South Korean Panel Recommends Moderna’s Covid Vaccine Eligible For Use
Moderna Inc.’s Covid-19 vaccine has been recommended in South Korea by a panel of experts, news agency Yonhap reported. As per the panel, the vaccine showed more than a 94 percent efficacy rate and is eligible for use.
The panel’s review is the first step of three separate independent evaluations before the Ministry of Food and Drug Safety gives final approval for the vaccine.
Reuters reported that the national pharmaceutical panel will make its recommendation on Thursday, while the government will wait for a third panel, which is yet to reach to its conclusion, before deciding whether to grant approval.
According to the Ministry, the advisory board consisting of outside experts reviewed the efficacy and safety of the Moderna vaccine based on clinical trials on 28,207 participants.
The panel noted that Moderna’s two full-dose regimen showed efficacy among all adults. Mild reactions were reported in some vaccine recipients, but symptoms disappeared in one or two days.
The South Korean government has signed a contract with Moderna for vaccines for 20 million people, and part of delivery is scheduled before June.
South Korea has already approved vaccines from AstraZeneca, Pfizer and Johnson & Johnson to use against the coronavirus.
Moderna’s COVID-19 vaccine received the emergency use authorization from the U.S. FDA in December last year in individuals 18 years of age or older. The company plans to initiate rolling submission for a Biologics License Application for the vaccine in the U.S. this month.
The European Medicines Agency has authorized Moderna COVID-19 vaccine’s use across the European Union. In late April, the WHO listed the Moderna COVID-19 vaccine for emergency use, making it the fifth vaccine to receive emergency validation from WHO. The vaccine is now approved in around 45 countries.
The company’s initial data from its ongoing phase 2 study showed that booster shots of its COVID-19 vaccine is effective against various coronavirus variants.
In late April, Moderna announced its plans to boost vaccine supply to meet the global demand and increased 2021 supply forecast to between 800 million and 1 billion doses. With additional investments, the company expects to increase global supply for COVID-19 Vaccine to up to 3 billion doses in 2022.
For fiscal 2021, the company now expects sales for its COVID-19 vaccine to reach $19.2 billion, higher than prior outlook for $18.4 billion.
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