Gaithersburg, Maryland-based Novavax Inc. has received emergency use authorization for its COVID-19 vaccine from regulators in Indonesia, its first approval for the protein-based vaccine.
The approval by the National Agency of Drug and Food Control of the Republic of Indonesia, means it will commercialize the vaccine for use with vaccine manufacturer Serum Institute of India Pvt. Ltd. under the name COVOVAX.
Initial shipments will begin immediately, Novavax said.
“This is a landmark moment for Novavax and our partner Serum Institute of India, and is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally,” said Novavax president and CEO Stanley Erck.
Last week, Novavax applied for regulatory approval for its vaccine in the U.K. and Australia. Other emergency use approvals are pending in India, the Philippines, the EU, Canada and with the World Health Organization.
Novavax, which received $1.6 billion through the federal government’s Operation Wrap Speed program for its vaccine development, expects to file for emergency use authorization with the Food and Drug Administration in the U.S. by the end of the year.
In Phase 3 trials in the U.S. and Mexico, Novavax has reported its vaccine demonstrated 100% protection against moderate and severe COVID-19 disease and 90.4% overall efficacy. Its vaccine requires two doses.
The Novavax vaccine is different from already-approved messenger RNA vaccines, using its recombinant nanoparticle technology, and is similar to its seasonal influenza vaccine, with less stringent storage temperature control requirements.
Last fall, Novavax began a manufacturing expansion in Gaithersburg with a new research and development facility.
