The Other Vaccine

Covaxin, the country’s first indigenous vaccine against the coronavirus, has been in the eye of the storm. In the summer of 2020 as Covid cases rose and a vaccine was still elusive, the emergence of an Indian vaccine came as a ray of hope, but was clouded by scepticism given the deadline set by the Government for a vaccine to be ready.

The Covaxin story began when the Indian Council of Medical Research’s (ICMR) National Institute of Virology (NIV), Pune, isolated strains of the SARS-CoV2 virus, less than two months after the first Covid case was reported in India on January 30th, 2020. By early May, Hyderabad-based biotechnology company Bharat Biotech received the strain. Since then, behind the secure walls of the Bio-Safety Level 3 (BSL-3) high containment facility in Genome Valley, about a hundred invisible faces pored over developing a vaccine against the coronavirus. For the next couple of months, they dedicated themselves to their mission, desisting from going home to their families, as a precaution against any chance of exposing them to the virus. In two months, the team completed animal toxicology and immunisation on rat, mice and rabbits, establishing 100 per cent safety on the animals.

Outside the high walls of the facility, Covaxin created a flutter. The Drug Controller General of India (DCGI) cleared it for human trials on June 29th. When Bharat Biotech announced that it has successfully developed Covaxin, BBV152, an inactivated virus-based Covid vaccine, in collaboration with ICMR and NIV, the company’s founder Krishna Ella, a scientist-turned-entrepreneur, was still unsure of the returns on investment. He described it as a “moral responsibility”. The company had shut down its injectable polio project and converted it for development of the coronavirus vaccine.

The announcement came on a day when Prime Minister Narendra Modi had reviewed India’s preparations for vaccinating the country’s over 130 crore population. June had witnessed a 66 per cent increase in the number of Covid cases reported till then. Two days later, ICMR Director General Balram Bhargava, in a letter to the 12 institutions chosen as clinical trial sites for the vaccines, underlined the need to fast-track the vaccine trials. He set a deadline of July 7th to enrol candidates for trials.

The haste sparked off a controversy, raising experts’ eyebrows and drawing political criticism, casting a shadow over the jubilation of developing an indigenous vaccine.

A low-profile Ella, who termed the vaccine as a “small drop in the ocean”, however, had not indicated any timetable for it. His goal was to give global access to people who needed the vaccine most. Bharat Biotech evaded getting drawn into the row, maintaining a stoic silence.

According to Dr Rajni Kant, director, ICMR Regional Medical Research Centre (RMRC), Gorakhpur, and head, Research Management, Policy, Planning and Coordination, ICMR Headquarters, Covaxin has shown safety and efficacy in pre-clinical, Phase 1 and Phase 2 studies. Bharat Biotech was chosen because of its state-of-the-art facilities and ICMR’s experience of working with it.

The dust had barely settled on the controversy over rushing the vaccine when it got embroiled in a new one. Covaxin, along with Covishield developed by Oxford University and AstraZeneca Plc, got the DCGI’s approval on January 3rd this year, even before the Phase 3 trial data for the Bharat Biotech vaccine was available. Ella, pushed into defending the vaccine, told the media that permission for Covaxin was based on immunogenicity data. “The tests on hamsters and monkeys displayed 100 per cent protection offering the best animal challenging data compared to other vaccines.” He said that approval means that the company will no longer be required to have a placebo group in its ongoing human clinical trial, and will vaccinate people in an open-label format. Vouching for its safety, he sought a few days to announce its efficacy level, as done by Pfizer, Moderna and AstraZeneca.

The Government came out with an explanation justifying its nod for Covaxin, and said it was for “restricted emergency use”. Health Minister Harsh Vardhan said Covaxin would be used in clinical trial mode, and claimed that it was more likely to work against newer variants like the UK one. Amidst apprehensions over its authorisation, the Government has ordered 40 lakh doses of Covaxin at Rs 309 each, besides 1.1 crore from the Serum Institute of India (SII) at Rs 220 per dose, for the inoculation drive beginning on January 16th. Covaxin was being purchased at a higher price because Bharat Biotech was also giving 16.5 lakh doses free of cost, taking the cost per dose to Rs 206.

Covaxin is based on traditional technology, in which vaccines insert an inactivated virus into the body. In the new mRNA vaccines, they teach cells how to make a protein to trigger an immune response inside the body, which produces antibodies protecting against the virus. Dr Sanjay Rai, who is the principal investigator for Covaxin trials at the All India Institute of Medical Sciences (AIIMS), says the main objective during Phase 1 trial was to establish the safety of the vaccine. “Covaxin is based on an old technology of making vaccine. That’s why the safety concern is minimal, even in the long term. There are nine vaccines in the world and two—Pfizer and Moderna—use the new mRNA method, for which there’s no evidence of long-term safety. All the information is in the public domain. Those who are in a dilemma should find out.”

Just when Covaxin was battling controversy, SII’s Adar Poonawalla said that apart from Covishield, only vaccines by Pfizer and Moderna had shown efficacy while others, including Covaxin, were only “safe, like water”. Ella, at a press conference refuted the charge, and said his company had carried out a “200% honest trial in national interest” without any financial aid, and did not deserve such a backlash.

For Ella, the biggest challenge is yet to come, once the vaccines start rolling out. As of now, he has moved away from public glare, focusing on the vaccine, for which Phase 3 trials involving 25,800 volunteers across India, each of whom will get two doses in a space of 28 days, had begun in November.

Founded in 1996, when Ella returned from the US after studying molecular biology, Bharat Biotech was started with a total cost of Rs 12.5 crore. It has a track record of innovation with more than 140 global patents, a product portfolio of more than 16 vaccines, delivering four billion doses of vaccines worldwide, four bio-therapeutics, registrations in more than 116 countries and WHO pre-qualifications. Among its biggest achievements is Rotavac, the vaccine for Rotavirus, the leading cause of diarrhoea in children across India.

In an interview nearly a decade ago, Ella had drawn similarities between science and business. “For both, you plan and implement ideas. If it is hypothesis in science, it is business plan in business. If it’s risk analysis in business, it’s testing the methods in science…There are dogmas against high technology and high capital-intensive projects. What I had planned was high technology and high capital intensive. The third dogma was the feeling that Indians could not do it. Fourth dogma was the belief that a scientist could not think like an entrepreneur.”

As of today, Ella is thinking more like a scientist.

About The Author

Amita Shah