AstraZeneca vaccine review underway with 40-day goal
Korea’s Ministry of Food and Drug Safety embarked on a review of AstraZeneca’s coronavirus vaccine Monday.
As part of the ministry’s fast-track efforts to fight the pandemic, a nod for AstraZeneca’s vaccine is likely to come within 40 days. Last month, the ministry pledged it would accelerate approval procedures with a goal of completing them within 40 days, instead of the usual 180-day period.
After use approval, it would take a maximum of 20 days for the vaccine to obtain a nod for lot release — a mandatory step for bio pharmaceuticals.
The ministry noted that AstraZeneca’s vaccine manufactured at SK Bioscience is already preparing to pass this step. SK is one of the British bio firm’s contract manufacturers for the Covid-19 vaccine.
Among vaccines from multinational firms that closed supply contracts with the Korean government, AstraZeneca’s vaccine is most likely to reach the country first. The deal between the parties stipulates the vaccine supply to start in the first quarter of 2021.
According to the Drug Safety Ministry, AstraZeneca’s vaccine will be allowed for people aged 18 and above. It will require two injections with a gap of four to 12 weeks in between. As a viral-vector vaccine, the substance can be stored and transported in an environment with a temperature of 2 to 8 degrees Celsius (35.6 to 46.4 degrees Fahrenheit).
AstraZeneca’s vaccine received emergency use authorization from British regulators on Dec. 30 and is currently undergoing a review for approval at the European Medicines Agency.
BY SONG KYOUNG-SON [firstname.lastname@example.org]
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