The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced today that it has granted emergency authorization for the COVID-19 vaccine developed by Pfizer and BioNTech, marking the first such approval outside of Russia and China.
“It is only 12 months since the first recorded case of COVID-19,” Arne Akbar, president of the British Society for Immunology, said in a public statement this morning. “To achieve this within this timescale is remarkable and the researchers should be applauded.”
The European Medicines Agency (EMA), the regulatory body for the European Union, said yesterday that its Scientific Committee for Human Medicines will meet on 29 December at the latest to discuss the Pfizer’s data. (A similar meeting for its key rival, Moderna, will take place no later than 12 January.) The U.S. Food and Drug Administration (FDA) has a meeting planned to discuss Pfizer’s data in depth on 10 December. The early approval of a vaccine in the United Kingdom may further increase political pressure on FDA to speed up its authorization process; U.S. president Donald Trump has reportedly already admonished FDA commissioner Stephen Hahn to do so.
It is only 12 months since the first recorded case of COVID-19…. To achieve this within this timescale is remarkable and the researchers should be applauded.
MHRA will only become fully independent on 1 January, following Brexit, but the U.K. government ushered through regulations allowing it the authority to grant authorizations on an emergency basis. The U.K. has bought 40 million doses of the Pfizer-BioNTech vaccine—enough for 20 million people—and health secretary Matt Hancock today announced that the first 800,000 doses will be available next week. The rollout will prioritize health workers as well as the elderly and other vulnerable populations, but the Joint Committee on Vaccinations and Immunisations has yet to offer its final guidance on the exact priorities.
Russia on 11 August allowed its COVID-19 vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology, to be used on certain groups of people, while China has granted emergency use authorizations for several vaccines and has already vaccinated hundreds of thousands of people with them.
The Pfizer vaccine, whose key ingredient is messenger RNA, was found to be 95% effective in a phase III trial in 43,000 people, but it presents logistical challenges for a widescale and rapid rollout, as it requires storage at -70C. The lesser demands of other vaccines—including a candidate developed by the University of Oxford and AstraZeneca—mean that they will likely still play an important role in providing vaccinations for the whole U.K. population—and for global coverage, according to Michael Head, a Senior Research Fellow in Global Health at the University of Southampton, “but, for now, this is wonderful news to wake up to.”