Resident doctors of Ram Manohar Lohia Hospital on Saturday demanded that they be given the Covishield vaccine instead of Covaxin as the former has completed its Phase 3 trials. Covaxin, developed by Bharat Biotech, is yet to complete its last stage trials.
The doctors also said that they would not participate in the vaccination process if they are administered the Bharat Biotech vaccine. The Serum Institute is the local maker of the other vaccine, Covishield, developed by Oxford University and pharmaceuticals company AstraZeneca.
“Covaxin manufactured by Bharat Biotech is being preferred over Covishield manufactured by Serum Institute in our hospital,” the Resident Doctors’ Association of the hospital said in a letter to the medical superintendent of the facility. “We would like to bring to your notice that the residents are a bit apprehensive about the lack of complete trial in the case of Covaxin and might not participate in huge numbers, thus defeating the purpose of the vaccination.”
India on Saturday began its coronavirus vaccination drive.
Covaxin has faced reservations from various sections, including the Congress, for getting approval before publishing data for the third phase human trials. However, Indian Council of Medical Research chief Balram Bhargava had defended the decision to grant approval to the two vaccines.
“The existing pandemic situation, high mortality, available science and lack of definitive treatments were considered by the subject expert committee on Covid-19 of CDSCO [Central Drugs Standard Control Organization] for granting accelerated approval to these vaccines, and that is in our legal provision,” he had said. Bharat Biotech developed the vaccine in collaboration with the ICMR.
On the doctors’ demands, Union Health Minister Harsh Vardhan said that there was no question of choosing between the two vaccines, according to NDTV. “We can’t generalise issues like that,” he said. “People should not believe in rumours. A lot of work has gone into making these vaccines.”
Meanwhile, those being administered the Bharat Biotech’s Covaxin were asked to sign consent forms that assured compensation if any adverse effect was found linked to the vaccine. Bhargava had on January 5 said that people who would be given Covaxin would have to sign consent forms since the vaccine has been granted permission for restricted use in clinical trial mode.
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. The form also says that the clinical efficacy of the vaccine is yet to be established and it is still in Phase 3 trials. “Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covid-19 need not be followed,” it says.
The form states that in case of any adverse effect, those who sign the form would be given medically recognised standard of care in a government-designated and authorised centers/hospitals. Compensation would be paid by Bharat Biotech if any serious adverse event is proven to be causally related to the vaccine, it added.
The recipients are also given a factsheet to report any adverse effects. They can note down any adverse symptoms within seven days.
Raising more questions on the efficacy of Covaxin, activist Saket Gokhale has filed a writ petition against Drugs Controller General of India asking that the safety and efficacy data of the vaccine submitted to it be furnished urgently, reported Live Law.
Earlier in the day, Prime Minister Narendra Modi launched India’s coronavirus vaccination drive, as the inoculation process kicked off in 3,006 sites across all states and Union Territories. Modi billed the vaccination process as the largest-ever in history. Around 100 beneficiaries would be vaccinated at each site on the first day.
India registered 15,158 new coronavirus cases on Saturday, taking the overall count to 1,05,42,841. The country’s toll rose by 175 to 1,52,093. The active cases stood at 2,11,033, while the number of recoveries reached 1,01,79,715.