The World Health Organization has issued an emergency authorization for the Covid-19 vaccine produced by Novavax of Maryland and the Indian Serum Institute, which has opened the door for the vaccine, also called Novavax, to be distributed in low-income countries around the world.
The announcement was made on Friday, about six weeks after the company filed an application. News of its resolution came as governments around the world re-imposed restrictions on the coronavirus in preparation for a spike in cases caused by Omicron, a new variant that appears to be the most contagious form of the disease. Its rapid spread has highlighted the urgency of tackling vaccine inequalities around the world in order to eradicate the pandemic.
The approval of Novavax, which is expected to make up a significant portion of the global vaccine supply, could lead to important changes. In February, Novavax announced an agreement to supply 1.1 billion doses for Covax, a United Nations-backed initiative to deliver vaccines to low- and middle-income countries. In September, Covax had to cut its planned 2021 dose shipments by a quarter, in part because Novavax had not yet received approval for its vaccine.
The gap in vaccination rates between high-income countries, many of which now call for booster vaccinations for most adults, and low-income countries remains huge. The WHO approval for Novawax is likely to help increase vaccine supplies for some of the world’s most at risk populations.
“This list aims to expand access, especially in low-income countries, 41 of which have still failed to vaccinate 10 percent of their population, and 98 countries have not reached 40 percent,” Dr Mariangela Simau, WHO Deputy Director-General. for access to medicines, the message says.
Novawax is ninth vaccine to receive WHO emergency clearance
Unlike the Moderna and Pfizer-BioNTech mRNA vaccines, Novavax uses an older technology in which nanoparticles made of spiked proteins trigger an immune response. It can also be stored and transported at normal refrigeration temperatures, which increases its availability to more countries.
Although the company was concerned about production delays, the Novawax vaccine, a two-dose vaccine, has proven highly effective in clinical trials in the United States and abroad. The vaccine showed an overall effectiveness of 90.4 percent in a trial of about 30,000 people, according to results published Wednesday in the New England Journal of Medicine. The effectiveness of Novavax against moderate to severe disease was 100 percent.
Novavax received its first approval from Indonesia last month and was approved for use in the Philippines shortly thereafter. The company also said it will file an application with the US Food and Drug Administration before the end of the year.