US company applies for approval to vaccinate children against India

The US company Ocugen asked the FDA to approve the emergency use of India’s Covaxin vaccine for ages 2-18, after WHO approved this vaccine.

The approval request is based on a study of 526 children aged 2-18 who received two doses of the Covid-19 vaccine, 28 days apart. The results were compared with those observed in a group of 25,800 adults in India, showing “similar protective effects in children”, Ocugen said on November 5.

A vial of the Covid-19 Covaxin vaccine is used at a hospital in New Delhi, India, in January. Photo: Reuters.

A vial of the Covid-19 Covaxin vaccine is used at a hospital in New Delhi, India, in January. Photo:Reuters.

Ocugen is a partner of Indian pharmaceutical company Bharat Biotech, which develops and manufactures Covaxin. Shankar Musunuri, the co-founder of Ocugen, called the FDA’s application for approval for Covaxin injections for children to the US Food and Drug Administration (FDA) an “important step towards hope” bringing the vaccine to market. American school.

Covaxin was approved for emergency use by the World Health Organization (WHO) on November 3 and has been licensed in 17 countries. Tens of millions of doses of Covaxin have been given to adults outside the US, especially India. This vaccine uses inactivated virus technology, common in other childhood vaccines such as polio.

In the clinical trial of 526 children, no serious adverse events or hospitalizations were observed. However, the size of the study is said to be not large enough to detect rare side effects, nor enough evidence for FDA approval.

The FDA has asked Pfizer and Moderna, the two pharmaceutical companies that develop licensed Covid-19 vaccines in the US, to conduct tests on thousands of children to get a closer look at any side effects. . Pfizer’s vaccine is the only one approved for use in children in the United States.

Luster (Follow AFP)

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