As Americans, Britons and Canadians begin receiving shots, pressure is building on the EU’s regulator to approve the Pfizer-BioNTech COVID-19 vaccine.
Harald Enzmann, the head of the European Medicines Agency’s expert committee, dismissed any suggestion that political influence had affected the decision.
“The focus was exclusively on the science,” he told reporters. “That was a scientific assessment, full stop.”
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The Amsterdam-based EMA is responsible for approving all new drugs and vaccines across the 27 EU member states, Iceland, Liechtenstein and Norway. It is roughly equivalent to the U.S. Food and Drug Administration.
The vaccine has already been given some form of regulatory approval in at least 15 countries.
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On Friday, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Moderna’s mRNA-based COVID-19 vaccine candidate, making it the second shot to receive a greenlight in the United States after Pfizer and BioNTech’s candidate obtained EUA one week prior. The authorization follows a recommendation from an independent advisory panel to FDA, which met last Thursday to review evidence and subsequently voted to endorse the vaccine for use in people 18 years of age and older. Data released in late November indicated that the Moderna vaccine showed 94 percent efficacy in its phase 3 clinical trial, leading the company to seek regulatory clearances in the United States and Europe. The Moderna vaccine does not require the same ultra-cold temperature storage as the Pfizer/BioNTech vaccine, allowing it to be delivered more widely in upcoming distribution efforts.
A medical assistant injects a vaccine in a file photo. | (Photo: Reuters/Michael Buholzer)
As ethical questions raised by COVID-19 vaccines have left many Christians wondering whether they should get vaccinated, three Christian ethicists have offered answers based on some primary considerations believers may have safety and efficacy, complicity with evil, and compliance with authority.
Dealing with the issue of safety and efficacy, Matthew Arbo, C. Ben Mitchell and Andrew T. Walker write that because the stakes are so high, “the scrutiny and oversight have never been more intense.”
Writing for the Public Discourse journal of the Witherspoon Institute, a conservative think tank in Princeton, New Jersey, the three authors quote Dan Barouch, a vaccine researcher at Harvard University: “Never before have there been vaccine trials that have been followed so closely from inception to onset to conduct.”
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Monday, 21 December, 2020 - 13:15
A father and his child are holding a sign as climate activists protest outside the Shell building in London, Britain, September 8, 2020. REUTERS/Dylan Martinez Asharq Al-Awsat
Rising global health risks driven by climate change will hit the poorest, most vulnerable people the hardest - and failure to prepare for those threats will mean more deaths and suffering, a leading environmental health scientist told Thomson Reuters Foundation.
From impoverished families living in flood-prone homes to women whose cultures require them to stay covered in extreme heat, climate impacts on health have a strong equity component , said Kristie Ebi, a professor at the University of Washington s Center for Health and the Global Environment.