Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3
Once sponsors decide to capture/share expanded access-derived data above and beyond that needed, what should IRBs do?
EUA
-
Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3 -
Read more: The Supreme Court Threatens to Undermine Vaccination Decisions Entrusted to the States The Supreme Court Threatens to Undermine Vaccination Decisions Entrusted to the States
The Supreme Court seems poised to say that the existence of a secular medical exemption to vaccine mandates means a state must offer a religious exemption.
-
Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2
In some cases there may be value in collecting “real world data” from Expanded Access.
-
Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1
Expanded access allows patients who lack other treatment options to try unapproved medical products in development.
-
Read more: Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines? 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.
-
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.
-
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.
-
Read more: Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal
As has been proven time and again, “gut feeling” and wishful thinking have never been shown to replace controlled clinical testing.
-
Read more: Can Colleges and Universities Require Student COVID-19 Vaccination? Can Colleges and Universities Require Student COVID-19 Vaccination?
Under existing federal statutes and case law, colleges and universities have broad discretion to require vaccination as a condition of a return to campus.
-
Read more: How the Government Can Prevent Individuals from Using Wealth to Cut the Vaccine Line How the Government Can Prevent Individuals from Using Wealth to Cut the Vaccine Line
There are several ways government officials can combat the wealth problem without sacrificing the speed at which vaccines are administered.
