pandemic. Companies are escalating the production of diagnostic tests and therapeutics in the race to successfully recognise and treat patients experiencing this exceptionally transmittable respiratory infection. In the long run, the organisation which is successful in developing and launching the vaccine for coronavirus would emerge as the leader. However, a commercially viable vaccine is still months away. Leading pharmaceutical companies are receiving pressure from governments to fasten their clinical trials.

However, hopes for a return to normal conditions are ultimately pinned on finding a vaccine or an effective treatment of the Covid-19 disease. There are over 100 potential vaccines in their developmental stages, and existing treatments for other diseases are being trialled to see if they could be effective against the deadly coronavirus.

GlaxoSmithKline PLC and Sanofi, the global pharma majors started the first and second phases of human clinical trials in the US on 3 September 2020 for the joint development of their vaccine candidate. The partner drug-makers will be studying the vaccine candidate in more than 400 healthy adults having being enrolled in the trial across various investigational sites in the US, and will evaluate the safety, immune response, and tolerability of the shot of their vaccine candidate.

The first results would be comping out in the month of December 2020 so as to support the initiation of a third phase trial in the same month. Based on these results, the firms will apply for the necessary approvals during the first half of 2021. French pharma company Sanofi and its British peer GSK said that both the companies are scaling up the production of the antigen and adjuvant in order to meet the objective of producing up to one billion doses in the year 2021.

What are the Sources of Funding?

The development of the Covid-19 antibody candidate is being upheld through funding and collaboration with the Biomedical Advanced Research and Development Authority, which is a part of the office of the U.S. Department of Health and Human Services.

What do the Drug-makers say Regarding the Development of Vaccine?

As per Thomas Triomphe, executive vice president and global head, Sanofi Pasteur, the initiation of the clinical study is a crucial step in the right direction, bringing the companies closer to a potential vaccine that could help defeat Covid-19 virus. The dedicated teams and partner continues to work around the clock, aiming to deliver the first results in early December.

Roger Connor, President of GSK Vaccines expressed that the transition of the vaccine into clinical development is an important moment in the progress towards addressing the global pandemic that the world is facing.

The companies are now looking forward to the data from the study, and if that is positive, they will definitely be initiating the phase III trial by the end of the year 2020.

Steps Undertaken to Make the Vaccine Available Globally

  • Sanofi and GSK had announced a collaborative effort with the U.S. government in July 2020, to supply up to 100 million doses of their Covid-19 recombinant protein-based vaccine in order to meet the U.S. government’s operation warp speed objective of making hundreds of millions of dosages of safe and effective Covid-19 vaccines available across the world.
  • The U.S. government has a further choice to talk about the acquisition of up to 500 million dosages in the longer term.
  • The firms have also consented to supply the UK government with up to 60 million doses of this protein-based Covid-19 vaccine.

To know more, do read: Coronavirus: Gsk Partners with Sanofi to Supply 60 Million Dosages of Potential Vaccine to UK

GlaxoSmithKline PLC: GSK is a science-led global healthcare company with the objective to help people do more, feel better, live longer. GlaxoSmithKline PLC (LON: GSK) stocks traded at GBX 1,429.80 on 4 September 2020 at 4:27 PM, down by 2.79 per cent from its previous close of GBX 1,470.80. The 52-week low price of the stock was GBX 1,374.60, and the 52-week high price was GBX 1,846.00. The market cap of the company was reported at £73,795.39 million, while it has given a negative return of 17.24 per cent on a year to date basis.

Sanofi: Sanofi is a global biopharmaceutical company focusing on human health, dedicated to supporting people through their health challenges. It is transforming scientific innovation into healthcare solutions around the globe, with more than 100,000 people in 100 countries.

Other Company Involved in the Development of Covid-19 Vaccine

AstraZeneca PLC: British drug maker, AstraZeneca PLC has been making the headlines for being close in finding the potential Covid-19 vaccine, as it has partnered with researchers at the University of Oxford. AstraZeneca published early findings of a closely monitored Phase 1/2 study, indicating that its vaccine candidate was healthy and triggered an immune reaction. Phase 2/3 experiments would also seek to show that the vaccine is shielding citizens against Covid-19. Results are due later this year in 2020, which will rely on infection levels within the studied populations, AstraZeneca stated.

To know more, do read: Next move on Vaccine: Government's agreement with AstraZeneca catering 25 million Australians

AstraZeneca PLC (LON: AZN) stocks last traded at GBX 7,970.00 on 4 September 2020, down by 1.86 per cent from its previous close. The 52-week low price of the stock was GBX 6,221.00, and the 52-week high price was GBX 9,320.00. The market cap of the company was reported at £106,570.89 million, while it has given a positive return of 4.05 per cent on a year to date basis.

To know more, do read: AstraZeneca Starts U.S. Final-Stage Trial


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