"In Case Of Serious Adverse Events...": What Covaxin Consent Form Says And What's Wrong With It

A massive controversy erupted today as India's vaccination drive began with Covid shots to health workers.?Those receiving Bharat Biotech's Covaxin were asked to sign consent forms that assured compensation if any adverse effect was found linked to the vaccine.

The consent form for Covaxin vaccine states that only phase 1 and 2 trials have been completed, and that phase 3 is still on. This comes as both Covishield and Covaxin are being administered to healthcare workers.?

What the consent form says

“In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against COVID-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed,” the consent form reads.

What is wrong with the 'consent form'?

The form says "COVAXINTM" is being offered under restricted use in an emergency situation and has been permitted in "public interest" as an abundant precaution.?

"In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in the government designated and authorized centers/hospitals. The compensation for serious adverse event will be paid by sponsor (BBIL) if the (adverse effect) is proven to be causally related to the vaccine."??

The recipients will also be handed over a factsheet and a form to report adverse effects, in which they have to note down symptoms like fever, pain within seven days.?

This means that vaccine is being administered to thousands of people without the vaccine having cleared?phase 3 trials. Additionally, it?requires a consent form (which covishield does not) and has no alternative available if one refuses to take covaxin.

The clearance to Bharat Biotech's Covaxin, even though it has yet to clear final-stage trials, has been criticized by opposition parties and a section of scientists.

Form against?the entire doctrine of informed consent?

Clamour has grown on Twitter against the vaccine and government, where many claim that "COVID warriors are now effectively nothing more than experimental subjects".?Many from the medical fraternity joined the bandwagon too, questioning the "meaning of such a consent".

In Delhi, for example, six central government hospitals will administer only Covaxin -- AIIMS, Safdarjung, Ram Manohar Lohia hospital, Kalawati Saran Children Hospital, ESI Hospital Basaidarapur and ESI Hospital Rohini. The remaining 75 Sites, which include Delhi government and private hospitals, will receive Covishield shots.

Authorities still defiant?

However, authorities have said that both Covishield and Covaxin approved for emergency use by Drug Controller General of India (DCGI) were safe and that there is no need for apprehension.

Oxford vaccine Covishield, manufactured by the Serum Institute of India, and indigenously developed Covaxin by the Bharat Biotech -- will be administered to priority groups. So far, the Central government has procured 1.1 crore Covishield and 55 lakh Covaxin vaccines at a cost of Rs 200 and Rs 206 per dose, respectively.?

The vaccine will be first offered to the healthcare workers, frontline workers and those above 50 years of age, followed by the below 50 population with comorbidities, and finally to the remaining population based on disease epidemiology and vaccine availability.?