When a vaccine is pre-qualified by the WHO, the manufacturers seek the agency’s stamp of quality, and approval for its use.
On Tuesday, 11 August, Russian President Vladimir Putin announced that the country was the first to developed and registered the first vaccine against the novel coronavirus. He claims that the vaccine that offers “immunity” against the SARS-CoV-2 coronavirus.
The World Health Organization (WHO) has responded to Russia’s claim 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.
“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 it’s being popularly called, is a name alluding to the Soviet launch of the first satellite in 1957 that caught the world by surprise. It 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 that WHO has listed as being in early human trials, in its 10 August update on global vaccines. The Russian health minister Mikhail Murashko, however, claims that the vaccine has shown high efficacy and safety, implying that Phase 2 trials have been completed.
“All the volunteers developed high titers of antibodies to COVID-19. At the same time, none of them had serious complications of immunization,” Murashko said.
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.
Over 20 countries, including India, have expressed their interest in the vaccine, according to Kirill Dmitriev, head of the country’s Russian Direct Investment Fund (RDIF) sovereign wealth fund and the main investor in the vaccine’s development.
Russia has got “preliminary applications” from around 20 countries to secure a total of over 1 billion doses of their Gamaleya vaccine, according to Dmitriev. They have inked agreements with five countries to produce a total of 500 million doses a year. The Phase 3 trials of the vaccine are expected to take place in Saudi Arabia, Philippines and the UAE, according to a Financial Times report.
Also read: Philippines to conduct human trials of Russia’s COVID-19 vaccine; President Duterte claims he has ‘huge trust’ in the shot
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 awaited
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 in development, as per a vaccine tracker from the London School of Hygiene & Tropical Medicine, the pandemic has seen 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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