Chhattisgarh Says Won't Use Covaxin Over Incomplete Trials, Harsh Vardhan Tells 'It's Safe'

Allaying concerns of Chhattisgarh over incomplete phase 3 trials of Covaxin, Union Health Minister Harsh Vardhan said both Covaxin and the other COVID-19 vaccine Covishield are safe and immunogenic and should be used expeditiously to mitigate the impact of the pandemic.

Chhattisgarh concerned over incomplete trials of Covaxin

Earlier, Chhattisgarh Health Minister T S Singh Deo said he had written to Vardhan urging him not to send Bharat Biotech's Covaxin till the phase-3 clinical trial results are completed while also expressing concern about the absence of expiry date on the vials of the vaccine.??

The primary concerns of the state, Deo said on Twitter, are the inhibitions regarding the incomplete third phase trials of Covaxin and the absence of expiration date on the vials of the vaccine.

PTI

"I have requested him to halt the supply of Covaxin to Chhattisgarh until these issues are addressed to the satisfaction of our Health Department to avoid the wastage of the early expiration doses of the drug," he said in another tweet.

Harsh Vardhan's response

Responding to his letter, Vardhan said he has got the matter examined in the ministry and as per New Drugs and Clinical Trials Rules, 2019, under Drugs and Cosmetics Act , 1940 and in light of urgent need due to COVID-19 pandemic in the country, the Central Drugs Standard and Control Organisation (CDSCO) has granted permission to manufacture the two vaccines based on the prescribed procedure and after due evaluation of pre-clinical and clinical trial data.

Only those COVID-19 vaccines that have been granted permission for restricted use in emergency situations by the DCGI i.e. Covishield and Covaxin are being used for COVID-19 vaccination drive in the country.

"Both these vaccines being supplied to the states /UTs are safe and immunogenic and should be used expeditiously to rapidly confer protection to prioritised beneficiaries thereby mitigating the impact of the pandemic at the earliest," he said.

"Your concern regarding unavailability of expiry date on Covaxin vial is also completely unfounded and without basis as the same is mentioned on the label of vaccine vials," Vardhan said in his letter.