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Covaxin not finding international takers even when supplied free of cost by India

Even as India makes it mark in the world with its vaccine diplomacy amid the Covid crisis, there are few international takers for its homemade vaccine Covaxin.Of the 8.1 lakh doses of Bharat Biotech’s Covid vaccine Covaxin that India promised as a grant in aid to seven countries, only 2 lakh doses have been procured by Myanmar. India’s first indigenous vaccine against Covid-19 was to be sent pro bono to Myanmar, Mongolia, Oman, Bahrain, the Philipines, Maldives and Mauritius as a goodwill gesture.

The decision was taken at a high-level meeting on January 18, at the health ministry between the Union Health Minister Harsh Vardhan, Minister of External Affairs S Jaishankar and MoS Pharmaceuticals Mansukh Mandaviya.

Before that, manufacturer Bharat Biotech International Limited was informed through an office memorandum dated January 15 that 8.1 lakh doses of Covaxin would be procured by the Minister of External affairs directly from them. The memorandum said that the procurement would start by January 22.

The government, on Friday, informed that 64.7 lakh doses of Covid vaccines have been supplied as a grant to other nations while 165 lakh doses have been supplied on a commercial basis. The statement was made by Anurag Srivastava, spokesperson, MEA.

Of the 64.7 lakh doses that have gone out pro bono, only 2 lakh are doses of India’s Covaxin. The rest are doses of Serum Institute’s Covishield, developed by the Oxford University.

A month on, there have been few takers for Covaxin. A source within the company told India Today TV that the decision to procure the vaccine lies with individual governments. “The fact that Myanmar has given the vaccine to its forces shows that they have faith in our vaccine,” he said on condition of anonymity.

But the fact that Covaxin is yet to complete its phase III trials is evidently a sore point. Bharat Biotech had started phase III trials for Covaxin in November 2020, enrolling 25,800 volunteers across India. Up until now, nearly 25,000 volunteers have received both doses of the vaccine. Unblinding the study would be the next step after which the efficacy data would become available. For this, the developers of the vaccine would require atleast 43 Covid positive cases among the volunteers.

On finding no takers for Covaxin, sources within the Indian government say that countries are free to carry out bridging studies of the vaccine in case their regulator wishes them to do so. The developers of the vaccine have accepted that generating the data with regard to efficacy can take time and it is a process that needs to be respected.

Bharat Biotech has taken assurance from the fact that the vaccine is generating Covid neutralizing antibodies. The data regarding safety and immunogenicity of the vaccine has been published in the Lancet — a development that was underscored by the Indian Council of Medical Research which has collaborated with BBIL for developing the vaccine.

The absence of efficacy data for Covaxin has seen a political tug-of-war in India as well with Congress-led states like Chhattisgarh opposing the Centre sending Covaxin to the state. In his latest barb, Chhattisgarh Health Minister TS Deo wrote on Twitter that the fears around the vaccine were “not unfounded”. “How can a vaccine be made available for regular use unless it has cleared the 3rd phase of trials and its reports are published?” he tweeted.

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