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.
The biopharmaceutical company said it intends to continue working with the FDA to evaluate the process for getting an emergency use authorization for pediatric use of Covaxin, it said in a March 4 statement that announced the health agency’s decision. The company had sought to authorize the shot for children aged 2 to 18.
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.
A large-scale clinical trial found that the vaccine provided decent protection against COVID-19, although it was carried out before the spread of the Omicron variant, which began to spread in the United States in late 2021.
Covaxin, unlike Moderna or Pfizer, doesn’t use mRNA technology; it uses inactivated coronavirus technology similar to Johnson & Johnson’s single-shot vaccine.
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.”
COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.
Reuters contributed to this report.