COVID-19: After Chhattisgarh’s skepticism over Covaxin, Harsh Vardhan says vaccines approved after due diligence

After studying the data of these trials, the DGCI approved Covaxin for emergency use.

Coronavirus vaccine Covaxin in India: After Chhattisgarh Health Minister TS Singh Deo wrote to the Union Ministry of Health and Family Welfare, expressing his concern over the Covaxin doses sent to the state, Union Health Minister Dr Harsh Vardhan said that the vaccine had been approved after due diligence. Deo expressed concerns regarding the indigenously produced coronavirus vaccine called Covaxin over the unavailability of Phase 3 clinical data and the lack of display of expiry date on the doses. In a reply to this, Dr Harsh Vardhan wrote a letter to the state health minister, stating that the two vaccines – Covaxin and Covishield – received approval from the drug regulator in India for emergency use only after due following of the prescribed procedure wherein pre-clinical as well as clinical data was properly examined.

He added that it was only after the two vaccines received the approval of the Drugs Controller General of India (DCGI) did their use for the vaccination drive begin in the country. He further said that both of the vaccines, which are being supplied to the states as well as Union Territories, are safe and they should be administered as quickly as possible. Addressing the concerns regarding the lack of expiry date, Vardhan also attached with the letter the images of Covaxin’s vial bottles, and stated that these concerns were also unfounded as the expiry date of the dosage was mentioned on the label on each vial.

He also cornered Deo on the slow vaccination process being undertaken in the state. Vardhan said that while Chhattisgarh had administered the first shot of vaccine to 69.87% of the healthcare workers in the state, as of now, only about 9.55% of all the frontline workers in the state have been covered under the first dose of the vaccination drive, he added. Notably, Chhattisgarh has a total of nearly 2.1 lakh frontline workers. Vardhan added that the state needed to significantly increase the immunization drive coverage among its population, especially since doses of both the vaccines were supplied in adequate quantities to Chhattisgarh.

Covaxin: Bharat Biotech’s vaccination details

Covaxin has been developed by Hyderabad-based Bharat Biotech, in collaboration with the Indian Council of Medical Research or ICMR’s National Institute of Virology in Pune. Apart from being indigenously produced, Covaxin is a preferred vaccination alternative in India because it needs to be stored at a temperature between 2 degrees Celsius and 8 degrees Celsius, a temperature that can be supported easily by the current cold storage facilities in India, as against several other vaccines like the ones by Moderna and Pfizer that require ultra cold storage facilities, which India is not yet equipped with.

Moreover, in the phase 1 trials of the Covaxin, conducted on 375 participants, the vaccine was found to be safe without prompting any side-effects. In the second phase of the trials, 380 participants were enrolled and it was found that the vaccine led to no adverse effects and generated the desired level of immunity. After studying the data of these trials, the DGCI approved Covaxin for emergency use.

However, as far as the phase 3 clinical trials are concerned, they are currently underway, according to the Bharat Biotech website, and the trials include 25,800 participants. While all the participants have been administered the first dose, the second dose or placebo is currently being administered and the company hopes to gather the interim results from these trials by the end of the month.

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