India Vaccine
A medical worker inoculates a security staff with a COVID-19 vaccine at Rajiv Gandhi Super Speciality Hospital, in New Delhi on January 19, 2021. Image Credit: AFP

How do you vaccinate a country of 1.3 billion? A gargantuan task indeed. That’s the challenge facing India as it launched a vaccination programme on January 16 to fight the coronavirus pandemic. Size and numbers have never intimidated India. After all, the country has been successfully running the world’s largest democratic exercise for more than seven decades. So the COVID-19 vaccination programme shouldn’t be too difficult despite the enormous hurdles.

Much like the rest of the world, India has been reeling from the onslaught of the coronavirus. COVID-19 infections have surged so much that India is second only to the United States with more than 10.5 million cases and over 150,000 deaths. The economy also has taken a hit. The country applied lockdowns early last year, yet the infections keep soaring. So vaccination offers the best solution to prevent the spread of the virus.

Despite the odds, some things have worked in India’s favour. India, which produces 60 per cent of the vaccines globally, is home to the world largest vaccine manufacturer. Serum Institute of India, which makes around 1.5 billion doses of vaccines a year, has collaborated with the British-Swedish pharma giant AstraZeneca to mass-produce the COVID-19 vaccine developed by the Oxford University. Bharat Biotech International Ltd has developed a home-grown version of the COVID-19 vaccine.

Indian health officials have ample experience in running the world biggest vaccination scheme. The country has a vast, established network which operates the Universal Immunisation Programme, inoculating around 55 million people per year. So there’s a working and dependable system in place. Still, vaccinating 300 million people in eight months is a formidable mission.

Photos: Watch how the first phase unfolded

What’s the vaccination plan?

The enormity of the task hasn’t stopped India from embarking on the world’s biggest vaccination programme. The plan to inoculate 300 million people (the equivalent to the US population) by August in the first phase started with efforts to vaccinate 30 million doctors, nurses and other frontline workers. It will be followed by shots for 270 million people who are either over 50 or in the high-risk group (people with illnesses or conditions that make them vulnerable to COVID-19).

The vaccines in the first phase are given free, and the modalities for more phases are being worked out. On the first day, at least 165,714 people were vaccinated, Dr Manohar Agnani, a health ministry official, said at a briefing, adding that the plan is to inoculate 100 people [a day] in each of the 3,006 vaccination centres across the country.

A digital portal, Co-WIN Vaccine Delivery Management System, will provide real-time information on vaccine stocks, their storage temperature and track the recepients of the vaccines, according to India’s health ministry.

More than 200,000 vaccinators and 370,000 team members have been trained ahead of the rollout. Large-scale trial runs have been conducted, and one trial included 615 districts covering 4,895 session sites in 33 states. At least 29,000 cold storage units have been readied to transport and hold the vaccine.

All this would work well in the first phase, which is mainly limited to urban areas. That wouldn’t be enough since 300 million would constitute only around 20 per cent of the population. The challenges will become more complex as the vaccination programme goes to the villages.

Transportation and storage are significant hurdles given the country’s topography and vast distances. Lack of regular power supply in far-flung places adds to the problems. All this would come up in the planning of the subsequent phases.

Indian officials repeatedly harp that the lessons from organising national elections and the universal vaccination programmes help with the COVID-19 vaccination scheme. But the challenges are manifold and very different. But newer technologies will help tide over many of the obstacles. As always, India will produce home-grown solutions for problems so unique to the country.

The coronavirus doesn’t give options.

India vaccine first phase
Image Credit: Seyyed Llata/Gulf News

What are the vaccines available?

On January 4, India approved two vaccines for emergency use. One was developed by Oxford University, and the other jointly by Indian company Bharat Biotech and the government-run Indian Council of Medical Research. Pfizer India is also reported to have applied for emergency use authorisation for the Pfizer-BioNTech mRNA vaccine.

The Serum Institute of India produces the Oxford University vaccine under the name Covidshield. Bharat Biotech’s indigenously developed vaccine is called Covaxin, and its rollout had come under criticism (see fact box) since its Phase 3 trial results are pending.

Image Credit: Seyyed Llata/Gulf News

What’s Covishield?

Covishield is the vaccine (ChAdOx1 nCoV-19) developed by Oxford University and manufactured in India by the Pune-based Serum Institute of India in partnership pharma major AstraZeneca.

The vaccine: It is made from a weakened version of a common cold virus (adenovirus), modified to prevent it from replicating and causing infection in humans. It can be stored in a regular fridge at temperatures between 2-8 degrees Celcius, making it easy to store and transport in a country as vast as India.

Production: Reports say that the Serum Institute would provide 100 million doses of the vaccine in India and other developing countries. But CEO Adar Poonawalla says the company will export only after India’s requirements are met.

Dosage: The two shots of the Covishield vaccine need to be administered with a gap of four to six weeks.

Efficacy: In interim findings announced in November, researchers say the Oxford vaccine offers an average 70 per cent protection against COVID-19.

Price: “The first 100 million doses of Covishield were being sold to the Indian government at a “special price” of 200 rupees ($2.74) per dose, after which prices would be higher. The vaccine will be sold on the private market at 1,000 rupees ($13.68) per dose,” Poonawalla told the Associated Press.

What’s Covaxin?

Covaxin is India’s home-grown vaccine against the COVID-19. The Hyderabad-based Bharat Biotech develops it in partnership with the Indian Council of Medical Research and the National Institute of Virology in Pune.

The vaccine: Covaxin uses an inactivated or dead coronavirus. The virus’ genetic material triggers an immune response from the body by releasing antibodies, which will fight the virus if it encounters it in the future.

Production: The company says they have 20 million doses now, and it can manufacture 700 million doses in 2021 (annual capacity).

Dosage: Two doses should be given four to six weeks apart

Price: It is not available yet, but reports say it could be less than 100 rupees per dose.

What the vaccine recipients say

Gautam Bhattacharyya, Senior Associate Editor, and Lata Rani, Patna Correspondent

I volunteered to be the first staff in our hospital to take the Covishield vaccine, which has been allotted for West Bengal. A dosage of .5 ml is so minimal that it takes possibly lesser time than that of a Tetvac, and I felt no problems at all. It’s been three days for me, and there have been no side effects.

- Dr Suman Sannigrahi, Bankura Government Hospital, West Bengal

A group of 54 of us took the vaccine on the first day of the programme at our hospital. Only two of them developed mild fever, which can happen with any vaccine, while one of our elderly staff reported a rise in blood pressure which was controlled with medicines.

- Sheila Debta, Nursing Head, Nandigram Super Speciality Hospital, Medinipur, West Bengal

I am very happy after getting the vaccine. That is the only way we can fight COVID-19 and drive coronavirus away from the country.

- Ram Babu, 35, a sanitation worker at a Patna hospital who got the first shot of the vaccine

I am happy to get an India-made vaccine and that we do not have to depend on others for it.

- Gita Devi, a nurse at a hospital in Lucknow, Uttar Pradesh

I had been living under the shadow of COVID-19 fear for the past nine months but now feeling very relaxed. Soon after taking the vaccine, I carried a COVID-19 positive patient on my ambulance, but this time all fears which haunted my mind earlier were gone.

- Amit Kumar, 32, ambulance driver, Patna
What’s the controversy over vaccine approval?
Covishield and Covaxin were approved for emergency use on January 4 by India’s drug regulator, the Central Drugs Standard Control Organisation. Since Covaxin, the indigenous vaccine made by Bharat Biotech, had completed only seven weeks of Phase 3 human trials, it was approved in “clinical trial mode”. India’s Health Minister Dr Harsh Vardhan said the “clinical trial mode” would mean that vaccine recipients will be tracked as if they’re in a trial.
This didn’t go down well with India’s medical fraternity, which accused the government of undue haste in approving Covaxin. But others point out that at least two other vaccines approved for emergency use in the world are awaiting results, and data from the first two phases show that the vaccines are safe and effective. The results of Covaxin’s Phase 3 trials are expected after March.
Adar Poonawalla
Adar Poonawalla, CEO, Serum Institute of India Image Credit: Supplied

Who is Adar Poonawalla?

Alex Abraham, Senior Associate Editor

When Adar Poonawalla, 40, joined the Serum Institute of India in 2001 and became its CEO in 2011, little did he know that the eyes of the world would be on him in a decade, hoping his company would mass-produce the vaccine that was so badly needed in the fight against COVID-19.

For Poonawalla, national pride is at stake. “The way the world has looked at India now, it’s been overwhelming because we were always ignored and thought about as backwards, in many respects,” Poonawalla said in an interview with The New York Times. “The world now has to recognise the capabilities of India to service the world and help the world, and that’s exactly what we’re doing,” he said.

Poonawalla is the son of Dr Cyrus Poonawalla, the billionaire who founded the company in 1966. And Serum Institute, by doses sold, is the world’s biggest vaccine manufacturer, producing a range of protections against diseases like polio, diphtheria, tetanus and measles. In fact, the company mass produces millions of doses of vaccines for sale in the poorest countries.

Photos: See the driving force behind Serum Institute

From stud farm to vaccines

Adar’s father, Cyrus Poonawalla, had figured out in the early 1960s that the family’s decades-old stud farm had no future. After trying his hand at designing a sports car, Cyrus focused on The Poonawalla Stud Farms which had been donating horses to a government-owned institute in Mumbai to obtain serum.

Serum from horse blood can give people the antibodies necessary to fight off some diseases, creating what is known as passive immunity. Tetanus serums began to be made in-house, leading to the production of tetanus and measles vaccines.

The elder Poonawalla felt he had a responsibility to set right the inequality in health care after seeing millions of children dying of preventable diseases in India and Africa. And he set up the Serum Institute of India in 1966 in Pune.

The Serum Institute supplies 4 out of 10 of the vaccines funded by GAVI, the Vaccine Alliance, and sells about 1.5 billion doses of a range of vaccines a year to 170 countries.

Adar Poonawalla, a Business Management graduate from the University of Westminster in London, concentrated on the company’s international market of 35 countries and got new products licensed and pre-qualified by the World Health Organisation, for supply to United Nations Agencies including the Unicef. In 2015, the company was exporting its products to over 140 countries, with 85 per cent of its revenues from abroad.

He is the recipient of many business and philanthropy awards and was listed as one of the 50 most influential young Indians by the GQ Magazine.

Krishna Ella
Krishna Ella, managing director of Bharat Biotech, Hyderabad, India Image Credit: PTI

Who’s Krishna Ella?

A research scientist in molecular biology, Dr Krishna Ella is the chairman and managing director of Bharat Biotech International Limited, according to the company website.

Hailing from a farming family in Thiruttani, at the border of Tamil Nadu and Andhra Pradesh, Ella obtained a PhD from the University of Wisconsin-Madison and worked at the Medical University of South Carolina. In 1996, Ellas and his wife Suchitra Ella launched Bharat Biotech at Genome Valley in Hyderabad to produce an indigenous Hepatitis B vaccine.

It diversified its portfolio with vaccines for rabies, polio, Japanese encephalitis, H1N1 influenza, and worked on an unsuccessful malaria vaccine, according to the Indian Express. Bharat Biotech grew to become a leading vaccine-maker, with more than 15 vaccines in the market.

Bharat Biotech makes Covaxin, one of the two COVID-19 vaccines that have been approved for emergency use in India. But the vaccine was dogged by controversy due to the unavailability of Phase 3 results (which will be ready after March).

“Don’t accuse us of inexperience. We are a global company...have manufactured 16 vaccines. It is not correct to say we are not transparent with data,” Dr Ella told Newstrack.