Consent form for Covaxin shot a cause for concern

Healthcare experts on Saturday raised concerns about Bharat Biotechrsquos consent form given before administering the Covaxin shot which stated that the vaccine is only being allowed for ldquoemergency use in clinical trial moderdquo 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 vaccinesmdashCovishield and Covaxin that he said were ready for rollout Incidentally health staff being administered the Serum Institute of Indiarsquos Covishield didnrsquot have to sign any consent formHealth staff received the Covaxin shot at the COVID19 vaccination centre at JJ Hospital on Saturday PicsAshish RajeAround 20000 Covaxin doses were supplied to the state along with 96 lakh doses from Covishield A senior state health official overseeing the vaccination programme said ldquoWe are in the process of compiling the data which is expected to come from a few more districts But as of 730 pm we have almost achieved nearly 65 per cent of the vaccination programmerdquo The official confirmed that no consent form was given along with CovishieldWhen asked about the ldquoconsentrdquo form that those receiving Bharat Biotechrsquos Covaxin had to sign the official said ldquoCovaxin 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 wersquove received so far no one had a problem taking the shotsrdquoDr 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 ldquointramuscular discomfortrdquo he was absolutely fine He said that all vaccine participants were told about the consent form ldquoOn 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 vaccinerdquoHowever 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 ldquothe 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 moderdquoDr Wiqar ShaikhHe said that if the Covaxin has been approved only for clinical trial the patient has to be explained this before administration of the vaccine ldquoParticularly the fact that hisher 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 HealthrdquoDr 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 ldquoLocal health regulatory bodies should also ensure that clinical data of each vaccine is made public at each centrerdquoBut Dr Subhash Hira professor of global health at the University of WashingtonSeattle and advisor to several UN and Indian health agencies assured that the move is not unprecedented ldquoGlobally too vaccine delivery is permitted while Phase III vaccine trials are still ongoingrdquo He added ldquoNevertheless 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 sectorrdquo Dr Dinesh Thakare medicosocio legal activist said ldquoBharat Biotech coming out with an informed lsquoconsentrsquo form also means that the end user of Covaxin is not being cheated The same should also be done by Serum InstituterdquoWhen contacted Bharat Biotech India Ltd a spokesperson said that she would revert at the earliest At the time of going to press midday was yet to receive a response Meanwhile Additional Municipal Commissioner Public Health Suresh Kakani said the vaccination drive went well at all ldquonine designated centres which had forty unitsrdquo