Russia Announces World's First Covid-19 Vaccine : WHO To Do 'Rigorous Review' Before Approval

  • August 13, 2020
  • Health

On Tuesday, August 11, Russian President Vladimir Putin announced that the country has ‘registered and developed’ world's first coronavirus vaccine, named 'Sputnik V' after the first artificial Earth satellite launched by the Soviet Union in 1957.

The announcement however, garnered mixed reactions, with The World Health Organization (WHO) and scientists being doubtful about it in the absence of proper human trials.

What Russia Claimed

Putin told media that this vaccine developed by Russia's Gamaleya Research Institute along with the Russian Defence ministry offers "sustainable immunity" against the SARS-CoV-2 coronavirus.

In June, the Gamaleya Research Institute of Epidemiology and Microbiology at the Health Ministry of the Russian Federation registered a combined Phase 1 and 2 trial on a vaccine and planned to test it on 38 volunteers.

"All the volunteers developed high titers of antibodies to COVID-19. At the same time, none of them had serious complications of immunization," the Russian health minister Mikhail Murashko, claimed on Tuesday. He further added that there will be mass vaccination campaign in October and it would be initially given to doctors and teachers. The vaccine is expected to go into civilian circulation on 1 January 2021, according to the registration certificate.

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" for over 1 billion doses of the vaccine from around 20 countries "Along with our foreign partners, we are already prepared to manufacture over 500 million doses of vaccine per year in five countries, and the plan is to ramp-up production capacity even higher," he added.

 

WHO’s Reaction?

World Health Organization (WHO) seems anxious of the safety and efficacy of this vaccine in view of accelerated clinical trials. “We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine, but again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data," WHO spokesman Tarik Jasarevic told media.

The Gamaleya vaccine is one of two candidates from Russia, and is among 21 global vaccine candidates in the human trial - clinical evaluation stage that WHO listed in its previous update on global vaccines. Referring this Jasarevic added, "As we have been always saying, we hope some of these vaccines will prove to be safe and efficient…But accelerating progress does not mean compromising on safety."

 

What Experts Believe

Russian President, in his statement on Tuesday, tried to assure the safety and efficacy of the vaccine by mentioning that one of his daughters has been inoculated with it. “One of my daughters had this vaccine. I think in this sense she took part in the experiment," he said. However, experts all over the world are skeptical about it and believes it hasn't been tested properly.

Rushed Trials, Not Studied Properly

Phase 1 and 2 trial were hurriedly completed within two months, which otherwise would have taken a year. Scientists have doubts about the efficacy and safety of the vaccine as Gamaleya Research Institute has not yet published its Phase 1 and 2 trial data, even after the official announcement by president on Tuesday.

  • “Unless some data are out in the open for people to see, including clinical trial phases and numbers, it is hard to believe that vaccine efficacy studies are successfully conducted between June 2020 and August 2020,” said Vineeta Bal, an immunologist from the Indian Institute of Science, Education and Research in Pune
  • Ayfer Ali, specialist at Britain’s Warwick Business School's research wing, considers it a large population level experiment. “Approvals that come through very quickly could mean that adverse effects of the vaccine may not have been studied or recorded”, he said
  • Even the results of clinical trials are not available "There's no data, there's no transparency, there's no FDA in Russia [and] they've got a history of approving drugs and vaccines with little or no testing," said Pitts, who is also President of the Centre for Medicine in the Public Interest.

Cleared without Phase 3 human trials.

Russia’s vaccine is being rushed to production even though the institute hasn’t completed Phase 3 trials. Scientists believe that Phase 3 trials can fail or reveal uncommon side effects that may not have shown up in the in the earlier phases. "Even vaccines that have produced promising data from early trials in humans have flopped at later stages,” notes Natalie Dean, a biostatistician and infectious disease expert at the University of Florida.

Tested on less population

Experts are of the opinion that this vaccine can cause serious and lifelong damage to people as it has been passed without large scale human trials. A Russian website claims that Phase 3 efficacy trial began on August 12, involving more than 2,000 people in Russia, the United Arab Emirates, Saudi Arabia, Brazil and Mexico. Whereas, all other ongoing Phase 3 human trials of coronavirus vaccines are almost ten times larger than this, with around 30,000 volunteers each.

 

In a nutshell, scientists advise that we should not pay heed to such ‘political statements’ and continue our efforts in ‘development of a solid, science-based vaccine’. Vaccines are among the safest medical products in the world and must go through intense rigorous clinical trials that test their safety and effectiveness.

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