Novavax (NVAX) said Tuesday that the WHO Strategic Advisory Group of Experts on Immunization or SAGE has recommended primary two-dose vaccination series of its COVID-19 vaccine NVX-CoV2373 in persons aged 18 and older. The panel of experts also recommended additional third dose of NVX-CoV2373 administered to immunocompromised persons.
The recommendations followed Emergency Use Listing 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).
The WHO's panel of experts has recommended 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.
The WHO's panel has also recommended use of the vaccine in specific populations, including persons with comorbidities, breastfeeding women, and those living with human immunodeficiency virus (HIV).
The experts panel has recommended 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.
Novavax recently received conditional marketing authorization for Nuvaxovid in the European Union, and Novavax and SII recently received emergency use authorization 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.
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