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“Modena Vaccine Evaluation Meeting on January 12”
It can be sold for one year in 27 member countries upon approval.
Pfizer / Bio & Tech’s COVID-19 vaccine is pending approval for sale from the European Medicines Agency (EMA). London = AFP Yonhap News
On the 29th it will be decided whether the European Medicines Agency (EMA), a medical regulatory authority of the European Union (EU), will approve the sale of the Corona 19 vaccine jointly developed by the US pharmaceutical company Pfizer and the German Bioentech to the EU.
According to the AFP statement, on day 1 (local time), the EMA confirms that it has received an emergency approval request from the two companies, and if the data presented is robust enough to draw conclusions on quality, safety and effectiveness. of the vaccine, is scheduled for at least 29 days. It was announced that the evaluation could be completed at a special meeting. The EMA also added that a separate evaluation meeting will be held on the 12th of next month at the latest for the Corona 19 vaccine from the US pharmaceutical company Modena, which has been requested for emergency approval.
Pfizer-Bioentech applied for urgent use of the vaccine to the US Food and Drug Administration (FDA) on 20 last month after announcing the final results of the phase 3 clinical trial that the immune effect of the COVID-19 vaccine developed jointly by the two companies was 95%. On the 30th of the same month, the EMA also submitted a request for approval.
The day before, Modena announced that the final analysis of its phase 3 clinical trial of the vaccine showed that it had a 94.1% preventive effect. On the same day, he requested the urgent use of his vaccine to the FDA and EMA.
An EU Commission spokesperson reportedly said that if the EMA grants the permit, official EU approval will likely take place within a few days.
The conditional sale approval granted by the EU is a process to respond quickly to emergencies that threaten public health, such as Corona 19. With the approval, medicines can be sold in 27 Member States for a year, even before they are obtained all the necessary information about the efficacy and side effects of the drug.
Meanwhile, the US FDA plans to decide whether to approve the use of Pfizer and Moder or vaccines through review meetings on the 10th and 17th, respectively.
Kwon Kyung-seong reporter [email protected]
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