Entering Late into the COVID-19 Vaccine Race, Could this Pharma Duo Measure up to Competition?

By T. Chakraborty, Ph.D.

As of September, COVID-19 has affected over 26 million people, claiming approximately 880,000 lives, while rendering millions with unknown neurological-effects. Biopharma companies around the world are scrambling to come up with an effective vaccine. Confronting the many frontrunners in this vaccine race, a collaborative effort between Britain’s GlaxoSmithKline (GSK) and French drugmaker Sanofi has made a late entry. On September 3rd, the duo announced that they have already initiated a Phase 1/2 clinical trial of their protein-based COVID-19 vaccine and that they aimed to reach the final testing stage by December. If all goes well and the results are deemed conclusive, the manufacturers hope to get the vaccine approved by the first half of 2021.

Phase 1/ 2 Clinical Trials

The clinical trial is looking to evaluate the safety profile, tolerability, and immune response in a cohort of 440 healthy adults located across 11 sites in the US. The vaccine candidate in question is made of the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines but will be coupled with an adjuvant, an immunological agent intended to create a stronger response to the vaccine, manufactured by GSK. The two companies are massively scaling up their operations to produce up to one billion doses in 2021.

Further Collaborations

Sanofi has further collaborated with a US company, Translate Bio, to work on creating another vaccine using mRNA. As previously established, RNA vaccines can provide design flexibility vaccine antigens that mimic antigens during infection. Additionally, since RNA is an essential component for protein synthesis, it does not integrate within the genome. Furthermore, since they can be synthesized and deleted by the body’s inborn mechanisms, the vaccines made using RNA can be considered safe.

Paul Hudson, CEO of Sanofi, in a recent interview with Reuters, said that data from the preclinical trials have boosted the group’s confidence in its two coronavirus vaccine candidates. Meanwhile, Sanofi and GSK have combinedly secured deals for their vaccine with the US and UK and are in advanced stages of negotiation with the EU for an estimated delivery of 300 million doses. The companies intend to supply COVAX, a COVID-19 vaccine, and treatment initiative co-led by the World Health Organization (WHO) that seeks to buy and distribute shots in a fair manner globally.

Global Competition

A number of potential vaccine candidates have already reached its final testing phase. The frontrunners include Cambridge, MA-based Moderna, AstraZeneca in collaboration with Oxford University, Sputnik V, a vaccine developed by Gamaleya Institute in collaboration with the Russian defense ministry, among a few others. Besides, several companies are aiming to bring a vaccine by the end of this year or early next year. This includes Johnson and Johnson, Pfizer and BioNTech, Chinese companies such as CanSino, Sinopharm, Sinovac, and smaller companies such as CureVac, Altimmune.

Editor: Rajaneesh K. Gopinath, Ph.D.

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References

1. https://www.sanofi.com/en/media-room/press-releases/2020/2020-09-03-07-00-00
2. https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-initiate-phase-12-clinical-trial-of-covid-19-adjuvanted-recombinant-protein-based-vaccine-candidate/

Author

Tulip Chakraborty