Korean Authorities Halt GSK's Tdap Vaccine Due To Packaging Defect

The Ministry of Food and Drug Safety (MFDS) has temporarily halted the sale and use of two batches of Boostrix, a vaccine produced by the London-based pharmaceutical company GlaxoSmithKline (GSK), due to a packaging defect. According to a safety alert issued last Friday, the MFDS reported that a small hole, approximately 1 millimeter in diameter, was found in the outer paper wrapping of disposable needles provided with the vaccine.

Despite the fact that the affected needles remain encased in protective caps, the MFDS has decided to suspend distribution as a precautionary measure to mitigate any potential risk of microbial contamination. This suspension specifically targets two batches of the Tdap vaccine imported by GSK into Korea, identified by the manufacturing numbers AC37B455BN and AC37B467AI, with expiration dates of November 30, 2026, and March 31, 2027, respectively.

In response to the issue, the MFDS has issued a Drug Safety Bulletin to healthcare providers, including doctors and pharmacists, emphasizing the importance of swift action to identify the cause of the defect and monitor for any related adverse reactions. Wholesalers and medical institutions in possession of the affected batches have been instructed to adhere to the suspension and report any irregularities.

GSK Korea has confirmed that it conducted an investigation at one of its vaccine manufacturing sites after the needle packaging defect was discovered in a small number of units. The company has implemented corrective actions and reported the incident to Korean regulators, including the MFDS. An official from GSK Korea stated that they are in close communication with the authorities to resolve the situation.