Good Vaccine Progress, Bad Politics

There’s no evidence the Food and Drug Administration or vaccine makers are cutting corners in clinical trials, and they have no incentive to do so. But by sowing distrust in the process, politicians may make it harder to convince Americans to get inoculated once a vaccine proves to be safe and effective.

Centers for Disease Control and Prevention Director Robert Redfield last week wisely tamped down hope that a vaccine could be available next month.
Pfizer
has said it could seek regulatory approval for its vaccine as soon as October if early data from its Phase 3 trial are strong.

But initial doses would likely be reserved for health-care workers, nursing-home residents and high-risk individuals. The FDA is also planning to issue guidance this week that manufacturers should track participants in Phase 3 trials for at least two months after their second shot before seeking emergency authorization. This makes it unlikely that a vaccine would be approved before Election Day.

Phase 3 trials test for efficacy and safety in some 30,000 people and are crucial because vaccines must generate antibodies that prevent illness in the real world. Rare side effects can also appear in larger populations, though these usually occur within 40 or so days of inoculation.

Politics aside, the Covid vaccine project looks so far like a private-public success story. Vaccines typically take a decade to develop, and the Covid-19 genome was deciphered only nine months ago. Companies are benefiting from years of investment in vaccine platforms for other diseases and advances in genetic sequencing. The FDA has helped by providing regular, nearly real time, feedback on their protocols and data analysis.

But manufacturers and the FDA aren’t sacrificing safety for speed. FDA Commissioner Stephen Hahn has promised to allow an outside panel of experts to review trial results. While companies are understandably reluctant to disclose their protocols for competitive reasons, Pfizer, Moderna and
AstraZeneca
have done so—which still hasn’t pleased the
Twitter
carpers who fear Mr. Trump might get some credit if a vaccine is approved before the election.

AstraZeneca this month halted its trial enrollment when a healthy 37-year-old volunteer developed transverse myelitis, a rare disease that causes spinal inflammation. The patient is recovering and the company has resumed enrollment in the U.K. after determining the disorder was not likely caused by the vaccine.

Other side effects may occur as trials continue. An estimated 10 individuals per million who received the swine flu vaccine in 1976 developed Guillain-Barré syndrome, in which the immune system attacks nerves. But about 80 to 160 new Guillain-Barré cases occur each week in the U.S., and the disorder has been linked to viruses including the flu.

If severe reactions emerge in trials, the public will have to keep perspective. Covid has also been found to cause long-term damage in previously healthy individuals, and regulators will have to weigh the overall public-health risks and benefits.

The good news is that Health and Human Services has invested in a portfolio of six vaccine candidates, lest some fail or prove less effective. It has also signed contracts with companies to produce hundreds of millions of doses in advance so they can be rolled out quickly upon FDA approval. This is a financial risk well worth taking.

The Administration is coordinating with
McKesson,
retail pharmacies and others to distribute vaccines. If one or more vaccines are approved this year, they could be widely available to most Americans in the spring. If that happens, the credit will go to drug-company innovation combined with government cash and coordination.