Recently Russia claimed to have produced the first vaccine against COVID-19, and has given the nod to use it for the general public. There has been strong reaction from researchers, especially from the West who believe that Russia didn’t follow the accepted protocol for vaccine production. Russia is among the list of countries who are currently carrying out clinical trials to produce vaccines against COVID-19. Major developed countries like China, USA, Great Britain, France, Germany, Australia, Japan and India have made certain progress in vaccine production. Chinese company, Sinopharm is claiming to introduce vaccine soon in the market, and there are three vaccines under different stages of trial as per recent claim by the Prime Minister of India.
The question arises: Why are developed countries in a haste to make vaccines? It may be recalled that in past vaccine production was a herculean task due to paucity of knowledge about diseases, and whatever efforts were made by doctors in the middle ages and 18th century were exceptional, and overarching purpose was to carry out research and save human life. The most important aspect was that production of vaccine or cure for particular diseases in the Middle Ages and early part of the industrial era was possible after decades. However, in recent times the vaccine industry has grown due to increased know-how & mushrooming of research centers across the globe. The sad part of the story is that vaccine production in 21st century is seen as a business opportunity, pride moment for the nation and a sort of scientific dominance. It is pertinent to mention that the majority of researchers who work tirelessly during various stages of vaccine production are not aware about this motive. Keeping in view the current scenario of vaccine production it is important to understand its history, production process & its politics.
History of vaccines
Historically, the first credit of vaccine production goes to Edward Jenner, when he introduced in 1796 the first natural vaccine against smallpox. However, there has been evidence that Chinese also contributed towards vaccine production and they employed smallpox inoculation around 1000 AD. This method developed by the Chinese was later on adopted by Africa and Turkey, before reaching Europe. The vaccine produced by Louis Pasteur in 1885 against rabies was the next milestone in the history of vaccines. The idea of vaccine production accelerated with the advances in bacteriology in the first quarter of the 1990’s. The development in the field of vaccine further advanced in 1930s and 1940s and vaccines against diphtheria, tetanus, anthrax, cholera, tuberculosis and other diseases were successfully produced. Vaccine research emerged as an active area after the middle of the 20th century as advanced research institutes were established in Europe and the USA. The successful culture of viruses in laboratory conditions, discovery of recombinant DNA technology and new delivery tools helped researchers to look into new directions for vaccine production. At present, vaccine development is not difficult if we compare it with the past (before 20th century) when scientists were having difficulty in saving lives from diseases. However, it is important to know that new emerging diseases are difficult to control as they are smart enough to cross the defense system of the host even after vaccination.
Production process & guideline
The protocol for production of vaccines has drastically changed over the years with the introduction of innovative technology. However, the basic framework is the same which is being currently followed. Major stages for processing of vaccines are simplified for layman understanding:
- Study of disease causing agent
- Selection of vaccine candidate
- In vivo trials
- In vitro trials on experimental animals
- Randomized vaccine trial on human population
- Collection of data and critical analysis
- Submission of data to the approved international health agency
- Approval after scrutiny.
The scientific procedure adopted for vaccine production which is being followed worldwide is as per Vaccine Reference Preparations TRS 932, Annex 2 (WHO). Most of the time (around 70%) is dedicated to quality control checks which represents hundreds of tests.
It is pertinent to mention that the results of experimental testing is critical for final approval and in the recent past some of the vaccines failed through these stages. The minimum duration for production of vaccines in the last 50 years has been reduced to a large extent. However, the pace with which vaccines can be produced has increased manifold in recent years, thanks to technological innovation. Still, the vaccine needs to cross all the major stages of trials and takes at least 12-36 months (duration may vary). The production of complex multivalent vaccine has greater duration i.e. more than 36 month.
Even after crossing all the stages of processing, scientists cannot guarantee the effectiveness of vaccine. That is why some health scientists are skeptical about the vaccine claims of different nations against COVID-19 and argue that the public have to live with the virus for some time. Currently, it seems that various countries are trying to cut short requisite time schedule in order to become the first in the race of vaccine production, which is against the basic principle of scientific and health protocol.
Why do we need to wait for a safe vaccine?
The competition for vaccine production across the globe is a positive message, but hasty decisions may increase the chances of errors if basic protocol and other ethical consideration are not followed in letter and spirit. Vaccine production should not become a matter of pride or dominance for a particular nation, rather it should be considered as selfless service which has been the aim of science over centuries. It seems that there could be a vaccine politics between West and the East, which could hamper the progress for achieving the aim of safe vaccine production. It is important for the World Health Organization (WHO) to come forward and take the lead role for combined efforts for the preparation of a single vaccine (like we had in the past) to avoid any confrontation between different competing parties. Furthermore, the general public should not be in a hurry to compel governments to produce vaccines, rather they should take preventive measures for some time to avoid infection. The dream of a safe and effective vaccine is only possible if the vaccine production process is taken cautiously following all guidelines approved by WHO and other recognized health agencies. Let us hope for the best as hope is the beacon that leads to prosperity.
Dr. Ummer Rashid Zargar is Assistant Professor, Department of Zoology, Govt. Degree College Anantnag.