INTERNATIONAL / ETHICS/ SCIENCE & TECH
Topic: General Studies 2,4:
- Effect of policies and politics of developed and developing countries on India’s interests
- Ethical issues in international relations and funding
Russia is jumping the gun with its vaccine
Context: Russian President Vladimir Putin announced the ‘approval’ of Russian COVID-19 vaccine, Sputnik V
Three Stages of Clinical Trials to test the safety & efficacy of drug
- Phase I: with an average sample size of less than 100, it is the preliminary study of safety, where the objective is to find the acceptable dose level which will not cause serious side-effects.
- Phase II is a study of safety and efficacy together, with a few hundred people or even fewer.
- Phase III- It is a detailed evaluation of effectiveness in comparison to some existing treatment or some similar-looking treatment having no effect (called placebo). This involves hundred to thousands of people. This stage even allows scientists to look for rare side-effects that can’t be spotted in smaller, earlier stage trials
What happens after three phases of Clinical Trials?
- After the three phases, if the vaccine is found to be safe and effective, the study report is forwarded to the regulatory agency, which, if convinced, permits its usage en masse.
- Phase IV is the postmarketing surveillance stage. Such surveillance can only be conducted after the drug is marketed.
Concerns with Russian Vaccine
- Standard Procedure not followed: The approval came before phase III of the required clinical trial was even started.
- Inadequately vetted vaccine: Russia has claimed to have tested its vaccine on just 76 people in the first two phases.
- Lack transparency: No research article is available in the public domain about the Russian vaccine.
- Researchers worldwide who are developing vaccines for COVID-19 publish their studies in peer-reviewed journals, which are constantly scrutinised by the relevant scientific community. The community, in effect, enhances the credibility of these studies.
- Short Duration: Russian vaccine is dangerously rushed — it got approval in less than two months of starting the trial.
- Top scientists and even WHO have repeatedly maintained that a vaccine is not expected before 12-18 months.
- Durability of Vaccine unknown: Nobody knows the durability of the antibody created by the Russian vaccine — is it durable for a few years or a few weeks?
- Impact on different segments of population untested:
- A carefully conducted clinical trials might even show that a vaccine could be harmful for a section of the population.
- For example, a new type of measles vaccine in the early 1990s was found to be detrimental to baby girls, and so it was never licensed for the general population.
- Lacks Support of Russian Doctors:
- In a survey of 3,040 Russian doctors and health specialists, conducted by the Doctor’s Handbook app, 52% said they were not ready to be vaccinated; only 24.5% said they were
- A leading respiratory doctor in Russia has quit the Health Ministry citing “gross violations” of medical ethics in the development of the COVID-19 vaccine.
Consequences of Russian Vaccine
- It is potentially dangerous for the people who receive it
- It could also impede global efforts to develop quality COVID-19 immunisations.
- Reduces the trust factor in vaccination programmes.
- Leads to Vaccine Nationalism (dealt in separate Article)
- People taking the Russian vaccine at this stage would effectively be part of a grand phase III clinical trial.