By Virginians for CHD

Virginia Gov. Ralph Northam on Nov. 18 told reporters he could see the “light at the end of the tunnel” after Pfizer and Moderna announced that preliminary results of their COVID vaccine clinical trials had demonstrated a high percentage of effectiveness.

Earlier in the year, Virginia’s health commissioner, Dr. Norman Oliver, told reporters he “… plans to mandate coronavirus vaccinations for Virginians once one is made available to the public.” He added, “It is killing people now, we don’t have a treatment for it and if we develop a vaccine that can prevent it from spreading in the community we will save hundreds and hundreds of lives.”

But neither of the results from the early Moderna and Pfizer press releases indicated that the COVID vaccines are designed to prevent transmission. They only reported a 90+% effectiveness rate, without providing details behind what “effective” actually meant.

Given that the Moderna and Pfizer vaccine trials didn’t show that the COVID vaccines demonstrate prevention of COVID-19 infection or transmission, we took a closer look to try to determine what the trials actually did reveal.

To date, and from what we have read in public press releases, there are multiple COVID vaccines with stated efficacy rates as high as 95%, initially from Pfizer and Moderna and more recently (with lower efficacy rates), from AstraZeneca. However, none of the companies have been clear about what they mean by “effective.”

A careful review of the design studies for the Moderna and Pfizer clinical trials reveals that the trials and studies are not designed to answer the questions that the general public has about the term “vaccine effectiveness.”

Specifically, the trials aren’t designed to answer this: Would a vaccine labeled “effective” prevent transmission?

At a very basic level, the general public has a common understanding of a vaccine being developed to protect a person from getting a disease and to prevent a person from transmitting the disease to other people.

Therefore, to communicate data about clinical trial results, the company must be clear about how it defines “effective.”

There must also be clear communication about the adverse events experienced by trial participants. And informed consent must also be a part of this discussion.

Using words like “effective” without providing context and without communicating potential or actual and documented adverse events, both known and unknown, only serves to undermine public trust.

Virginians deserve better.

Use of term ‘effective’ is premature

In the Pfizer and Moderna trials, we find that the primary success criterion of the studies is not prevention of infection. Neither, as it happens, is the primary success criterion for the development of the vaccine designed for the prevention of transmissivity.

In fact, in a statement to The BMJ, Tal Zaks, chief medical officer at Moderna, said “… our trial will not demonstrate prevention of transmission.”

Since the vaccine is neither expected to, nor is being tested for, prevention of infection, the studies therefore necessarily analyzed for the infected, and whether or not the infected have “less disease,” i.e. symptom reduction or mitigation, when compared to those infected and not vaccinated.

Within the vaccine trial it was determined that in order for symptom mitigation to be assessed as a successful vaccine criterion, symptoms of infected, vaccinated test subjects must be compared with broad-based symptomatic data from clinically infected non-vaccinated patients.

The issue of diverse population broad-based symptomatic data from infected, non-vaccinated patients presents and raises additional questions regarding the clinical trials. But as Zak also told The BMJ, “… the trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here.”

It is important to note that comparisons of symptoms across broad swaths of populations who have varying degrees of pre-existing health conditions were not a robust consideration of this effort — specifically, the test volunteers were not indicative of the diverse population that will be receiving this vaccine.

The terminology used within these early press releases regarding “effectiveness” of the vaccines must be made clear. Virginia’s governor and health commissioner have an ethical duty to be transparent in communicating this data. And to date, the data suggests that the use of the term “effective” is premature.

Other ethical questions

In addition to the fact that the word “effectiveness” has been misused in the context of COVID vaccine trials, another ethical, possibly precedent-setting question is emerging — Are we really now going to mandate a vaccine that promises only to suppress symptoms, not prevent disease?

Is the medical establishment taking a precarious step toward forcing someone to take medications or therapeutics for a symptom(s) of an illness or condition that they do not have?

Are they setting precedent with the trend for symptom reduction via a therapeutic or biologic, and/or medications with known and unknown risks, to ensure symptom suppression?

How far can this precedent extend? What other symptom-only prevention of illnesses will be treated via mandated medical prophylactic interventions?

Any reasonable person should ask these questions.

In order for Virginians to have a healthy debate — in the public square, within families, with caregivers and with our healthcare representatives — issues around mandates, medical ethics and what the term “effectiveness” means must be thoroughly communicated, debated and understood.