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Thursday, August 27, 2020

ANALYSIS/OPINION:

With companies racing to test potential COVID-19 vaccines, the pandemic’s end may finally be in sight. A cure for this deadly disease is right over the horizon, and millions of vaccine doses will soon be ready for distribution. But, unless regulatory agencies agree to cooperate and expedite approval processes, these promising treatments will lie in limbo as the world continues to suffer. 

With the right-sized regulatory approach, however, the world will finally be able to close the book on COVID-19.


One potential vaccine being developed by University of Oxford and AstraZeneca researchers is now in its final stage of testing. Oxford vaccinologist Dr. Adrian Hill predicts there could be more than a million doses manufactured by September. Other organizations and companies such as Pfizer and Moderna continue to make groundbreaking progress on a coronavirus cure and will have hundreds of millions of doses ready for the public if further trials support the efficacy of their products.

As teams of researchers ready their products for human testing, they’ll face substantial scrutiny from the Food and Drug Administration (FDA) and the agency’s foreign counterparts. Thus far, the FDA has been clear about two main criteria for vaccine approval: Products must be safe and at least 50% effective.

The FDA’s commissioner, Dr. Stephen Hahn, and others believe that the 50% threshold “was a reasonable floor given the pandemic,” even as medical experts such as Dr. Anthony Fauci publicly hope for 60% or higher efficacy levels. 

These expectations may be unrealistically high for an early, widely-distributed coronavirus vaccine. Vaccines already approved for other deadly ailments like the flu have effectiveness rates below 50%, but still significantly cut down on death and illness for patients. In February, the Centers for Disease Control and Prevention estimated that this past season’s flu vaccine was 45% effective. And, despite this less than 50% effectiveness rate, the flu vaccine is still considered a success.

This performance was actually an improvement over previous years, considering that the 2018-19 flu vaccine was less than 30% effective. Despite these lower figures, experts still urge the public to get their flu shot each year. Cleveland Clinic infectious diseases expert Dr. Alan Taege notes, “The more people you protect, the healthier the population is, and fewer people are going to have influenza to spread it to the rest of the population.” That’s why, even though the flu vaccine is far from perfect, all major medical bodies in the U.S. encourage Americans to get the flu shot each year.

America’s experience with flu vaccination also demonstrates that average effectiveness figures don’t tell the whole story. The effectiveness of the vaccine varies from age group to age group. Even though this past season’s vaccination was 45% effective on the whole, it was 55% effective in protecting children and teens against the flu.

If a preliminary coronavirus vaccine had similar efficacy for children, schools could safely reopen at a fraction of the current risk. Teachers would be able to do their jobs knowing that a majority of their students weren’t carrying the deadly disease. Likewise, parents would be able to send their kids to school without fearing for their health and safety. Yet, such a promising vaccine wouldn’t pass muster with the FDA if the regulatory body continues to insist on a 50% efficacy benchmark.

Regulatory and public health officials should re-evaluate their current approval standards and allow vaccines of comparable effectiveness to the flu shot. In addition, the agency should commit to paying close attention to differential effects by age groups. The agency must also collaborate closely with foreign counterparts such as the European Medicines Agency to ensure that regulators around the world are on the same page. While it’s important for different regulatory bodies to have flexibility, a coronavirus vaccine good enough for France and Germany should be quickly approved in the United States.

The upside of even a moderately effective vaccine cannot be overstated. In the current environment, medium- and large-sized indoor events have to be continually put off, forcing millions of businesses and their employees to play a gut-wrenching guessing game over when things will be “safe enough” again. The public health focus cannot and must not be on eliminating risk, but rather on effectively mitigating risk to allow life to return to normal again. While the flu and the novel coronavirus have important, notable differences, risk thresholds for the flu are a useful guide to coping with COVID-19. 

As the United States and the world stand at the cusp of a treatment for the coronavirus, it’s critical that agencies like the FDA stick to a light-handed, evidence-based approach. Millions of lives depend on it. 

• Ross Marchand is the vice president of policy for the Taxpayers Protection Alliance and a Young Voices senior contributor.


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