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Brazilian health agency starts reviewing coronavirus vaccine registration

Both vaccines, if approved by Anvisa, can begin vaccination in December

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  • Coronavirus vaccination may be closer in Brazil: Sinovac and Oxford waiting for Anvisa’s approval;
  • Anvisa changed the regulatory procedure over vaccines against COVID-19 registration to speed up the process.

Hoping to speed up the process, the Sao Paulo state government handed over to the Brazilian National Health Surveillance Agency (Anvisa, in Portuguese) the existing documentation about the coronavac vaccine, the immunizer from the Chinese Sinovac which will be produced in the country in a partnership with the Brazilian Butantan Institute, according to O Estado de São Paulo. The vaccine against COVID-19 is being tested in Brazilians. On Thursday, Anvisa also received the documentation from the AstraZeneca-Oxford vaccine.

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If approved, both vaccines can begin to be applied in Brazil in December. “Anvisa received the information through a digital platform. These documents have already been sent by the Butantan Institute to register the vaccine against the coronavirus. Our goal is to make this process faster, but always within scientific standards, following all protocols “, said São Paulo’s governor João Doria, during a press conference.

O Estado de São Paulo reported that Anvisa created a new regulatory procedure in the case of vaccines against COVID-19, called continuous submission. It was prepared by the agency to speed up the analysis due to the urgency imposed by the pandemic. With this simplification, it will no longer be necessary to wait for all technical data and documents to be available, nor for the regulatory requirements necessary to register the vaccines.

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On Wednesday, the São Paulo government signed a contract with Sinovac to supply 46 million doses of coronavac by December this year. By the end of 2020, the pharmaceutical company will send 6 million doses of the vaccine, while another 40 million will be formulated and packaged in São Paulo. Another 14 million doses are expected to be delivered by February next year, but that is not yet under contract.

In the press conference, São Paulo’s governor stated that, if the coronavac passes the testing phase in volunteers and is approved by Anvisa, the vaccination can occur as of December 15 and will start in health professionals from public and private health units in São Paulo.

The study of the coronavac vaccine was expanded in the country, from 9,000 to 13,000 volunteers. Both in China and Brazil, clinical tests started to involve volunteers over 60 years old. Coronavac is being tested in Brazil since July and, currently, clinical studies in volunteers take place in 12 research centers in five states and the Brazilian Federal District.