RIO DE JANEIRO, BRAZIL – Brazilian pharmaceutical company União Quimica plans to press ahead with production of Russia’s Sputnik V vaccine with a view to exporting it to other parts of South America.
It and Russian sovereign wealth fund RDIF, which is marketing Sputnik V for Russia’s Gamaleya Institute, last week filed for emergency use approval from Brazilian health regulator Anvisa, but were told more documentation was needed.
The company’s international business director, Rogerio Rosso said a new meeting was scheduled with Anvisa on Thursday.
However, “we do not need to have the vaccine registered in Brazil to export it to other countries that have approved it,” he told Reuters in an interview on Tuesday.
Argentina has begun using the Russian vaccine, which has also been registered for use in Bolivia, Venezuela and Paraguay.
An RDIF spokesman said 10 more countries would register it by next week, under emergency use procedures not requiring local clinical trials.
Rosso said the potential market for Sputnik V in Latin America, including Brazil, was 300 million doses in 2021.
“Our priority goal is Brazil, but export is a real opportunity, because the demand for vaccines in the world is much greater than supply,” he said.
RDIF agreed last week in Moscow to supply União Quimica with raw materials to make 10 million doses in the first quarter of 2021 and 150 million by the end of the year, the fund said.
Mexico aims to administer 7.4 million doses of Sputnik V by the end of March which could start arriving next week, even though its use has not yet been approved, according to a government plan presented on Tuesday.
If the Russian vaccine does not obtain emergency use authorization in Brazil, it would need full registration to be used and that can only be granted if Phase III clinical trials are conducted in the country, according to Anvisa.