EMA could approve vaccine application in coming days

  • 3 years ago
유럽의약품청 “며칠 내 코로나19 백신 판매승인 신청 예상”

The first application for marketing approval of a COVID-19 vaccine in the EU is set to begin.
While the European Medicines Agency have not revealed which company is expected to file,... many believe it'll be Pfizer-BioNTech's vaccine.
Lee Seung-jae reports.
According to the European Medicines Agency Thursday,... the first application for marketing approval of a COVID-19 vaccine in the European Union should arrive in the next few days.
While the drug watchdog did not reveal which drugmaker is expected to file,... many pundits believe Pfizer and BioNTech are currently at the most advanced stage of the regulatory approval process.
The U.S.-German duo has already applied for approval in the U.S., while the U.K. has asked its medical regulator to assess its vaccines.
The drugmakers also sent results of their vaccine tests earlier this week to the office of Brazil's health regulators,... a necessary step in approving and registering the vaccine.
Pfizer says it's set to present information related to the vaccine in stages,... including its data showing 95-percent efficacy.
Back in Europe,... the EMA told AFP that it could approve the first vaccine by the end of the year,... with countries like France, Spain and Italy being among the first to receive them.
In Russia,... after announcing a 95-percent success rate on its Sputnik V vaccine,... a second vaccine is now in phase three trials.
This time, it is the EpiVacCorona vaccine in late stage trial,... and it could be available by the end of the year.
With many countries seeing record numbers of daily infections,... drugmakers around the world continue to push for their first vaccine approvals.
Lee Seung-jae, Arirang News.

Recommended