As the countdown to the Covid-19 vaccination is underway in India, the death of Phase 3 trial participant for Bharat Biotech-ICMR’s Covaxin is once again raising questions regarding the vaccines. However, the firm denies that the death was related to the vaccine.
On Saturday, news reports came out on the death of 45-year-old Deepak Marawai in Bhopal, Madhya Pradesh. Reportedly, Deepak, a daily wage worker, died on December 21, nine days after taking the first shot of Covaxin. Deepak’s post mortem reports said that the cause of death is suspected ‘poisoning’.
Soon, Bharat Biotech issued a statement saying that the death was related to the vaccine or the placebo. “As per the post-mortem report issued by the Gandhi Medical College, Bhopal, the probable cause of death was due to cardio-respiratory failure as a result of suspected poisoning and the case is under police investigation as well. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded,” the firm said, adding that the ‘serious adverse reaction’ had been ‘thoroughly investigated’.
Bharat Biotech also added said several factors can cause an adverse event during a clinical trial, including the patient’s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident.
Last week, Drug Controller General of India VG Somani approved Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin for emergency use. The approval came following the expert committee’s recommendations on January 1 and 2.
“After adequate examination, Central Drugs Standard Control Organisation (CDSCO) has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of Serum Institute of India and Bharat Biotech are being approved for restricted use in an emergency,” a press release said.
However, the decision was criticized in the political as well as scientific communities.
The main issue is that the DCGI approved Covaxin with the Phase III details yet to be released. Independent scientists asked the government how the latter can claim that the vaccine is effective against the mutant strain when there is no published data regarding it. Bharat Biotech, while having furnished hopeful numbers in its first and second phase, has not yet given any data on Phase III. It is especially concerning how the Centre could grant emergency use authorization for such a candidate. There are no peer-reviewed journal articles since the Indian Council of Medical Research hasn’t even published anything on it.
Moreover, the use of language also perplexes many experts. They claim that the use of “clinical trial mode” makes no sense. The fact of the matter is that administering Covaxin as a viable candidate is unethical at this point as the efficacy data is yet to be released. The experts believe that data comes first, depending on which the approval is provided. Besides, the language of the SEC recommendation is different for Covishield and Covaxin, with the wording being complicated for the latter.