Concerns over Covaxin as some cite ‘lack of data’

Doctors from a prominent Delhi hospital and Tamil Nadu raised concerns over being administered the homegrown vaccine developed by Bharat Biotech as the nationwide vaccination programme kicked off on Saturday.

The Bharat Biotech vaccine, called Covaxin, is currently undergoing late-stage clinical trials, which are crucial to determining the efficacy of the shot. India’s drug regulator gave emergency authorisation to the vaccine — along with the Oxford-AstraZeneca vaccine manufactured by Pune-based Serum Institute of India — on January 3

The Resident Doctors’ Association (RDA) of the Ram Manohar Lohia Hospital in New Delhi on Saturday requested the medical superintendent of the facility to administer SII’s coronavirus vaccine, Covishield, amid apprehensions about Covaxin.

The resident doctors were “a bit apprehensive” about Covaxin and may not participate in the immunisation drive in large numbers, the association said in a letter.

“We have come to know that the COVID-19 vaccination drive is being conducted by the hospital today. Covaxin manufactured by Bharat Biotech is being preferred in our hospital over Covishield manufactured by Serum Institute.

“The residents are a bit apprehensive about the lack of complete trial in case of Covaxin and might not participate in huge numbers thus defeating the purpose of vaccination. We request you to vaccinate us with Covishield, which has completed all stages of trial before its roll-out,” the letter stated.

The controversy escalated during the day as reports said those receiving Bharat Biotech’s Covaxin were asked to sign consent forms before being inoculated because the jab had been allowed by the government in “clinical trial mode”.

“...the clinical efficacy of COVAXIN is yet to be established and it is still being studied in phase 3 clinical trial,” said the form.

Spokesperson for Bharat Biotech said the company was misquoted and that they never claimed they would compensate all Covaxin recipients for any adverse reactions.

However, under the clinical trial mode condition, the screening and consent form mentions that in case of any adverse events or serious adverse events, recipients will be provided medically recognised standard of care in the government designated and authorised centres/hospitals.

“The compensation for serious adverse event will be paid by sponsor (BBIL) if the serious adverse event is proven to be causally related to the vaccine,” said the form.

No comments were made on the reports that many doctors expressed apprehension about taking the Covaxin shot.

“No comments from the company on this,” said a Bharat Biotech spokesperson.

The Tamil Nadu Government Doctors Association (TNGDA) also reportedly recommended its members to get vaccinated, but preferably with the Covishield shot.

“There was some hesitation among the doctors in receiving the vaccine, but if I did not believe that the vaccine was safe why would I take it. I will speak to the doctors and try to allay concerns,” said Dr AK Singh Rana, medical superintendent of Ram Manohar Lohia hospital, where 31 people were vaccinated and some resident doctors asked the hospital for Covishield vaccine.

Dr Suneela Garg, professor of community medicine at Maulana Azad Medical College said: “Vaccine hesitancy had a major role to play when it came to the low vaccination rate on Saturday. Many people were comparing the two vaccines, many people wanted to wait and see what happens, and others wondered whether they needed it, having recovered from the infection recently. When people were asked to sign the consent forms, that also led to a lot of anxiety. But, with no major adverse events reported, I think more people will come forward in coming days.”

Urging people to have faith in India’s researchers, scientists and regulatory authorities, All India Institute of Medical Sciences (AIIMS) director Dr Randeep Singh Guleria reassured the nation that Covaxin was safe.

Dr Guleria along with NITI Aayog member VK Paul were administered the Covid-19 vaccine shot at AIIMS Delhi on the inaugural day of the nationwide roll-out of vaccination. Paul, too, said Covaxin was safe to be administered.

Bharat Biotech has received a government purchase order for the supply of 5.5 million doses of Covaxin. In Tamil Nadu, 99 people received the Covaxin shot, and in Delhi at least 152 health care workers received Covaxin shot, on Saturday.

According to Union health ministry, Serum Institute of India’s Covishield was supplied to all states and Union Territories, while Bharat Biotech’s Covaxin was supplied to 12 States and Union Territories.