Approval of ’16 years of age or older’ through the final inspection committee including external experts from the Ministry of Food and Drug Safety
Must be stored in’cryogenic’… 5 other domestic vaccines in the early stages of clinical trials
[시사경제신문=이다인 기자] As the second new coronavirus infectious disease (Corona 19) vaccine in Korea, Pfizer’s’Cominatiju’ has received product approval for those aged 16 or older.
The Ministry of Food and Drug Safety held a final inspection committee including external experts on the 5th, and determined that 95% of the prevention effect was sufficient as the result of the two previous expert consultations conducted on Pfizer vaccines, and announced official approval.
However, this clinical trial was designed for people 16 years of age or older, and it was determined that the immune response of adolescents would not be different from that of adults, so it was approved for those aged 16 years or older. Our quarantine authorities exclude those under the age of 18 from being vaccinated against Corona 19.
In addition, there is also a condition that the storage and distribution temperature must be maintained at the’ultra-low temperature’ level as before. Recently, the US Food and Drug Administration (FDA) has relaxed the standard so that Pfizer’s vaccine can be stored at -25 to 15°C, which is the level of a normal freezer for two weeks, but the Korean government approved it at -90 to 60°C for 6 months.
In response, KFDA Minister Kim Kang-rip said at a briefing held at the Osong Food and Drug Administration on the 5th, “We have not submitted a request for permission for distribution conditions as Pfizer submitted to the FDA.” After that, we can finally decide the permission.”
As a result of multi-national clinical trials conducted in the United States, there were 8 out of 18,198 vaccine groups and 162 out of 18,325 controls. There was one case of drug-related hypersensitivity reaction after vaccine administration, and no anaphylaxis, acute severe drug-related allergic reaction, was reported.
On the other hand, the development of the domestic Corona 19 vaccine is in progress with approval of clinical trials by five companies, all of which are in the early stages of phase 1 or 1/2a.
The vaccine approved this time is separate from the 55,000 Pfizer vaccine, which began vaccination for corona 19 treatment medical staff from the 27th of last month. This is the quantity introduced through the international vaccine joint purchase project’Covax Facility’ and has been approved for’special import’ to import medicines without official approval in Korea.
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