Russia has announced that it has approved a vaccine against COVID-19, but it’s been in testing for only 2 months. Experts worry that the fast approval will lead to safety issues with the vaccine.
Russian authorities have not provided information on the vaccine’s safety, immune response and efficacy. Russian Direct Investment Fund CEO Kirill Dmitriev claims over 20 countries have requested 1 billion doses of the vaccine, named Sputnik V (after the Russian space satellites from the Cold War era) for distribution in foreign markets.
The original four Sputnik spacecrafts circled in space but never made it to the moon. What are the Russians trying to tell us here?
Russian President Vladimir Putin stands by the safety and efficacy of the vaccine and claims it has been given to his own daughters.
Said President Putin:
“I know that it works rather effectively, forms a stable immunity, and, I repeat, it passed all the necessary inspections.”
He says no one should be forced to take the vaccine against their will.
Francois Balloux of the Genetics Institutute, University College, London, U.K., called use of the barely tested vaccine “unethical.”
“Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.”
But Nikolay Briko of the Russian Health Ministry told news agency TASS:
“This vaccine wasn’t developed from scratch, the Gamelei Research Center had a serious, significant research base on vaccines.”
Early stage Russian trials of the vaccine were held at Sechenov University, Moscow. The vaccine technology is based on an adenovirus. (Some versions of the common cold are caused by adenoviruses.) According to scientist Vadim Tarasov of Sechenov University, the artificially created proteins in the vaccine replicate the proteins of SARS-CoV-2, triggering “an immune response similar to that caused by the coronavirus itself.”
Russian scientists now plan to begin a Phase III trial. In these final-stage trials, thousands of human volunteers are tested. Such tests are necessary even when a vaccine has proved safe and effective for humans in smaller trials. Sometimes only in the large Phase III trials do rare and serious vaccine side effects show up. In most nations, no vaccine receives approval without first going through a Phase III trial.
According to Peter Kremsner of University Hospital in Tuebingen, Germany, approving the Russian vaccine without a Phase III trial first is “reckless.” Kremsner is involved with clinical trials of a vaccine candidate from CureVac.
Around the world, 6 other drug manufacturers have COVID-19 vaccine candidates in Phase III trials. Moderna, Pfizer and AstraZeneca all expect to publish final Phase III trial results and safety data by the end of the year. All three companies plan to make over 1 billion doses of vaccine next year. The AstraZeneca trial in Britain could be completed as early as this month. Moderna trial results are expected in November or December.
In China, some experimental vaccines have been approved for use in select groups (like the military), but none of these vaccines have been approved for use in western nations. Clinical trials of these vaccines by Chinese companies are ongoing.
Disclaimer: This article does not provide medical advice. Do not take action based solely on this article and always consult with an appropriate healthcare professional. This article is purely for informational purposes.