3-month import suspension for PCV 'Prevenar 20'

The Ministry of Food and Drug Safety (MFDS) issued an administrative suspension of the product with a different specification than the standard guidelines

Will be included in the National Immunization Program (NIP) for infants

MFDS-Pfizer Korea "There are no issues related to the supply"

Product photo of 'Prevenar 20 Pre-filled Syringe' 

The imported pneumococcal vaccine 'Prevenar 20 Pre-filled Syringe' will be subjected to a three-month suspension of import operations starting on the 12th. However, no issues are expected regarding its supply.

This is interpreted as having sufficient existing imported inventory. As this vaccine is the most in-demand in the pneumococcal vaccination market, concerns about supply instability arose following the import suspension.

The Ministry of Food and Drug Safety (MFDS) announced that the import operations for Prevenar 20 Pre-filled Syringe (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) will be suspended for three months, from the 12th of this month to April 11th.

The administrative measure was issued in accordance with relevant laws after it was confirmed in June last year that needles of a different specification than the authorized ones were being used.

At that time, the MFDS distributed a safety letter ordering a temporary suspension of use. Pfizer faced significant challenges just as it launched a new product.

However, after the issue was resolved, the product was initially supplied to the market through co-promotion with Chong Kun Dang. In October of that year, the supply was expanded as it was selected for the National Immunization Program (NIP) for infants from 2 months to children under 5 years of age. Once chosen for the NIP, eligible recipients can receive the vaccination free of charge.

Concerns arose following the news of the sudden import suspension, but it has been confirmed that there are no issues with the supply.

The MFDS stated, "Currently, there are no cases reported to the MFDS regarding the supply of this item," and added, "It has been confirmed by the company that there are no supply-related issues."

Because this vaccine is used in the NIP and adult vaccinations are increasing, it seems that sufficient inventory was secured before the suspension. However, some question the effectiveness of the administrative measure, noting that if inventory is adequate, a fine should have been imposed rather than an import suspension.

Prevenar 20 is the first new pneumococcal vaccine introduced by Pfizer in 14 years, adding seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) to the previously available Prevenar 13.

This vaccine is expected to replace the existing Prevenar 13. While competing products include Prodiax 23 and Vaxneuvance, Prevenar 20 is anticipated to take No.1 in the market, given that the previous Prevenar 13 has dominated with an outstanding market share.