Three-month import suspension for Pfizer’s Prevnar 20

Due to the import of non-conforming products versus approved specifications… follow-up disposition after issuing safety letter in June last year

Pfizer’s pneumococcal vaccine ‘Prevnar 20 Prefilled Syringe’ is subject to a three-month import suspension in Korea.

The administrative action was imposed for importing and selling products that differed from the product specifications and standards described in the marketing authorization.

On the 12th, the Ministry of Food and Drug Safety (MFDS) announced that it will suspend the import operations of Prevnar 20 Prefilled Syringe (Pneumococcal Diphtheria CRM197 Protein Conjugate Vaccine) for three months, from today through April 11.

The MFDS explained that the action was taken because the company imported and sold products that differed from the product standard and specifications described in the marketing authorization.

In June last year, the MFDS issued a safety letter and temporarily suspended the use of Prevnar 20 products that were supplied with injection needles that did not match the approved specifications.

The vaccine is designed to be administered by attaching the enclosed needle to the syringe. While the approved needle length is 25 mm, the enclosed needles supplied were shorter, at 16 mm.

At the time, the action was taken shortly after the product had entered the market. The current administrative penalty is understood to be a follow-up action based on the results of that investigation.

Prevnar 20 is Pfizer’s first new pneumococcal vaccine in 14 years. It adds seven serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, 33F) to the existing Prevenar 13 vaccine.