This applies to “specific batches… of unpunctured and undamaged Comirnaty® (30microgram/dose) vials”, as agreed following talks with Pfizer and the Medicines and Healthcare Products Regulatory Agency (MHRA), NHSE&I wrote in a letter sent on Monday (January 17).
“This extended shelf life will enable more patients to access these critical and life-saving vaccines over the coming days,” it wrote.
Stability assessments positive
Stability assessments of the affected batches by Pfizer did not identify any impact on product quality when the post-thaw expiry date was extended to 45 days.
The MHRA is therefore “reassured” that extending the expiry date in this way will not impact the vaccines’ “safety, quality, or efficacy”, NHSE&I wrote.
Those responsible for storing and handling the affected vaccines should amend the post-thaw expiry dates accordingly, it advised.
The affected batches are: