The EU drug regulator said it has received an application from Novavax to authorize US biotechnology company coronavirus Vaccine, a request that could significantly increase the continent’s supply of vaccine if it is granted.
In a statement on Wednesday, the European Medicines Agency said it has begun evaluating data submitted by Novavax for its two-dose vaccine. An accelerated review process could decide within weeks if the data presented is sufficiently robust and complete to show the vaccine’s efficacy, safety and quality, the agency said.
Novavax’s COVID-19 vaccine is made using a different technology than others currently on the market, including messenger RNA vaccines made by AstraZeneca and Johnson & Johnson and manufactured by Moderna and Pfizer-BioNtech.
Novavax’s shot is made with lab-grown copies of the spike protein that coats the coronavirus, which then triggers an immune response.
In June, Maryland-based Novavax announced that the vaccine had been shown to be about 90% effective against symptomatic COVID-19 in a study of nearly 30,000 people in the United States and Mexico. The company said that it also worked against variants airing in those countries at the time.
The company said side effects were mild and included tenderness, headache, aches and pains and fatigue at the injection site.
To date, the European Medicines Agency has authorized vaccines made by Pfizer-BioNtech, Moderna, AstraZeneca and Johnson & Johnson. It is currently reviewing vaccines made by China’s Sinovac and France’s Sanofi Pasteur, as well as Russia’s Sputnik V.
Novavax previously said it would prioritize getting approval in developing countries because its vaccine is easier to transport; Indonesia gave its green signal earlier this month. The vaccine is pending authorization by the World Health Organization and countries including the United Kingdom, Australia and Canada.
Europe, which last week had more than two-thirds of confirmed COVID-19 cases worldwide, is currently the epicenter of the pandemic. National authorities are looking to reimpose lockdown restrictions and ramp up vaccination efforts.
In October, Novavax addressed concerns that raw material shortages and other issues had slowed production of its vaccine. The company said it plans to achieve a capacity of 150 million doses per month by the end of the fourth quarter through partnerships with Serum Institute of India, SK Bioscience in South Korea and Takeda in Japan.
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