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Pfizer, which is developing a COVID-19 vaccine, applied for emergency use of the vaccine to the US Food and Drug Administration for the first time.
Once approval is granted, distribution of the vaccine is expected to begin next month.
Reporter Han Soo-yeon covered it.
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Pfizer is the first pharmaceutical company in the world to request urgent use of the vaccine from the US FDA.
Two days have passed since the final announcement that the COVID-19 prevention effect reached 95% in the third phase of clinical trials.
[앨버트 불라/화이자 CEO]“I’m very proud, happy, and a bit reassuring. Right now, the urgent use of the corona vaccine is in the hands of the FDA.”
It is reported that the FDA Advisory Committee meeting to discuss emergency approvals will be held around the 8th of next month.
In the case of emergency use approval, since the requirements are not stricter than the formal procedure, the chance of approval is high.
[제시 굿맨/전 FDA 관계자]“There is also the possibility that the FDA will not receive all the data or complete the review, so we will approve the rush use as a limited, short-term measure of efficacy and safety.”
Pfizer expects the FDA to approve emergency use by the middle of next month.
Also, as soon as approval is passed, the plan is to start production of 50 million doses, which can be inoculated by 25 million people for distribution.
Pfizer announced that its vaccine is effective in preventing the elderly over 65.
The FDA is also reported to have submitted safety data for 100 adolescents.
[앤서니 파우치/미 국립알레르기·전염병연구소 소장]“The vaccine is at hand. It will come soon. Sooner or later, we will get a lot of help from a very effective vaccine.”
The UK government has also entered the process of evaluating the suitability of the Pfizer vaccine.
The UK has officially announced that once the vaccine is approved, large-scale vaccines will start in December and next year.
However, there are concerns that it may be difficult to mass-produce in a short period of time, as Pfizer’s vaccine is the first vaccine to be made from an mRNA vaccine and genetic material.
Additionally, the need to maintain a cryogenic freeze condition at -70 degrees Celsius can be an obstacle to distribution.
This is Suyeon Han from MBC News.
(Video edit: Garam Kim)
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