The United Kingdom on Wednesday 2nd December 2020 became the first country to approve a Covid-19 vaccine developed by Pfizer and its partner BioNTech.

Both the Pfizer/BioNTech and Moderna vaccines have been shown in large trials to reduce the risk of developing symptomatic Covid-19 infection by more than 90%.

“The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants. Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.”

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. This is the first authorisation for this vaccine.

The MHRA’s decision was based on independent advice from its Commission on Human Medicines following a rolling review of trial data that included an interim analysis of the Phase III programme led by the University of Oxford. The data were also published in The Lancet on 8 December 2020.