Explained: Why has the US FDA declined emergency use nod to Covaxin?

The United States has decided not to give emergency use authorisation (EUA) to Bharat Biotech's Covid-19 vaccine, Covaxin. Does this mean there is something wrong with the vaccine?

The United States has decided not to give emergency use authorisation (EUA) to Bharat Biotech’s Covid-19 vaccine, Covaxin. The Indian Express looks at what has happened:

What is Covaxin?

Covaxin, India’s first indigenous Covid-19 vaccine, is what is known as an inactivated whole virus vaccine — it was made using particles of the SARS-CoV-2 virus that were grown and killed in a high biosafety level laboratory.

It received proper restricted emergency use permission in India in March.

Clinical stage biopharmaceutical company Ocugen has partnered with Covaxin developer Bharat Biotech to seek an EUA for the vaccine in the US.

Why does the US not want to give an EUA for Covaxin?

The main reason for this is insufficient information to make a decision on an EUA request for this vaccine.

According to Ocugen, the US Food and Drug Administration (US FDA) has recommended that it pursue full authorisation for Covaxin through a biologics license application (BLA). In its feedback, the FDA has “requested additional information and data”, and Ocugen is in discussions with the regulator to understand what additional information is required for a BLA submission. It expects that data from an additional clinical trial will be required.

The development is a major setback, as Ocugen will now have to work harder for a licence to provide Covaxin in the US. It is expected to take much longer to receive a BLA compared with an EUA.

Does this mean there is something wrong with the vaccine?

Not really. But what it means is that the US FDA will need to see more information from more human clinical trials to be convinced that the vaccine is safe, prompts an immune response and has an acceptable efficacy–its ability to bring down symptomatic Covid-19 cases compared with those who are not vaccinated.

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