WHO advisory group issues interim recommendations for Covovax use

Gaithersburg:  Novavax, Inc. has announced that the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) has published its interim recommendations for use of NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.

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."

WHO recommends the following:

• A 2-dose primary vaccination series of NVX-CoV2373 in persons aged 18 years and older administered 3-4 weeks apart, as well as administration of an additional dose of NVX-CoV2373 to immunocompromised persons between one and three months after dose 2 of the primary series;
• Use of the vaccine in specific populations, including persons with comorbidities, breastfeeding women, and those living with human immunodeficiency virus (HIV);
• Use of NVX-CoV2373 vaccine in pregnant women if the benefits of vaccination to the pregnant woman outweigh the potential risks; and
• Coadministration of an inactivated seasonal influenza vaccine and any dose of NVX-CoV2373 is acceptable.

The SAGE recommendation is based on the totality of preclinical and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 which included 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable safety and tolerability profile.

"Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed," the company said.

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 recently received conditional marketing authorization (CMA) for Nuvaxovid in the European Union, and Novavax and SII recently received emergency use authorization (EUA) for COVOVAX in Indonesia and the Philippines. The vaccine is also currently under review by multiple regulatory agencies worldwide. The company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the U.S. FDA for review by the end of 2021. The brand name Nuvaxovid has not yet been authorized for use in the U.S. by the U.S. FDA.

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.

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