All citizens who are to be administered Bharat Biotech’s Covaxin during India's nationwide vaccination drive on January 16 will be required to sign a consent form before they can be given the first shot. The consent form for the Bharat Biotech’s Covaxin vaccine states that only phase 1 and 2 trials have been completed, and that phase 3 is still on. This comes as the vaccine drive for COVID-19 kicks off on Saturday, with both Covishield and Covaxin being administered to healthcare workers. “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.
It states that the Central Licensing Authority has granted permission for the sale or distribution of Covaxin for restricted use in an emergency situation in public interest “as an abundant precaution, in clinical trial mode.”
“In case of any adverse events or serious adverse events, you will be provided medically recognised standard of care in the government designated and authorised centers/hospitals,” it adds.
For those receiving Covaxin, their health status will be examined and scrutinised before giving the vaccine and after vaccination they will be monitored for seven days for any adverse events. Similar process will be followed after the second dose which will be given after four weeks.
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.
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.
In Chennai, the consent form was only available in English, and not in Tamil as only nurses and doctors are receiving the vaccine. It will be available from Sunday, authorities said.
At the Rajiv Gandhi Government General Hospital in Chennai, 52 persons have been registered for Covishield and 31 persons have been registered to receive Covaxin.
In Andhra, at the Vijayawada Government General Hospital where Chief Minister Jagan Mohan Reddy will be observing, only Covishield is being administered. The state has received 4.77 lakh doses of Covishield and 20,000 of Covaxin, so the Bharat Biotech vaccine has been kept in reserve.