COVID roundup: J&J submits vaccine to WHO, plus Novavax-COVAX and Pfizer-BioNTech
A week ahead of FDA’s Vaccines and Related Biological Products Advisory Committee meeting to discuss COVID-19 Vaccine Janssen from Johnson & Johnson (NYSE:JNJ), the pharma announced it submitted an application to the WHO for emergency use listing of the adenoviral vaccine.
The application is based on data from the Phase III ENSEMBLE trial that showed a one-shot regimen was 57-72% effective in South Africa, Latin America and the US. An emergency use listing from the WHO is a prerequisite to supply vaccines to lower income countries through the COVAX Facility.
Novavax to provide 1.1B vaccines to COVAX
Novavax Inc. (NASDAQ:NVAX) announced a memorandum of understanding Thursday with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of NVX-CoV2373 to the COVAX Facility. Novavax and the Serum Institute of India will manufacture and distribute the protein-based vaccine, which is in Phase III testing.
Pfizer, BioNTech seek label change regarding vaccine storage
Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) are seeking an FDA label update for Comirnaty to allow storage at normal freezer temperatures of -25°C to -15°C (-13°F to 5°F) for up to two weeks. Currently, the mRNA vaccine can be stored at 2-8°C (36-46°F) for up to five days and requires special freezers for long-term storage at -80°C. The label update could ease logistical hurdles that limit the vaccine’s distribution.