Health and Family Welfare Minister Dr Harsh Vardhan, speaking at the World Bank Inter-Ministerial Meeting on December 10, announced, “India’s world-class research institutes have spearheaded the campaign against Covid-19 and are currently working towards facilitating capacity-building for producing, distributing and administering the vaccine. 260 vaccine candidates are in different stages of development globally. Out of these, eight are scheduled to be manufactured in India, including three indigenous ones. We have enthusiastically leveraged the support of international partners like Oxford University, UK, and Thomas Jefferson University, USA, for vaccine research with Indian entities, both public and private.”
On January 3, the Subject Expert Committee of the Central Drugs Standard Control Organisation gave the ‘Restricted Emergency Approval’ for Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin. It was noted that Covishield was the result of “transfer of technology” from Oxford/AstraZeneca, that the drug trials for it were conducted abroad and the vaccine was administered to 23,745 individuals above the age of 18, and a Phase II/III clinical trial on 1,600 participants in the country. But it was interim data. The CDSCO found the results of the Covishield trials in India to be commensurate with those overseas. But the clinical trial in India involving the 1,600 volunteers was to continue.
In the case of Covaxin, the CDSCO said that Bharat Biotech shared the safety data of animal trials, and of Phase I and II clinical trials with a sample of 800 volunteers. It also said that Phase III trials were underway, and out of the sample of 25,800 volunteers, data for 22,500 was available till date, and it found it to be safe. It is based on this information that Covaxin was given approval “for restricted use in emergency situation.”
The CDSCO has also given the reasons for giving permission to Covaxin: “…as an abundant caution, in clinical trial mode, to have more options for vaccinations, especially in case of infections by mutant strains.” And it added, “The clinical trial ongoing within the country by the firm will continue.”
The third vaccine candidate, Novel Corona Virus-2019-n Cov-Vaccine, which is based on a DNA platform (whereas Covishield is based on Recombinant Chimpanzee Adenovirus vector, and Covaxin on Vero cell platform) was developed by Cadila Healthcare Ltd. The Phase I/II clinical trials involving 1,000 volunteers was ongoing, the interim data showed that it was safe and that it generated immunogenicity with three doses. And the Subject Expert Committee recommended the Phase III clinical trial, involving 26,000 volunteers.
It is on January 9 that Prime Minister Narendra Modi presided over a high-level meeting of officials, including the Cabinet Secretary, Principal Secretary to the Prime Minister and the Health Secretary. And it was decided that priority groups would be the three-crore healthcare and frontline workers and 27 crore persons above the age of 50. On January 3, Serum’s Adar Poonawala said that he had a stock of 40 to 50 million vaccine doses which were ready to be dispatched, and that the company had the capacity to manufacture 50 to 60 million doses every month. And according to reports, 144 million vaccine doses were distributed to the states and Union Territories, of which 127 million were Covishield and 17 million Covaxin.
The trouble is that the Modi government is keen to manage with these two vaccines under the misplaced belief that they symbolise ‘Atmanirbhar Bharat’. At a time when it was imperative to step up the rate of vaccination, it was rather unwise to depend on just two manufacturers. Of the two, Bharat Biotech is on weaker ground in terms of production capacity.
The government’s thinking was based on a different perception. On January 3, Modi greeted the announcement about Covishield and Covaxin being given the green signal with the tweet: “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Atmanirbhar Bharat, at the root of which is care and compassion.” Strangely the tweet is dated 9.48 pm, January 2, 2021.
The PM’s tweet was quite inaccurate. Covishield vaccine was developed at Oxford University and by the British pharma company, AstraZeneca. All that was done in India was the Phase III trial involving 1,600 volunteers, and the manufacture of the doses in large quantities. Modi had no option but to acknowledge Covishield and somehow appropriate it as Indian. The research and development wing of the Serum Institute of India had no contribution in developing Covishield.
When the ‘interim’ results for the Phase III trials were announced for Covaxin on March 3, Dr Balram Bhargava, director of the Indian Council of Medical Research (ICMR) said, “The bench-to-bedside journey of the completely indigenous Covid-19 vaccine in less than eight months’ time showcases the immense strength of Atmanirbhar Bharat [self-reliant India] to fight the odds and stand tall in the global public health community. It is also a testament to India’s emergence as a global vaccine superpower.”
It indicates quite clearly that the Modi government was keen to use Covaxin to vaccinate India along with Covishield, but the pride of place belonged to Covaxin. The sense of pride in the making of Covaxin is quite justified, but it is a surprise that those at the helm did not think of producing Covaxin in sufficiently large numbers to be administered in India and in other countries. Of course, the mood of triumphalism was much before the second wave surge in the middle of April, and the government had to run hither and thither to buy other vaccines in the market. It was on April 13 that the Drugs Controller General of India (DCGI) gave Dr Reddy’s Labs in Hyderabad, the Indian collaborator of the Russian vaccine, Sputnik V, “restricted use in emergency situations” approval. National pride had to be set aside in the face of an emergency. It still remains a mystery, how and why did the field of eight vaccine candidates in December 2020 get reduced to two in January 2021?
(The writer is a New Delhi-based political commentator)