The FDA should not offer emergency use authorization for COVID-19 vaccine until Phase 3 trials are complete
Today's Managing Health Care Costs Number is 30,000
FDA Commissioner Stephen Hahn has announced that the Food and Drug Administration is open to giving an emergency use authorization (EUA) to a COVID-19 vaccine even before clinical trials are complete.
This is the approach taken by Russia and China, which have begun inoculating soldiers (China) and civilians (Russia) without completing clinical trials.
The phases of clinical trials:
Phase 0: checking how the drug is processed in the body - usually just a handful of people.
Phase 1: Checking different doses to be sure the drug does not cause significant harm (safe)
Phase 2: Larger studies - looking at safety and also assessing whether there are positive effects of the drug
Phase 3: Population studies to ascertain whether the drug is safe and effective. These are usually randomized trials. For immunizations, these are generally studies with 30,000 participants
The FDA should not give emergency use approval until the clinical studies are completed and analyzed!
Here's why:
The vaccine MIGHT turn out to be useless, or even frankly dangerous. We won’t know this until after the phase 3 trial is complete. (Example: Dengue Fever vaccine can only be given to those who have had the disease in the past. If given to those who have no previous exposure, it makes infections worse, not better).
It makes sense to give an EUA for a drug of potential value to people who would otherwise be likely to die. But it’s ethically questionable to do this when the vaccine will be given to otherwise healthy people!
An early EUA is likely to make it much tougher to get enrollment in clinical trials – and also might increase the difficulty of recruiting volunteers for randomized studies of future vaccine(s) that might turn out to be more effective
Trust in vaccines is already low – and a perception of political meddling in the science of vaccine approval could lead to a whole new crop of antivaxxers – which could impede rather than advance our effort to reach herd immunity.
Like all human beings, I desperately want a vaccine to be proven safe, effective, manufactured to scale, and distributed and administered to as many people as possible as quickly as possible. But we have to follow all the steps. If we don’t prove it’s safe and effective before we start to vaccinate a lot of people, the results are likely to be very bad.