Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?
Because of differences in how they were tested in clinical trials, it is difficult to make apples-to-apples comparisons for COVID-19 vaccines.
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Read more: “Stick to the Science”? FDA, Ethics, and Pandemics “Stick to the Science”? FDA, Ethics, and Pandemics
This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability moving forward.
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Read more: What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)? What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)?
A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.
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Read more: New Rule Might Increase Out-of-Pocket Drug Costs for Patients New Rule Might Increase Out-of-Pocket Drug Costs for Patients
Patients may face increased out-of-pocket drug costs as a result of a rule finalized by the Centers for Medicare & Medicaid Services in July 2020.
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Read more: How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing? How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing?
The difficult manufacturing issues involved in the therapeutic antibody context, and what might be done to address them.
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Read more: Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19? Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19?
The rapid development of therapeutic antibodies is a triumph of biomedical innovation. But they won’t help unless they make it to patients.
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Read more: What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout? What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout?
In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.
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Read more: From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization
The history of EUA involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.
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Read more: Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts
Given the potential legal challenges policymakers may face, legislation to remedy the COVID-19 educational crisis must be carefully drafted.
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Read more: How Can Policymakers Encourage COVID-19 Vaccine Trials for Children? How Can Policymakers Encourage COVID-19 Vaccine Trials for Children?
We explain why COVID-19 vaccines are only just starting to be tested in children and what policymakers can do to spur pediatric vaccine trials.
