BRASILIA (Reuters) – The Brazilian pharmaceutical company that will make Russia’s Sputnik V vaccine against COVID-19 expects regulatory approval for Phase III tests by this week or early next at the latest, its Chief Executive Officer Fernando Marques said on Tuesday.
Marques said the strong efficacy results from late stage trials in Russia, published on Tuesday by The Lancet – 91.6% effective against symptomatic COVID-19 – will help speed up approval in Brazil sought by his firm União Quimica.
“As soon as Brazil’s health regulator approves the trials, we will start and they will take 60-90 days,” he told Reuters.
The company has started making pilot lots of the active ingredients for the vaccine at its biotech facility in Brasilia as part of a technology transfer deal with the Russian Direct Investment Fund (RDIF), which is marketing Sputnik V.
Health regulator Anvisa said publication of the results in The Lancet was good news, but it still needed to see complete data from Phase I through III clinical trials.
Marques expects commercial production to start in April and reach 8 million doses a month by May, for sale in Brazil and to neighboring nations that inquired about supplies of the vaccine.
Interest in the Russian vaccine has come from Uruguay, Paraguay, Bolivia and Ecuador, plus Argentina which started vaccinating its people in December with the Russian vaccine.
Marques said his priority was to sell to the Brazilian government for its national immunization program before considering sales to the private sector.
“First the Brazilian population, so the country can return to function normally without this virus disrupting the economy,” said Marques, who is the main owner of the family business.
When production scales up, Marques expects that his company will be able to produce the vaccine for less than $10 for two doses, which are required to inoculate each person.
(Reporting by Anthony Boadle and Tatiana Bautzer; Editing by Alistair Bell)