Indonesia, hard-hit by the coronavirus pandemic, became the first country to approve the new vaccine for COVID-19 created by US-based Novavax, the company announced Monday.
The approval will give Indonesia, which has strained to obtain adequate supplies of coronavirus vaccine for its 270 million people, first access to the vaccine, which will be manufactured in India under the brand Covovax.
The vaccine uses a different technology than those which already have gained general approval and circulated around the world.
Unlike the mRNA products from BioNTech/Pfizer, Moderna and Curevac, Novavax's two-jab vaccine relies on a more traditional technique, using proteins to carry fragments of the coronavirus rendered harmless to produce an immune reaction.
In addition, the vaccine can be held at higher temperatures than others — 2-8 degrees Celsius — making its transportation and storage easier, especially in developing countries.
"The first authorization of Novavax's Covid-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population," said Novavax chief executive Stanley Erck.
The vaccine will be produced by the Serum Institute of India, and deliveries will begin "imminently," according to a statement from Novavax.
In June, the company reported that tests of the vaccine on 30,000 people in the United States and Mexico demonstrated that it is 90.4 percent effective in preventing symptomatic infection and 100 percent effective against moderate and severe disease.
The company has submitted applications for approval of the vaccine in numerous countries and the European Medicines Agency, and has sought emergency use listing with the World Health Organization.
An application to the US regulator, the Food and Drug Administration, will be made by the end of the year, the company said.
It also has preliminary orders, pending approval, for 200 million doses from the European Commission and 150 million from Japan.
"Novavax continues to deliver regulatory filings that we expect will bring the first protein-based COVID-19 vaccine based on Phase 3 data to the world," Erck said.
