After UK’S Historic Move, FDA Defends Process For Approving COVID Vaccine
The European Union, which the U.K. withdrew from earlier this year, was also blunt in defending its approach, saying its longer approval process requires more checks than the emergency procedure chosen by Britain.
The Wall Street Journal:
FDA Head Defends Covid-19 Vaccine-Approval Process
Food and Drug Administration Commissioner Stephen M. Hahn defended his agency’s vetting process for Pfizer Inc.’s Covid-19 vaccine, saying a thorough and meticulous review is needed to assure a skeptical public of the vaccine’s safety and effectiveness. In an interview with The Wall Street Journal, Dr. Hahn said his agency has had 150 people working days, nights and weekends in parallel teams to review the test data submitted by Pfizer and German partner BioNTech SE. (Burton, 12/2)
The Hill:
CDC Panel Chair: US Will Learn About Pfizer Vaccine's Dry Ice Transport System From UK
The head of the Centers for Disease Control and Prevention’s (CDC) panel on immunizations said the U.S. will take note of how the United Kingdom distributes a coronavirus vaccine after the country cleared Pfizer's candidate for emergency use. Jose Romero, chair of the CDC Advisory Committee on Immunization Practices, said on CNN Wednesday morning that he’d be looking at Britain’s delivery method, particularly its use of dry ice to keep the vaccine cold as it travels across the country. (Axelrod, 12/2)
Reuters:
EU Criticises 'Hasty' UK Approval Of COVID-19 Vaccine
The European Union criticised Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday, saying its own procedure was more thorough, after Britain became the first western country to endorse a COVID-19 shot. ... In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain. (Guarascio, 12/2)
Politico:
UK’s Speedy Coronavirus Vaccine Approval Sparks Hope (And Questions)
The message from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) Wednesday was definitive. “No corners have been cut,” said Chief Executive June Raine during a televised briefing. Expert scientists and clinicians have been “working around the clock, carefully and methodically, pouring over tables and analyses and graphs for every single piece of data,” she said. That includes over a thousand pages of data. The work involved “critically analyzing pre-clinical evidence, clinical trials, manufacturing and quality controls and down to the final sampling,” Raine added. Asked how the process differed from the European Medicines Agency and the U.S. Food and Drug Administration’s own approval regime, Raine said the MHRA process was “equivalent to all international standards.” There will, she added, be longer term follow up on the vaccine. (Collis and Furlong, 12/2)
Also —
The Wall Street Journal:
How The U.K. Beat The U.S. And Europe To A Covid-19 Vaccine
Britain’s first-in-the-West authorization of a Covid-19 vaccine thrusts its little-known medicines watchdog into the global spotlight—weeks before the U.K.’s split from the European Union adds to the regulator’s responsibilities. The Medicines and Healthcare Products Regulatory Agency signed off Wednesday on a vaccine developed by Pfizer Inc. and Germany’s BioNTech SE, setting in motion its rollout in the U.K. It reached a decision ahead of higher-profile watchdogs, such as the U.S. Food and Drug Administration and the European Medicines Agency. (Strasburg, Hinshaw and Pancevski, 12/2)
AP:
Who, When And How? A Look At The UK's Vaccination Rollout
How much of the vaccine does the U.K. have? Not enough. The U.K. has put in orders for 40 million doses, which can inoculate 20 million people, since each person gets two doses 21 days apart. Other vaccines will be needed for all the 53 million or so people eligible for shots; the U.K. only plans to immunize the population over age 16. (Pylas, 12/2)
Los Angeles Times:
Is COVID-19 'Vaccine Nationalism' Real? UK May Tell
For months now, public health experts have fretted about the phenomenon of “vaccine nationalism” — countries loudly touting their own efforts to fight the COVID-19 pandemic, sometimes at the expense of worldwide cooperation and coordination. How does Britain’s first-in-the-world approval Wednesday of a stringently tested vaccine, with large-scale inoculations set to start next week, fit into that debate? (King, 12/2)
