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Facing shortages, Brazil could turn to Russian vaccine
Renato Alves . Jan 22, 2021
Photo: Vovidzha/Shutterstock
Brazil enjoyed a rare glimmer of hope last weekend, as the first coronavirus vaccinations were administered in the country. However, government officials have warned that immunization may face a 30-to-40-day stoppage, due to a lack of vaccine stocks. Indeed, Brazil is a long way away from being able to offer inoculation to its 211 million inhabitants. It is in this scenario of slim pickings that the Russian-made Sputnik V vaccine has emerged as a potential option for immunizing the Brazilian population.
Constantly dismissed by the government of far-right President Jair Bolsonaro, Sputnik V is gradually becoming a suitable candidate, but lacks regulatory approval.
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<p>As of now, the only coronavirus vaccine Brazil has access to is the Chinese-made <a href="https://brazilian.report/coronavirus-brazil-live-blog/2021/01/12/coronavac-has-overall-efficacy-of-50-4-percent-says-butantan/">CoronaVac</a>, manufactured by the Butantan Biological Institute in <a href="https://brazilian.report/podcast/2020/10/21/podcast-electoral-calculations-around-covid-19-vaccine/">São Paulo</a>, in partnership with pharmaceutical firm Sinovac in China.</p>
<p>CoronaVac began distribution in Brazil on Monday, after health regulators Anvisa approved an emergency use request for 6 million ready-to-use doses. Another emergency request is currently pending, for another 4.8 million shots.</p>
<p>The Butantan Biological Institute is expected to receive a total of 46 million doses by April, which would be enough to vaccinate the high-priority group in the country’s immunization plan. However, there is a lack of inputs to produce CoronaVac in Brazil.</p>
<p>The other immunizer cleared for use in Brazil is the Oxford/AstraZeneca vaccine, but the country has yet to receive a shipment of doses from India.</p>
<h2>Russia offers a solution</h2>
<p>On Thursday, the Indian government confirmed that it would send Brazil 2 million doses of the Oxford/AstraZeneca vaccine, which are expected to arrive on Sunday. However, the country has no assurances of further vaccine shipments from India or China. And this is where Russia could step in.</p>
<p>Unlike many of its peers, the Russian government has been keen to spread its Sputnik V vaccine to as many countries around the world as possible, and there is already a deal in place with pharmaceutical company União Química to manufacture the immunizer in Brazil.</p>
<p>União Química board members met with Anvisa on Thursday, after having submitted an emergency approval request for Sputnik V on January 15. Regulators rejected the petition the following day, saying that it lacked the “minimum requirements for submission and analysis.”</p>
<p>The main sticking point for Sputnik V in Brazil is the fact it has not held late-stage clinical trials in the country, which is one of Anvisa’s prerequisites for analyzing emergency approval requests. </p>
<h2>Vaccines made in Brazil</h2>
<p>União Química reports that it has the capacity to produce around 8 million doses of Sputnik V in its factory on the outskirts of Brasília. The shots would then be packaged at another facility in the city of Guarulhos, outside São Paulo.</p>
<p>“If we produce vaccines on Brazilian soil we will be less dependent on imports and the availability of immunizers on behalf of international laboratories. And this is mainly down to technology transfer,” says União Química’s international business director, Rogério Rosso.</p>
<p>The company adds that another 10 million doses of the vaccine are available to Brazil, which could be shipped from Russia. “Roughly 600,000 would come in January, 3.4 million in February, and 6 million in March,” says Mr. Rosso, who is a former governor of Brazil’s Federal District.</p>
<p>Mr. Rosso points out that over 2 million people are being inoculated with Sputnik V in Russia, Argentina, Paraguay, Belarus, Serbia, Palestina, and Algeria, “with no severe side effects and 91.4 percent [effective].”</p>
<h2>Regulatory hurdles weigh against Sputnik V</h2>
<p>The emergency approval request for Sputnik V was filed by União Química in conjunction with the Russian Direct Investment Fund (RDIF) and the Gamaleya Institute, which led the development of the vaccine.</p>
<p>The Brazilian states of Bahia and Paraná have <a href="https://www.gazetadopovo.com.br/parana/e-dificil-cravar-data-diz-ratinho-jr-sobre-producao-da-vacina-russa-no-parana/">already signed deals</a> to purchase the vaccine. These agreements were reportedly made with the RDIF, which pledged to provide a laboratory in Brazil to manufacture the immunizer.</p>
<p>On Wednesday, Supreme Court Justice Ricardo Lewandowski ordered that a second analysis of the vaccine’s emergency approval request be carried out within 72 hours, after a complaint made by the Bahia state government.</p>
<p>State officials had requested import restrictions be removed on Covid-19 vaccines which had been approved by health regulators in the U.S., European Union, Japan, China, or United Kingdom.</p>
<p>Hungary approved the emergency use of Sputnik V on Thursday, making it the first European Union nation to accept the Russian coronavirus vaccine. Hungarian regulators decided that the immunizer is safe and effective after reviewing data from clinical trials held in Russia.</p>
<p>The eastern European nation joins Argentina, Venezuela, Paraguay, Bolivia, Serbia, the United Arab Emirates, Palestina, Belarus, Turkmenistan, and Russia as the countries which have approved Sputnik V for use.
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