It’s going to require radical transparency to give Americans assurance to take COVID-19 vaccines
This post was originally published on this site
One week ago, the leading manufacturers of vaccines against COVID-19 came together to issue a press release seeking to reassure a very uncertain nation. In part, that release insisted that the manufacturers—including AstraZeneca, Moderna, and Pfizer, whose vaccines are all now in Phase 3 testing—that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
However, just one day later, the trial of the vaccine manufactured by AstraZeneca, which originated from researchers at Oxford University and was widely regarded as likely to be one of, if not the, first available, was temporarily suspended after one participant in the trial developed a serious potential reaction. Then three days ago, AstraZeneca announced that they were resuming their trials. But both the suspension and the resumption came with this comment from the company: “AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information.”
It’s not unusual for drug companies engaged in a Phase 3 trial to hold results, even safety results, close to the chest. But the result of refusing to provide any further information is that the high-minded statement signed last week actually resolves to a simple statement of “you’re going to have to trust us.” And right now—a lot of people simply don’t.
In normal times, vaccine manufacturers stay quiet for a number of reasons. One is that there may be confidential information in the study, not just in how their vaccine is made, but how it is administered. Another is that none of them want to talk about any adverse reactions before they’ve had a chance to rule out other possible causes. A third reason may be concerns that revealing too much information risks violating HIPAA or other regulations around patient privacy.
But these are not normal times. Though anti-vaxxers have made problems in specific areas of the nation (in particular because measles is insanely contagious), Americans by and large have had a high level of trust when it comes to vaccines. A Harvard poll out just last year found that 84% of Americans favored requirements that all students be vaccinated before attending school, and only 8% felt that vaccines were not safe. Still, that’s a little less than the average around the world where vaccines enjoy 92% support.
As Donald Trump has made increasing calls for work on a COVID-19 vaccine to be rushed into production, the number of Americans who say they would consider taking the vaccine has dropped precipitously. Study after study, poll after poll, have shown that Trump has so politicized the process of developing and releasing a vaccine that fully one-half of the nation has already determined not to get a COVID-19 vaccine if it becomes available under Trump. And, unfortunately, this distrust in Trump has provided a boost to anti-vax groups that see the declining faith in both the FDA and CDC as an opportunity to turn Americans against necessary childhood vaccinations.
A COVID-19 vaccine may provide good protection to an individual patient, but there are many people in the U.S. who, because of compromised immune responses or other reasons, legitimately cannot take vaccines. Their protection counts on eliminating the free spread of virus in the population. That may never happen unless the vaccine is widely accepted and used.
It’s critical that, in this season, vaccine manufacturers worry less about proprietary information and engage in “over share.” AstraZeneca should be telling everything possible about the incident that caused a temporary halt in their trials. Other manufacturers should be providing interim data, trial details, and preliminary results without regard to whether the numbers have been arranged to put their product in the best light.
Faith in the entire medical system may be a decade in returning. Even once Trump is gone, neither the FDA nor the CDC is likely to enjoy the cachet they’ve held for decades. If Americans are going to take an available COVID-19 vaccine in sufficient quantities, it’s going to take more than a statement saying “trust us.” You’re going to have to show us.
Radical transparency—it’s not just a good idea. It could save thousands of lives.