PAFSC committee (Japan) approves Comirnaty and Spikevax for booster, use limited to high-risk people with COVID 19
A key Japanese health ministry panel on April 25 gave approval to the fourth shot use of COVID-19 vaccines developed by Pfizer and Moderna, with a label update expected as early as April 26.
However, the target for such use will be limited to people at a high risk of developing severe disease, such as older adults.
The Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Second Committee on Drugs endorsed the two companies’ respective vaccines, Comirnaty and Spikevax, for fourth inoculations, or a second booster, to be given to the “elderly, etc.,” at least five months after the third dose. According to the Ministry of Health, Labor and Welfare (MHLW), “elderly, etc.,” includes not only older adults but also other individuals with high risks of severe COVID-19, including those with underlying medical conditions. The scope of eligible people for the fourth shot, such as age limits, will be discussed separately by the Health Science Council’s (HSC) immunization and vaccine subcommittee.
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