FOUR TAKEAWAYS FROM THE FIRST COVID ADCOMM - POLITICO Prescription Pulse

The much-anticipated, nine-hour initial public meeting of FDA’s advisory committee on vaccines broached diversity in clinical trials, when placebo patients should get the real thing and how to counteract sinking public confidence in the government and vaccines.

This was the first of what will be a string of Vaccines and Related Biological Products Advisory Committee meetings, with future ones centered on specific shots.

Here are the highlights:

 Trials need to keep going. Pfizer says it wants to give placebo patients their shot once it’s cleared for emergency use, but doing so would disrupt randomized trials and could stall concrete answers. "Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back,” said Doran Fink, a deputy director of vaccine reviews at FDA.

 Diversity is still a big issue. Historically underserved communities of color, particularly Black and Latinx people, are still under-represented in trials despite being hit disproportionately hard by the virus. There are also age questions: Only Pfizer is enrolling children as young as 12 years old, and experts discussed whether they would feel comfortable with bridging adult data to authorize vaccine use in children.

— Mistrust is a huge problem. The most sobering presentation of the day came from the Reagan Udall Foundation, which shared responses to its poll about trust in the government and medical establishments. People of color said they don't want to be “guinea pigs” in an experiment, and that Black people are treated differently by doctors.

 

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