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Chhattisgarh Health Min Refuses Covaxin Over Efficacy Doubts, Vardhan Replies

Chhattisgarh Health Min Refuses Covaxin Over Efficacy Doubts, Vardhan Replies

Union health minister Harsh Vardhan. Photo: Facebook/Dr Harsh Vardhan.

Bengaluru: On February 11, 2021, Chhattisgarh health minister T.S. Singh Deo wrote to Union health minister Harsh Vardhan asking the Centre to halt supply of the Covaxin candidate vaccine to the state. Deo said he was founding his request on two concerns: that the vaccine candidate lacked efficacy data from phase 3 clinical trials and that Covaxin vials are missing expiry dates.

On January 3, 2021, the Drug Controller General of India (DCGI) had approved two COVID-19 vaccine candidates, Covaxin and Covishield, for conditional use in the government’s forthcoming immunisation programme. Covaxin, made by Hyderabad-based Bharat Biotech, didn’t have efficacy data from phase 3 trials even at that time, kicking up a major controversy over its approval.

As such, Deo has articulated his first concern over a month later.

But on the same day, Union health minister Harsh Vardhan replied to Deo’s letter with one of his own, according to NDTV. Vardhan reportedly denied both of Deo’s concerns and also urged Deo to pick up the pace of vaccinations in the state.

The Congress is currently in power in Chhattisgarh, and the back-and-forth between the two ministers is tied to the broader political issues entwined with India’s COVID-19 vaccination drive, which began on January 16. For example, Vardhan said in his reply that it doesn’t “befit Deo to stoke inhibitions regarding efficacy” and that Deo should “not further vested interests”.

In the first phase of the vaccination drive, the Government of India had planned to inoculate 300 million frontline and healthcare workers around the country. And in its early days, there had been considerable vaccine hesitancy because recipients don’t have a choice of vaccine candidates to receive, and were wary of Covaxin having been approved without insufficient data.

Nonetheless, according to NITI Aayog member V.K. Paul, India is closing in on 10 million vaccinations. Paul also said that vaccine hesitancy “may still be there at an individual level, but largely it is not there” – without clarifying what he meant.

Vardhan said in his letter to Deo that all vaccine supplies to the state are “safe and immunogenic” and that Deo should “appreciate the need” to significantly improve vaccine coverage. Thus far, Chhattisgarh has administered the first dose of either vaccine candidate to 69.87% of its targeted healthcare workers but only 9.55% of the targeted frontline workers (police, municipal workers, etc.). Both Covaxin and Covishield are double-dose vaccines.

Vardhan also rubbished Deo’s allegation that Covaxin vials were being delivered without specifying the expiry dates, and shared a photo on Twitter of a vial and a carton of Covaxin shots with their expiration dates on display.

Earlier, in an effort to push back on vaccine hesitancy, Union home secretary Ajay Bhalla had notified chief secretaries of the states to penalise anyone who spread rumours about Covaxin’s or Covishield’s safety or immunogenicity.

But even then, as now, the efficacy of Covaxin has been under question, not safety or immunogenicity. However, phase 3 clinical trial data is also useful to determine long-term safety as well as to look out for rare side effects (which may become common when vaccine doses are administered to millions of people).

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