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.
Late-stage trials of the experimental vaccine, developed with researchers at the University of Oxford, were suspended this week after illness in a study subject in Britain, casting doubt on an early launch.
“Delighted that AstraZeneca has resumed trials. The suspension of trials clearly showed the fallacy of the approach, when entire countries rely exclusively on new and unproven platforms when choosing a vaccine for widespread use, including the use of an adenovirus vector. of mono or mRNA technology, “said Kirill Dmitriev, executive director of the Russian Direct Investment Fund (RDIF).
RDIF said on Friday that more than 1 billion people would receive its COVID-19 “Sputnik-V” vaccine in 2020-21, Interfax news agency reported.
The Russian Direct Investment Fund (RDIF) has already signed two agreements to export the vaccine abroad and in the Brazilian state of Bahia on Friday agreed to conduct phase III clinical trials of the vaccine.
Speaking more about Sputnik-V, Dmitriev said: “We have frequently discussed the potential risks that new technologies can pose, as well as comparing these risks with the Sputnik-V vaccine, which is based on a well-studied platform using human adenoviral vectors. , something that has been shown to be safe and effective. At the same time, in the US and Western Europe, the proven and safe platform of human adenoviral vectors represents only 15% of the volume of total vaccine procurement. “
“The postponement of the clinical trial (by AstraZeneca) calls into question some pharmaceutical companies’ request for full compensation for any risk of their vaccines by purchasing nations. Russia will not follow that approach, as it demonstrated the safety of its platform of human adenoviral vectors, including Sputnik. V, “said Dmitriev.
Oxford University confirmed the resumption, saying: “In large trials like this one, some participants are expected to feel unwell and each case needs to be carefully evaluated to ensure a careful safety assessment.”
After the hiatus, AstraZeneca had said it was hopeful that the vaccine might still be available “by the end of this year, early next year.”
But drug companies, including AstraZeneca and scientists, have raised concerns about political pressure to rush a vaccine, especially 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 purchase 50 million doses to market in Brazil, authorities said.
The Russian vaccine is being developed by the Gamaleya Research Institute in Moscow and commercialized by the Russian Direct Investment Fund (RDIF), which last month also reached 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 the state of Bahia, RDIF said in a statement.
Governor Rui Costa said an agreement was signed this week to carry out the tests and that Bahia will receive 500 initial doses as soon as Brazil’s health regulator Anvisa approves the protocol for the tests.
Bahia is one of several Brazilian states that have stepped up on their own to ensure access to COVID-19 vaccines, motivated at least in part by distrust in 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 world’s first registered coronavirus vaccine, although 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 period of time.
If the trials expected to begin in October are successful, Bahia will seek to commercialize the Russian vaccine in Brazil through its Bahiafarma pharmaceutical research center, said Fabio Vilas-Boas Pinto, Bahia state health secretary.
Brazil has the third highest number of cases in the world, with more than 4 million confirmed cases.
RDIF has already signed several agreements to export the vaccine abroad. Kazakhstan is slated to purchase more than 2 million doses initially and could then increase the volume to 5 million doses.
It also agreed to sell 32 million doses to a private company in Mexico, Landsteiner Scientific.
The fund said this week that it expects to supply up to 100 million doses of the vaccine to Latin America, about a fifth of what it hopes to be able to produce annually through global manufacturing partnerships.
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