Food and Drug Safety Minister Kim Gang-lip announces the authorization for Novavax's coronavirus vaccine on Jan. 12. (Yonhap/EPA-EFE/Shutterstock)

SEOUL — South Korea’s drug regulator on Wednesday granted final authorization to Novavax’s coronavirus vaccine for use in adults, health officials said in a news release, making it the fifth coronavirus vaccine available in the country.

Although the authorization is conditioned on the Maryland-based company’s submission of the final results of clinical studies regarding its vaccine, the Ministry of Food and Drug Safety said Novavax’s coronavirus vaccine has received “final” approval in South Korea. The vaccine, which will be produced locally, is effective and safe, the regulator said.

The AstraZeneca-Oxford, Pfizer-BioNTech, Moderna and Johnson & Johnson coronavirus vaccines have been in use in South Korea, where 84 percent of the country’s 52 million people are fully vaccinated. The vaccine by U.S. firm Pfizer and German partner BioNTech has been the one most commonly used, according to government data.

In June, Novavax announced that its coronavirus vaccine was 90 percent effective at protecting people from illness. Last month, the biotech company said it “showed strong immune responses against Omicron and other circulating variants.”

South Korea’s authorization of the Novavax vaccine comes after the European Medicines Agency last month recommended it for use in the European Union, the World Health Organization validated it for emergency use and India’s drug regulator granted it emergency use authorization. Novavax said last month it expects to submit its application for emergency use in the United States around late January.

Novavax’s vaccine was one of six candidates initially backed by the U.S. government, which awarded a $1.6 billion contract to the company in 2020 even though Novavax had never produced a vaccine that crossed the regulatory finish line. The company later encountered production and clinical delays, while competitors raced ahead.

The company is now poised to produce doses for use worldwide and has plans to develop a coronavirus vaccine targeting the omicron variant. The company hopes to produce more than 2 billion doses in 2022, John Trizzino, Novavax’s chief commercial and business officer, told The Washington Post last week.

Novavax’s vaccine is a two-dose regimen to be administered three weeks apart and can be stored in normal refrigerator temperatures of about 36 to 46 degrees Fahrenheit. This makes the vaccine easier to be shipped to underdeveloped parts of the world. Novavax and its partner, the Serum Institute of India, have agreed to send the global vaccine-access program Covax about 1.1 billion doses.

The WHO is aiming to vaccinate 70 percent of the population in every country by mid-2022. It did not meet its goal of vaccinating 40 percent of every country by the end of 2021, as lower-income nations struggled to obtain enough supplies.

Covax promised 2 billion vaccine doses to help the world’s neediest in 2021. It won’t deliver even half that.

And with the advent of the omicron variant, which has been shown to be better at dodging protection provided by existing coronavirus vaccines, the world is again facing a supply problem, health experts warned.

Last week, a team of public health advocates and scientists concluded that the world will need 22 billion coronavirus mRNA vaccine doses to slow the pandemic’s spread. That is far beyond the world’s current production capabilities, the experts said in a report. Scaling up capacity to meet this need will cost up to “$12 billion in capital expenses” and six months, they said in their report: “The time to act is now.”

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