The World Health Organisation (WHO), Strategic Advisory Group of Experts on Immunisation (SAGE), has recommended that post the two-dose primary vaccination of the Novavax vaccine in persons aged 18 years and older administered 3-4 weeks apart as well as administration of an additional dose of the vaccine to immunocompromised persons between one and three months after dose 2 of the primary series.

Second, the use of the vaccine in specific populations, including persons with comorbidities, breastfeeding women, and those living with human immunodeficiency virus (HIV).

Third, the use of the vaccine in pregnant women if the benefits of vaccination to the pregnant woman outweigh the potential risks; and finally, co-administration of an inactivated seasonal influenza vaccine and any dose of the vaccine is acceptable.

 The recommendations follow Emergency Use Listing (EUL) of the vaccine by WHO, which will be manufactured and marketed as Nuvaxovid Covid-19 vaccine (recombinant, adjuvanted) by Novavax in Europe and other markets, and as Covovax in India and licensed territories by the Serum Institute of India Pvt. Limited (SII).

"This interim recommendation from WHO provides helpful guidance for the use of our COVID-19 vaccine as countries that rely on EUL begin their own assessment and underscores the critical role that we expect the vaccine will play in the global fight against the coronavirus," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We look forward to delivering our recombinant protein-based vaccine to hundreds of millions of people around the world in partnership with our partner, Serum Institute of India."

The WHO EULs for Nuvaxovid and Covovax leverage Novavax' manufacturing partnership with SII, the world's largest vaccine manufacturer by volume, which will supply initial doses for the Covax facility. The EUL application for Nuvaxovid will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.

Novavax' Covid-19 vaccine 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. The current assigned shelf-life of the vaccine is 9 months.