Monday, June 08, 2020

U.S. company uses innovative base for coronavirus vaccine

The American pharmaceutical group Pfizer is one of those in the race to develop an efficient vaccine against the new coronavirus. With 60 years of history in Brazil, the company is testing four possibilities of formulas for the disease, from an innovative technique that uses as a basis the RNA of the virus itself to develop protection in human organisms. The expectation is to start production in October this year.
The messenger RNA-based tests used in the development of the Covid-19 vaccine were started in 2018, targeting other diseases, in partnership with the German biotechnology company BioNTech. That's because Pfizer already had a long history of antibacterial vaccines, but they had never produced one that would fight a virus. Two years later, in January, when the disease began to spread in China, the company realized that it could apply the same logic to the new coronavirus.
"Two years ago, when we started this research, our focus was influenza. Now, all this development and partnership are being evaluated as a potential vaccine against Covid. It was an interesting coincidence, because with the discovery of genetic material by the Chinese in January, we were already able to start testing with the same platform to see if it would be effective against coronavirus," explained Márjori Dulcine, medical director of Pfizer Brazil.
In practice, the vaccine uses an excerpt from the virus's genetic code, the messenger RNA, which is synthesized in the laboratory and inserted into the immunization formula. When in contact with the human body, RNA will lead to "recipe" of coronavirus composition, stimulating that the body's cells produce a part of the protein very similar to the original virus.
Subsequently, the immune system will identify something strange, which is not produced naturally by the body. At this point, the immunization process begins from the production of antibodies against coronavirus. The new proteins to protect against the virus will continue to circulate in the bloodstream and an immune memory is created for this disease. Thus, when it comes into contact with the new coronavirus, the body will already have the antibodies needed to fight it.
"The survey is being conducted in Europe and the United States, with 200 and 360 participants respectively. They are healthy people in two age groups: 18 to 55 years and, later, 65 to 85 years. Only then, with a higher level of security, did we go for testing on people in the risk group. The process is so fast that we are calling this phase 1 and 2, which happen simultaneously," said Márjori Dulcine.
The medical director stressed that, in normal situations, the process of developing a vaccine takes 10 to 15 years. For coronavirus, the idea is to start mass global distribution from 2021, after all required security and regulatory procedures. After the pre-clinical phase, the company began human trials in early May, with the two initial phases articulated.
Now, the main focus is to evaluate vaccine safety and immunogenicity, that is, the body's reaction to produce antibodies stimulated by messenger RNA. The optimal dose of the vaccine is also studied and, when chosen, the process will move to phase three, tested in thousands of patients around the world. From the production of robust data, the vaccine starts to regulate health agencies and can begin to be produced.
"We hope by the end of this month to have a return of the first participants. But we are very optimistic, since there are other companies with positive results in small groups, using the same platform. This means that the messenger RNA was even able to produce the neutralizing antibodies, which are the most important," Márjori said.
The vaccine development project for the new coronavirus mobilized about 8,000 researchers from the company, as well as indirect collaborators. The investment is about 650 million dollars, of which 500 million is for research alone and the rest for production.
Upon completion of a safe and efficient end product to immunize people, the great challenge for pharmaceutical industries, health regulators and governments around the world is precisely to balance distribution. The director of Pfizer explained that the company is in constant contact with the Brazilian authorities and the National Health Surveillance Agency (ANVISA) about the process of research and distribution of the future vaccine.
"The whole world is looking for a solution and Brazil is standing out for the number of cases, unfortunately. Together with regulatory agencies, delivery will be made first to the areas of greatest need. Based on demographic data of patients produced by international organizations and countries, monitored throughout the clinical development process, we are already trying to understand the logistics to serve these regions," he said.
Epoca - 07/06/2020 News Item translated automatically
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