RIO DE JANEIRO, January 9. /TASS/: The Brazilian Health Regulatory Agency (Anvisa) requested additional information on Russia’s Sputnik V coronavirus vaccine. This is according to a statement on agency's website, which was published on Friday.
Earlier, the Uniao Quimica pharmaceutical company, which is a partner of the Russian Direct Investment Fund (RDIF), applied for permission to conduct the third phase of clinical trials of the vaccine in the country.
"Anvisa has started to analyze [the data obtained], however, they revealed the need for additional information, which they requested from the laboratory," the press service of the regulator said. As specified, as of 03:30 am Moscow time, the pharmaceutical manufacturer had not provided the required data.
At the end of December, Uniao Quimica applied to Anvisa for a permission to conduct Phase Three clinical trials of the Russian preparation in the country. This is a prerequisite for registering any medicine in Brazil. Then the department said that, judging by the experience of considering previous applications, a decision on the Russian vaccine can be prepared within 72 hours.
On Wednesday, the company's press service announced the receipt of cell bulk from Russia for the manufacture of the Sputnik V vaccine, which, as it was specified, will be produced at factories in Brasilia (federal district) and Guarulhos (state of Sao Paulo). Earlier, it became known about the company's plans to apply to the regulator for an emergency use of the vaccine in Brazil, which will allow the drug to be included in the national vaccination plan.
