BRASILIA (Reuters) – The Brazilian pharmaceutical company that plans to produce Russia’s coronavirus vaccine Sputnik V said on Tuesday it expects to overcome regulatory obstacles in “two or three” days to obtain authorization to make and sell the shot in Brazil.
After a 5-hour video conference with União Quimica executives and members of Moscow’s Gamaleya Institute, Brazil’s health regulator Anvisa said there was still information missing before it could approve the vaccine.
“Anvisa still requires a few more things from Moscow on their Phase 3 trials and I expect to deliver those in two or three days,” the company’s chief executive and owner Fernando Marques said.
União Quimica requested emergency use authorization more than two months ago and Marques has complained that “political interests” have held up the approval process for vaccine that is being used in Russia and 40 other countries.
Marques said his company still hopes to start producing the vaccine in April at its Brasilia plant, but a shipment offered by Moscow of 10 million ready-made doses in the first quarter to this year has been lost.
With Brazil’s dire need of vaccines to quell a surge of COVID-19 that made it the epicenter of the pandemic, another source of shots has been sought by state governments unhappy with the slow vaccination program.
So far, less than 8% of the country’s 210 million people have had their first shot, and les than 3% both shots, while deaths from COVID-19 have surged to record levels in the last two weeks driven by a contagious new local variant.
Anvisa said in a statement the meeting dealt with “critical” issues that the developers of Sputnik V have not responded to, included the full results of late stage trials in Russia and access to the data bank of studies on the vaccine.
Anvisa said it also wanted details for quality control of the vaccine’s production in Russia, though it has certified the production line based on a Turkish report for another product.
Source: Read Full Article
