Clouds of doubt still looming, India's COVID vaccination drive begins
A consent form that the beneficiaries of Covaxin have to sign states that medical care and compensation will be given if any adverse effect was found.
As India begins the world’s largest vaccination drive across the country on Saturday, the doubts and differences around the use of Bharat Biotech’s Covaxin also continue to echo as India’s frontline workers get vaccinated in the first phase. Oxford-AstraZeneca’s Covishield developed by the Pune-based Serum Institute of India and Covaxin are the two vaccines currently being administered in the country. 3,006 session sites across the country were to give vaccines to 100 beneficiaries each today.
Prime Minister Narendra Modi inaugurated the vaccination drive on Saturday morning, asking people to stay away from rumours. He also added that the Drug Controller General of India (DGCI) gave approval after they were satisfied with the data of the two vaccines. However, it is important to note that Bharat Biotech has been given approval without its third phase trial data, over which several doctors and health sector experts have raised concerns.
Transparency investigator Saket Gokhale, who had revealed the anomalies in the Covaxin’s approval, has filed a writ petition against DGCI asking that safety and efficacy data submitted by Bharat Biotech for Covaxin be furnished urgently. The resident doctors at one of Delhi's Ram Manohar Lohia Hospital have demanded that they be administered Covishield vaccine and not Covaxin since the former has completed all three stages of trials as required under the protocol. People will not be able to choose between Oxford-Astrazeneca’s Covishield and the government-backed Covaxin. However, the government has stated that getting a vaccine will remain voluntary, as it does not need to vaccinate everyone to achieve herd immunity.
There are govt-mandated voice messages saying Indian-made vaccines are safe, yet the form says people getting #Covaxin are actually enrolling for 3rd phase trials! And if you say no to this, you won’t get the Oxford vaccine. Insane #VaccineForIndia https://t.co/7f2QFTlknS— Meenal Baghel (@writemeenal) January 16, 2021
Amidst the controversy, the consent form that the beneficiaries of Covaxin have to sign states that medical care and compensation will be given if any adverse effect was found linked to the Covid-19 vaccine. “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 centres and hospitals. The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine," the form states.
Manish Kumar, a 33-year-old sanitation worker from AIIMS became the first person in the country to be vaccinated. While Dhawal Dwiwedi was the second person to be vaccinated, AIIMS Director Dr Randeep Guleria and NITI Aayog's senior member, Dr VK Paul was the third person to get the vaccine, a report by NDTV says.
Currently, there are more than 10.5 million people have been affected by COVID-19 and 1,52,000 people have died of the disease.