The world has encountered the worst kind of pandemic after almost 100 years, since the beginning of January 2020. The spread of the virus, SARS-CoV2 has challenged scientists all around the world in a ruthless manner.
The COVID-19 disease caused by the infection of SARS CoV-2, was first reported in Wuhan, China in December 2019. Today’s modern and globally-connected world allowed the virus to quickly spread across multiple countries. In India, the first case was reported in January 2020.
This situation demanded for extraordinary efforts from the scientists across the world, working with various vaccine-manufacturing organisations and institutes.
There has been a phenomenal progress in the development of vaccines in a very short time frame required for encountering this challenging situation.
In the midst of a once-in-a-century pandemic, India has been gifted with two vaccines to fight the SARS-COV2 virus. Both these vaccines and their manufacturing organisations should be highly commended for their efforts in addressing the public health needs of India and the world. This has placed India into the top echelon of nations such as the US and China, where more than two COVID-19 vaccines have been developed and manufactured. In fact, India has been blessed by the fact that it has several other vaccines which are under development or under manufacturing scale up.
Product development
Diseases to human beings are caused due to the infections by pathogenic organisms like viruses or bacteria. Vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine used for viral infections typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the virus or using modified genetic material of the known virus in a non-infectious form. The agent stimulates the body’s immune system to recognise the agent as a threat, destroy it, and to further recognise and destroy any of the microorganisms associated with that agent that it may encounter in the future.
Indian scientists and Indian organisations immediately took necessary actions to fight against this deadly infection of SARS CoV-2 which had started spreading fast in India and in many other countries.
In this emergency situation, there were two good options in front of the Indian organisations working in the vaccine field. The first option was to collaborate with reputed international institutes or multi-national companies which can share technology, developed by the basic research to quickly launch the vaccine with technology transfer. In technology transfer model, product development, clinical trial, manufacturing and quality control data is received from the technology-providing organisation.
The second and more challenging option was to use knowledge, vaccine manufacturing expertise acquired in the last many decades and to develop a new vaccine indigenously.
With great efforts, Covishield vaccine was launched with the first option, whereas Covaxin was launched with the later one.
The first option required a highly reliable and technically-advanced competent partner, who can offer the basic research data including clinical studies, strain or stable well-characterised vector to be used as a vaccine and a validated manufacturing process, etc. This option also demanded capable workforce, qualified facilities and adequate resources, along with the technology-receiving company.
The second option demanded for the complete product development cycle, which included stages like virus strain selection, development of the master and working cell cultures, cell bank management, pilot scale studies, scale up studies, process optimisations and validations, quality control tests for the critical quality attributes, stability studies, clinical trials, and finally, a regulatory approval to reach to the commercial product which can be launched in the market. Nevertheless, it also required capable workforce, qualified facilities and adequate resources.
AstraZeneca’s Covishield was successfully launched by Serum Institute in a timely manner which proved to be a great relief to the suffering world. The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222, which is sold under the brand names Covishield and Vaxzevria, among others, is a viral vector vaccine for prevention of COVID-19. It was developed in the UK by the collaboration of Oxford University and a British-Swedish company called AstraZeneca, using a vector-modified chimpanzee adenovirus ChAdOx1.
Covishield has conducted bridging clinical trials in ~2000 subjects in India and has also relied on data from foreign sources to augment and support its data generated from India.
On the other hand, Covaxin was developed by Bharat Biotech in India successfully by completing the herculean research task and generating product development, clinical trial, manufacturing and quality control data by itself indigenously in a stipulated time frame.
COVAXIN has conducted all its clinical trials in India including approximately more than 27,000 subjects, and has published all its data in more than 12 publications, in peer-reviewed journals including The Lancet.
Regulatory process
Both the vaccines received approvals for emergency use in India simultaneously during early January 2021, which was a landmark decision by the Central Drugs Standard Control Organization (CDSCO) and Drugs Controller General of India (DCGI).
This Emergency Use Authorisation (EUA) was granted based on the satisfactory data provided by both these organisations. Covaxin and Covishield dossiers were submitted for regulatory approvals globally with WHO, and several other countries.
One of the most creditable achievement for Bharat Biotech is that Covaxin, as an innovative product, has been submitted for regulatory approvals in the US market, and when it will be successful, it will be considered as a great achievement for our country.
Manufacturing scale
The scale of manufacturing for both the vaccines Covaxin and Covishield has established India as a global vaccines manufacturing powerhouse.
Covishield started with a capacity of 40 million doses per month from January 2021, and reaching to a capacity of 200 million doses per month during November 2021. This is a great feat achieved by no other company in the world under a single location and reiterating the fact that the largest vaccine manufacturer in the world by volume is located in India.
Covaxin modestly started with a monthly capacity of 10 million doses during January 2021, and reaching a capacity of 50 million doses/month during October 2021. Apart from that, Covaxin is a product of the indigenous herculean efforts, this performance is more commendable when one understands the differences in manufacturing complexity between live and inactivated vaccines. Live vaccines such as Covishield are inherently easier to manufacture when compared to inactivated vaccines such as Covaxin. Live vaccines have less process steps than inactivated vaccines resulting in more yields. The live viruses in inactivated vaccines also have to be killed and highly purified in multiple steps to retain only the intact whole viral particles, resulting in losing 80 per cent of the yields.
Conclusion
Serum has successfully provided millions of Covishield dosages with a technology transfer model whereas Bharat Biotech has provided millions of Covaxin dosages with its indigenous technology supporting Atmanirbhar Bharat Abhiyan (Self Reliance Campaign).
India has completed over 100 crore doses within nine months and has also supported many other countries. We are all proud of both the organisations for their great contribution to the humanity. Prime Minister Narendra Modi tweeted “India scripts history. We are witnessing the triumph of Indian Science, enterprise and collective spirit of 130 crore Indians. Congrats India on crossing 100 crores vaccination. Gratitude to our doctors, nurses and all those who worked to achieve this feat.”
Covaxin is like the sun and Covishield is like the moon of the Indian vaccine industry. Like the sun generates heat and light of its own, Bharat Biotech, with its own R&D, has self-illuminated by offering great services to humanity, rescued and blessed India in a short period of time; and, like a moon, Serum Institute has offered services to humanity in the dark night of the pandemic.
Just like how we need the sun and the moon for our survival, our country needs both strategies of innovation and technology transfer. Both the strategies should be respected and the efforts should be appreciated.
Agreed!
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