What will be the two vaccines against COVID-19 that will be ready in the second half of 2021

The French pharmaceutical Sanofi said in recent days that it will provide support for the manufacture of the vaccine for COVID-19 to the American Johnson & Johnson. Once the alliance is authorized, provide J&J with access to the established infrastructure and expertise of its vaccine manufacturing facility in Marcy l’Etoile, France, to formulate and fill vials of J & J’s Janssen COVID-19 candidate vaccine in 2021, at a rate of approximately 12 million doses per month.

In another line, Sanofi and GSK recently announced the initiation of a new Phase II study with 720 volunteers over 18 years of age to select the most appropriate antigen dose for Phase III evaluation of their COVID-19 adjuvanted recombinant protein vaccine candidate..

In exclusive dialogue with Infobae via Zoom, André Soresini, general manager of Sanofi Pasteur for the Southern Cone, who has a master’s degree in Business Administration (MBA) and in Arts and a degree in Mechanical Engineering and Product Development, advanced: We have decided to develop two vaccines and both should be ready in the second half of this year.. We believe that the recombinant DNA will be ready to be on the market being registered around the month of November or December 2021″.

French President Emmanuel Macron listens to a researcher as he visits an industrial development laboratory at the vaccine unit of French pharmaceutical company Sanofi Pasteur, in Marcy-l’Etoile, near Lyon, France (Laurent Cipriani / Pool via REUTERS / File Photo ) 

“But in the meantime, we made our capacity and technology available to support the global need and demand for vaccines. At this time We announced two collaborations: one to produce 125 million doses of vaccines for Pfizer BioNTech and another to produce 12 million doses of Johnson & Johnson vaccines per month at our plant in France. We will use the technological capacity that we already have to support our competitors in this global pandemic situation, in an unprecedented way ”, he added.

In December, the companies Sanofi and GSK announced a delay in their coronavirus vaccine research program to try to improve the immune response in people over 50 years of age. The interim results of the Phase I / II study showed an immune response comparable to that of patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in those older than this age, “probably due to at an insufficient concentration of the antigen ”, they warned.

“In recent weeks, our teams have worked to refine the antigen formulation for our recombinant protein vaccine, building on the learnings from our initial phase 1/2 study. We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data. This new phase 2 study will allow us to identify the definitive formulation of the vaccine for adults of all ages.”, Commented in statements to the press the executive vice president and director of Sanofi Pasteur, Thomas triumph.

The firm told Infobae that it will seek to produce 125 million doses of vaccines for Pfizer BioNTech and 12 million doses of Johnson & Johnson vaccines per month at its plant in France (Shutterstock)

André Soresini, born in Brazil, shared with this medium how he views the current panorama of science and the development of vaccines against COVID-19, taking into account that one year after the pandemic was declared there is already 6 authorized inoculants, 6 approved and more than 20 projects in Phase III, 28 in Phase II and 41 in Phase I: “This unprecedented situation we are facing has fueled accelerated development everywhere. We applaud that, because for the first time such accelerated development is seen in so many ways, with a multiplicity of new technologies emerging, and it is important to see that there is so much interest for the pharmaceutical industry to help stop this pandemic ”.

According to the expert, “it is very important to consider that this accelerated development process implies a much greater ambition, industry engagement, and from the beginning of the pandemic We are committed to developing vaccines, providing potential treatments and also maintaining our productive capacity, taking into account that 80% of the products we produce are considered essential ”.

Asked about the way in which the variants, new strains and different mutations that are appearing in different parts of the globe interfere in the preparation of vaccines, he specified: “Many of the vaccines that are being developed, especially those in Phase II and III, have the ability to make adjustments to be able to immunize and protect against these new virus mutations.. In our case, the intent from the development of Sanofi is that it can also protect against new mutations. It is natural that the virus continues to undergo mutations, it is in its nature. It is necessary to continue observing, so that the vaccine that we can develop is the most positive in the immunization against these new mutant strains ”.

Globally, there are more than 114 million accumulated confirmed cases of COVID-19, more than 2.5 million people who died, and 64 million recovered, according to data from Johns Hopkins University (Shutterstock) 

Recombinant protein and messenger RNA

“From Sanofi what we decided to do was develop two different vaccines to maximize the chance of success”, He told Infobae Soresini

One of them has a recombinant protein platform, which is a technology already used for influenza vaccines. “We already have millions of doses produced with this technology and in the case of this vaccine it has been supported by the United States Advanced Biomedical Research and Development Authority (BARDA), which is the accelerated research and development organization of the US Government. UU. “, Detailed Soresini.

“This vaccine has the antigen developed by Sanofi, with the collaboration of GSK, another multinational company, producer of vaccines. We will use the adjuvant of GSK, to increase the potency of the vaccine and that it can generate a faster, more efficient immune response and with the lower amount of antigens. And in this way to be able to immunize many more people at the same time ”, he added.

In parallel they develop a vaccine with messenger RNA. It is a novel technology, which they have been studying for some years and have been developing in parallel. “Sanofi has been studying messenger RNA technology in collaboration with Translate BIO, a startup company, for several years.. During the pandemic, we have accelerated collaboration, even to investigate other forms of vaccines in the future, “the expert highlighted, who advanced:”The recombinant DNA vaccine has just entered Phase II, and the messenger RNA vaccine will enter Phase I / II this quarter”.

Sanofi’s recombinant DNA vaccine has just entered Phase II, and the messenger RNA vaccine will enter Phase I / II this quarter

Regarding alliances between pharmaceutical companies, he said: “It is a matter of responsibility. If we think that Sanofi Pasteur was created with a vision of creating a world in which no one suffers or dies from a vaccine-preventable disease, it is clear that we need to do everything possible to help the industry stop this pandemic. , is the commitment that the industry made, the pharmaceutical industry as a whole. With COVID-19 there have been unprecedented collaborations. Never before have we made our infrastructure, our capacity, our technology available to produce a competitor’s vaccine. At this time, our competitors are allies, we need to ally and support each other by offering the strength that each one has”.

Para Soresini, “if any vaccine is available, it has already managed to pass all phases of clinical development, we applaud this, but we need to support them in that effort, and that is what we are doing”.

When asked whether the large inoculant manufacturing companies should release their vaccine patents in this extraordinary and exceptional context of the global health crisis, André Soresini responded to Infobae: “The development of a vaccine involves very elaborate clinical process stages. And clearly the productive capacity is not very simple either. It is a capacity that is not so simple to be developed, that requires a lot of technology and knowledge. I don’t know how this discussion will evolve, but it is important to understand the limitations of this approach. The common objective we have as an industry is to support this global health crisis that we are facing, regardless of whether the patent belongs here or there, is to reach the doses necessary to immunize the world population as quickly as possible.”.