Brazil Approved Emergency Use of Oxford-AstraZeneca and Sinovac Coronavirus Vaccines

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The Butantan Institute, linked to the São Paulo governorate, has a license to manufacture the Chinese Sinovac vaccine (EFE / Sebastiao Moreira)

Brazil approved this Sunday the emergency use of the coronavirus vaccines developed by the Chinese pharmaceutical company Sinovac and the one developed jointly by the British laboratory AstraZeneca and the University of Oxford.

The decision was made after a meeting held by the Collegiate Directorate of the National Health Surveillance Agency (Anvisa, regulator). Unanimously, the five directors of Anvisa spoke in favor of authorizing the vaccines. Meiruze Freitas, speaker of the applications, was the first to vote and conditioned the application of the antidote to the signing and publication, before February 28, of a term of commitment on the ability of the vaccine to stimulate the immune system and produce antibodies.

The two antidotes will be produced in the country by the state laboratories Instituto Butantan and Fundación Fiocruz. The first, linked to the Government of the state of Sao Paulo and working for several months in the development of the Chinese vaccine, and second, which does the same with AstraZeneca and the British University of Oxford, carried out tests of their antivirus in thousands of volunteers.

In this way, the doses already have the necessary approval to be used in Brazil, and the Government can begin the National Immunization Plan. The Minister of Health, Eduardo Pazuello, called a press conference at the end of the Anvisa meeting to announce details about the immunization plan, whose start date has not yet been defined.

With an average 50.4% and 70% efficacy, the Sinovac and AstraZeneca vaccines, respectively, are Brazil’s firm bets to reduce the number of hospitalizations and deaths from covid-19, after a skyrocketing increase in cases in the middle of the second wave of the pandemic without ever having controlled the first.

Brazil is the second country most affected by the pandemic in the world (REUTERS / Bruno Kelly)
Brazil is the second country most affected by the pandemic in the world (REUTERS / Bruno Kelly)

Of the 354 million doses of vaccines that the Ministry of Health has confirmed for this year, 212.4 million are from the product of AstraZeneca and another 100 million from Sinovac. Of this total, Brazil already has 6 million Sinovac vaccines stored in the country and expects to receive 2 million of the AstraZeneca product on Monday imported from India to be able to start the immunization campaign with 8 million doses.

At the end of January the country will already be able to count on the vaccines that will be produced directly in the country. The Oswaldo Cruz Foundation (Fiocruz), a medical studies center linked to the Ministry of Health, has a license to produce the Oxford vaccine in Brazil and has the capacity to manufacture more than 15 million monthly doses. The Butantan Institute, linked to the São Paulo governorate, has a license to manufacture the Sinovac vaccine and plans to produce up to 50 million doses in the first half of this year.

Two other antidotes, that of the US-German consortium Pfizer-BioNTech and that of the Belgian Janssen, the European arm of the North American multinational Johnson & Johnson, also carry out three-phase studies with volunteers in Brazil, but neither has asked the regulator to use emergency so far.

For its part, Anvisa rejected this Sunday the request for emergency authorization of the Russian vaccine Sputnik V. The entity explained through a statement that the reason is that the documents did not present “minimum requirements for presentation and analysis, and related issues with good manufacturing practices ”. The request – finally vetoed – for the emergency use of 10 million doses of the Russian vaccine was presented by the pharmaceutical company União Química on Friday, January 15.

The Oswaldo Cruz Foundation (Fiocruz) is licensed to produce the Oxford vaccine in Brazil
The Oswaldo Cruz Foundation (Fiocruz) is licensed to produce the Oxford vaccine in Brazil

In the statement, Anvisa cited the lack of clinical studies on the phase three vaccine. Last week, the agency determined as one of the criteria for the request and emergency use of the vaccine that the laboratory carry out phase three of the studies – the clinical analysis phase – in Brazil. So far, Russian development has not started this stage of the process in Brazilian territory. The agency clarifies that it is not enough for the request for authorization of phase three of the clinical trial to be submitted for emergency use. These studies need to be ongoing in the country.

The government of President Jair Bolsonaro has been the target of criticism for not having a start date for the vaccination campaign despite the fact that several countries have already begun to immunize their populations, including some Latin Americans such as Argentina, Chile, Mexico and Costa Delicious.

Brazil is one of the global epicenters of the pandemic and the second country with the most deaths from the disease in the world after the United States, with more than 204,000 victims, and the third with the most infections after the North American nation and India, with about 8.2 million confirmed cases.3

Keep reading:

Brazil rejected the request to evaluate the emergency use of the Russian vaccine Sputnik V

Ben Oakley
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