announced today it has granted emergency authorization for the COVID-19 vaccine developed by Pfizer and BioNTech. So far, only vaccines developed in Russia and China have been approved for use, and none of them in Western countries.The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)
“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), which regulates drugs and vaccines in the European Union, said yesterday that its Committee for Medicinal Products for Human Use will meet on 29 December at the latest to discuss Pfizer’s data. (A similar meeting for its key rival, Moderna, will take place no later than 12 January 2021.) 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.
MHRA will only become fully independent on 1 January 2021, following Brexit, but U.K. regulations allow it to grant authorizations on an emergency basis. The United Kingdom has bought 40 million doses of the Pfizer/BioNTech vaccine—enough for 20 million people—and health secretary Matt Hancock today announced 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 Vaccination and Immunisation 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, and China has granted emergency use authorizations for several vaccines and has already vaccinated hundreds of thousands of people with them.
The speedy approval by MHRA immediately took on political dimensions. Andreas Michaelis, German ambassador in London, criticized U.K. Cabinet member Alok Sharma for a tweet saying the United Kingdom had “led humanity’s charge against this disease.” The victory was “European and transatlantic,” Michaelis said in a tweet, rather than a national story.
In an interview on Italian radio, former EMA Director Guido Rasi linked the speed to political grandstanding on Brexit, suggesting the U.K. government rushed the decision to be able to say that “without Europe, you come first.” Indeed, Hancock and fellow Conservative Member of Parliament Jacob Rees-Mogg both attributed the speed of the decision to Brexit, but were contradicted by MHRA head June Raine, who pointed to existing U.K. implementation of EU law that allows rapid, temporary authorizations in emergencies, including pandemics. Raine told Reuters the regulatory process met international standards and resulted in a “rigorous assessment.”
Moncef Slaoui, scientific head of the U.S. government’s Operation Warp Speed, today praised MHRA as “an extremely high-grade agency” during a press conference. He pointed out that MHRA, alongside counterparts in other large EU nations, was EMA’s “scientific engine” before the United Kingdom’s departure from the bloc.
The Pfizer vaccine, whose key ingredient is messenger RNA that encodes the spike protein of the pandemic coronavirus, was found to have 95% efficacy, a clinical trial measurement of effectiveness, 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 –70°C. The lesser demands of other vaccines—including a candidate developed by the University of Oxford and AstraZeneca—mean 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 global health researcher at the University of Southampton, “but, for now, this is wonderful news to wake up to.”