Pfizer/BioNTech apply for vaccine approval in Japan
Tokyo, Dec 18 (efe-epa).- United States pharmaceutical giant Pfizer and its German partner BioNTech on Friday applied to the Japanese government for approval of their Covid-19 vaccine, the companies reported in a statement.
They are the first pharmaceutical firms to file such an application for manufacturing and marketing in the country. If approved, vaccinations in Japan could begin in March.
Pfizer/BioNTech have provided Japan’s Ministry of Health with non-clinical, quality and clinical trial materials. In addition, a Japanese study to evaluate the safety, tolerability and immunogenicity of the vaccine is underway with the second of two inoculations completed, they said.
“It is expected that the main data will be obtained and the results will be finalized by February next year, and will be submitted as soon as they are finalized,” Pfizer/BioNTech said in the statement.
Japan had already reached an agreement with the companies to supply 120 million doses of the vaccine, enough for 60 million people, just under half of the Japanese population, in the first half of next year.
The Asian country also signed agreements with the US’ Moderna and the British AstraZeneca, responsible for the other two most promising candidates, to receive enough doses to cover the entire population when they are successfully developed.
The Japanese parliament enacted a law at the beginning of December to guarantee free vaccination for residents of the country, and had already assured that in the event of serious side effects, the State would bear the costs of the relevant medical expenses, compensation or pension.
The US and the United Kingdom have already started vaccinating their populations against Covid-19 with the vaccine developed by Pfizer and BioNTech.
The companies claim the vaccine has a 95 percent efficacy rate consistent across age, gender, race and ethnicity.
Countries have registered several cases of serious allergic reactions to the injection, which has raised concerns about the vaccine, developed in record time – less than a year.
The fastest vaccine development program to date had been the four years it took to manufacture the mumps vaccine, authorized in 1967. EFE-EPA