Reuters news agency reported on Friday that the US Food and Drug Administration (FDA), on 25 February 2021, approved storage and transportation of the COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.
Reportedly, the companies had asked the US health regulator last week to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers.
The director of the FDA's Centre for Biologics Evaluation and Research, Peter Marks, was quoted as saying: "Alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites."
In December 2020, the US FDA had granted emergency use authorisation to the Pfizer-BioNTech vaccine and current label to be stored at temperatures between minus 80ºC and minus 60ºC, implying it has to be shipped in specially designed containers.
Merck launches Phase 3 trial for dengue vaccine candidate V181
BioNet and Bio Farma sign MoU on TdaP vaccine
Dx&Vx accelerates universal COVID-19 vaccine development
Moderna withdraws application for flu-COVID combination vaccine pending additional efficacy data
CTP delivers 18,000 sqm Serbian facility for SCHOTT Pharma to support global expansion
LakeShore Biopharma launches novel packaging solution for YSJA rabies vaccine (Vero cell)
Scancell partners with NHS Cancer Vaccine Launch Pad to accelerate melanoma trial recruitment
Orexo reports positive results for powder-based intranasal vaccine using AmorphOX technology
GC Biopharma's BARYTHRAX receives Korean regulatory approval
GSK grants USD2m to boost adult vaccination efforts
Valneva and LimmaTech begin Phase 2 infant trial for Shigella vaccine candidate S4V2
Circio Holding and Entos Pharmaceuticals collaborate on circular RNA delivery
AKAGERA Medicines completes first cohort in phase 1 SAD/MAD study of AKG-100