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Diagnostics COVID-19, Clinical care, Regulation and standards, Technology and innovation

COVID-19 Vaccine Approval

The UK medicines regulator, the MHRA, has granted temporary authorization to Pfizer/BioNTech’s mRNA-based COVID-19 vaccine (BNT162b2) for emergency use. The vaccine will be made available across the UK from next week – with Pfizer having signed an agreement to supply 40 million doses to the country to be delivered in 2020 and 2021. The vaccine requires two doses, meaning there will be enough to vaccinate around 20 million people – nearly a third of the UK’s population. Distribution of the vaccine in the UK will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI). The top three priority groups are: older adults living in care homes and care home workers; all those over the age of 80, and health and social care workers; and those over the age of 75. 

The MHRA has based its decision on a rolling submission, which includes data from the phase III clinical study that demonstrated efficacy of 95 percent in participants without prior SARS-CoV-2 infection. According to Pfizer, “efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65.” 

The vaccine requires stringent cold chain (-70°C ± 10°C), and Pfizer and BioNTech have designed specialized temperature-controlled shippers that can maintain the correct storage conditions using dry ice. Once the shipper has been opened, it can also be used as a temporary storage solution (up to 30 days). Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C) conditions. The shippers contain GPS-enabled thermal sensors to track the location and temperature of each vaccine shipment.

The vaccine has also been submitted to other regulators, including the FDA and EMA, for review – and Pfizer and BioNTech say they are “anticipating further regulatory decisions across the globe in the coming days and weeks” – according to a press statement. 

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