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The National Health Surveillance Agency (Anvisa) withdrew, on Wednesday (3), the requirement of phase 3 studies carried out in Brazil to approve the emergency use of vaccines against Covid-19. In cases where this occurs, the company says that the deadline to analyze the order will be up to 30 days.
Anvisa’s drug manager, Gustavo Mendes, says that now the resolution dealing with the issue began to mention that the phase 3 study should be “preferably” also carried out in Brazil.
According to Mendes, when the company chooses not to drive, it must meet other criteria:
- Follow-up of participants to assess the efficacy and safety of study participants for at least 1 year;
- Guarantee of access to the data generated in its entirety;
- Demonstration that preclinical and clinical studies were conducted in accordance with nationally and internationally accepted guidelines.
In the case of phase 3 studies not conducted in Brazil, Anvisa places as a condition for the company:
- Commit to complete the development of the vaccine in all aspects, present and discuss the results with Anvisa and request its sanitary registration;
- The analysis period for vaccines without a study developed here in Brazil will be up to 30 days.
The manager also said that it is important to highlight that the company that did not have clinical development in Brazil must commit to requesting the health registry in the country.
The decision may facilitate the importation of vaccines such as Sputnik V and Moderna, which have phase 3 studies with results published in scientific journals, but carried out outside the country.
Previously, the agency required any vaccine manufacturer to conduct phase 3 testing No brazil to be able to request an emergency use. Four developers have tested it in the country: Pfizer, Johnson, Oxford and Sinovac. So far, only the Oxford and Sinovac vaccines have been emergency approved and are being applied to the population.
Of these two, only Oxford published preliminary results in a scientific journal of its phase 3 trials, which is when the vaccine is tested on a large scale, with thousands of volunteers, to assess its safety and efficacy.
Pfizer, which published the results and carried out the tests in Brazil, offered doses to the country, but has not yet received approval for emergency use from Anvisa and negotiations with the federal government have faced obstacles.
Johnson has recently published his results, but has not yet published them in a journal. Publication in a scientific journal means that the vaccine data has been evaluated and validated by other scientists.
Moderna and the Gamaleya Institute, which developed Sputnik V, published the data, but since they had no evidence in Brazil, they were unable to request emergency use of their vaccines.
The União Química company, which has a transfer agreement to produce Sputnik V in Brazil, asked Anvisa to authorize the tests in the country. On Tuesday, when the vaccine had the data published in a magazine, the agency said that the effectiveness, 91.6%, was “good news”, but listed pending points in the application.
In a note to G1Anvisa said that “there is an order for a phase 3 study company open in Anvisa. This order has pending issues indicated by Anvisa and that are being contributed by the company.”
