It’s been a bad week in Lake Wobegon, Garrison Keillor’s fictional town from Prairie Home Companion. This imaginary Minnesota village is right in the middle of the pandemic. Other midwestern states such as North Dakota, South Dakota, Iowa, Wisconsin and Nebraska are also being hammered by COVID-19. In fact, the U.S. and Europe have been hit hard this fall. Will the Pfizer vaccine save the day?
By the Numbers:
Let’s be honest. The second, or perhaps we should call it the coronavirus third wave, is upon us. At last count, we are way past 10 million cases in the US. We are heading for 250,000 total deaths in a matter of days. The pain and misery are incalculable.
We know that many visitors to this website do not believe these numbers. They are convinced that such statistics have been manipulated. But there is one number that can be trusted: hospitalizations! Many states are experiencing dangerous increases in hospitalized patients. Intensive care units (ICUs) are reaching capacity. Healthcare workers are overwhelmed. Mobile morgue units are reappearing. Some models predict close to 400,000 deaths by Feb. 2, 2021.
We need some good news! The Pfizer Vaccine:
This week Pfizer and BioNTech announced that their vaccine, BNT162b2 was highly effective. The Pfizer vaccine press release from November 9, 2020, stated:
• “Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
• Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
• Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
• Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
• Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints”
What Do We Really Know About the Pfizer Vaccine?
The phrase that captured headlines all around the world was that the Pfizer vaccine is:
“more than 90% effective in preventing COVID-19.”
That sounds fabulous. But we have to remind you, dear reader, that this preliminary information comes from a press release. Only the Data Safety Monitoring Board knows how many of the 94 people who caught COVID while participating in the trial received the vaccine and how many were on placebo. Until the study is completed and the data are released, we won’t know how effective the Pfizer vaccine truly is.
Readers of our work know that we are obsessive about absolute risk reduction vs. relative risk reduction. We apologize for beating this drum so often, but it is a critical difference. We recently wrote an article titled:
Big Pharma’s Secret Strategy to Fool You
Do you have any idea how effective your medicine really is? Drug companies have a secret strategy: misleading drug stats can confuse doctors.
In it we described for the umpteenth time the classic case of the Lipitor (atorvastatin) ad. The company bragged that its cholesterol-lowering drug could reduce the risk of heart attacks by 36 percent. But there was an asterisk next to that number. Anyone who bothered to read the fine print learned:
“That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”
The 36% reduction in heart attacks was a relative risk reduction. The absolute risk reduction was 1%. If that doesn’t make sense to you, you can read the detailed explanation at this link.
So, How Effective Is the Pfizer Vaccine?
The answer is, we do not know! The data have not yet been made available. Specifically, we need to know the absolute risk reduction in coronavirus cases among the vaccinated volunteers. It would also be helpful to know about the details of the 94 confirmed cases of COVID-19.
How many of the 94 received the Pfizer vaccine and how many got the placebo injections? If the shot were capable of preventing at least 90 people out of 100 from getting the virus, that would be fabulous. We hope that is the case, but we do not know. Heck, we would be delighted if 60 people out of 100 were protected from the coronavirus. We await more details from scientists who do not have a financial horse in the race.
Other Questions About the Pfizer Vaccine:
1) Does the vaccine protect people from catching COVID-19 entirely or developing severe symptoms? Does the Pfizer vaccine prevent deaths from the coronavirus?
2) Does the protection last for a few months, a few years or indefinitely?
3) Will the Pfizer vaccine protect high-risk individuals such as older people and those with pre-existing conditions?
4) How will the Pfizer vaccine compare to other COVID-19 vaccines?
5) How long will it take to distribute the Pfizer vaccine to tens of millions of Americans? How soon will we have other effective vaccines ready for distribution?
6) What are the side effects of the vaccine(s)?
COVID-19 Vaccines: Hope for the Future:
We are very hopeful that the Pfizer vaccine will be a game changer when it comes to controlling COVID-19. We want to see the data as soon as possible. We also hope that the research on other vaccines will soon be completed so that we can learn about their potential effectiveness.
We are grateful for all the people who will be working around the clock to distribute the vaccines once they get the green light from the FDA. When the data become available, we promise to share it with you promptly and explain it as clearly as possible.
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