The Putin government hasn’t released any data relating to Phase I and II trials of the COVID-19 vaccine. Trials for Phase III are yet to be conducted.

Countries across the world are in a race to create a vaccine for the novel coronavirus. Russia, which said earlier it would come up with the first vaccine, has kept its promise. Russian President Vladimir Putin on August 11 announced that the country has approved a vaccine against SARS-CoV-2 for widespread use.

The approved Russian vaccine hasn’t completed the final phase of human trial. Putin did not release any data related to vaccine development. Immunologists around the world are doubting the effectiveness and safety of the approved vaccine.

While more than 30 vaccines that are currently in trial stages are not expected to be ready for launch before 2021. The Moscow-based Gamaleya Institute cleared regulatory approvals for the Russian vaccine swiftly, raising concerns.

What do we know so far?

The vaccine was created using adapted strains of a virus called adenovirus to trigger an immune response. Adenovirus is a virus that causes the common cold. Russian scientists said that the vaccine’s early-stage trials were conducted and the results were positive.

Termed as ‘Sputnik V’, in reference to the first satellite launched by the USSR Sputnik 1 in 1957. The Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, which comes under the Russian Health Ministry, developed the vaccine.

The vaccine will be given to humans in two shots, 21 days apart. The vaccine is developed based on the viral vector approach, this is a standard approach being followed by all other groups who are currently developing a vaccine.

Testing conducted so far

A vaccine normally needs to pass three tests before it can be used globally. During the Phase 1 trial, a small group of volunteers were given vaccine shots with the intention to ascertain the safe dose amount. In Phase II, a larger group of people are tested to examine whether the vaccine triggers an immune response and to understand the side effects.

Coming to Phase III is the most important trial round as here, it is studied whether or not the vaccine protects against the virus. Russian scientists claim they conducted Phase I and Phase II trials in the first week of August and said the vaccine had no side effects and triggered an immune response. However, no results have come out in the public domain yet.

Now, Russia has announced its plan to conduct Phase III trials in Brazil, Mexico UAE, and Saudi Arabia. This proves that the Russian government announced a vaccine ‘under trial’ as a successful vaccine against the SARS-CoV-2. 

Till now, the data for Phase I and Phase II has not been released and Phase III will start soon. This proves that there is no authentication to prove that the vaccine is safe and effective.

Criticism around the world

Health experts all around the world have suggested several potential risks this vaccine may cause. Adenovirus used for protein spikes is common among humans, yet with no data available regarding the Russian vaccine we can’t ignore the threat it poses. 

The vaccine may not provide the required immunity to stop the spread of the coronavirus. People who may take it and think they are immune to the virus can end up being a carrier and spread the virus further. This poses serious risks in countries where the virus is still prevailing.  

“This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is 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,” Francois Balloux, a geneticist at University College London, said in a statement distributed by the UK Science Media Centre.

Vaccine development programs

Currently, there are 139 vaccines under development in the pre-clinical stage for the novel coronavirus. While 25 vaccine programs are under the Phase I trial stage, 17 vaccine programs are under the Phase II trial stage, and 7 are under Phase III or the human trial stage.

The vaccine being developed by the University of Oxford is under Phase II/III in the UK and under Phase III in South Africa and Brazil. Vaccines by the American biotech company Moderna are under Phase III, and this vaccine is considered to be mass-produced more easily than a traditional one.