The World Health Organization has responded to Russia's claim of having developed and registered the first vaccine against the novel coronavirus by saying that a rigorous review of the vaccine's safety data needs to be submitted if the country wants the WHO's stamp of approval. Russian President Vladimir Putin announced Tuesday that the country was the first to approve a vaccine that offers "immunity" against the SARS-CoV-2 coronavirus.
"Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data," Tarik Jasarevic, spokesperson for WHO, said during an online press briefing.
"We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine."
Registered but unverified Sputnik V vaccine
The 'Sputnik V' vaccine, as its being called, was developed by Russia's Gamaleya Research Institute along with the Russian Defence ministry. The Gamaleya vaccine is one of two candidates from Russia, and is among 21 candidates from around the world in Phase 1 trials, as per a WHO update on global vaccines on 10 August.
Kirill Dmitriev, head of the country's Russian Direct Investment Fund sovereign wealth fund and the main investor in the vaccine's development, said that Russia had already received requests from more than 20 countries to pre-order a total of over 1 billion doses.
Phase 3 trials, he said, begin on Wednesday, and industrial production is expected to begin by September this year. Russian Health Minister Murashko said that a mass vaccination campaign against the novel coronavirus will begin in October, with the first doses given to doctors and teachers, as per a Livemint report. The vaccine will also be 'free of charge', with the expenses coming out of the national budget, he added.
While Russia has made clear its intent on being the first in the world to develop a vaccine against COVID-19, there is still no large-scale trial of the vaccine to support the claim that it works. This is, experts told Reuters, a "reckless" step.
"Russia is essentially conducting a large population level experiment," Ayfer Ali, specialist at Britain’s Warwick Business School's research wing, said. Approvals that come through very quickly could mean that adverse effects of the vaccine may not have been studied or recorded.
While adverse effects are rare in nature for vaccines, part of the reason for this is the lengthy processes of observation and approval before releasing a vaccine for the general population. Even if any adverse effects do come about, they could be serious and cause lifelong damage, Ali said.
WHO's stamp of approval
Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory, Jasarevic explained at the WHO briefing. "WHO has in place a process of pre-qualification for vaccines but also for medicines," he said.
When a vaccine is pre-qualified by the WHO, the manufacturers seek the agency's stamp of quality and approval for its use.
"To get this, there is a review and assessment of all required safety and efficacy data that are gathered through the clinical trials. WHO will do this for any candidate vaccine," Reuters quoted Jasarevic as saying.
With an estimated 230 vaccine candidates, as per a vaccine tracker from the London School of Hygiene & Tropical Medicine, the pandemic has prompted an unprecedented mobilization of research and funding to find a working prevention tool against the coronavirus.
"As we have been always saying, we hope some of these vaccines will prove to be safe and efficient," Jasarevic said. "But accelerating progress does not mean compromising on safety," he added.
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