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File photo of a vial with the Russian vaccine Sputnik V for the coronavirus. Jan 6, 2021. REUTERS / Fedja Grulovic

The National Health Surveillance Agency of Brazil (Anvisa) rejected the request for emergency authorization of the Russian vaccine Sputnik V, according to a statement published by the agency.

As detailed in the text, the reason is that the documents did not present “minimum requirements for presentation and analysis, and issues related to 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.

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.

According to the agency, the emergency use authorization request “must include strategies that the applicant will apply to ensure that ongoing clinical trials of the vaccine can evaluate long-term safety and efficacy.”

União Química formally requested Anvisa, at the end of December, authorization to begin phase three of the Sputnik tests, but the request has not yet been approved by the agency because it was identified that “documents are missing.” Thus, on January 4, the Agency asked the laboratory to submit the missing and supplementary information. On January 6, the company responded that as soon as it can meet the requirement it would complete it. But, says the statement, “so far, Anvisa is waiting for the company to comply with the requirement to complete the analysis of the study request.”

Sputnik V was approved in Argentina, Venezuela, Bolivia, Mexico, Paraguay, Egypt, South Korea, India, Nepal, Belarus, Kazakhstan, Uzbekistan, and Algeria.

Argentina began to vaccinate with Russian development on December 29 (Gastón Taylor)
Argentina began to vaccinate with Russian development on December 29 (Gastón Taylor)

Key day for the vaccination campaign in Brazil

LAnvisa decides this Sunday if it authorizes the use in the country, due to emergency conditions, of the only two vaccines whose laboratories did complete their processes to register their products: the Chinese pharmaceutical company Sinovac and the one developed jointly by the British laboratory AstraZeneca and the University of Oxford.

Five Anvisa directors will participate in this meeting on an exceptional basis, which is scheduled to begin at 10 in the morning and will last five hours. In this final evaluation, if at least three directors vote in favor of emergency use, the vaccines can be used in Brazil, and the government can start the National Immunization Plan.

The Butantan Institute, linked to the São Paulo State Government and which has been working for several months on the development of the Chinese vaccine, and the Fiocruz Foundation, which does the same with AstraZeneca and the British University of Oxford, carried out tests of your antivirus in thousands of volunteers.

With 50.4% and 70% on average 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.

A refrigerated container with China's Sinovac vaccines against the coronavirus disease (COVID-19) arrived at the Sao Paulo International Airport in Guarulhos, Brazil, on December 30, 2020. The banner reads "The Brazilian vaccine".  REUTERS / Amanda Perobelli
A refrigerated container with China’s Sinovac vaccines against the coronavirus disease (COVID-19) arrived at the Sao Paulo International Airport in Guarulhos, Brazil, on December 30, 2020. The banner reads “The vaccine from Brazil.” REUTERS / Amanda Perobelli

Of the 354 million doses of anticovid 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 imported from India on Monday in order 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.


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