Russia approves the first-ever COVID-19 vaccine but experts are concerned
As the entire world is grappling with the coronavirus pandemic, the race for a viable COVID-19 vaccine has intensified. Several countries are in various stages of testing vaccines to fight the virus.
While we may be months away from the final lap owing to the long and careful process of clinical trials, on the 11th of August, Russia registered the world’s first vaccine against the SARS CoV-2 virus named Sputnik V. Addressing the cabinet in a meeting on Tuesday, Russian President Vladimir Putin declared that the vaccine developed by the Gamaleya Institute in Moscow is safe and effective, and has already been given to his own daughter.
The decision was met with outrage and skepticism as the vaccine has been rolled out without the completion of phase three trials. Tested in just 76 people in less than two months, Russia’s Ministry of Health has issued a registration certificate for the vaccine that permits it to be administered to a small portion of the population that is highly vulnerable, including medical workers.
Sputnik V is a dual vector vaccine based on adenovirus—which is linked to common cold. It is fused with the protein of the SARS CoV-2 virus spike helping the immune system produce antibodies to fight the virus. The vaccine is to be administered in two doses, and is claimed to help develop immunity to the coronavirus that causes COVID-19 for at least two years.
However, unlike most vaccines, Sputnik V has been approved before what is known as Phase 3 of clinical trials, which is generally considered a pre-requisite for the mass production of any vaccine. The vaccine has undergone two trials but much of the understanding of the vaccine is lacking as the trial results have not been published. Francois Balloux, an expert at University College London's Genetics Institute asserted that, “Mass vaccination with an improperly tested vaccine is unethical.”
The Association of Clinical Trials Organizations (ACTO) in Moscow, in a letter to the ministry, has advised against fast-tracking the vaccine: “It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth.”
Expert voices around the world chimed in disagreement with the vaccine’s quick approval. Danny Altmann, a professor of Immunology at Imperial College London, said that he could not find any published details of Phase 3 plans for the vaccine and that dispensing this vaccine without knowing its safety "would exacerbate our current problems insurmountably." On social media, Florian Krammer, a virologist at Icahn School of Medicine at Mount Sinai in New York City, expressed his concern, “Nobody knows if it’s safe or if it works. They are putting [health-care workers] and their population at risk.”
Do you think Sputnik V is ready to be deployed for mass use? Share your thoughts in the comments.
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