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Sputnik-v Does a Bypass on Its Rush to the Podium

Russia's Health Ministry has given regulatory approval for the world’s first COVID-19 vaccine after less than two months of human testing.

SPUTNIK-V DOES A BYPASS ON ITS RUSH TO THE PODIUM

Russia's Health Ministry has given regulatory approval for the world’s first COVID-19 vaccine after less than two months of human testing.

"This morning, for the first time in the world, a vaccine against the new coronavirus was registered in Russia,” announced Russian President Vladimir Putin, on August 10, during a televised video-conference call with his ministers. He said the vaccine has proven effective and efficient during tests and promises to offer sustainable immunity against the coronavirus.

Russia is the first country to register a COVID-19 vaccine, Sputnik-V, well ahead of western timelines and despite incomplete testing. Scientists, both in Russia and abroad, have questioned Moscow's decision to register the vaccine before Phase 3 trials that usually last for months (or even years). But Mr Putin emphasised that the vaccine has undergone the necessary trials and that all vaccinations would be voluntary. The announcement came even though no published information is available about the vaccine’s safety and efficacy, and data has not been made available for independent scientific review. Further, scientists have yet to complete the final phase of clinical testing to determine whether it works.

Russian officials have said that large-scale production of the vaccine will begin in September, and mass vaccination may start as early as October. Among one of the first world leaders to laud Russian efforts was the Philippine President, Rodrigo Duterte, who said that his country is ready to work with Moscow on vaccine trials, supply, and production.

IN THE WORKS

Researchers at the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology, part of the Russian Health Ministry, developed the two-part vaccine. Both parts start with viruses that cause the common cold — adenovirus 5 and adenovirus 26. Using two adenoviruses instead of one is unusual, but may help solve potential problems. This approach is similar to other coronavirus vaccines in the works.

According to a report by Science News, usually, vaccines go through three phases of clinical tests. The first two phases test the vaccine among a small number of people for safety and may collect data on whether antibodies are produced or other responses to the vaccine. The third phase tests the vaccine on thousands of people to determine whether it lowers the infection rate. The crucial third phase has not begun for Sputnik-V. In an open letter to the Minister of Health, the Moscow-based Association of Clinical Trial Organizations has urged the government to delay approval of the vaccine until after Phase III data is in. The Sputnik-V vaccine probably would not be approved for use in other countries without Phase III trials.

TRIAL TRACK

According to the latest trial information on Sputnik-V, available at clinicaltrials.gov, a U.S. website that tracks clinical trials, 38 people first got a shot containing the engineered adenovirus 26 component. Three weeks later, they received booster injections of the engineered adenovirus 5 component. Results of the study have not yet been published. Members of the Russian oligarchy, the armed forces and politicians, including one of Mr Putin’s daughters, have also been given access to the vaccine, says Bloomberg.

FIRST WAVE OF VACCINATIONS

The first set of the produced vaccine will be given to what is considered 'at-risk' groups such as medical and healthcare workers, teachers, first responders, and others on the frontline.

HAS RUSSIA WON?

The very name of the vaccine, Sputnik V — after the Russian satellite that beat the U.S. in the race into space during the Cold War era of intense competition — signals geopolitical considerations in a distorted form of vaccine nationalism, which upholds the ‘my country first’ principle.  

Various reports have emerged about the methods and process used in the development of the vaccine, involving the use of the vast Soviet-era industrial bases and biological capabilities, including testing on state soldiers.

Several countries around the world, including the U.S. and China, are racing to produce a viable vaccine for their populations, but none has been thoroughly vetted yet. The Russians are being accused of data misinformation, intellectual property theft, and inappropriate testing. As countries race towards the finish line, weighty economic concerns, speed, national pride, as well as political and electoral considerations could potentially compromise the safety of the vaccine produced.

ASSESSMENTS

  • Questions abound regarding the international regulatory hurdles and multilateral institutional approval that the vaccine will need to pass before being made available to the public locally and internationally. Apparently, in his typical decisive manner, President Putin could not be bothered by such formalities as long as the rising death rate in Russia can be controlled, besides making for excellent optics internally.
  • In a worst-case scenario, a vaccine that does not work 100 per cent effectively will only serve to decimate the public’s trust in vaccines.  Even scarier is the thought of how the infection will spiral if millions of people give up on basic precautions deeming themselves as immunised.  
  • With its disregard for international protocol, Sputnik V is nowhere close for an international launch.  Therefore, the search for a vaccine for global inoculation goes on.

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