DCGI nod to Covaxin: Congress asks 'why Stage III trials given a miss?'

The Congress has cast aspersions on the process followed by the Centre in approving two vaccine candidates for emergency use recently.

The party’s official statement read: “The government must explain why mandatory protocols and verification of data from stage III trials have been dispensed with while granting permission to ‘Covishield’ and ‘Covaxin’. Our question is vital and needs an answer immediately because no other country has apparently dispensed with these key processes.”

Meanwhile, the Drug Controller General of India (DCGI) on Sunday (January 3) granted permission for restricted use of Covid-19 vaccines of Serum Institute of India and Bharat Biotech.

At the time of approving ‘Covaxin’, manufactured jointly by Bharat BioTech and ICMR, DCGI VG Somani had said, “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe.”

‘Covishield’ has been developed by Oxford University and pharma major AstraZeneca and is being manufactured in India by the Serum Institute of India. Hyderabad-based Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR), is the producer of the other drug, Covaxin, which was granted permission on Saturday (January 2).

“Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,” Shashi Tharoor of the Congress tweeted on Sunday. He urged Union Health Minister Dr Harsh Vardhan to wait till full trials of the vaccine are completed.

Noted senior Congress leader, Jairam Ramesh, too raised concerns about the approval process. Another Congress leader Salman Nizami tweeted: “Vaccine is a fraud.”

Also read: WHO welcomes India’s nod to 2 COVID-19 vaccines for emergency use

Senior Congress leader Anand Sharma said the phase-3 trials of Covaxin have not been completed and, therefore, data on safety and efficacy had not been reviewed.

“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,” Sharma, who heads the Parliamentary panel on Home Affairs, told PTI.

Also read: Covaxin gets expert panel nod; Centre confirms Oxford vaccine also approved

The panel had earlier 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.

On Covaxin’s ongoing trials, the Union Ministry for Health and Family Welfare stated: “The phase III efficacy trial was initiated in India…and the vaccine has been found to be safe as per the data available till date…The clinical trial ongoing within the country by the firm will continue.”

On Saturday, Dr Randeep Guleria, director of New Delhi’s All India Institute of Medical Sciences, told NDTV that Serum Institute’s Covishield will be the main vaccine in India, whereas Covaxine would be considered only a backup for emergency use in cases of reinfection.