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The Chemical Union and the Russian sovereign fund, which finances the development of the Sputnik V vaccine against Covid-19, requested Anvisa this Tuesday (29) to approve the clinical tests in phase 3 of the immunizer in Brazil.
According to the CNN Thaís Arbex, the action indicates a sign of a first application for registration of a vaccine in the country, since, with this phase of tests completed, the Brazilian company already intends to request the emergency use of the immunizer in Brazil.
This Tuesday, Argentina began immunizing its population with the Russian vaccine. On Thursday (24), the country received 300,000 doses of Sputnik V. In addition to reaching a small percentage of the population (0.6% of the almost 45 million Argentines), the shipment does not resolve itself either.
Sputnik V is made up of two injections, which have different contents.
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Also today, Belarus began using the vaccine in its population. The country hopes to vaccinate some 200,000 people with Sputnik V in the first phase of its national program, Health Minister Dmitry Pinevich said last week.
Anvisa changes the rules for the use of emergency vaccines
Last Monday, President Jair Bolsonaro (without a party) again commissioned the laboratories that produce the vaccine against Covid-19 to look for Anvisa to seek approval of the immunizer in Brazil.
This Tuesday, the National Health Surveillance Agency (Anvisa) released a new version of the rules for the emergency authorization of vaccines against Covid-19.
Anvisa simplified the section that required a schedule to make the doses available and joined the United Kingdom in the section dealing with the consent form to be signed in the event of immunization within the emergency use of vaccines.
The changes cover items XVI and XIX of the guide published by Anvisa. In item XVI, interested parties only need to indicate how many doses they can supply to Brazil, without stipulating an availability schedule at the time of the protocol.
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In item XIX, which deals with the consent form for emergency vaccination, Anvisa begins to stipulate the term used in the United Kingdom as a model for those interested in the registry. The term is a simple template, with only one page and few fields to complete.
