Ocugen said the U.S. Food and Drug Administration (FDA) declined to issue an emergency use authorization for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for children.
Ocugen had entered into a deal with vaccine maker Bharat in late 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market.
Covaxin, which isn’t cleared for any age group in the United States, is one of the two most widely used COVID vaccines in India and also has an emergency use listing from the World Health Organization.
The FDA has only fully authorized Pfizer’s two-shot mRNA vaccine for children aged 5 to 17. There are currently no COVID-19 vaccines authorized for children under 5.
Ocugen said it’s continuing to seek full approval for the vaccine within the United States; the company previously said it would start enrolling adult U.S. volunteers for a clinical trial.
Some health experts have argued that most healthy children should not receive the vaccine, as a number of studies and data have shown that children have an extremely low chance of dying from COVID-19 or developing severe symptoms.
The Centers for Disease Control and Prevention (CDC) currently recommends that children aged 5 and older receive the Pfizer COVID-19 vaccine.
On March 7, Florida Surgeon General Joseph Ladapo told reporters that his state “is going to be the first state to officially recommend against the COVID-19 vaccines for healthy children.”
Florida Gov. Ron DeSantis said during the same event that there’s “a failure to weigh costs and benefits, whether that’s lockdowns, whether that’s school closures, or whether that’s even something about whether a healthy 7-year-old kid should get the COVID vaccines.”
