The press often gets science and medicine wrong. Often it is the result of ignorance born out of a lack of time, lack of education, or a lack of curiosity. Sometimes, it is the result of a malign attempt to gin up readership. Sometimes the correspondent simply reports what the scientific paper reports and the fault lies with the researchers and the Journal.
This article is a perfect example in which a journalist misunderstood the nuance behind a single word and thereby wrote a very misleading article. It cries out for comment.
Novavax coronavirus vaccine is safe, published results show
By Jen Christensen, CNN
Updated 8:33 PM ET, Wed September 2, 2020
https://www.cnn.com/2020/09/02/health/novavax-vaccine-safe/index.html
The title of this short article indicates that the experimental vaccine is “safe”. This is not a direct quote from the scientific publication in the esteemed New England Journal of Medicine. There, the article indicates that that vaccine was administered to a total of 105 subjects (in two different ways) and “appears to be safe”. That one word means of world of difference.
Drug and vaccine development proceeds in three phases. In each phase we learn specific and important things and we treat greater numbers of patients. Phase I is designed to test the safety of one, or usually more than one dose, and to gather some data on the effects of the drug or vaccine, if possible. By far the most important goal of a Phase I study is to administer the experimental therapeutic (hereafter eRx) to a small number of subjects in order to rule out the possibility of common and very serious side effects.
When a small number of subjects are exposed, we limit the potential harm that we can cause. At the same time, we greatly limit how much certainty we have in it’s safety. An example might be illuminating. If an eRx causes a harmful reaction in 5% of subjects (something that would completely disqualify a vaccine that might be given to millions of people from approval) and we only test it in 20 subjects, then there is an excellent chance that none of the subjects will develop the adverse reaction. Only when a larger number of subjects are exposed can we be confident that a serious side effect as common as 5% be ruled out.
When drug developers (I spent many years doing this work) summarize the results from a Phase I study, they never state that the eRx is “safe”. Instead, we might summarize the results of a study by saying the eRx had “an acceptable safety profile” within the limits of the study, or “appeared” to be safe. The qualification is crucial.
What does it mean for a vaccine to be “safe”? Firstly, we know that nothing is entirely safe. Even water, given to excess, can be harmful. If an experimental vaccine causes liver failure in 1% of recipients, most people would consider it unsafe. What about 0.1%? Or 0.01%? There is no standard for safe. Approval of an eRx are based on its risk/benefit balance.
A vaccine for COVID-19 is destined to be given to millions of people. Yes, COVID-19 is serious (it sends a large proportion of those who catch it to the hospital) and deadly. so far in the US we are at ~6 million cases and 200,000 deaths. That means that one in every 30 people who have been infected have died, at least according to official statistics. There is a great need for a vaccine to help us prevent further illness and death, and to allow us to all get our lives back to normal. But, we must remember that most all new cases of COVID-19 can be prevented by masking and social distancing. If a vaccine causes serious illness in 1% of the population, and it is administered to 200 million people, we can expect 2 million cases of the adverse reaction and perhaps thousands of deaths. This would be little better than we can expect from COVID-19 alone and would not be acceptable. Only a study with many hundreds or even thousands of subjects exposed to the vaccine itself (and not to placebo) can establish that it is safe enough to be administered to the American people.
Writing a big headline in a major media outlet that a vaccine is “safe” is misleading the public. Misleading the public, or just failing to properly educate and inform them, damages public confidence, especially when, as happens, it is later found that the vaccine is not safe. It may be less sexy to write that an experimental vaccine has appeared to pass its Phase I test (a decision that is ultimately up to the FDA) or that the study did not uncover any high-frequency serious side effects, but keeping the public properly informed is vital if we are to gain their confidence. Without that confidence, the vaccine will not be accepted and will not protect the American public.
We must hold journalists and media to a higher standard. It may cost more for media to hire more specially-trained journalists who understand the important nuances in their fields, but poor reporting is a serious adverse event with grave consequences for our democracy.