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Because of differences in how they were tested in clinical trials, it is difficult to make apples-to-apples comparisons for COVID-19 vaccines.
A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.
The difficult manufacturing issues involved in the therapeutic antibody context, and what might be done to address them.
The rapid development of therapeutic antibodies is a triumph of biomedical innovation. But they won’t help unless they make it to patients.
In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.
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.
Pharmaceutical companies are now also engaging the public themselves in an attempt to build trust in their products.
Moderna’s vaccine works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world.
No vaccine for the novel coronavirus has been approved. Nevertheless, governments and organizations are making deals for tens of millions of doses.
With the sudden spike in hospitalized patients with COVID-19 symptoms, physicians are using these drugs faster than manufacturers are making them.
