Russia's COVID-19 vaccine candidate to be registered this week
What's the story
Russian health officials are set to register a vaccine candidate for the novel coronavirus disease, COVID-19, as early as this week. The shot, if cleared by the regulators, will officially become the world's first inoculation against the deadly respiratory infection, which has been wreaking havoc around the world, claiming thousands of lives every day. Here is all you need to know about it.
Clearance
Vaccine may be cleared within 3-7 days of registration
In a recent conversation with state news agency Sputnik News, Russia's Deputy Health Minister, Oleg Gridnev, said that the COVID-19 vaccine candidate will be registered on August 12. Once registered, the regulators might take three to seven days to give necessary approvals and clear the vaccine for widespread civilian use, a person familiar with the process told Bloomberg News.
Stage
Currently, the vaccine is in Phase-3 of human trials
Developed jointly by Gamaleya Institute and the Russian Direct Investment Fund, the COVID-19 vaccine in question is currently moving through Phase-3 human trials, which will be continued following the registration. The clinical data related to Phase-1/2 trials has not been published but Russia's Health Ministry says that it is being reviewed by an expert panel, which will make the decision on the registration.
Phase 3
1,600 volunteers to be vaccinated in Phase-3
In Phase-3, Russia plans to immunize 1,600 volunteers with its vaccine to gain more data on safety and efficacy. These tests will reportedly be carried out parallelly with the vaccinations of civilians. "The trials are extremely important. We have to understand that the vaccine must be safe," Gridnev said, noting, "Medical professionals and senior citizens will be the first to get vaccinated."
Effectiveness
Vaccine being touted as safe and effective
Although there is no official data on the efficacy and safety of this fast-tracked vaccine, it is being touted as effective inoculation, a success story for Russia. Following Phase-1/2 trials, the Russian Defense Ministry said, "The results clearly demonstrate an unmistakable immune response [in all participants] attained through the vaccination. No side effects or issues with the body of the volunteers were found."
Request
WHO has urged Russia to follow established guidelines
With Russia accelerating towards vaccine registration, the World Health Organization urged the country to follow the established guidelines for developing and testing vaccines. "There are established practices and there are guidelines out," WHO spokesman Christian Lindmeier told reporters. "Between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference," he added.
Plan
Mass-production in September, immunization in October
Even as many remain skeptical of Russia's vaccine development and consider it incomplete and unproven, the country is planning to mass-produce it next month and begin wide-immunization drives in October, government officials have said, according to reports. CNN also reports that as many as 20 countries, including India, have shown interest in sourcing the shot, although the report remains unconfirmed as of now.
Information
26 candidates are in human trials
Along with Russia's vaccine, 25 other candidates, including two from India, are moving through clinical human trials. Out of these, six are in the final stage and those from Moderna and Oxford University are leading closest to being available, following complete testing and verification.