by Antonino Napoleone, Giuseppe Scarlata, Domenico Gangemi | April 22, 2020

On April 22, 2020, 2,611,182 cases of Coronavirus Disease 2019 (Covid-19) are registered worldwide distributed in 185 countries. The spread of the virus does not want to stop, along with the related consequences heavily affecting the health, social, and economic-financial sector. The restrictive policies adopted at different levels by world governments seem to be effective if applied drastically and over a prolonged period of time. The world anxiously awaits a solution from researchers to develop a safe and effective vaccine able to activate a specific and long-lasting immune response against the virus. Two big pharma companies leading the vaccine development and manufacturing sector have played their cards against the virus by signing an unprecedented collaboration agreement. On April 14, 2020, GlaxoSmithKline (GSK) and Sanofi officially decided to ally themselves in the fight against Covid-19 by pooling their resources, technologies, expertise, and more importantly, the enormous manufacturing capacity that in synergy would be able to make and deliver hundreds of millions of vaccines worldwide by the end of next year, according to Emma Walmsley, CEO of GSK. In fact, here lies the greatest strength of this remarkable collaboration, because behind vaccines discovery and development, tremendous manufacturing efforts must be considered regarding the large-scale production of millions of doses in complete safety conditions (Good Manufacturing Practices, GMPs) and in the shortest time, as well as the subsequent distribution for each country worldwide. What are the reasons behind a such decision from two competitors to ally rather than compete in the race for the vaccine? Paul Hudson, CEO of Sanofi, said that the development and production of the vaccine will require substantial investments in a limited time period, and considering the economic and health crisis that the world is facing, it is clear that no company can move alone to succeed. The economic resources invested have not been disclosed, but the scientific-technological platforms were revealed. The vaccine will be based on the already existing recombinant DNA technology used by Sanofi to produce the SARS-CoV-2 antigen. This recombinant antigen corresponds to the Spike protein (S-protein) integrated into the surface of the virus, which mediates the viral entry into the target cells. The DNA sequence encoding this protein will be integrated with the Baculovirus expression vector system, already established system for the development of viral antigens for potential vaccines and the basis of the already patented “Flublok®” influenza vaccine commercialized by Sanofi. This approach has the advantage of reproducing a totally non-infectious and safe viral protein.
On the other hand, GSK will contribute with the already proven and patented adjuvant technology previously adopted in the H1N1 influenza pandemic. The use of appropriate adjuvants is particularly useful and functional to increase the quantity, quality, and duration of the immune response to vaccination and potentially to reduce the antigen doses per person needed to trigger an immunological memory and long-term protection. The strategies adopted by both companies rely on already tested and effective technologies applied in the development and production of vaccines already available on the market. In perspective, this approach could drastically accelerate the pre-clinical trials that define the mechanism of action and the toxicological and safety profile of the vaccine on animal models. After this phase, the vaccine will enter into the clinical trial phase in humans that is already planned by both companies for the second half of 2020. If this phase is also successful, the vaccine will be submitted to the regulatory authorities until it is fully developed and authorized for commercialization before the end of 2021. Sanofi also announced that the development of the recombinant candidate vaccine against Covid-19 has also been supported and funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to highlight the role they are playing in this game. Strategic alliances between leading pharmaceutical industries and government organizations are essential to accelerate the development, manufacturing, and distribution of an effective and safe vaccine against Covid-19. If this investment is successful, the candidate vaccine based on Sanofi recombinant DNA technology and GSK adjuvants will have a high potential for the successful delivery and supply of a large number of people worldwide and for bringing the pandemic to an end. Share and have faith in medical sciences rather than the media, we all need to work together to stop all of this, as competitors do.

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Figure 1. Overview of Potential SARS-CoV-2 Vaccine Platforms.

References:

  1. https://www.gsk.com/en-gb/media/press-releases/
  2. https://www.sanofi.com/en/media-room/press-releases/
  3. https://systems.jhu.edu/
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