Unlike AstraZeneca's Covid-19 vaccine, Sputnik-V is based on a well-studied platform: RDIF CEO3 min read . Updated: 12 Sep 2020, 09:33 PM IST
'Clinical trial's postponement (by AstraZeneca) puts into question some pharma companies' request for full indemnification from any risks from their vaccines by purchasing countries,' says Kirill Dmitriev
New Delhi: Russia's sovereign wealth fund CEO on Saturday said he's 'delighted' that AstraZeneca has resumed trials of its Covid-19 vaccines but said the suspension of trials "clearly showed fallacy of their approach".
AstraZeneca has resumed British clinical trials of its Covid-19 vaccine, one of the most advanced in development, after receiving the green light from safety watchdogs, the company said on Saturday.
The late-stage trials of the experimental vaccine, developed with researchers from the University of Oxford, were suspended this week after an illness in a study subject in Britain, casting doubts on an early rollout.
"Delighted that AstraZeneca has resumed trials. Suspension of trials clearly showed fallacy of the approach, when entire countries exclusively rely on novel and untested platforms when choosing a vaccine for widespread use, including the use of a monkey adenovirus vector or mRNA technology," said Kirill Dmitriev, CEO, Russian Direct Investment Fund (RDIF).
RDIF said on Friday that more than one billion people would receive its COVID-19 vaccine "Sputnik-V" in 2020-21, the Interfax news agency reported.
The Russian Direct Investment Fund (RDIF) has already signed two deals to export the vaccine abroad and on the Brazilian state of Bahia on Friday agreed to conduct Phase III clinical trials of the vaccine.
Speaking further about Sputnik-V, Dmitriev said, "We've frequently discussed potential risks that new technologies may pose, as well as comparing these risks with Sputnik-V vaccine, which is based on a well-studied platform that uses human adenoviral vectors, something that has been proven to be safe and effective. At the same time in the US and Western Europe, proven and safe platform of human adenoviral vectors account for only 15% of the volume of total vaccine procurement."
"Clinical trial's postponement (by AstraZeneca) puts into question some pharma companies' request for full indemnification from any risks from their vaccines by purchasing nations. Russia won't follow such approach as it demonstrated safety of its human adenoviral vector platform, including Sputnik-V," said Dmitriev.
Oxford University confirmed the resumption and said: "In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety."
After the pause, AstraZeneca had said it remained hopeful that the vaccine could still be available "by the end of this year, early next year".
But pharma companies including AstraZeneca and scientists have expressed concern about political pressure to rush a vaccine out, not least from US President Donald Trump.
The Brazilian state of Bahia has signed an agreement to conduct Phase III clinical trials of Russia's Sputnik V vaccine against COVID-19 and plans to buy 50 million doses to market in Brazil, officials have said.
The Russian vaccine is being developed by Moscow's Gamaleya Research Institute and marketed by the Russian Direct Investment Fund (RDIF), which last month also entered an agreement with the Brazilian state of Paraná to test and produce the vaccine.
Russia will sell up to 50 million doses of the Sputnik-V vaccine to Bahia state, RDIF said in a statement.
Governor Rui Costa said an agreement was signed this week to undertake the trials and Bahia will receive an initial 500 doses as soon as Brazil's health regulator Anvisa approves the protocol for testing.
Bahia is one of several Brazilian states that have struck out on their own to secure access to COVID-19 vaccines, motivated at least in part by a distrust of the federal government's response.
Deliveries are expected to start in November subject to approval by Brazil’s regulators, RDIF said.
Russia has touted Sputnik as the first vaccine against coronavirus to be registered in the world, even though Phase III trials have yet to be completed.
A Phase III trial is a large-scale one involving thousands of people - in Russia, 40,000 - over a longer stretch of time.
If the trials that are expected to start in October are successful, Bahia will look to market the Russian vaccine in Brazil through its pharmaceutical research center Bahiafarma, said Fabio Vilas-Boas Pinto, Bahia state Health Secretary.
Brazil has the world's third largest number of cases, with more than 4 million confirmed cases.
RDIF has already signed several deals to export the vaccine abroad. Kazakhstan is set to buy more than 2 million doses initially and could later increase the volume to 5 million doses.
It has also agreed to sell 32 million doses to a private company in Mexico, Landsteiner Scientific.
The fund said this week it expects to supply up to 100 million doses of the vaccine to Latin America, around a fifth of what it expects to be able to produce annually through global manufacturing partnerships.