‘Wonderful news to wake up to:’ U.K. greenlights Pfizer’s COVID-19 vaccine – Science Magazine

The United Kingdomhas bought 40 million doses of the Pfizer/BioNTech vaccine, enough for 20 million people. Health secretary Matt Hancock today announced that the first 800,000 doses will be available next week.

By Cathleen OGradyDec. 2, 2020 , 6:15 AM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

The United Kingdoms Medicines and Healthcare Products Regulatory Agency (MHRA)announced todayit 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, which regulates drugs and vaccines in the European Union,said yesterdaythat its Committee for Medicinal Products for Human Use will meet on 29 December at the latest to discuss Pfizers 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 Pfizers data in depth on10 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 hasreportedly already admonishedFDA 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 2021, following Brexit, butU.K. regulations allow it to grant authorizations on an emergency basis. The United Kingdom has bought 40 million doses of the Pfizer/BioNTech vaccineenough for 20 million peopleand 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 vaccinesand has already vaccinated hundreds of thousands of peoplewith them.

The Pfizer vaccine, whose key ingredient is messenger RNA that encodes the spike protein of the pandemic coronavirus, was found to have95%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 70C. The lesser demands of other vaccinesincluding a candidate developed by the University of Oxford and AstraZenecamean they will likely still play an important role in providing vaccinations for the whole U.K. populationand 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.

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'Wonderful news to wake up to:' U.K. greenlights Pfizer's COVID-19 vaccine - Science Magazine

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