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COVID-19 vaccine are safe and immunogenic, says Harsh Vardhan as he replies to TS Deo’s concern

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New Delhi : Replying to the concern of Chattisgarh Health Minister over COVID-19 vaccine, the Union Health Minister Dr. Harsh Vardhan on Thursday said both the COVID-19 vaccines – Covaxin and Covishield are safe and immunogenic and should be used expeditiously to confer protection to the prioratised beneficiaries thereby mitigating the impact of the pandemic at the earliest.

Dr. Vardhan said this in reply to Chhattisgarh’s request to halt the supply of Covaxin citing concerns about incomplete phase 3 trials.

On Thursday, Chhattisgarh Health Minister T S Singh Deo wrote to the Union Health Minister Dr Vardhan expressing his concern about the absence of expiration date on the vials of the vaccine. Deo also requested Dr. Vardhan to stop sending Bharat Biotech’s Covaxin until the phase-3 clinical trial results are completed.

Replying via letter, Dr Vardhan stated: “I have got the matter examined in the ministry. 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 two COVID-19 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 Drug Controller General of India (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 /Union Territories (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,” the Union Health Minister said in a letter.

“Your concern regarding the 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,” Dr Vardhan noted.

Dr. Vardhan said that Chhattisgarh has achieved 69.87 per cent coverage of its healthcare workers by giving them the first dose of the vaccine, the state has been able to cover only 9.55 per cent of 2,09,512 frontline workers through the first dose of the vaccine.

“You would appreciate that this coverage needs to improve significantly since the adequate quantity of both the vaccines is available with the state. I look forward to your continuous oversight and guidance to the ongoing COVID-19 vaccination drive in the state of Chhattisgarh which remains crucial for its success,” said the Union Health Minister.

It may be noted that Chattisgarh Health Minister Deo in a tweet said: “Wrote to honourable Union Minister of health Dr Harsh Vardhan ji addressing the concern of Chhattisgarh government regarding the supply of COVAXIN to the state.

The primary concerns of the state are the inhibitions regarding the incomplete 3rd phase trials of COVAXIN (1/2)”

“The absence of expiration date on the vials of the vaccine.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.” (ANI)

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