The American pharmaceutical company Ocugen said on Friday that the Food and Drug Administration had rejected its application seeking emergency authorization for an India-made Covid vaccine for those ages 2 to 18.
The vaccine, made by the Indian pharmaceutical company Bharat Biotech, has not yet been tested in the United States, nor has it been authorized for any age groups in the United States. It is not clear if the vaccine has a path forward with American regulators, when the country already has a surplus of authorized doses.
A clinical trial in India that enrolled those ages 2 to 18 found that two doses of the vaccine generated strong immune responses and did not cause serious side effects. Another large-scale clinical trial in adults in India found that the vaccine provided good protection against Covid, with very strong protection against severe disease. Both of those studies were conducted pre-Omicron, when earlier versions of the virus were circulating.
The vaccine is widely used in India. It has been authorized in about 20 countries as well as by the World Health Organization. Ocugen has a deal with Bharat to try to bring its vaccine to the U.S. market.
Pfizer makes the only Covid vaccine authorized in the United States for those ages 5 to 17. There are no vaccines currently authorized for younger children, but those ages 6 months through 4 years of age could become eligible for Pfizer’s vaccine as soon as next month.
Representatives of the F.D.A. did not immediately return a request for comment on Friday. The agency generally declines to comment on medical products it has declined to authorize.
Ken Inchausti, a spokesman for Ocugen, said the company is “disappointed” by the agency’s decision. The company said in a news release that it still wants to try to find a path forward for the vaccine to be made available for 2- to 18-year-olds in the United States. Ocugen’s stock fell 23 percent on Friday.
Ocugen is continuing to seek full approval for the vaccine in the United States. The company has said it plans to soon start enrolling adult volunteers in the United States for a clinical trial that will evaluate the immune response generated by the vaccine.