[국제]EMA “Jansen Vaccine May Be Related to Blood Clots… Should Add Warning to Product Information”

EMA “Jansen Vaccine. Finding Potential for Specific Thrombosis Cases”
“We need to add warning information for potential specific blood clots in Janssen vaccine products”
CDC discusses whether to resume Janssen vaccination on the 23rd
Pre-purchase contract for 6 million people through individual negotiations with Korea and Janssen


[앵커]

The European Medicines Agency determined that the Janssen vaccine may have been associated with a specific case of blood clots, and decided that a warning should be added to the Janssen vaccine’s product about the potential for blood clots.

US health officials have made a decision to recommend discontinuation of vaccination, but EMA has made it clear that vaccination should be given because the benefit of the vaccine outweighs the risk of side effects.

Reporter Kang Seong-ok reports.

[기자]

The European Medicines Agency, the EMA Safety Committee, says it has discovered the possibility that the Janssen vaccine may have been associated with very rare cases of specific blood clots with platelet reduction.

He then advised that warnings about possible peculiar blood clots should be added to the Janssen product information.

Although such cases should be included as a very rare side effect of Janssen’s vaccine, we concluded that the product should be launched normally.

[에머 쿡 / 유럽의약품청장 : 백신이 출시되고 많은 사람들에게 투여했을 때, 매우 드문 부작용이 발생할 수 있으며, 이러한 부작용들이 임상 실험에서 반드시 확인되지는 않을 것입니다.]

The U.S. Food and Drug Administration, the FDA, the Centers for Disease Control and Prevention, and CDC recommended discontinuation on the 13th based on six cases of’rare but severe’ blood clots among Janssen vaccinations.

Since then, decisions have been made in the United States and other parts of the world to stop getting the vaccine or postpone its introduction.

The US CDC will hold an advisory panel meeting on the 23rd local time to discuss whether to resume the Janssen vaccine.

It is noted whether it will come to a different conclusion than the EMA.

Korea signed a pre-purchase contract with Janssen for 6 million people through individual negotiations.

Unlike other vaccines that require two doses, the Janssen vaccine has an average preventive effect of 66% even if it is given only once, and it was evaluated as an advantage of being refrigerated.

However, anxiety about vaccination has been raised as cases of side effects of blood clots have been reported with the adenovirus carrier vaccine, which is the same method as the AstraZeneca vaccine.

This is YTN Kang Seong-ok.

[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]

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