• Kyodo

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Japan will establish a system to allow vaccines and drugs to be granted approval in emergency situations once their safety has been verified, making the screening process shorter than under the existing fast-track system, government sources have said.

The plan, to be finalized by the end of the year, comes amid criticism that Japan lagged other countries in approving drugs and vaccines to deal with the COVID-19 pandemic. Currently, drugs are required to pass both safety and efficacy tests before they can be approved.

Under the proposed new system, if the efficacy of a drug approved for emergency use cannot be confirmed within a set time limit, its approval will be revoked, the sources said Wednesday.

A related bill will be submitted to an ordinary session of the Diet, Japan's parliament, next year, they said.

Once a pharmaceutical company files a new drug application with the health ministry, having already conducted clinical trials on humans to verify a drug's efficacy and safety, it usually takes around a year to obtain approval.

COVID-19 vaccines developed overseas were approved under a fast-track system that allowed the review process to be simplified using data from countries where the vaccines were already being administered. But even under that system, approval for the vaccines in Japan were delayed up to five months after approvals in the United States and Europe.

The government has already agreed with U.S. pharmaceutical company Merck & Co. on the procurement of 1.6 million doses of molnupiravir, an orally administered drug that prevents the COVID-19 virus from entering or multiplying in the body. Japan sees the medicine as a key to stemming the pandemic.

The government plans to enable the drug to be delivered to patients' homes as well as providing up to ¥2 billion for the development of oral medicines in Japan.

In the United States, the use of unapproved drugs and medical devices can be allowed under the Emergency Use Authorization framework.

As for COVID-19 vaccines, the health ministry has urged local governments to prepare for the administration of the vaccine to children age 5 to 11, expanding inoculations to this age group from February or thereafter, ministry officials said Wednesday.

While the Ministry of Health, Labor and Welfare sent the notice to municipalities dated Tuesday, some health experts have expressed concern amid uncertainty over the efficacy and safety of the vaccine in children under the age of 12.

U.S. pharmaceutical giant Pfizer Inc. and German partner BioNTech SE applied last week for approval from the government for use of the vaccine they jointly developed to inoculate children in the age group.

Pfizer's vaccine is currently available free of charge only to people age 12 and above in Japan.

In the United States, vaccinations of children age 5 to 11 have already begun, following approval by the U.S. Centers for Disease Control and Prevention.

Data from clinical trials conducted by Pfizer in the United States and other countries show that administration of a third of an adult dose of the vaccine was 90.7% effective in preventing COVID-19 infections in children age 5 to 11.

The trials also showed that while the subjects experienced sore arms, fatigue and headaches the next day, the side effects disappeared quickly and there were no safety issues.

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