I reiterate our call:
“slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”
FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.
Peter Doshi, senior editor, The BMJ.
Doshi’s research focuses on the drug approval process, how the risks and benefits of medical products are assessed and communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications.