FDA concludes "no specific concerns" identified in Moderna's COVID-19 vaccine
- 3 years ago
미 FDA "모더나백신 효과적"…화이자 이어 18일께 두번째 승인 + "화이자-얀센과 백신 구매계약 합의 순조로워…조만간 결과발표"
The United States could have two Covid-19 vaccines before the week is over: Moderna's vaccine was found "highly effective" in a detailed review by FDA scientists and appears to be on track for approval by regulators.
This as the European Medicines Agency moves up expert review of the Pfizer vaccine to approve its first vaccine ahead of Christmas.
South Korea is also expected to soon announce the details of its deals with vaccine producers.
Kim Sung-min has details.
Moderna's COVID-19 vaccine is one step closer to getting the green light in the U.S.,...as the Food and Drug Administration on Tuesday gave a positive statement about the vaccine.
Confirming the overall efficacy of 94-point-1 percent,... the FDA report said that the vaccines are very effective and no safety concerns were found that would setback the issuance of an Emergency Use Authorization.
This comes two days ahead of the meeting of experts on whether to authorize the vaccine.
The panel of experts are set to offer their recommendation on the vaccine on the 17th, and the final FDA decision is expected to follow a day after.
Once approved, the first batches could start rolling out next week.
If these plans go smoothly, the U.S. would become the first country to authorize Moderna's vaccine.
That would make Moderna the second vaccine producer to receive the green light in the country,...following Pfizer.
Meanwhile in South Korea, the government is close to sealing a deal with two global vaccine producers,...Pfizer and Janssen.
"The agreement with Pfizer and Janssen has been going smoothly so far. So if there is no setback, we will be able to make the deal and announce it soon.
South Korea earlier announced it would secure enough doses for 10 million people through the COVAX facility, and reach an agreement with global pharmaceuticals firms for another 40 million.
Kim Sung-min, Arirang News
The United States could have two Covid-19 vaccines before the week is over: Moderna's vaccine was found "highly effective" in a detailed review by FDA scientists and appears to be on track for approval by regulators.
This as the European Medicines Agency moves up expert review of the Pfizer vaccine to approve its first vaccine ahead of Christmas.
South Korea is also expected to soon announce the details of its deals with vaccine producers.
Kim Sung-min has details.
Moderna's COVID-19 vaccine is one step closer to getting the green light in the U.S.,...as the Food and Drug Administration on Tuesday gave a positive statement about the vaccine.
Confirming the overall efficacy of 94-point-1 percent,... the FDA report said that the vaccines are very effective and no safety concerns were found that would setback the issuance of an Emergency Use Authorization.
This comes two days ahead of the meeting of experts on whether to authorize the vaccine.
The panel of experts are set to offer their recommendation on the vaccine on the 17th, and the final FDA decision is expected to follow a day after.
Once approved, the first batches could start rolling out next week.
If these plans go smoothly, the U.S. would become the first country to authorize Moderna's vaccine.
That would make Moderna the second vaccine producer to receive the green light in the country,...following Pfizer.
Meanwhile in South Korea, the government is close to sealing a deal with two global vaccine producers,...Pfizer and Janssen.
"The agreement with Pfizer and Janssen has been going smoothly so far. So if there is no setback, we will be able to make the deal and announce it soon.
South Korea earlier announced it would secure enough doses for 10 million people through the COVAX facility, and reach an agreement with global pharmaceuticals firms for another 40 million.
Kim Sung-min, Arirang News