US Pfizer Vaccine Returned Due to Temperature Maintenance Failure During Transport..."Temperature Dropped Too Low"

Temperature Plummets to Minus 92 Degrees During Delivery
US Health Authorities Review Safety with Pfizer

[Image source=AP Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] It has been reported that some of the Pfizer COVID-19 vaccines were returned due to failure to maintain the required temperature during transportation. Previously, Pfizer vaccines required a stringent shipping condition of maintaining below minus 70 degrees Celsius, raising concerns about potential shipping issues. U.S. health authorities stated that they plan to review the safety of the vaccines together with Pfizer.

According to foreign media including CNBC on the 16th (local time), Lieutenant General Gustave Perna, Chief Operating Officer (COO) of the U.S. COVID-19 vaccine development and distribution program called 'Operation Warp Speed,' said at a press briefing that "some of the Pfizer vaccine transport boxes in California and Alabama dropped to minus 92 degrees Celsius, which is lower than the appropriate level of minus 70 degrees, and were returned to Pfizer." He added, "The vaccines with temperature maintenance issues were not unloaded from the trucks and were immediately returned to Pfizer, and replacement supplies were sent."

The Pfizer vaccine is an mRNA antibody-based vaccine that requires maintaining a temperature below minus 70 degrees Celsius during transportation to ensure efficacy. However, efficacy and safety have not been established at temperatures excessively lower than this. Lieutenant General Perna added, "The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) will jointly initiate an investigation into the vaccine's safety." The returned shipment consisted of two transport boxes, each containing approximately 975 doses of the vaccine.

The cause of the excessive temperature drop in the transport boxes is still unknown. Pfizer has also not responded to related inquiries. Concerns about potential issues during the shipping process requiring maintenance below minus 70 degrees Celsius had been raised even before the vaccine received approval for administration. Soumi Saha, Vice President of Premier, a hospital and nursing home consulting firm, said in an interview with CNBC, "Such low temperatures are an entirely new territory unprecedented in the healthcare system," adding, "Distributing the vaccine while maintaining its integrity is a new challenge."