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Could the FDA Be Making the Pandemic Worse?

June 29, 2021

June 29, 2021
By Naomi Lopez

With many offices and schools reopening, social distancing rules being eased, and mask requirements being eliminated for the vaccinated, we’re beginning to get a glimpse into Life After COVID. But we’re not out of the woods yet—and we can lay some of the blame at the feet of the U.S. Food and Drug Administration (FDA). The lack of a fully approved COVID vaccine, coupled with the rising threat of the Delta variant, is leaving some to worry that the FDA approval process still remains unacceptably slow—and in fact, that FDA inaction may be helping to extend the pandemic.

Pfizer and BioNTech applied for full FDA approval for their COVID-19 vaccine for those ages 16 and over on May 7—nearly two months ago. The vaccine was granted temporary Emergency Use Authorization (EUA) in December of last year—more than six months ago. Similarly, Moderna applied for full approval on June 1. Yet despite growing calls among experts to approve these vaccines, it remains unclear when the FDA will act.

So far, more than 170 million doses of the Pfizer vaccine and more than 130 million of the Modern vaccine have been administered in the United States—in addition to their use in dozens of countries around the world. That’s fantastic news, but not all the news is good: The rate of COVID vaccinations in this country has slowed dramatically since peaking in April. Fewer than half of eligible Americans are fully vaccinated, and we’re quickly reaching the ceiling of people willing to receive one of the vaccines.

But the FDA can help raise that ceiling and bring us ever closer to herd immunity. Last week, President Biden told a North Carolina audience, “I predict, as soon as we go from temporary approval to permanent approval, which just takes time… it’s going to increase the number of people willing to move as well.” And the data bears that out: A recent poll from the Kaiser Family Foundation suggests that one-third of those that remain unvaccinated would be more likely to obtain the vaccination once the vaccines receive full FDA approval. So this is no time for the FDA to drag its feet: With one-third of U.S. adults still fully unvaccinated and the prospect of “dense outbreaks” looming, full approval must be a priority.

It’s time that the FDA embrace innovation and technological potential instead of overcaution and outdated processes. Currently, the FDA reviews manufacturing processes in addition to re-analyzing the raw data from clinical trials (as opposed to the submitted manufacturer data) and other sources (rather than topline data which is the practice in other countries). The European Medicines Agency (EMA), for example, reviews data on a rolling basis, and, while it is true that the FDA evaluates a broader swath of data, these in-depth reviews, which too often rely on decades-old information capacity that is failing to keep up with 21st century capabilities. Congress has already directed the FDA to use more Real World Evidence (RWE) in its clinical evaluations. In our recently released blueprint for healthcare reform, the Goldwater Institute offers up proposals for unleashing the full potential of treatments by further removing bureaucratic obstacles and barriers.

While the worst of the COVID-19 pandemic seems to be behind us, the threat does still remain—and our government should not be putting us in a more vulnerable position. FDA slowness must not put us at greater risk of being affected by emerging variants of the virus. Rather than letting our guard down or continuing with business as usual, we must recognize the opportunity that we have: the opportunity to seek reforms that will help bring about the modern healthcare system we need, one that prioritizes patients over bureaucratic red tape.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.



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