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Russia Produces First Batch of Vaccine; Read on the Roots of Safety Concerns

Russia Produces First Batch of Vaccine; Read on the Roots of Safety Concerns

Russia has produced the first batch of its new vaccine for COVID-19, the Interfax news agency quoted the health ministry as saying on Saturday, hours after the ministry reported the start of manufacturing.

“The first batch of the novel coronavirus vaccine developed by the Gamaleya research institute has been produced,” the health ministry said in a statement quoted by Russian news agencies.

Putin’s announcement on Tuesday about the vaccine was met with caution from scientists and the World Health Organization who said it still needed a rigorous safety review.

Western scientists were sceptical, with some warning that moving too quickly on a vaccine could be dangerous, but Russia denounced criticism as an attempt to undermine Moscow’s research.

Some scientists said they fear that with this fast regulatory approval Moscow may be putting national prestige before safety amid the global race to develop a vaccine against the disease.

Russia has said the vaccine, the first for the coronavirus to go into production, will be rolled out by the end of this month.

Russia has been pushing hard to quickly develop a coronavirus vaccine and said earlier this month it hoped to launch mass production within weeks and turn out "several million" doses per month by next year.

The World Health Organization last week urged Russia to follow established guidelines and go "through all the stages" necessary to develop a safe vaccine. 

The pandemic has seen an unprecedented mobilisation of funding and research to rush through a vaccine that can protect billions of people worldwide.

The vaccine has been named "Sputnik V" in homage to the world's first satellite launched by the Soviet Union. President Vladimir Putin has assured the public that it is safe, adding that one of his daughters had taken it as a volunteer and felt good afterwards.

Moscow's Gamaleya Institute, which developed the vaccine, said previously that Russia would be producing about 5 million doses a month by December-January, Interfax said.

What about the Safety of Russian Vaccine?

Russian President Putin said the vaccine was safe and that one of his own daughters had been inoculated, though clinical trials were not yet complete and final stage testing involving more than 2,000 people only started this week.

Russian approval comes before trials that would normally involve thousands of participants, commonly known as Phase III. Such trials are usually considered essential precursors for a vaccine to secure regulatory approval, this making the first safety concern among people.

The Russian researchers have preregistered phase I and phase II trials, and according to one website for the vaccine, these trials were completed in early August. It claims that there were no adverse effects, and that the vaccine triggered the desired immune response. But no detailed results have been released. It also claims that a phase III trial will commence today in a number of countries including Brazil, Mexico, Saudi Arabia and the UAE.

 A phase I trial involves a small number of volunteers, and is intended to determine a safe dose. Phase II requires more people, because it tests whether the vaccine triggers an immune response, and also looks more carefully for side effects. Then a large phase III trial is used to find out whether the vaccine actually protects against infection. 

In a virtual Palace briefing, Presidential Spokesperson Harry Roque announced that the Philippines will begin Phase 3 of the Russia-funded clinical trials of the vaccine from October 2020 to March 2021.

Phase 3 of clinical trials will be done in the Philippines simultaneously with Russia after a vaccine expert panel review on the results of clinical trials for Phase 1 and Phase 2 is conducted in the month September.

So the Phase III is still pending, the other safety concern.

In other words, the vaccine hasn’t been through the full gamut of tests. Without the data from phase I and II, we don’t know how safe it is. And without phase III, we don’t know if it works. 

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