The Covaxin Conundrum

Self-sufficiency is the new normal in the wake of Covid-19. And while a developing country like India, struggled to grapple with the pandemic, the domestic biotechnology company Bharat Biotech came up with a Covaxin vaccine against the widespread disease. The news of India’s own vaccine arriving in the market calmed the people who were rather petrified during the second wave. While the Indian authorities prioritized the administration of the vaccine to the citizens, they also eyed exporting the vaccines to other nations as well. The distribution of the vaccines and their acceptance across the globe would only add to India’s credibility and portray the country’s sound investment in human resources. However, things didn’t pan out as India imagined.  With different countries rejecting or pondering over the vaccine’s conduct, Indian authorities are caught up in various enquiries by the foreign delegations as well as Indian citizens.

Why was the vaccine not approved in the US?

The Food and Drug Administration (FDA) reserved their approval against Bharat Biotech’s Covaxin for emergency use. The denied approval rested on the fact that data on clinical trials were insufficient and insubordinate to the requirements and that more trials are sought. Furthermore, it is also imperative to understand that the US is no longer in a situation to hurry and fast-track the approvals for vaccines. The country is already flush with a number of vaccines – Pfizer, Moderna, Johnson & Johnson to name a few, through its Operation Warp speed initiative. As a result, the country has already vaccinated a significant percentage of the population and has attained ‘good’ herd immunity.

The Covaxin-conundrum largely depends on the WHO approval, which it is devoid of. While the approval is foreseen to be granted by the end of October, Bharat-Biotech financial deals also seem to be stuck in the pipeline till the approval. The process for approval by WHO can broadly be categorized into four steps – manufacturer’s Expression of Interest (EOI), Pre-submission meeting between WHO and manufacturer, Acceptance of the dossier for review, Final decision regarding approval or denial. In the case of Bharat biotech’s Covaxin, the cart is stuck in the first step itself. The EOI from the manufacturer was not exactly well-received by WHO and therefore the organization has sought more information on the matter. However, the counterpart of Covaxin i.e., Astrazeneca’s Covishield was successfully approved by WHO as it smoothly cleared all four steps.

Is there something wrong with the Covaxin? 

The long pause of Covaxin approval in foreign countries has worried the already vaccinated. The Hon’ble Prime Minister of India Narendra Modi, who commenced the whole vaccination drive by getting the first Covaxin jab in front of the whole world, is now scrutinized for the vaccine’s credibility as the same is not getting approvals in foreign lands. However, it is entirely the wrong narrative to believe that the vaccine is ineffective and unproductive. In fact, the US FDA itself has recommended Ocugen (Bharat Biotech’s American partner) to apply for full authorization of the vaccine instead of emergency approval. Since the application for complete authorization warrants additional data and information to the US FDA, the vaccine would undergo more human trials and shall seek to convince the authorities that it is safe and responsive.

What about other Countries?

Along with the USA, many other countries like Brazil also flagged issues about Covaxin. The local health regulator of Brazil, ANVISA, rejected the application of Covaxin when an inspection at the Bharat Biotech’s site in Hyderabad was carried out in March. The issues flagged were mechanical but were potential enough to risk the quality of the vaccine and extensively, can affect the health of the receiver. However, in June, ANVISA approved the import and use of limited quantities of Covaxin under stringent conditions.

So far, countries namely – Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin.

India’s Stance

As per the statements from the Indian government, the country exceedingly respects the decision by the FDA as each country has its own regulatory procedure, but also has asserted that the denial of approval shall not impact the Indian vaccination programme. The Information and Broadcasting Minister, Mr Prakash Javadekar also addressed the issue of Indian citizens who were banned to travel to the US as they are Covaxin vaccinated and called this step as baseless and discriminatory. He added that since WHO has not banned passengers and tourists who are Covaxin vaccinated, then the US should adhere to the same.

 

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