Gaithersburg, Maryland-based Novavax, expected to formally apply for U.S. Food and Drug Administration emergency use approval for its protein-based COVID-19 vaccine next week, has added Israel to countries buying the vaccine.
Israel’s Ministry of Health announced an agreement to purchase an initial 5 million doses of the vaccine, with the option to buy another 5 million. Novavax will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel, pending regulatory approval.
“Israel has been at the forefront of the fight against COVID-19 and has demonstrated strong leadership throughout the pandemic,” said Novavax CEO Stanley Erck.
To date, Novavax has received conditional authorization from the European Union and Emergency Use Listing from the World Health Organization.
It has also received authorization for its vaccine in India, and its two-dose vaccine is already being distributed in Indonesia and the Philippines. Novavax has authorizations pending in several other countries, including South Korea and Japan.
Novavax completed submission of the final data package to the FDA Dec. 31, the last prerequisite in the FDA’s emergency use authorization application process. The submission started a one-month procedure of review; pending the outcome of that review, the formal request for a EUA comes next.