美國FDA宣布除了最後一支Novavax 疫苗可以採用緊急授權機制外，
以後將不再發布EUA任何一家疫苗，美國 FDA 可能不會在大流行期間
審查新的 COVID-19 疫苗對 EUA 請求。
這是不是意味高端聯亞在取得美國FDA 認證EUA上將面臨新的變數。
網址https://reurl.cc/EnRexR
The U.S. Food and Drug Administration said on Tuesday it may decline to
review and process new emergency use authorization (EUA) requests for
COVID-19 vaccines for the rest of the pandemic, if a company has not already
begun discussions.
So far, vaccines from Pfizer Inc (PFE.N), Moderna Inc (MRNA.O) and Johnson &
Johnson (JNJ.N) have been authorized for emergency use in the United States.
(https://bit.ly/3fOpP2S)
Novavax Inc (NVAX.O) has had discussions with regulators and said it does not
expect to seek regulatory authorization for its COVID-19 shot in the United
States, Britain and Europe until the third quarter of 2021. read more
Canadian drug developer Medicago said it was in discussions with the FDA for
an EUA for its plant-based COVID-19 vaccine candidate, which is enhanced by a
GlaxoSmithKline (GSK.L) treatment.
AstraZeneca (AZN.L) also has discussed plans for its COVID-19 vaccine with
U.S. officials. However, the Wall Street Journal earlier this month reported
that it was considering skipping U.S. emergency-use authorization and instead
pursue the more time-intensive application for a full-fledged license to sell
the shot. read more
AstraZeneca and Novavax did not immediately respond to requests for comment.
Our Standards: The Thomson Reuters Trust Principles.
這是真的嗎?