As I write this column, daily coronavirus cases continue to rise, and there’s no sign of the virus letting up. New York has seen its cases increase by 73%, Texas became the first state to surpass 1 million cases of the virus, and California has seen COVID cases increase by 37%. As hospitalizations increase across the country and many states struggle with figuring out how to combat the virus, doctors and scientists alike are warning Americans to stay home for Thanksgiving and Christmas, effectively changing the way millions of people celebrate both holidays.

Yet as the presidential election comes to an end and it appears President Trump is preparing to accept the reality that Biden is president-elect, Pfizer and Moderna along with the National Institute of Health have announced vaccines to combat the novel coronavirus. Initially, Americans were increasingly skeptical of the COVID vaccine, but the tides have now changed. According to Gallup, “Fifty-eight percent of Americans in the latest poll say they would get a COVID-19 vaccine, up from a low 50% in September.”

While the vaccines are promising, makers of the vaccines must be transparent about all potential side effects. It is very important that we keep the public informed on the issue of COVID-19. There has been far too much mis and disinformation. Truth is all that matters. There are two issues discussed below: 1) questionable science and 2) the EUA process.

On Nov. 10 Pfizer announced preliminary data from their vaccine trials at “90% effective.” Please note that the VP of Pfizer Safety used the word “effective,” not efficacy. The difference here is important because efficacy is what is measured in a controlled study under ideal conditions. Efficiency is how something performs under real-world conditions. The proper verbiage here should have been efficacy.

The results from the Pfizer study, as reported, were quite remarkable (astonishingly high) considering the CDC posted a major study finding that the influenza vaccine is only between 40 to 60% effective. The first flu vaccine was developed in the 1930s.

Not but six days from the Pfizer announcement, on Nov. 16, Moderna, along with the National Institute of Health, announced that their vaccine had achieved an efficacy of 94.5%. Two days later, Nov. 18, Pfizer announced that, in fact, after a full analysis, their vaccine efficacy is 95%. The change from 90 to 95% is significant when looking at the FDA’s Emergency Use Authorization (EUA) power.

The EUA grants the FDA authority to fast track drugs (and other instruments under the FDA’s purview) for the purpose of addressing a national health emergency. In other words, the FDA is granted special powers to waive standard regulatory requirements (e.g., Good Manufacturing Compliance) if certain statutory criteria are met. The EUA process can only be used if the secretary of the Department of Human Health Services declares that circumstances exist to justify its use.

Will Pfizer receive a EUA? Let’s dig into what has been made publicly available. Under Evidence of Effectiveness, the study featured nearly 44,000 subjects. The drug was tested on more than 22,000 subjects, and the placebo group had an additional 22,000+. Out of the almost 44,000 individuals in the study, there were only 170 confirmed cases (162 cases of COVID-19 were observed in the placebo group versus 8 cases in the vaccine group). Pfizer here claims 95% efficacy. We will forget for a moment that within a week, Pfizer had improved their numbers by 5% and focus on the more interesting statistical point that no one seems to be focused on, the placebo group. Out of 22,000 subjects, which effectively received zero treatment, only 162 cases were confirmed. This means that in the placebo population, not even 1% of subjects contracted COVID.

Moderna’s numbers were eerily similar (95 out of 15,000+ in the placebo group). However, in Moderna’s press release, they were careful to add the phrase “symptomatic COVID-19.” There are two points here to consider: first, regardless of symptomatic or asymptomatic subjects, these numbers seem awfully low for both Moderna and Pfizer. This calls into question both studies. How can the rate of COVID in the placebo groups be so small? Second, to ignore the asymptomatic cases is irresponsible and wrong. Studies not only demonstrate that damage can occur sub-clinically in asymptomatic cases, but also asymptomatic subjects are infectious carriers.

We should all applaud the fact that a potential vaccine exists, but we also need to be sure that it works. The only way to assure its effectiveness and success is to question its efficacy to hold our scientists accountable to protect the millions of us who will ultimately benefit from a vaccine.