FDA Slow Walks COVID-19 Vaccine

Every day thousands of Americans are dying of COVID-19, while lockdown measures edge many others into poverty or disrupt their educations. The impact will be felt for years to come. Yet cumbersome regulations continue to block more vaccines able to save lives and help us return to normal.

On December 30, the U.K. became the first country to grant emergency authorization to the Astra-Zeneca vaccine. Wide-scale inoculation immediately ensued. So far, over 10 percent of U.K. adults have been vaccinated, many of them with the Astra-Zeneca vaccine.

Other countries have begun to allow the vaccine and, interestingly, the E.U. is currently fighting with the U.K. to get their hands on it. Meanwhile, Americans will be forced to wait until April at the earliest.

So, what is going on here?

The Astra-Zeneca vaccine has notable advantages. It is far cheaper than either the Moderna or Pfizer vaccines, at only $2-4 per shot. Not that we should be pinching pennies, but this vaccine would make it much more cost-effective to inoculate the large portion of our population required to reach herd immunity.

Additionally, transportation is much easier. The Astra-Zeneca vaccine requires refrigeration at only 2-8 degrees Celsius. For comparison, the Pfizer vaccine requires storage at -70 degrees, making logistics incredibly difficult.

While there are concerns about efficacy for older populations—those most at risk—there is also some evidence that this vaccine may be no less effective for the older population. Remember COVID-19 is much more lethal with age, and the elderly have the weakest immune system response to vaccines, so we are most concerned about the over-65 demographic.  

To be sure, there are some shortcomings which are a cause for concern. Clinical trials have shown that the Astra-Zeneca vaccine is less effective than the two vaccines authorized in the U.S. The others are 95 percent effective, while Astra-Zeneca is in an estimated range of 60 to 70 percent.

Why do we have an estimated range of effectiveness instead of a single percentage? It turns out that an issue with the trial caused problems with the data. The Astra-Zeneca trial had a smaller sample size than Pfizer and Moderna, which makes analysis more difficult, though not impossible.

If the smaller sample size weren’t enough to shake consumer confidence, it appears there was also a mistake with the administration of the vaccines themselves. Some of the treatment group received a half-dose for the initial injection. Oops. The vaccine was about 90 percent effective for this group, which was odd, but not impossible. This error did cause regulators rightly to question the efficacy of the vaccine.

Where does this leave us? The FDA, wedded to bureaucratic procedure and what I would call “methodolatry,” is requiring a new full trial to be conducted before granting an EUA. This is despite the U.K. using it widely for over a month already. While questions about the vaccine need to be answered, is this the best way to find those answers?

First, instead of waiting months for people in the new trial to be exposed to COVID-19, human challenge trials could be used. In such trials, people are inoculated and exposed to the virus so that clinicians can quickly measure vaccine effectiveness. Almost 40 thousand volunteers have signed up to participate, but the FDA refuses to allow them to proceed. If permitted, such human challenge trials would cut the time in the phase III trial significantly, and help us get the vaccine sooner.

Second, the FDA could accept the data used by the U.K., and have Astra-Zeneca supplement that data with new data that address specific concerns. One such concern is its effectiveness for adults over 65. To address that concern, Astra-Zeneca could focus on gathering data for the older population, and use existing data for younger groups, making the process simpler and faster.

The current emergency calls for flexibility, but unfortunately the FDA is known for its byzantine approval process. The agency should be willing to communicate with Astra-Zeneca, explain concerns, and request data addressing them. This may not be the ideal relationship for normal drug and vaccine development, but in an emergency of this scale the balance of costs and benefits necessarily changes.

In the U.K., regulators required fewer formal applications and accepted different data formats in order to ease the process. American regulators do not have to lower standards (and shouldn’t), but they should increase flexibility. In the U.K., the focus appears to be trying to find and approve good vaccines, so they can be administered and help people as promptly as is feasible.

The FDA is far more risk-averse. Their focus appears to be preventing ineffective and harmful vaccines from being approved, regardless of how long it takes good drugs to be approved. These delays of good drugs also cost lives, and right now they are costing a lot of lives. This difference in regulatory approach is causing a divergence between the U.S. and U.K.

As deaths continue to mount, the U.S. is delaying the emergency authorization of another vaccine. While serious questions persist about the vaccine’s effectiveness that require more exploration, the FDA should not treat this as if it were a normal situation. Flexibility is important, and ensuring that we have every tool available to bring the pandemic under control should be the top priority. No one wants an ineffective vaccine being used; by the same token, lives should not be needlessly sacrificed on the altar of bureaucratic forms.

Conor Norris is a research analyst at the Knee Center for the Study of Occupational Regulation at Saint Francis University. He graduated from George Mason University with an MA in economics.