Anvisa’s evaluation will define if there is a need for more clinical tests
“We have the contract to be the producer for Brazil and for all of Latin America. It is evident that, for this to happen, it will depend on Anvisa to authorize and validate the entire process and grant the vaccine registration”, said the executive in an interview to Agência Brasil.
In August, the Brazilian pharmaceutical company signed a technology transfer contract with the Russian Direct Investment Fund (RDIF) and the Gamaleya Epidemiology and Microbiology Research Institute, responsible for the development of the Russian vaccine. Brazilian technicians were at Gamaleya in September for a 12-day training, and União Química has been working on preparing its biotechnology unit in Brasilia, Bthek, to receive the technology for producing the vaccine content, called an active pharmaceutical ingredient ( IFA).
According to Castro Marques, Anvisa’s evaluation will determine whether more clinical tests of the vaccine will be needed in Brazil or if the results obtained in Russia are sufficient. If further testing is needed, the pharmacist should conduct them.
“As soon as they receive our documents, which we will make available in the near future, they will evaluate, and this will be fundamental to speed up the production process”, said the executive, who avoided estimating how many doses will be produced in Brazil, but said that the number could be increased rapidly in the first quarter of 2021. “We are evaluating the quantity that we will have in the first stage and we are [preparing] to rapidly expand production capacity to serve the rest of Latin America.”
In addition to the production of IFA in Brazil, the União Química Group also assesses how the vaccine will be filled, a process in which doses are separated into bottles. Group units in Guarulhos (SP) and Porto Alegre can be mobilized for work. Another alternative is to outsource the service.
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The agreement between the Brazilian pharmaceutical group and the Russian laboratory was announced on Monday by the CEO (executive director) of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, in an interview with journalists in Latin America. Dmitriev said that the technology transfer process is taking place at an accelerated pace because of the covid-19 pandemic and that, in addition to Brazil, other countries such as China, India and South Korea will also produce doses outside of Russia.
The Russian vaccine against covid-19 is called Sputnik V and is among those that are at the most advanced stage of development in the world. The vaccine uses viral vector technology, in which another type of virus is modified and used to carry genetic information about the new coronavirus. When it comes into contact with these genes, the body produces defenses and prepares itself for when the new coronavirus actually tries to cause an infection. Vaccines like those currently being developed by AstraZeneca / Oxford, Janssen and Cansino also work in this way.
Sputnik V, however, is the only one among them to use two different types of human adenovirus as viral vectors, one in each of the two predicted doses. The other vaccines of this type use only one type of adenovirus, human or chimpanzee, to carry genetic information from the new coronavirus and trigger the response of the body’s defenses.
During the press conference, researcher Denis Logunov, from the Gamaleya Institute, explained that the strategy of using two different adenoviruses seeks to produce a more lasting immunity. Logunov said that clinical trials in Russia have not needed to be stopped so far for any occurrence of serious adverse effects. Only mild symptoms were recorded, such as fever or pain at the application site.
Edition: Nádia Franco