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1030 EUA v EA
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Expanding access to COVID-19 vaccines

Imminent release of interim data will force FDA to make tough decisions about pre-approval access to COVID-19 vaccines

Imminent release of interim data will force FDA to make tough decisions about pre-approval access to COVID-19 vaccines

Oct 31, 2020 | 3:35 AM GMT

As lightning-quick vaccine development comes close to catching up with a runaway pandemic, FDA must quickly decide how it will respond to the first clear signs that a vaccine candidate may be effective.  

Former senior agency officials are advocating that FDA respond to favorable interim data from COVID-19 trials by allowing expanded access rather than by issuing emergency use authorizations. The goal is to gain more control over the launch of the first COVID-19 vaccines. 

Expanded access, its proponents contend, would be less likely than EUA to cause sponsors to unblind Phase III trials. They also believe the pathway makes it possible for a narrowly defined population to receive the vaccine, preserves the integrity of ongoing Phase III trials, and reduces the potential for unexpected adverse effects to sap public confidence in all COVID-19 vaccines. 

By allowing for a more gradual rollout while additional data are collected about efficacy and safety, granting expanded access would make it easier to pull the plug if unexpected safety issues arise. 

Proponents of EUAs

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