On the first day of India’s COVID-19 vaccination drive, healthcare workers from some government hospitals in Delhi expressed apprehension about Covaxin, which was developed by the pharmaceutical company Bharat Biotech. This is due to the government clearing the vaccine for use despite the company having not published any of its phase three clinical trial data. Many health workers refused to go to their vaccination sites on the morning of 16 January.
India granted emergency approval to two vaccines in early January. One was Covishield, manufactured by the Serum Institute of India in association with Oxford University and the British-Swedish pharmaceutical Astrazeneca. The other is Covaxin, made by Bharat Biotech in collaboration with the Indian Council of Medical Research. Astrazeneca’s vaccine has completed phase three trials and the company claims an average efficacy of 70 percent. Covaxin’s phase three trials are still being conducted and there is no efficacy data on the vaccine as of yet. The Covaxin consent form, which beneficiaries have to sign before they get the vaccine, acknowledges that “clinical efficacy of Covaxin is yet to be established and is still being studied in phase three clinical trial.” This lack of efficacy data and the fact that the healthcare workers did not get the chance to choose between the two vaccines led to many doctors opting out of the vaccination drive.
“This is a matter of grave concern,” Dr Pawan Sinhmar, general secretary of the resident doctors association at the All India Institute of Medical Sciences in Delhi, said. “Yes, this is in essence a voluntary exercise. If we were being offered Covishield, we might still have gone for it, but I don’t see the point of getting inoculated with a vaccine whose trial is still going on and whose efficacy is unknown.” Sinhmar is a volunteer in the phase three of the Covaxin trial at AIIMS Delhi and still disapproved of the vaccine being launched for general use before the trial was complete. He told me that if he had not volunteered for the trial, he would not have participated in the vaccination drive held at AIIMS. “There is a difference between volunteering for a trial and getting vaccinated against a disease,” he clarified. “In a trial, you know there are risks involved and you know that you cannot be sure of the efficacy of a vaccine. But when the vaccine has been approved, it should be because it has established efficacy against fighting the disease.”