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India's drugs regulator, the Central Drugs Standard Control Organisation (CDSCO) on Sunday approved the Oxford University's COVID-19 vaccine 'Covishield', manufactured by the Serum Institute of India (SII), and the indigenously-developed 'Covaxin' of the Hyderabad-based Bharat Biotech for restricted emergency use in the country.

It paves the way for the roll-out of at least two vaccines in the country in the coming days, while two more are in advance stages of development.

However, ever since the news broke, the granting of emergency use approval to 'Covaxin' has attracted a host of controversies, owing to the vaccine's chequered past with regard to the trials.

Veteran politicians have now joined in on the debate. Senior leaders of the Congress and the Samajwadi Party have questioned the sanction of the vaccine, and expressed concern over the lack of efficacy results for 'Covaxin'.

Granting emergency use approval to Covaxin is 'premature', potentially 'dangerous': Shashi Tharoor

Senior Congress leader Shashi Tharoor on Sunday said that the emergency approval to COVID-19 vaccine -- Covaxin is premature and could be dangerous as it is still under phase 3 trial. He urged Union Health Minister Dr Harsh Vardhan to wait till full trials of the vaccine are completed.

Taking to Twitter, the Member of Parliament from Kerala's Thiruvananthapuram said, "The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous."

He further urged Union Health Minister Dr Harsh Vardhan to avoid Covaxin till full trials are over.

"Union Health Minister Dr Harsh Vardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime," he added in the tweet.

No country has dispensed with mandatory Phase-III trials: Anand Sharma

Senior Congress leader Anand Sharma also raised concerns over India's drugs regulator granting permission for the restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.

Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.

As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, he said.

"The Health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category," he told news agency PTI.

Sharma said there are some concerns expressed by the news of recommendation for restricted use emergency authorisation in case of one vaccine which is still undergoing phase 3 trials and that has raised bonafide concerns as that would involve the health safety issues.

Centre should clarify on Phase-III trial data: Jairam Ramesh

Another senior Congress leader Jairam Ramesh also raised concerns and asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials are being modified.

"Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister Harsh Vardhan should clarify," he said on Twitter.

The issue was earlier dealt in-depth by the Parliamentary Standing Committee on Home Affairs.

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The panel has recommended to the government that any vaccine against COVID-19 should be granted emergency use authorisation only after proper consideration and conducting its trials on a sufficient sample size.

In its report submitted on December 21 to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the Parliamentary Standing Committee noted that the CDSCO has given no emergency use authorisation in the past, and suggested that all necessary and mandatory requirements must be duly fulfilled and all trial phases completed.

(With inputs from agencies)

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