FDA concludes "no specific concerns" identified to Moderna's COVID-19 vaccine
- 3 years ago
미 FDA "모더나 백신 효과적"…화이자 이어 18일께 두번째 승인
Following the roll out of the Pfizer-BioNTech COVID-19 vaccine in the U.S.,... the FDA on Tuesday issued an encouraging statement on the Moderna vaccine,... hinting at an emergency approval by later this week.
Lee Seung-jae reports.
The U.S. FDA on Tuesday issued a positive statement on Moderna's COVID-19 vaccine,... ahead of a meeting of experts on whether to give it the green light.
Confirming the overall efficacy of 94-point-1 percent,... the regulators said there were "no specific safety concerns that would preclude issuance of an Emergency Use Authorization.
Now a panel of outside experts will hold a meeting,... and offer their recommendation on the vaccine on Thursday,... with a final FDA decision expected shortly after.
If the FDA does approve the vaccine,... the first shipments could start rolling out next week.
Moderna's vaccine would be the second after Pfizer won authorization last week,... and began rolling out their vaccination program on Monday.
On the other side of the Atlantic,... the European Medicines Agency is set to hold a meeting among its human medicines committee to consider a conditional marketing authorization application for the Pfizer-BioNTech vaccine.
The meeting was originally schedule for December 29th,... but it has been brought forward to the 21st.
A favorable opinion on the vaccine on Monday would mean the vaccine could be authorized in Europe a few days later.
The EU has an agreement with Pfizer for up to 300 million doses,... with deliveries to start by the end of this year.
Lee Seung-jae, Arirang News.
Following the roll out of the Pfizer-BioNTech COVID-19 vaccine in the U.S.,... the FDA on Tuesday issued an encouraging statement on the Moderna vaccine,... hinting at an emergency approval by later this week.
Lee Seung-jae reports.
The U.S. FDA on Tuesday issued a positive statement on Moderna's COVID-19 vaccine,... ahead of a meeting of experts on whether to give it the green light.
Confirming the overall efficacy of 94-point-1 percent,... the regulators said there were "no specific safety concerns that would preclude issuance of an Emergency Use Authorization.
Now a panel of outside experts will hold a meeting,... and offer their recommendation on the vaccine on Thursday,... with a final FDA decision expected shortly after.
If the FDA does approve the vaccine,... the first shipments could start rolling out next week.
Moderna's vaccine would be the second after Pfizer won authorization last week,... and began rolling out their vaccination program on Monday.
On the other side of the Atlantic,... the European Medicines Agency is set to hold a meeting among its human medicines committee to consider a conditional marketing authorization application for the Pfizer-BioNTech vaccine.
The meeting was originally schedule for December 29th,... but it has been brought forward to the 21st.
A favorable opinion on the vaccine on Monday would mean the vaccine could be authorized in Europe a few days later.
The EU has an agreement with Pfizer for up to 300 million doses,... with deliveries to start by the end of this year.
Lee Seung-jae, Arirang News.