Consent form for Covaxin shot a cause for concern

Dr Ranjit Mankeshwar, dean of Grant Medical College and JJ Group of Hospitals, was the first to receive the Covaxin dose at the centre

Healthcare experts on Saturday raised concerns about Bharat Biotech's consent form, given before administering the Covaxin shot, which stated that the vaccine is only being allowed for "emergency use in clinical trial mode". The form also states that the Phase III trial is still underway. This comes after Prime Minister Narendra Modi on Saturday morning announced the launch of two vaccines - Covishield and Covaxin that he said were ready for rollout. Incidentally, health staff being administered the Serum Institute of India's Covishield didn't have to sign any consent form.

Health staff received the Covaxin shot at the COVID-19 vaccination centre at JJ Hospital on Saturday. Pics/Ashish Raje

Around 20,000 Covaxin doses were supplied to the state, along with 9.6 lakh doses from Covishield. A senior state health official, overseeing the vaccination programme, said, "We are in the process of compiling the data, which is expected to come from a few more districts. But, as of 7.30 pm, we have almost achieved nearly 65 per cent of the vaccination programme." The official confirmed that no consent form was given along with Covishield.

When asked about the "consent" form that those receiving Bharat Biotech's Covaxin had to sign, the official said, "Covaxin was distributed to Government medical colleges in Aurangabad and Nagpur, the grant medical colleges in Mumbai and Solapur, and the Amravati and Pune district hospitals. From the information we've received so far, no one had a problem taking the shots."

Dr Ranjit Mankeshwar, dean of Grant Medical College and JJ Group of Hospitals, who was the first to receive the Covaxin dose at the centre, said that apart from some "intra-muscular discomfort," he was absolutely fine. He said that all vaccine participants were told about the consent form. "On Friday evening, during a discussion, a central health official told us that even if 30 to 40 people agree to take the vaccine, it is a positive sign. People are only going to develop confidence, only when they are assured that there are no side effects of the vaccine."

However, Dr Wiqar Shaikh, senior allergy and asthma specialist and professor of medicine at Grant Medical College and Sir JJ Group of Hospitals, felt there was reason to be apprehensive. The consent form for Covaxin mentions that "the Central Licensing Authority has granted permission for sale and distributions of Covaxin for restricted use in emergency situations in public interest as an abundant precaution in clinical trial mode".

Dr Wiqar Shaikh

He said that if the Covaxin has been approved only for clinical trial, the patient has to be explained this before administration of the vaccine. "Particularly, the fact that his/her data will be used in the completion and analysis of the Phase III clinical trials. This confusion needs to be clarified by both, Bharat Biotech as well as the Ministry of Health."

Dr Ketan Vagholkar, professor of surgery at DY Patil Medical College, said that since recipients are not being given any choice in the vaccine they are to receive, they should at least be given a copy of the vaccine statement and the consent form. "Local health regulatory bodies should also ensure that clinical data of each vaccine is made public at each centre."

But, Dr Subhash Hira, professor of global health at the University of Washington-Seattle and advisor to several UN and Indian health agencies, assured that the move is not unprecedented. "Globally too, vaccine delivery is permitted while Phase III vaccine trials are still ongoing." He added, "Nevertheless, the fact that Bharat Biotech has agreed to compensate for serious adverse effects puts to rest another major concern that bioethicists in India and abroad have. We await the government appointment of a central health regulator, who will address all emerging issues of the health sector." Dr Dinesh Thakare, medico-socio legal activist said, "Bharat Biotech coming out with an informed ‘consent' form, also means that the end user of Covaxin is not being cheated. The same should also be done by Serum Institute."

When contacted, Bharat Biotech India Ltd, a spokesperson said that she would revert at the earliest. At the time of going to press, mid-day was yet to receive a response. Meanwhile, Additional Municipal Commissioner (Public Health) Suresh Kakani said the vaccination drive went well at all "nine designated centres, which had forty units".