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Controversy erupts over COVAXIN after pan India rollout of COVID-19 vaccination drive, matter reaches Bombay High Court

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(Image: Twitter@SerumInstIndia and PTI)


Congress MP Manish Tewari, on Saturday, has raised doubts over the efficacy and safety of COVAXIN vaccine, developed by Hyderabad-based company Bharat Biotech in collaboration with the Indian Council of Medical Research.

Prime Minister Narendra Modi had, on Saturday, launched the pan India rollout of COVID-19 vaccination drive via video conferencing, touted as the world’s largest vaccination programme covering the entire length and breadth of the country.

Manish Tewari has questioned the procedure of giving the approval of using COVAXIN as he claimed that there is no policy framework to authorise the vaccine for emergency use.

In a tweet, he said, “As vaccine roll out begins, it is all a bit puzzling. India has no policy framework for authorising emergency use, Yet Two vaccines have been approved for restricted use in emergency situation. COVAXIN is another story – Approvals sans Due Process,”

“Many eminent doctors have raised questions with regard to the efficacy and safety of COVAXIN with govt saying that people will not be able to choose as to which vaccine they would like to take. This goes against the entire doctrine of informed consent,” Tewari was quoted as saying by ANI.

“If the vaccine is so safe and reliable and the efficacy of the vaccine is beyond question then how is it that not a single functionary of the government has stepped forward to get themselves vaccinated as it has happened in other countries around the world?” he asked

However, the vaccine is yet to clear its phase-III trials, due to which the government had earlier said it was to be used only in case of emergency as a secondary option.

“Is Bharath Biotech vaccine safe for human use? Can govt guarantee both it’s safety and efficacy? Aren’t palliatives for emergency use & vaccines a preventive measure?  Can vaccine be a palliative?” he had tweeted on 11 January.

Meanwhile, social activist Saket S Gokhale has moved the Bombay High Court against the Drugs Controller General of India (DCGI), urging that the safety and efficacy trial results of Bharat Biotech’s Covid-19 vaccine COVAXIN be made public.

The petition states that whereas vaccinations in India are to begin from January 16, and it is being claimed that COVAXIN is safe and provides a robust immune response, the data submitted by the company in this behalf has not been made available in the public domain.

Gokhale contends that COVAXIN is still in phase 3 of clinical trial and hence there remains a great possibility of harm to the life of members of the general public that are being administered this vaccine.

Gokhale has referred to a press note issued by the Government of India on January 3 that states that COVAXIN has been approved for “restricted use in emergency situation”, reports Live Law.

Meanwhile, in another big development, the resident doctors at Delhi’s Ram Manohar Lohia Hospital, on Saturday, demanded that they be administered Covishield vaccine and not COVAXIN.

According to the resident doctors, while Covishield has completed all three stages of trials as required under the protocol, COVAXIN is still only undergoing stage-III trials.

The resident doctors have even said they might not participate in huge numbers if COVAXIN is used. The Resident Doctors Association has written a letter to the medical superintendent of the hospital stating, “We request you to vaccinate us with Covishield which has completed all stages of the trial before its rollout.”

“Covaxin manufactured by Bharat Biotech is being preferred over Covishield manufactured by Serum Institute in our hospital. 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,” the letter added.

(With agency inputs)

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