The trial of the Oxford/AstraZeneca Covid-19 vaccine has resumed after an adverse reaction in a participant. The hiccup shows how risky the technology is, and why Sputnik V is not using it, the Russian vaccine funder’s CEO said.
AstraZeneca announced the suspension of its phase-three trial on Tuesday, after one of the trial participants suffered a “serious adverse reaction.” The trial was resumed on Saturday with the approval of British regulators.
“We are delighted that AstraZeneca has resumed its trials and continues to move forward,” said Kirill Dmitriev, CEO of the Russian Direct Investment Fund, which is financing Sputnik V’s development by Moscow’s Gamaleya Institute.
At the same time, the suspension of trials clearly showed the fallacy of the approach, when entire countries exclusively rely on novel and untested platforms when choosing a vaccine.
AstraZeneca’s vaccine uses a monkey adenovirus that shares a gene with the Covid-19 coronavirus – a platform that hasn’t been subjected to any long-term studies. Russia’s Sputnik V, in contrast, uses human adenoviruses as a vector – an approach that has been studied extensively for more than half a century.
Dmitriev added that the push by Western pharmaceutical companies for indemnity from lawsuits over vaccines illustrates the uncertainty surrounding monkey adenoviruses and mRNA technology – another untested method of vaccine development. AstraZeneca was granted immunity from legal action earlier this summer, while a legal framework to shield pharmaceutical firms already exists in the US.
“Russia will not follow such an approach,” he said, “as it has demonstrated the safety and efficiency of its human adenoviral vector platform, including its Sputnik V vaccine.”
The first batches of Sputnik V have been sent out to all of Russia’s 85 regions, with deliveries expected on Monday. Earlier this month, respected British medical journal The Lancet confirmed that the vaccine was 100 percent effective and caused no serious adverse effects, but stressed the need for further long-term trials.
Russia was criticized in the West for allegedly rushing the development of Sputnik V, and for rolling out the vaccine before concluding a third stage of clinical trials. However, Dmitriev stressed that earlier stages had been just as effective as those conducted by Western pharmaceutical companies, and that the human adenovirus platform has long been regarded as safe.
Sputnik V’s phase-three trials began last month and preliminary results will be published in the coming two months. The Russian shot is the world’s first Covid-19 vaccine to be registered and distributed since the pandemic began. The first batches of the vaccine have been sent to all of the country’s regions to test the supply system, Russia’s Health Minister Mikhail Murashko said on Saturday.
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