COVID-19 Vaccine - Wait What!

In the fervor and excitement about COVID-19 vaccines, pause and take a moment to read or even listen to an Audible excerpt of the book Medical Apartheid by Harriet Washington. Ask yourself when in the history of America have African Americans been offered premium, gold standard medical care let alone ushered to the front of the line to get it? 

Three things are happening right now.

1) The media is using the term “vaccines” as if all four vaccines coming on-line are equivalent. Aspirin is aspirin but we cannot say that about the four main COVID-19 vaccines coming onto the market in the US. Pfizer, Moderna, the Johnson and Johnson vaccine, and AstraZeneca. Each are different vaccines with different ingredients and qualities. They also have had widely different efficacy rates in their clinical trials. PEOPLE SHOULD ASK WHICH VACCINE THEY ARE GETTING AND DO RESEARCH.

2)Emergency authorization from the FDA means “we want to distribute this medication although it is not fully vetted.”  NORMALLY, the next step would be to conduct a clinical trial to see how this vaccine works in the real world. Medical researchers recognize that volunteers in phase 1,2 and 3 of the vaccine research trials differ in significant ways from the general population. 

3) News people and even some doctors are confusing efficacy and effectiveness and using these terms interchangeably. In the research world, research efficacy is not the same as research effectiveness. For example, the Pfizer vaccine, per their report, had roughly 94% efficacy in research clinical trials based on two months - only 8 weeks- of post-vaccination research. The vaccination phase for Pfizer ended October 1, 2020. People in the research trials will be studied for two and a half years. Efficacy is used to describe the vaccines’ performance during research trials. The efficacy rate may change over the next several weeks for the research trial participants as local infection rates rise.

Researchers know that the effectiveness of these vaccines will be measured when the vaccines are used under real-world conditions, not research populations. Efficacy rates can drop over time. Efficacy may drop by week 12 or week 16 and no one knows if these vaccines provide long-term immunity or conferred immunity.

Effectiveness rates can drop well below efficacy rates in real-world scenarios and usually do.

There was evidence of “volunteer bias” in the clinical trials studies which would artificially elevate efficacy rates. The infection rate in the placebo groups was surprisingly low given the infection rates within their communities. Overall, volunteers in the clinical trials might have been more health-conscious than the general public and likely more stringently practicing biosafety measures.

We just read an article from a community physician who confused efficacy and effectiveness when he wrote the vaccines were 95% effective. Doctors have clinical degrees, and some may not be well versed in research design. Rookie mistake.

We both have research degrees. Dr. Rolling is a physician with decades of both real-world and scholarly experience in infectious diseases. Dr. Blessman is a clinical psychologist. While we are not providing medical advice, we would encourage everyone to be informed and aware.  In the midst of panic, emotional turmoil, psychological distress, and fear people could be led to make decisions, not in their specific best interests. We believe we can make science accessible so people can truly make an informed decision. We salute those who are going first to take the vaccine.   Our frontline workers and nursing home caregivers and residents are most at risk. With their sacrifice, we hope that they are being followed clinically as they advance the science and our understanding of what this crop of vaccines can or cannot do. From them, we will learn how effective these vaccines are, whether there is a drop in infectious rates, hospitalizations, and deaths in those who were vaccinated in the first wave. We hope the government, or the vaccine makers are also offering to take care of any medical costs associated with any adverse events/side effects that will arise.

The public should be made aware that vaccine companies cannot be sued. The FDA report on the Pfizer vaccine mentions the cautions and the groups of people they do not have sufficient data on. “There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.” Page 49.

https://www.fda.gov/media/144245/download

Know your own medical profile. Your primary care doctor is trying to figure this out just like you are.

We are not anti-vaxxers. We acknowledge that some vaccines have been a medical boon and have saved lives. We have taken vaccines as well as gotten our children vaccinated where appropriate.  As researchers and clinicians, we have a lot of questions about this current crop of COVID vaccines that need to be answered before considering recommending one way or another that any one of my loved ones take it.  It's too early.

We are not going to let the current hysteria or the fear of COVID get in the way of making a reasoned decision taking into consideration our personal health profiles, our risk of exposure, and our capacity to execute stringent Biosafety security protocols.

PS: Best case scenario, even with a perfect, working vaccine, with current infection rates climbing we are months away from being able to ramp up and vaccinate 70% of the population. The reality is that we may be a day late and a dollar short on this one. COVID-19 is here and the crest of the surge may occur before vaccines will be available. Wear a mask, hand wash, social distance, and get our book so you can have great biosafety protections.  Share the book with ten people.

https://www.auset-isis.org/navigatinganewworld