The American pharmaceutical firm Ocugen stated on Friday that the Meals and Drug Administration had rejected its utility looking for emergency authorization for an India-made Covid vaccine for these ages 2 to 18.
The vaccine, made by the Indian pharmaceutical firm Bharat Biotech, has not but been examined in the USA, nor has it been licensed for any age teams in the USA. It’s not clear if the vaccine has a path ahead with American regulators, when the nation already has a surplus of licensed doses.
A medical trial in India that enrolled these ages 2 to 18 discovered that two doses of the vaccine generated robust immune responses and didn’t trigger critical unintended effects. One other large-scale medical trial in adults in India discovered that the vaccine offered good safety in opposition to Covid, with very robust safety in opposition to extreme illness. Each of these research have been carried out pre-Omicron, when earlier variations of the virus have been circulating.
The vaccine is broadly utilized in India. It has been licensed in about 20 nations in addition to by the World Well being Group. Ocugen has a cope with Bharat to attempt to carry its vaccine to the U.S. market.
Pfizer makes the one Covid vaccine licensed in the USA for these ages 5 to 17. There aren’t any vaccines presently licensed for youthful kids, however these ages 6 months via 4 years of age might change into eligible for Pfizer’s vaccine as quickly as subsequent month.
Representatives of the F.D.A. didn’t instantly return a request for touch upon Friday. The company usually declines to touch upon medical merchandise it has declined to authorize.
Ken Inchausti, a spokesman for Ocugen, stated the corporate is “dissatisfied” by the company’s choice. The corporate stated in a information launch that it nonetheless desires to attempt to discover a path ahead for the vaccine to be made obtainable for 2- to 18-year-olds in the USA. Ocugen’s inventory fell 23 p.c on Friday.
Ocugen is constant to hunt full approval for the vaccine in the USA. The corporate has stated it plans to quickly begin enrolling grownup volunteers in the USA for a medical trial that may consider the immune response generated by the vaccine.
Supply: NY Times