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The Times via AP Certified Nurse Assistant Kisa Kniola, left, gives a COVID-19 vaccination to Registered Nurse Lindsay Kreighbaum at Franciscan Health on Friday in Michigan City, Ind.
The Yomiuri Shimbun
14:31 JST, December 19, 2020
The use of Pfizer Inc.’s coronavirus vaccine could start as early as February next year, after the U.S. pharmaceutical giant applied for approval of the vaccine to the Health, Labor and Welfare Ministry on Friday.
In general, it takes about one year for a drug to be approved while there is a special approval system that can reduce the monitoring period. In May, the government revised relevant ordinances so that drugs related to the novel coronavirus can be applied for the fast-track system.
Pfizer has applied for the special approval of the vaccine and had in advance submitted data including its clinical trials conducted overseas to the ministry.
The special approval has been applied in three cases in the past. Two vaccines from two overseas companies that were submitted during an influenza epidemic after 2009 were approved within two to three months. The other case was for remdesivir, a drug for the treatment of COVID-19, and it was submitted in May and was approved three days later.
“We want to proceed with the monitoring promptly,” Chief Cabinet Secretary Katsunobu Kato said on Friday regarding Pfizer’s application for the vaccine. “As soon as the application is approved, we will start vaccination of medical personnel who are in the highest ranking for inoculation, and will be ready for gradually expanding the vaccination program.”
The vaccine was jointly developed by Pfizer and German firm BioNTech SE. The vaccine is made by artificially synthesizing messenger RNA, or mRNA, the genetic material of the coronavirus, as its main ingredient. The vaccine has a mechanism in which the body of the inoculated person produces a protein of the new coronavirus and becomes immune to it.
