FDA meeting (part 1)
Okayyy here’s your halftime FDA meeting report...
As expected, the first half was dry and boring, but important. A few committee members made key touchdowns (I tried with the puns, but for everyone’s sake I stopped here) with their suggestions on some issues.
In short, two critical questions were discussed and answered...
1. An EUA is always warranted ONLY when there’s no adequate, approved product. So, the question was, if they were to approve a COVID19 vaccine (like Pfizer) today, can the FDA approve another vaccine down the road (like Moderna)? The short answer is yes. That’s because the product is in short supply and this is an authorization (not an approval; two different things). This is great news.
2. What to do with the placebo group? Pfizer wants to give the placebo group the vaccine. The FDA does not, as there is a TON of value in having long term placebo data. Especially with new biotechnology. And, there’s no ethical obligation to give the placebo group the vaccine. However, even if they don’t give placebo group the vaccine, the participants can still go get the vaccine themselves. Which would ruin the study. Dr. Steven Goodman (Stanford) came up with an interesting solution: vaccinate placebo recipients, but maintain the blinding. “If someone had received placebo shots originally, they’d be given vaccine. If someone had received vaccine doses, they’d get placebo shots. They would not be told what their original status was — but all would be confident that they had received vaccine.” By doing this we lose that comparison group, but people would be more likely to stay in the study and we could continue to follow them over time. This would allow us to rigorously study the immune response.
Second half is coming up. Grab your hot dog or beer (it’s 2020, no one’s judging). Will be back after the next stretch.
Love, YLE
Data Source: https://www.statnews.com/.../tracking-the-fda-advisory.../