Skip to content
Subscriber Only
Max Nisen

The FDA Wants a Covid-19 Vaccine That Really Works

New guidelines on what will qualify as effective are appropriately strict.

Show me the data, says the commissioner.

Show me the data, says the commissioner.

Photographer: Al Drago - Pool/Getty Images

As the entire world awaits a vaccine against Covid-19, the U.S. Food and Drug Administration is explicitly rejecting one of the fastest possible paths to releasing one. That’s a good thing.

On Tuesday, the agency issued guidance on the standards it will use in evaluating and approving a vaccine. Its benchmarks are nonbinding, but have teeth nonetheless. The FDA has let vaccine developers know that it won’t be enough to show evidence that their candidate can merely provoke an immune response in a blood test — the kind of data that could be available relatively quickly. Vaccine hopefuls will have to demonstrate real-world safety and effectiveness in large trials.