On Sept. 16, 2022, Novavax announced that the Israel Ministry of Health has granted an import and use permit which provides individuals aged 12 and older access to the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series and as a heterologous booster for those previously vaccinated with mRNA vaccines. The permit is based on the Israeli Advisory Committee on Epidemics’ recommendation.

Nuvaxovid has received authorization for use in adults aged 18 and older from more than 40 markets, including the U.S. and from the World Health Organization. In the 12 through 17 year-old population, the vaccine has been authorized in more than 10 markets including the U.S., the European Union, and the United Kingdom. Nuvaxovid has also been authorized in the European Union, Japan, Australia, New Zealand, and Switzerland as a booster in adults aged 18 and older. The vaccine is actively under review in other markets.

Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.  

Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.  

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.