TOKYO – U.S. pharmaceutical giant Pfizer Inc. and its German partner BioNTech SE on Friday applied to Japan’s Health Ministry for the manufacturing and marketing approval of its novel coronavirus vaccine, Pfizer’s Japanese arm announced.
It is the first application in the country for the regulatory approval of a COVID-19 vaccine.
"COVID-19 continues to increase in Japan and other countries around the world, and our efforts to deliver safe and effective vaccines are progressing at an unprecedented speed in collaboration with the regulatory authorities of each country,” Pfizer Japan Inc. President and CEO Akihisa Harada said in a statement.
“This manufacturing and marketing approval application is based on data obtained from scientifically strict and highly ethical research and development, and when approval is obtained, we will promptly give vaccines to Japanese people as well. I would like to deliver it and contribute to the normalization of social life,” he added.
Pfizer Inc. and BioNTech SE have agreed with the Japanese government for the supply of 120 million doses of their COVID-19 vaccine, enough for 60 million residents, in the first half of 2021 if regulatory approval is obtained.
“We will consider giving approval to COVID-19 vaccines, and the Health Ministry is giving the first priority to the safety and efficacy of the vaccines,” Chief Cabinet Secretary Katsunobu Kato told a press conference prior to Pfizer Japan’s announcement.
“The government is going to secure the vaccines for all the people in Japan by the end of the first half of next year,” he noted.
He added that the government would make the necessary preparations for the delivery and transportation of vaccines to medical facilities.
The Pfizer-BioNTech COVID-19 vaccine, which was proven 95 percent safe and effective, is already being administered in the U.K., the U.S. and Canada. - Florenda Corpuz