By Gautam Kumar
"The Prime Minister claiming the world’s largest vaccination program is set to start and the DCGI claiming that the vaccines are 110% safe, is nothing but a nationalistic claim to cover the opaque system of governance in our country."
A disease that changed the entire discourse of economical crisis from a failed state to corona-hit economy, that gave rise to the migrant crisis, that exposed the crumbling health infrastructure, is set to an end with the restricted emergency approval for the vaccine candidates Covaxin (Bharat Biotech & ICMR) and Covishield (Serum Institute of India & Oxford). This comes after the center said it is ready to introduce COVID19 vaccines within 10 days from the date of emergency use authorization. Despite having a history of vaccine hesitancy and certain studies predicting the same in the current situation, the government approved the two candidates in a way that enhances the hesitancy. A survey by Local Circles showed a dramatic increase in the percentage of citizens to 69% who were hesitant to take a vaccine against coronavirus since October 2020.
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| World's largest Vaccination Program is set to begin in India: PM Modi | Photo Credit: ANI |
Many experts have raised serious concerns regarding the due process of emergency use authorization of the vaccines. Further, it is supplemented by the opposition leaders announcing in public that they will not take the vaccine. However, certain leaders who spoke in public regarding the trust issue are not the reason behind this crisis.
Throughout the discourse, actions of the central government indicate the lack of transparency and involvement of political pressure on the Subject Expert Committee (SEC) appointed by the DCGI which approved the two vaccines. This has given birth to the current crisis. Although the issue is not much regarding the Oxford & Serum Institute of India’s Covishield, the controversy majorly revolves around ICMR & Bharat Biotech’s Covaxin. The two, however, were given the emergency approval for two different reasons.
The meeting minutes of the Subject Expert Committee summarizes the whole issue as explained by Chinu Srinivasan of All India Drug Action Network (AIDAN). He said “If you look at the minutes of the meeting from December 30 and Jan 1, 2, there is an intellectual leap. On the first two days, they are asking for data on immunogenicity and efficacy, and then on Jan 2, they are saying they have considered Bharat Biotech’s request and will be giving them “emergency approval. There is no mention of data. The minutes do not reveal what made the SEC change its mind about the data submitted by Bharat Biotech over the course of two days”. Also, in the same article published in National Herald, public health expert Dr. Anant Phadke commented on the minutes, “On December 30, the committee members had one view and two days later, they had another view when in reality the material reality has not changed. These are experts, so why did they not realize the same thing on December 30 itself?”
A vaccine hesitancy arises when there is not much information on the efficacy and the side effects of a vaccine. Two experts, Shahid Jameel while talking to The Wire Science, and Gagandeep Kang while talking to CNBC TV 18, said that Bharat Biotech has not presented efficacy data thus far. Shahid Jameel is the director of Trivedi School of Biosciences at Ashoka University and Gagandeep Kang is an Indian virologist who is a Professor in the Department of Gastrointestinal Sciences at the Christian Medical College.
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| A section of the minutes of the meeting held on 02.01.2021 CDSCO, HQ New Delhi |
Moreover, the meeting minutes of the SEC show that on 2nd January, the firm presented updated data though it was not specified what the updated data was (see the above image). The company only presented efficacy data from the non-human primate challenge study.
Different stories of Covaxin and Covishield
Now, it must be noted that the two candidates “Covaxin” and “Covishield'' are given nod by the Drugs Controller General of India (DCGI) for two different reasons. The nature of approval for both the vaccine candidates are different. It has noted Covishield’s safety and efficacy data from phase 1, 2, and 3 clinical trials. However, with Covaxin, it was such that everyone who got shots of this vaccine would be treated as participants in an open-label clinical trial to ascertain Covaxin efficacy against the new, more contagious strain of the novel coronavirus.
This further is justified by the AIIMS Director Randeep Guleria who said that the central procurement would mainly be Covishield and Covaxin would be considered as a backup. Balram Bhargava, who is the Director-General of the Indian Council of Medical Research said “Bharat Biotech’s vaccine has been given the emergency authorization use license in a preemptive manner because of the new variant strain.” However, in a media Address, Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech International Limited, said that the company doesn’t yet have “confirmatory data” that Covaxin works against the new strain. Journalists during his media address kept asking about the term Open-label clinical trial or clinical trial mode at which Ella said it was all new to him and he needed some time to understand the situation. (See the source)
The vaccine has been approved by the DCGI for something that the vaccine maker is not aware of. Consequently, the government will use Covaxin for something which the vaccine maker is not aware of. It means, the vaccine is trialed (till now) for one purpose and now, it will be used for another purpose which is unknown to Mr. Ella as he said he is not much aware of the Clinical Trial Mode. Technically, if the use-case of vaccine changes, the vaccine maker is required to conduct another set of clinical trials to test the immunogenicity (immune response), safety, and efficacy. Even if we put all our trust in the scientists/doctors who made great efforts to prepare a vaccine for covid19, this is something that must worry us all.
The repercussions of non-transparency
NDTV reportedly spoke to over a dozen people who claim they were misled into taking part in trials held by a local private hospital, the People's College of Medical Sciences. The report says the hospital staff reached out to the people from the poorest and worst 1984 gas tragedy-affected communities and offered ₹ 750 - a princely sum for many in these communities - in exchange for the injection. They said they were not informed about the trial or the risks, but told only that the injection would prevent Covid. However, the hospital says it followed the rules. Madhya Pradesh Medical Education Minister Vishwas Sarang told NDTV the matter would be investigated. The contrasting accounts of the victims and hospital reflect the complex task of vaccine trials in a country with low levels of literacy and awareness. The Covaxin controversy has led to similar conflicts among experts who relatively have better literacy and awareness.
Jitendra Narwaria, 37, who works as a daily wage labourer and is the sole earner for a family of 5, says he was vaccinated few days later, he began vomitting and became feverish, and could not go to work. He said nobody told him it's a trial! #TrustYourVaccine @ndtvindia @ndtv pic.twitter.com/TrFvXmlC8c
— Anurag Dwary (@Anurag_Dwary) January 4, 2021
The Prime Minister claiming the world’s largest vaccination program is set to start and the DCGI claiming that the vaccines are 110% safe, is nothing but a nationalistic claim to cover the opaque system of governance in our country. There is a dire need to tackle the current crisis. The government must release phase 1 and phase 2 data of Covaxin trials in public to put an end to this controversy. Also, the government must define the term “clinical trial mode” coined by the DCGI. If the Covaxin would still be in the trial mode, it is high time for the government to clear its stand on Vaccine Injury compensation in which a volunteer is given compensation whenever there is an adverse event after vaccination.
