The news: The UK’s regulator has approved Pfizer/BioNTech’s vaccine, making it the first country in the world to provide emergency authorization for a covid-19 vaccine. The UK had already signed an agreement to buy 40 million doses due to be delivered this year and in 2021, with the first batch set to arrive in the coming days. The vaccine requires two doses, so that is enough for 20 million people. The vaccine will be delivered in stages to each country that has bought it, in order to make sure the doses can be allocated fairly, the two companies said. The US and EU are expected to provide emergency authorizations for vaccines in December too.
The basis for the decision: The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) studied Pfizer and BioNTech’s data on a rolling basis as it came in from the trials, including data from the phase 3 clinical trial, which found the vaccine to be 95% effective. Pfizer said it recorded 170 covid-19 cases (in 44,000 volunteers), with just 162 recorded in the placebo group versus eight in the vaccine group. Pfizer reported that there were no serious safety concerns related to the vaccine in its study. Side effects included fatigue and headache, but these were not severe and seemed to mostly affect younger participants. “We believe that the rollout of the vaccination program in the UK will reduce the number of people in the high-risk population being hospitalized,” said Ugur Sahin, CEO and cofounder of BioNTech. The vaccine is the fastest to ever be developed, taking just 10 months, as opposed to the many years development usually requires.
A project like no other: Now that the vaccine has been approved, the enormous task of distribution can start. A particular challenge is that it needs to be kept at -70 °C. Pfizer and BioNTech have developed containers that use dry ice to keep the vaccine at these ultra-cold temperatures. The UK is on the precipice of the biggest vaccination campaign in its history. Its government has drawn up plans to start immunizing elderly and vulnerable patients within days. It has drafted a priority list, which starts with care home residents, people over 80, and health and social care workers. When more stocks become available, the UK will start vaccinating everyone over 50, as well as younger people with preexisting conditions. Its National Health System will contact people to invite them for the shot when it is their turn.