RUSSIA SAYS IT HAS A COVID VACCINE READY. HAS IT JUMPED THE GUN?

There are several COVID-19 vaccine candidates that are racing to pass the approval stage, but the distance seems to be getting longer and longer.  However, as per reports, Russia's Sechenov University is said to have successfully cleared clinical trials of the ‘world's first novel coronavirus vaccine’.

Vadim Tarasov, the Director of the Institute for Translational Medicine and Biotechnology, claimed that the trial of the vaccine developed by the Gamaleya Institute, an epidemiology research centre in Moscow had been completed.

Earlier, the Russian Health Ministry had sanctioned the trial on June 16. The first group of 18 volunteers received the vaccine on June 18, while the second group of 20 volunteers received the vaccine on June 23 at the Practical Research Centre for Interventional Cardiovasology. The first group of volunteers would be discharged on July 15 and the second group on July 20.

WAIT, A VACCINE READY IN LESS THAN A MONTH?!
If these reports are anything to go by, this vaccine cleared ‘clinical trials’ and became the ‘world’s first COVID-19 vaccine’ in under a month of starting trials.

However, the announcement seems baffling considering the fastest vaccine ever to be developed – mumps vaccine – took four years and rarely has any vaccine been developed under 5 years.   

Just to put the improbability of this into perspective, vaccine development involves several stages which span across years. The stages involved during vaccine development are:

Exploratory stage
Pre-clinical stage
Clinical development
Regulatory review and approval
Manufacturing
Quality control

Clinical development has three phases. In Phase I, small groups of people receive the trial vaccine to check if the vaccine is safe for further trails. In Phase II, the clinical study is expanded and vaccine is administered to groups that have characteristics similar to the target population. In Phase III, the vaccine is given to thousands of people and tested for efficacy and mass results to see if there are any side effects.

Compare this to the duration of the Russian study and the sample size of the participants, this most likely corresponds to the Phase 1 of the Clinical development.

So, how reliable is the Russian announcement?
Well, it might just be a case of the authorities being misquoted or maybe the original version has snowballed into something else that now makes it sound like the vaccine has been developed and is ready to be dispatched. At least, that’s what it seem like on social media.

NOT THE FIRST TIME
It is not the first time we have been hearing about a ‘major breakthrough’ or the ‘world’s first COVID-19 vaccine’. Vaccine development is a laborious process and due procedures need to be followed to ensure efficacy and human safety. 

If the processes could be telescoped and the time-frame shortened, as ICMR tried to do last week, vaccine developers in the U.S. and Europe would have already marketed their vaccines by now.

There can be some exceptions or it might be fast-tracked given the nature of the pandemic, however, bypassing crucial phases would mean risking lives, something no vaccine developer of any reputation would dream of. Like they say, you can’t hurry science.

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