New York (US) | Agencies: Ocugen Inc, the biopharmaceutical firm which has partnered with India's Bharat Biotech for its anti-COVID-19 vaccine, has applied to the United States (US) Food and Drug Administration (FDA) for emergency use authorisation of Covaxin in children in the age group 2 to 18 years, said the company in a statement on Friday.

However, for the nod, the FDA authorities will likely ask Ocugen Inc to submit more data about Covaxin as information collected by the company from clinical trials outside the US may not be enough for granting the permission.

Earlier this week, the World Health Organisation (WHO) gave a go-ahead to Covaxin for emergency use. The India-made vaccine has already been cleared for use in 17 countries.

Tens of millions of doses of Covaxin have already been administered to adults outside the US, notably in India. Inactivated virus technology, which is commonly used in other childhood vaccines, is used in Covaxin to neutralise the COVID-19 infection.

Meanwhile, Ocugen is seeking approvals from the authorities based on the results obtained from a study where a total of 526 kids aged between 2 and 18 were inoculated with both doses of Covaxin 28 days apart.

The findings were compared with those from a group of 25,800 adults in India, which suggested "similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years," the company said.

Ocugen co-founder Shankar Musunuri in a press release called the move "a significant step toward our hope to make our vaccine candidate available here."

In the clinical trial with 526 children, no serious adverse events or hospitalizations were observed, but the study's sample size may not have been large enough to detect rare side effects.

The FDA asked Pfizer and Moderna, whose Covid-19 vaccines have already been authorised in the United States, to conduct trials with thousands of children to have a better insight into any side effects.

Pfizer's shot is the only one approved in the United States for children under the age of 18, and health authorities cleared the way this week for 5 to 11-year-olds to receive the vaccine. 

(With agency inputs)

Posted By: Mallika Mehzabeen