The initial volume of Kobax is also popularly mentioned… Cryogenic distribution system required
(Seoul = Yonhap News) Reporter Jandi Kim = Pfizer Pharmaceutical’s new coronavirus infection (Corona 19) vaccine, which is being introduced next month, is expected to go through the domestic product approval procedure within this month.
According to the pharmaceutical and bio industry on the 21st, Pfizer Pharmaceuticals Korea decided to apply for a formal item license with the Ministry of Food and Drug Safety within this month, and is working at the end.
However, as AstraZeneca’s Corona 19 vaccine has already been approved and reviewed by the Ministry of Food and Drug Safety, it is unclear which product will be approved first.
Pfizer Pharmaceutical has been following up since it applied for a preliminary review of non-clinical and clinical (Phase 1, 2, 3) data before applying for approval of the Corona 19 vaccine to the Food and Drug Administration on January 18.
However, Pfizer Pharm drew a line that it could not confirm the specific schedule.
An official of Pfizer Pharmaceutical said, “We are going to apply for a corona 19 vaccine item permission with the Ministry of Food and Drug Safety as soon as possible, but it is difficult to mention a clear date.” .
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The Ministry of Food and Drug Safety is reviewing non-clinical and clinical data on Pfizer’s COVID-19 vaccine. The Ministry of Food and Drug Safety has set up a’licensing exclusive review team’ for rapid COVID-19 vaccination, and shortened the approval review period from 180 days to within 40 days.
Until now, the Ministry of Food and Drug Safety has repeatedly emphasized that it will promptly review the approval so that there will be no disruption in the Corona 19 vaccination schedule, so there is a possibility that the approval will be issued without filling the 40 days.
In particular, Pfizer’s Corona 19 vaccine is known as the first product to be brought in through the COVAX facility, an international project for joint purchase and distribution of vaccines, and there is high hope that it will go through the relevant procedures quickly.
The Korean government has secured a total of 56 million Corona19 vaccines through COVAX with overseas pharmaceutical companies, and is negotiating with NovaVax of the United States to secure an additional 20 million people. Start vaccination next month as soon as possible.
The initial volume to be received from Kovacs is about 50,000 people, and Pfizer’s vaccine is being widely discussed.
Pfizer’s Corona 19 vaccine is a’nucleic acid vaccine’ developed using messenger ribonucleic acid (mRNA, messenger RNA) containing the genetic information of the virus. This vaccine should be administered twice every 28 days.
However, there is a limitation that Pfizer vaccine must be distributed through a’cold chain’ at cryogenic temperatures below -70℃. In order to introduce it into Korea, a system that can distribute and store vaccines in cryogenic conditions must be established in advance.
Currently, the Ministry of Food and Drug Safety is reviewing the approval of AstraZeneca’s COVID-19 vaccine and preliminary review of data related to clinical trials of Pfizer Pharmaceuticals and Janssen’s COVID-19 vaccine.
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2021/01/21 14:58 sent
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