U.K. Approves Pfizer-BioNTech Coronavirus Vaccine; Distribution Expected To Begin Next Week But Logistical Challenges Remain; Trump Administration Increases Pressure On FDA

CBS News: U.K. is 1st country to approve Pfizer COVID-19 vaccine, with distribution to start next week
“Britain has become the first country in the West to approve a COVID-19 vaccine for public use. The U.K. Department of Health and Social Care confirmed in a statement to British news agencies that the vaccine developed jointly by American drugmaker Pfizer and Germany’s BioNTech would be distributed starting next week. Pfizer was the first of three major Western pharmaceutical companies to apply in both the U.S. and Europe for emergency use authorization…” (Reals, 12/2).

The Guardian: How does the Pfizer/BioNTech vaccine work and who will get it?
“…The Pfizer/BioNTech vaccine, while exciting, brings logistical challenges. Among them, the vaccine must be stored and transported at about -70C. … Matt Hancock, the health secretary, has said he expects 10m doses of the Pfizer/BioNTech vaccine to be available in 2020: the NHS has been told to prepare for the first doses to be given as early as next week. While the government’s Joint Committee on Vaccination and Immunisation (JCVI) put care home residents and care home workers at the front of the queue for a Covid vaccine, it is likely that NHS staff will be the first group to receive the Pfizer/BioNTech jab…” (Davis, 12/2).

Washington Post: Britain first country to grant Pfizer coronavirus vaccine emergency authorization
“…Drug regulators in Britain have a global reputation for being tough but fast, and Wednesday’s decision is likely to intensify the focus on the U.S. Food and Drug Administration, which has faced increasing pressure from the Trump administration to approve Pfizer’s vaccine. On Tuesday, White House Chief of Staff Mark Meadows summoned Stephen Hahn, the head of the FDA, to ask why the agency was not moving faster…” (Booth/Adam, 12/2).

STAT: U.K. approves Pfizer’s Covid-19 vaccine, putting pressure on FDA
“…The FDA normally conducts the most rigorous reviews of medical products in the world, re-analyzing the databases from clinical trials and conducting its own reviews of the safety and efficacy of products, as well as independent statistical reviews of their clinical trials. A key part of that process is scheduled for Dec. 10, for the Pfizer/BioNTech vaccine, and Dec. 17, for the Moderna vaccine. That is when an FDA advisory panel of outside experts is scheduled to go over the data in meticulous detail in a public meeting. These advisory panels are not necessary for an emergency use authorization, as opposed to a full approval, but it is extremely unlikely that the FDA would issue a decision without waiting for the meetings to occur…” (Herper, 12/2).

Additional coverage of the U.K.’s approval of the Pfizer-BioNTech coronavirus vaccine is available from CNBC, CNN, The Economist, Financial Times, NPR, POLITICO, Reuters, and Science.

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