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MFDS reviews Pfizer COVID-19 vaccine used without dilution

By Lee, Tak-Sun | translator Alice Kang

21.11.30 18:43:47

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Applied for approval on the 30th¡¦ was approved in the US and EU in November



On the 30th, the Ministry of Food and Drug Safety had announced that it had started reviewing the approval of Pfizer¡¯s COVID-19 vaccine that does not require dilution – ¡®Comirnaty inj. 0.1§·/§¢ (registered name)¡¯ – after the company applied for the authorization of its import product license.

The product contains the same active ingredient as the previously approved Pfizer vaccine, ¡®Comirnaty inj,¡¯ but is more user-friendly as it may be used directly without dilution. Its single dose is 30§¶, same as that of the already approved vaccine.

The ¡®Comirnaty inj. 0.1§·/§¢¡¯ vaccine that is applying for approval this time comes in a vial with a gray cap, which can be different

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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