Novavax stock fell 3% Monday after the firm was only able to submit data to the Food and Drug Administration pertaining to the manufacturing procedures of its Covid-19 vaccine, indicating that the FDA's emergency use permission for the shot is still a long way off.
The data submission, which is now complete, is a need for the corporation to file an emergency usage authorization application with the agency later this month. The chemical, manufacturing, and controls modules are all included in the Friday contribution. By December 31, the company was scheduled to file for EUA.
Novavax's U.S. submission has been delayed multiple times due to development and production issues, all of which have now been overcome.
The shots are also awaiting approval in Japan, where Takeda Pharmaceutical will manufacture and sell the vaccine.
The World Health Organization, the European Union, India, Indonesia, and the Philippines all approved the company's vaccine last month.
Only one manufacturing location, India's Serum Institute, is listed in the company's registration. Novavax stated that data from other sites will be filed at a later date.
Unlike messenger RNA (produced by Moderna and Pfizer-BioNTech) and viral vector vaccines (Johnson & Johnson) that were cleared previously, the Novavax shot is protein-based.