By Dhirendra Tripathi
Investing.com – Novavax stock (NASDAQ:NVAX) slipped 3% Monday as the company managed to only submit data related to the manufacturing processes of its Covid-19 vaccine to the Food and Drug Administration, a sign that the FDA’s emergency use authorization for the shot is still some time away.
The data submission, which is final now, is a prerequisite for the emergency use authorization application that the company will file with the regulator this month. The Friday submission includes the complete chemistry, manufacturing and controls module. The company was expected to file for EUA by December 31.
Novavax has had to delay its U.S. submission several times due to development and manufacturing setbacks, all of which are now resolved. The shots also await approval in Japan, where its vaccine would be manufactured and distributed by Takeda Pharmaceutical.
Last month, the company’s vaccine secured approvals from the World Health Organization, the European Union, India, Indonesia and the Philippines.
The company’s filing includes only one manufacturing site, belonging to India’s Serum Institute. Novavax said it expects to file data from other sites at a later date.
The Novavax shot is protein-based, unlike messenger RNA (made by Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE)-BioNTech (NASDAQ:BNTX)) and viral vector vaccines (Johnson & Johnson (NYSE:JNJ)) that were cleared earlier.