The Real Cost of an Early EUA

The biggest drawback to one of the vaccine candidates receiving an FDA Emergency Use Authorization: it would halt the Phase III trial and destroy any chance of getting more data about that vaccine’s safety, efficacy, and longevity.

On the This Week in Virology podcast, TWiV #661, guest Ralph Baric detailed what exactly is at stake if an EUA is issued early in a vaccine trial: it would compromise the original end-point of the study. We would forfeit the chance to learn about late-developing effects such as antibody-dependent enhancement (in which a vaccine sometimes exacerbates the virus it was designed to tame). This link starts at 31:12 in the YouTube video (emphasis added).

“[If an EUA were issued] It’s going to be pretty early to make a conclusive call about the long-term safety and durability of the vaccine. … Ethically all the individuals in the vaccine trial that have received the placebo have to be informed that the FDA has approved for emergency use a vaccine formulation. And they have to be offered that vaccine. … That happened in the Remdesivir trial. … That’s why, to some extent, we don’t know whether Remdesivir really does improve survival rates or not. Because everyone has to be given Remdesivir now. And we probably won’t know the answer.”

Antivirals

In a glimpse into our near future, Dr. Baric discussed the prospects for effective antiviral drugs (not vaccines) that might be given, orally or by nasal spray, upon a positive test for Covid-19. Watch for about two minutes beginning at 26:32:

“There’s going to be something along those lines I think within 6 months, most likely. … Most of the population at least in the US won’t be vaccinated probably until the end of 2021, so drugs are going to be critical for that interim interval.”

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The Real Cost of an Early EUA

Antivirals

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