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Last Minute Allocation Shake Up? Pfizer’s One-Dose Data Could Change COVID-19 Vaccine Rollout

 
• By Sarah Karlin-Smith

New data released ahead of 10 December advisory committee is raising questions about whether the US government’s plan to hold back doses of Pfizer/BioNTech’s vaccine is the right move. Still, most experts don’t expect this to be a one-and-done vaccine. But testing the hypothesis might help FDA solve its dilemma on when to vaccinate placebo patients.

illustration from Pfizer briefing document and photo by Dan Kitwood/Getty Images
Pfizer likely needs more data to bring the efficacy of a single dose of its COVID-19 vaccine into focus, but such a study could solve the dilemma of what to do with patients in the placebo arm of the trial. • Source: illustration from Pfizer briefing document and photo by Dan Kitwood/Getty Images

Pfizer Inc.and BioNTech SE’s COVID-19 vaccine appears to offer some benefit after the first dose of the planned two-course regimen, but Pfizer, the US Food and Drug Administration and independent health policy experts say it’s too soon to pivot to a one-and-done vaccination campaign. 

That’s because the amount of data on patients with one dose is limited by the short period of time between doses, and because a one-dose regimen might not have the same level of durability as a two-dose option

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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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