The Brazilian health regulator Anvisa held a conference on Sunday to decide on the requests for emergency use of Covid-19 vaccines submitted by the Butantan Institute, for the CoronaVac vaccine produced in partnership with Chinese laboratory Sinovac; and filled by the Oswaldo Cruz Foundation (Fiocruz), for the immunizer developed by Britain’s AstraZeneca in partnership with Oxford.
All of the five members of Anvisa’s director board voted to authorize the emergency use of both vaccines. To be approved, at least 3 out of the 5 votes had to be favorable.
The Butantan Institute’s request, filed on January 8, stands for 6 million imported doses of the Coronavac vaccine, while the request from Fiocruz, submitted on the same date, refers to 2 million doses imported from the Serum laboratory in India, which produces the vaccine developed by the University of Oxford and the AstraZeneca laboratory. Both Butantan Insitute and Fiocruz also develop the vaccines in Brazil.
Starting at 10am this Sunday, Anvisa’s meeting began with initial speeches from the head of the country’s health regulator Antonio Barra Torres, who said that a change in social behavior was needed to face the pandemic.
“Anvisa never granted this type of authorization before. We have never experienced a situation like this, with so much exposure and so much sense of urgency,” said Gustavo Mendes Lima, general manager of medicines and biological products at the regulator.
While the authorization of both immunizers depended on the vote by the board of the regulator, Anvisa’s technical staff recommended, during the conference, the approval of Covid-19 vaccines for emergency use from Butantan Institute/Sinovac as well as Fiocruz/AstraZeneca, stressing out the importance to monitoring and periodic reassessment.
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Lima, who presented the data submitted by Butantan Institue and Fiocruz to Anvisa, as well as the methodology and technical information regarding the immunizers, confirmed the 50.39% effectiveness of Coronavac, highlighting the uncertainties about the vaccine, such as few elderly people tested and lack of information from all patients about the intervals between the first and the second dose.
Anvisa’s general manager of medicines and biological products recommended the approval for emergency use of Coronavac, “conditional on the monitoring of uncertainties and periodic reevaluation”.
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“In view of the pandemic scenario, in view of the increase in the number of cases and in view of the absence of therapeutic alternatives. The situation we are experiencing is a situation of great concern and a lot of tension due to the necessary inputs, the general management recommends the approval of emergency use,” he said.
As for the immunizer developed by Britain’s AstraZeneca in partnership with Oxford and led in Brazil by Fiocruz, Lima reported total effectiveness of 70,42% and also spoke of a few uncertainties about the vaccine such as few older people tested and virus seed bank at Instituto Serum (laboratory in India) differing from AstraZeneca’s bank. The General Management of Medicines also recommended the approval of the emergency use of the Oxford vaccine, “conditional on the monitoring of uncertainties and periodic reevaluation.”
Anvisa’s second director, Meiruze Freitas, who was also in charge of reporting the conference, said the benefits of the two vaccines exceed the risks. She highlighted that “a vaccine is only effective if people are willing to get it,” and voted by the approval for emergency use of both immunizers.
“Our country currently accounts for 10% of the total deaths observed in the world. So far, we do not have an alternative therapy to treat the coronavirus. Therefore, it is up to each of us in our sphere of activity to take all measures within our reach to reduce the impact on life in our country in the shortest time,” she stated during the conference.
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In addition to Freitas, another four directors of the agency voted on the topic: head of the country’s health regulator Antonio Barra Torres, Cristiane Jourdan, Romison Mota and Alex Campos. To be approved, applications must get a simple majority on the board.
Romison Mota, director representing Anvisa’s fourth board, followed Freitas’ by voting for the approval of Butantan Institute and Fiocruz’s immunizers. “Vaccines are the most effective way to prevent infectious diseases, saving millions of lives worldwide,” he said.
Next, the director of Anvisa’s fifth board, Alex Machado Campos, was the third member of the regulator to vote by the approval of the two immunizers at stake, forming the majority of votes favorable to the emergency use of vaccines Coronavac/Sinovac and Oxford/AstraZeneca.
Antonio Barra Torres and Cristiane Jourdan voted likewise.
Next steps
With the authorization, permission for emergency use of vaccines becomes effective as soon as the laboratories are notified. The emergency authorization for use allows immunization only in groups predefined in the studies delivered to Anvisa.
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As Sunday’s vote stands for emergency use only, for the vaccine commercialization and wide immunization without the need to specify groups, it is necessary to get the final registration.
