Is the FDA Too Cautious in Its Approach for Approving COVID-19 Vaccines?

Yes, but the Trump administration's politicization of the hunt for a vaccine is undermining public trust.


"The vaccines are coming momentarily," asserted President Donald Trump in his post-hospitalization video yesterday. The same day the White House reportedly first blocked and then scrambled to approve under pressure the Food and Drug Administration's (FDA) proposed guideline that COVID-19 clinical trial vaccine recipients be followed for two months to evaluate vaccines' safety before they can be approved for inoculating millions of Americans. The justification for first blocking the FDA guidance appears to be that that timeline would make it essentially impossible for a COVID-19 vaccine to be approved by the agency prior to Election Day.

Generally, it has taken 10–15 years for a new vaccine to be developed, tested, and approved. However, vaccines for COVID-19 are being developed and put into clinical trials in less than a year, an unprecedented speed. Given how the pandemic is evolving, is the FDA being too cautious?

An August 31 op-ed by two Harvard researchers in the Journal of the American Medical Association urged that the FDA stick to strict approval standards requiring that the COVID-19 vaccines show clinical benefit, not just pass some biomarker threshold such as producing a certain level of antibodies, before they are deployed. The authors warned:

Some have argued that extreme clinical need warrants backing away from the FDA's historical standards requiring clinical benefit. This trend coincides with increasing political popularity of the libertarian "right to try" movement for medications, which advocates that patients should be able to access treatments not approved by the FDA. This approach was likely reflected in the presidential reasoning about unproven COVID-19 treatments: "Try it; what do you have to lose?"

The researchers conclude that "the nation's health will be far better served by reliance on the usual rigorous approach to vaccine evaluation. Premature rollout before the planned trial data are even collected would not be a medical breakthrough; it could represent a major public health misstep."

A strongly contrary view arguing for the immediate release of many current COVID-19 vaccines was expressed by Harvard biotechnologist George Church and his colleagues in an August 14 op-ed in Rejuvenation Research. "For this pandemic, open the gates and release the vaccines," the researchers urge. They specifically suggest, "nucleotide vaccines are ready. They should have virtually zero safety issues."

These innovative vaccines use coronavirus messenger RNA (mRNA) sequences to induce our cells to produce viral proteins that provoke the immune system to develop antibodies to fight off infections from future coronavirus exposures. Moderna and Pfizer mRNA vaccines are already in Phase 3 efficacy clinical trials. "The extremely rapid scaling of RNA vaccine makes it the superior method for mass deployment," assert the researchers. They further argue that modern biotechnology makes other types of vaccines also safer to develop and deploy nowadays.

"Foot dragging and wild misjudgment of vaccine risk are not acceptable. Likewise, withholding vaccines because of bureaucracy when a pandemic is raging," argue Church and his colleagues. "Nothing is absolutely zero risk. But risk must be weighed against certainty of doing nothing, which here and now is too extreme." They ominously conclude, "When nations are at risk of serious economic disruption or overwhelming health care facilities, there is no justification for current policies that leave no alternative but mass death and severe economic damage. It is worth remembering that the last global depression was ended by world war and a new world order."

The argument for the rapid rollout of COVID-19 vaccines by Church and his colleagues would be greatly strengthened through establishing a robust regime of post-deployment safety surveillance to detect and react to any serious side effects that might crop up.

An even better and faster way to assess the safety and efficacy of COVID-19 vaccines would have been human challenge trials. Researchers would have recruited some healthy young people, injected them with various experimental coronavirus vaccines, and then exposed them to the virus to see if any of them worked. But it's too late now to use this alternative given how far down the Phase 3 clinical trial path vaccine makers are now.

If a fall or winter wave of the pandemic is building, then effective vaccines should be made available to the public sooner rather than later. People of goodwill can differ on which approach toward COVID-19 vaccine deployment they think is appropriate. For my part, I think that Church and his colleagues make the stronger argument. However, the Trump administration's transparently self-interested political motivations to rush the approval of COVID-19 vaccines has undermined public trust in them. As an unfortunate result, millions of Americans may hesitate or even refuse to avail themselves of safe and effective vaccines that would protect themselves, their families, and their neighbors from the COVID-19 plague.