Novavax has delayed seeking regulatory authorization for its coronavirus vaccine in the U.S., U.K. and Europe until the third quarter.
That means Korea, which typically waits for other countries to take the lead, will not be authorizing the vaccine either and a much-needed boost to vaccine supplies here will have to wait till the end of the year.
Novavax said Monday it will not be seeking regulatory approvals with the U.S. Food and Drug Administration, European Medicines Agency and Medicines and Healthcare Products Regulatory Agency in the U.K. until the third quarter.
The reason seems to be a shortage of raw materials. The U.S. drug maker had hoped to produce 150 million doses every month in the third quarter, but that has now been revised to 100 million doses by the third quarter and 150 million doses a month until the end of this year.
SK Bioscience, which was to produce the vaccine under license here, has secured enough raw materials for about 2 million doses and was scheduled to produce them by July at its plant in Andong, North Gyeongsang Province.
The hope was that it could then produce enough doses for 10 million people in the third quarter and for another 10 million in the fourth.
The government on Tuesday claimed it will roll out the Novavax vaccine as scheduled, but an official at the Ministry of Food and Drug Safety here admitted that authorization of the Korean-made vaccine will only happen “around the same time as the U.S., Europe and the U.K.” That means the third quarter or later, so any supplies accumulated until then will sit in the refrigerator.
The delay raises Korea’s reliance on Pfizer. Korea hopes to bring in Pfizer vaccines for 29.5 million people in the third and fourth quarters. Most of them would have to arrive in the third quarter to meet the government’s target of achieving herd immunity or 70 percent vaccination by November.
Korea is also buying Moderna vaccines for 20 million people, but mass production will only start after local manufacturers are chosen in August. The government has also signed a deal with Johnson & Johnson for doses for 6 million people, but reports of side effects could prompt people to shun it.
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