Gaithersburg, Maryland-based Novavax, which still hasn’t filed for Food and Drug Administration emergency use approval for its COVID-19 vaccine in the U.S., adds India to the growing list of countries where its vaccine is eligible to be distributed.
The approval in India comes a week after Novavax received approval for its vaccine by the European Union. It will begin distributing its vaccine in the EU next month.
The two-dose Novavax vaccine is already being distributed in Indonesia and the Philippines.
In India, where 42% of the population is fully vaccinated, the vaccine is being produced by Serum Institute of India Pvt. Ltd, the world’s largest vaccine manufacturer.
“No one is safe until everyone is safe and today’s authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country’s ongoing efforts to control the pandemic,” said Stanley Erck, Novavax president and CEO.
Novavax and its partners have vaccine approvals pending in several other countries, including South Korea and Japan. It has previously said it intends to complete the package for filing for emergency use authorization in the U.S. with the FDA by the end of this year.
The Novavax vaccine uses a recombinant nanoparticle technology, unlike the messenger RNA vaccines from Pfizer and Moderna.
It can be shipped and stored at much higher refrigeration temperatures, potentially increasing access in hard-to-reach areas. It is distributed in vials containing 10 doses each.