Ever since the covid-19 pandemic made its way to the United States, the question of whether Americans would accept a potential vaccine has lingered over everything. First, there was the concern that the antivaxxer movement might dissuade people from taking a legitimate vaccine. More recently, the worry has been that President Trump would rush out an unproven vaccine to earn an election bump in November. It’s all gotten to the point that pharmaceutical giants seem to think the world could use some reassurance.
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On Tuesday, nine of the world’s biggest pharmaceutical companies (AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi) signed on to a pledge assuring the public of their “on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”
But what does that mean? The pledge outlines four particular points that the companies promise to uphold:
Always make the safety and well-being of vaccinated individuals our top priority.
Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
If the goal is to make people feel safer about a future vaccine, it seems unwise to make a big deal out of vague shit like making patient safety a “top priority.” But the vow to complete Phase 3 clinical studies is helpful to some degree. In the long-form letter, the companies said that they will follow the FDA’s approval process, which requires “that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.”
The FDA has done some damage to its credibility over the last six months. In June, the agency revoked an emergency authorization of hydroxychloroquine for treating covid-19 patients after scientists determined that it was ineffective and could cause serious side effects. The whole episode left many…
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