WHO Approves Novavax Covid Vaccine for Emergency Use, to Aid Supply In Lower-Income Countries Medicines & Vaccines 17/12/2021 • Aishwarya Tendolkar Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The World Health Organization on Friday issued an emergency use listing for a novel COVID vaccine produced – in a move that should help ramp up new rounds of COVID vaccine distributions to low- and middle-income countries in coming months. Approval of the novel vaccine, developed by the US-based firm Novavax, and to be produced by the Serum Institute of India under licence, is long awaited because of it’s particularly high marks in clinical trials and modest cold chain requirements – the vaccine remains stable at only 2 to 8 °C. Some 350 million doses of the vaccine, dubbed Covovax™, have been promised to Gavi, The Vaccine Alliance, for the COVAX vaccine facility portfolio, which supplies COVID vaccines to some 93 low and middle-income countries. Prior to the WHO authorization, the SII-produced vaccine had so far only received authorisation for use in Indonesia, and is in the process of being approved in Japan. Another version of the same vaccine is also under review by the U.S. Food and Drug Administration and European Medicines Agency. The WHO move opens the way for the jump-starting of Covovax vaccine distribution under the COVAX framework – even ahead of the FDA or EMA approvals. WHO approval also allows low-and middle-income countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. SII expects to manufacture 1 billion doses of Covovax in 2022 According to reports, the Pune-based Serum Institute of India is expected to manufacture one-billion doses of Covovax for supply to low- and middle-income countries by the end of 2022. COVAX is co-led by the Coalition for Epidemic Preparedness Innovations, Gavi and the WHO to accelerate the development and manufacture of COVID-19 vaccines, along with fair and equitable access for every country in the world. CEPI also invested financially in the R&D of the new Covovax vaccine. According to reports on the phase-3 trial of the vaccine in North America, Covovax was 90.4% effective against infection and was 100% effective against moderate to severe illnesses. The shot has proven effective against COVID-19 infection in the United Kingdom and South Africa, according to the New England Journal of Medicine. “This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products in a press release. First Of A Kind Vaccine The vaccine is the first of a different class of COVID-19 vaccine – a protein-based vaccine and one would need two doses of it for protection against the virus. The vaccine is produced using an engineered baculovirus that contains a gene for a modified SARS-CoV-2 spike protein. “With robust data on safety and efficacy against several variants, strong potential in mix and match and booster regimens, a nine-month shelf life, and standard storage temperatures, this vaccine can be used in a variety of contexts and will provide countries with another critical option in the quest to protect their populations,” said Dr Seth Berkley, CEO, Gavi, the Vaccine Alliance. According to the press release, the originator product produced by Novavax, named NuvaxovidTM, is currently under assessment by the European Medicines Agency (EMA). WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation. The Technical Advisory Group for Emergency Use Listing that is convened by the WHO determined that the vaccine meets WHO standards for protection against COVID-19 and that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally, according to the press release. The vaccine was assessed under the WHO’s EUL procedure based on the review of data on efficacy, quality, safety, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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