"Do Adolescents Also Get Vaccinated?"... Pfizer Applies for Approval Change on Dosage Age and Storage Period

'Request for Change to "Refrigerated Storage Up to 31 Days"'

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] On the 21st, the Ministry of Food and Drug Safety announced that Pfizer Korea has applied for changes regarding the storage period of the thawed COVID-19 vaccine 'Comirnaty' after freezing and the eligible age for administration.

Currently, the Pfizer vaccine is authorized to store unopened thawed vaccines at 2?8℃ for up to 5 days after freezing (-90 to -60℃). Pfizer Korea has applied for a change in authorization to allow refrigerated storage for up to 31 days based on additional testing.

Additionally, they have applied for a preliminary review to extend the authorized age for administration from 16 years and older to include adolescents aged 12 to 15, based on clinical trials conducted on this age group.

Kim Kang-lip, Commissioner of the Ministry of Food and Drug Safety, stated in a briefing, "We plan to conduct an expedited review of this change application to shorten the review period as much as possible. A preliminary review for changing the age to allow vaccination for adolescents aged 12 to 15 has also been applied for. If a formal application is submitted along with additional supporting data, we intend to process this promptly."

He added, "Since we have not yet fully reviewed all the data, an internal review is necessary to confirm the completeness of the materials. However, regarding the extension of the refrigerated distribution period to 31 days applied for today, we aim to proceed with the application within this month as much as possible."

This content was produced with the assistance of AI translation services.