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Wednesday, May 31, 2023

Here is how media slandered Covaxin over US FDA approval

Bharat’s indigenous Covid-19 vaccine Covaxin has been time and again slandered by those who harbor a personal bias against PM Modi and others who grow uncomfortable at the thought of a self-reliant (Atmanirbhar) Bharat. The media used denial of emergency use approval by the US regulatory body FDA  (Food and Drug Administration) as yet another excuse to undermine Bharat Biotech’s Covaxin.

The media as usual resorted to half-truths in order to mislead the public regarding Covaxin and also insinuate that the Bharatiya government had been hasty in approving the indigenous vaccine.

The launching of Covaxin in the US has been delayed as Bharat Biotech’s American partner Ocugen that had earlier applied for emergency use approval from the US FDA (Food & Drug Administration) has now changed its original plans and decided to seek a full approval based on the regulator’s advice.

As per reports, US authorities said there is no longer an emergency scenario related to Covid-19 in the US and thereby advised Ocugen to go through the normal route and acquire full approval instead. Ocugen CEO and Co-founder Dr. Shankar Musunuri issued a statement on 10 June in which he said “Although we were close to finalizing our EUA (emergency use authorization) application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US”.

It must be mentioned here that Ocugen has entered into a contract with Bharat Biotech to manufacture Covaxin for both the US and Canada markets. The company has applied for approval with Canadian health regulatory authorities in addition to the US FDA.

The Bharatiya mainstream English-language media, however, went to town with the headlines ‘Covaxin denied approval in the US’ highlighting how it was a “setback” for Bharat Biotech. What the media has conveniently hidden is that the US doesn’t need emergency approvals for vaccines anymore because they’ve enough stocks of vaccines and have even been accused of hoarding the same.

The Bharatiya government, on its part, has made it clear that the US FDA decision wouldn’t have any impact on Bharat’s vaccination drive. The DGCA (Drugs Controller General of India) has confirmed in its statement that it is satisfied with Covaxin data and hence there will be no disruption in the vaccination drive here.

In a press briefing last week, Niti Aayog member VK Paul has been quoted as saying;

Every country has a different regulatory system. The scientific framework might be the same but nuances change depending on the context. They have their own parameters which we respect. Our regulatory authorities too have separate parameters. When our vaccine makers make vaccines for our children, the nutritional status, the genetic background are taken into account to find out whether the vaccine will be fully effective. If one vaccine is effective on our children, it may not work in Argentina. That is a different cohort of people.

In their blind hatred, the Bharatiya media has been disparaging Bharat Biotech’s Covaxin at every opportunity even if their slandering is devoid of facts.

(Featured Image Source: The Financial Express)

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