You Can Trust the FDA’s Vaccine Process

The agency can roll out a Covid shot safely, quickly and without bowing to political pressure.

A nurse prepares a shot for a study of a possible Covid-19 vaccine.

Photo: Hans Pennink/Associated Press

If one or more Covid vaccines prove safe and effective in large clinical trials, the Food and Drug Administration should make them available, in a careful and limited way, to those at highest risk of contracting infection and suffering a bad outcome.

Last week we wrote on these pages how the FDA could allow a Covid vaccine to be used by specific groups of patients through an Emergency Use Authorization. This authority, created by Congress to allow the FDA to respond to a public-health emergency, lets the agency authorize the distribution of a product before a full approval.

There is concern that an EUA is a lower bar than the FDA’s rigorous standard for safety and effectiveness. Or that the EUA decision could be subject to political influence similar to some clumsy, recent intrusions into reports issued by the Centers for Disease Control and Prevention. We reject the claim that a vaccine EUA inherently falls short of FDA’s gold standard review, or that the process will be hijacked.

The process enables the FDA to grant a staged entry of a vaccine. The FDA has made clear that a vaccine must first demonstrate safety and effectiveness in a rigorous clinical trial with at least 30,000 people. It must show fewer and less severe infections, not merely an immune response as a proxy. It must also show no significant safety issues, which generally arise within the first month or two after vaccination.

Those trials should proceed to their conclusion. Then, based on the evidence, it’s possible that an EUA could be issued in the late fall or winter. The FDA won’t have all the long-term data it usually requires for a novel vaccine. These data are important to eliminate remote risks and to see how long immunity lasts. But initially the vaccine would only be used for, say, health-care workers and elderly people in nursing homes. For these people, evidence on the benefits of vaccination is more likely to outweigh the uncertainty.

The FDA engages in such risk and benefit balancing across its entire regulatory portfolio. A vaccine appropriate for an 80-year-old at great risk of Covid could be a nonstarter in a 20-year-old at much lower risk of bad Covid outcomes, where the bar for safety would be higher.

The EUA process affords the FDA other flexibility to make the vaccine available sooner. For example, a fully licensed vaccine might require months of stability testing, since the vaccine might sit on the shelf of a distributor or doctor’s office for six months or longer. But for the Covid emergency, the EUA allows the FDA to act without some of this testing, since these vaccines are intended to be delivered to patients quickly.

The EUA process also allows the FDA to require more data as a condition of authorization. Active collection of benefit and risk information should be required, for example through connecting vaccine records with data from secure electronic medical-record or insurance-claim databases to assess outcomes.

We also reject the idea that the FDA’s professional staff can be cowed by outside influences. Beneath all the political rhetoric, the process for developing Covid vaccines has been rigorous. The FDA has prescribed an extensive process for meeting its vaccine EUA standards, including a public assessment by independent experts. The FDA also announced that it will soon articulate its standards for emergency authorization in guidance.

Political appointees shouldn’t intrude in these endeavors, though the FDA’s thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent. That should reassure those worried about furtive influences.

Dr. Gottlieb and Dr. McClellan served as FDA commissioners, from 2017-19 and 2002-04, respectively. They serve on the boards, respectively, of Pfizer and Johnson & Johnson, companies developing Covid vaccines.

Journal Editorial Report: The week's best and worst from Bill McGurn, Jason Riley, Mary O'Grady and Dan Henninger. Images: Getty Images Composite: Mark Kelly

Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Appeared in the September 21, 2020, print edition.