Russian President Vladimir Putin on August 11, 2020, announced that Russia has launched the first vaccine worldwide against SARS-CoV-2 with the cooperation of Gamaleya National Research Centre and the Defense Ministry of Russia, the vaccine has also achieved regulatory approval and has been named Sputnik V.
As optimistic as it sounds, is this vaccine really as credible as it proclaims to be? Or is it just a matter of ambition and pride for Russia to come first in this race of developing a vaccine against COVID-19, as much as we all want this vaccine to work, we must first go through some fact-checking.
The Process of Developing A Vaccine:
Developing a vaccine for a virus is no easy task, it has taken several decades for some vaccines to developing because it is not just a matter of creating it but it is also a matter of checking it on several humans and will it be productive for all of them, the vaccine that has consumed the least number of years against a virus is that of Mumps, it took four years to develop its vaccine during World War II.
While averagely a vaccine takes not less than 20 years to develop, in the present situation it has been just nine months that the world is trying to invent a vaccine against this virus that has infected over two million people across the globe.
After a vaccine is manufactured and tested on animals, it then has to be successful in all the three Phases of its testing:
- Phase 1: This is to give an idea of the amount of vaccine needed and in what dosage it must be given to the infected
- Phase 2: During this phase, the vaccine is tested in the required dose on a larger group of people to assess the response on various genders, ages, ethnicity, etc.
- Phase 3: This is the most important and the trickiest phase while trying out a vaccine, in this phase the vaccine is tested on a much larger group of target people with distinctiveness to accomplish how the vaccine works on a varied group of individuals, the trials conducted in this phase determine whether the registration and market use of a vaccine is safe or not.
A Major Question Mark on Sputnik V:
While Russia has proudly claimed that it has created the first-ever Corona Vaccine and will be marketing it soon, beginning with teachers and health workers, there is one question of prime importance that should be considered which is, whether they have conducted the Phase 3 trials?
This phase takes months and there is no clear news of Russia having concluded the phase 3 trials. It began Phase 1 trials on 17th June and released the results later in mid-July showing that none of the volunteers were infected, beginning from July 13th it initiated phase 2 of the clinical testing and later reported on August 3rd that the trials have successfully been completed, however, there was no public disclosure of the same.
Russia asserts to complete the Phase 3 trials after the regulatory approval, which is such a big loophole for the acceptance of this vaccine.
Experts concerns over the Russian vaccine:
The vaccine has quite naturally become the talk of the town and there have been several questions and concerns raised by many experts from all around the world related to the Sputnik V and the speed with which it is being launched, some of these are:
- The first and the foremost is from WHO, asking Russia to slow down the process as all the phases of clinical testing of the vaccine are essential.
- An Association of Clinical Trial Organisation from Moscow has urged the Russian Government to collect the phase 3 data and then receive the approval, in an open letter to the Ministry of health.
- Onyema Ogbuagu from Yale School of Medicine, who is also conducting phase 3 testing of Pfizer has called the process of Russia reckless without phase 3 data.
- Germany’s Health Minister has produced a warning saying it hasn’t been fully tested.
- Dr. Fauci who is a top US infectious disease specialist has also raised concerns on the hasty approach of Russia.
Concluding all of the above information and questions on the Vaccine, it does not seem fit to use this vaccine in a country like India, with Billions of people without testing and completion of all the clinical trials required for registration of a vaccine.
Till then let’s all hope and pray that Sputnik V helps us combat this pandemic as it claims to do.