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- Edming based his argument on an anecdote about another drug, but that was a hormone supplement, not a vaccine, and it was approved under far more lenient FDA requirements more than 80 years ago.
- The timeline in this case was drastically sped up due to scientific cooperation and breakthroughs, ample funding and fast-tracked paperwork. But the vaccines still went through the normal testing and approval process.
- The COVID-19 vaccines were together tested on more than 100,000 people (in addition to animals) before their release, following a standard three-phrase testing.
- The most obvious evidence the vaccine is safe comes from the more than 100 million Americans who have received a dose so far, with minimal complications reported despite the massive sample size.
State Rep. James Edming doesn’t trust the COVID-19 vaccine.
He even told a Wisconsin Assembly committee, "we should eliminate" it.
Explaining his objection, the 75-year-old Republican from Glen Flora, in rural northern Wisconsin, has repeatedly cited a personal anecdote, most recently in a March 23, 2021, floor session of the Wisconsin state Assembly.
As lawmakers debated several bills that would prohibit mandatory vaccinations, Edming told of a friend whose wife died of cancer.
"His wife was 70 years old, and 71 years ago, there was a vaccination that they gave women so they wouldn’t have a miscarriage, and his mother-in-law took that vaccination," Edming said. "His mother-in-law died at age 70. His wife died at age 70, and their daughter is sterile.
"That’s what the research has been able to follow up on in 70 years, and you think I’m going to take something because some scientist says that it’s good for me. And looking at and listening to what my friend has to say, there’s got to be a little more research before I take something. There may be a vaccination that’s for this, but you can’t tell me they can solve this in eight to 10 months. Or a year. It takes more time than that. There hasn’t even been any animal research on this."
Edming covers a lot of territory here. A few quick notes before we go deeper.
His anecdote references a treatment that has indeed proven to have tragic, long-term consequences. But it wasn’t a vaccine, and it was developed in very different circumstances more than 80 years ago. More on this later.
But we’ll focus mostly on the timing-based claim. Is it really not realistic to develop a safe vaccine in less than a year?
The most obvious rebuttal to Edming’s claim is that millions of Americans have been safely vaccinated.
The CDC requires all deaths following vaccinations to be reported, which sparks a review of the death certificate, autopsy and other documents to check for a connection. Through March 22, 2,216 deaths were reported among 126 million vaccine doses administered so far in the U.S. But that doesn’t mean those are tied to the vaccine. In a sample so large, there will be people who die of other causes and, according to the CDC, those documents "revealed no evidence that vaccinations contributed to patient deaths."
Meanwhile, some people have reported side effects, including two to five per million who experience anaphylaxis — a severe allergic reaction.
But Edming’s criticism focused on the speed of the process, so let’s dig in to how the vaccines got to this point so quickly.
Defending Edming’s claim, his staff pointed to a vaccine history website from the College of Physicians of Philadelphia that says, "Vaccine development is a long, complex process, often lasting 10-15 years."
However, the same website details CDC guidance on the COVID-19 vaccines, including this: "Millions of people in the United States have received COVID-19 vaccines, and these vaccines have undergone the most intensive safety monitoring in U.S. history."
That gets to the heart of where Edming goes wrong.
The process that led to today’s COVID-19 vaccines is unlike anything that came before it. The unprecedented global consequences of the coronavirus pandemic spawned an equally unprecedented global cooperation in pursuit of a vaccine.
This was made possible by a new method of developing vaccines, mass numbers of infections that accelerated clinical trials and governments willing to eliminate bureaucratic and financial roadblocks, the New York Times reported. While the vaccine process involved breakthroughs, they were built on research that goes back decades.
"These vaccines were fast-tracked, but the parts that were fast-tracked were the paperwork; so the administrative approvals, the time to get the funding," Dr. Andrew Badley, COVID-19 Research Task Force Chair at the Mayo Clinic, said in a video produced by the hospital system. "Because these vaccines have such great interest, the time it took to enroll patients was very, very fast. The follow-up was as thorough as it is for any vaccine."
Each of the three vaccines now in use in the U.S. went through the standard three phases of human testing. Stage 3 testing conducted prior to receiving emergency use approval from the U.S. Food and Drug Administration involved 43,448 people for the Pfizer-BioNTech vaccine, 30,420 people for Moderna and 43,783 people for Johnson & Johnson.
The FDA describes the process this way on its website:
"In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety."
In the U.S., that government funding came from Operation Warp Speed, an initiative launched under the Trump Administration that laid out $18 billion to accelerate vaccine development and manufacturing.
Steps to speed the process included beginning large-scale manufacturing during clinical trials, running some phases of clinical trials at the same time and investing in multiple types of vaccines to increase the chances of success, according to a February 2021 report from the nonpartisan Government Accountability Office. Among the six potential vaccines Operation Warp Speed invested in, two used messenger RNA, two used viral vector technology that deploys an altered cold virus and two focused on the virus’s spike protein.
The first two vaccines approved here — Pfizer-BioNTech and Moderna — are particularly noteworthy in their use of messenger RNA, a new approach to vaccine creation. Vaccines built on mRNA have a general structure into which the genetic code needed to address a virus can be quickly loaded, rather than developing an entire vaccine from scratch. Moderna likens the process to loading a program or app into a computer’s operating system.
"There have been over three decades of mRNA vaccine research and development on vaccines for other disease such as influenza, Zika virus, and rabies virus. Additionally, mRNA-based cancer vaccines have been used in numerous cancer clinical trials with promising results," the doctors said in a joint statement. "The mRNA COVID-19 vaccine development was actually preceded by decades of research into understanding the efficacy and safety of mRNA vaccines and has made the COVID-19 vaccine a miracle of circumstances. It has allowed for a COVID-19 vaccine to be developed and tested much more rapidly."
Before we wrap up, let’s circle back to the anecdote Edming cited. It’s the same story he shared in a March 3 hearing before the Committee on Constitution and Ethics, where he recalled the friend’s deceased wife as an "awesome, awesome lady."
Tyler Longsine, a research assistant for Edming, said they didn’t know the nature of the drug involved — despite Edming’s repeated use of the story.
But experts consulted by PolitiFact Wisconsin say his description lines up with the history of a drug called Diethylstilbestrol, or DES. It’s a hormone supplement that was given to between 5 and 10 million women as a pill, injection, cream or suppository from the 1940s to the 1970s, the CDC reported. Doctors believed it would prevent miscarriages.
The National Institutes of Health said few studies were done on the drug before it was produced, however, causing it to be given to women worldwide in inconsistent doses. DES was in use long before a sweeping 1962 bill overhauled FDA drug approval requirements, making manufacturers prove the effectiveness of drugs before marketing them.
By 1953, research had shown DES did not prevent miscarriages or premature birth. But many doctors continued using it until research in early 1970s revealed children exposed to DES in utero were more likely to suffer from infertility and cancer of reproductive tissues — in line with Edming’s story.
As tragic as this outcome was for Edming’s friend and countless other families, their situation is not comparable to the COVID-19 vaccine. DES was a medication, not a vaccine. And it was developed 82 years ago under looser standards that led it to be administered erratically.
"The only similarity between DES and vaccines is that both may be given through injection," Murphy and Nolan said in their statement. "We give many medications by injection — think of insulin, for example — and they have nothing to do with vaccines."
In a speech detailing his distrust of scientists and the COVID-19 vaccine, Edming said, "You can’t tell me they can (develop a safe vaccine) in eight to 10 months. Or a year. It takes more time than that."
Edming leaned on criticism of a medical treatment — not a vaccine — developed in the 1930s and released without a fraction of the scientific scrutiny given to the COVID-19 vaccines.
And in any case, his conclusion is contrary to the overwhelming medical consensus and what we can clearly see from the worldwide rollout. Vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson (with others on the way) were able to develop as quickly as they did due to a breakthrough vaccine mechanism, billions in federal funding and an array of bureaucratic fast-tracking that allowed faster production, simultaneous trials and timely approvals.
Those vaccines were together tested on more than 100,000 people. And with millions of people now safely and effectively vaccinated, we see that safety claims made based on the trials were indeed valid. Which makes Edming’s claim ridiculous.
We rate Edming’s claim Pants on Fire.
WisconsinEye, Floor session of the Wisconsin state Assembly, March 23, 2021
Mayo Clinic, Anaphylaxis, accessed March 26, 2021
CDC, Reported Adverse Events, March 22, 2021
History of Vaccines, Vaccine Development, Testing, and Regulation, accessed March 25, 2021
New York Times, Politics, Science and the Remarkable Race for a Coronavirus Vaccine, Nov. 21, 2020
Mayo Clinic, COVID-19 vaccines: Get the facts, accessed March 25, 2021
PolitiFact National, Two vaccine trial participants died, but the FDA didn’t connect their deaths to the vaccine, Dec. 11, 2020
New England Journal of Medicine, Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine, Feb. 4, 2021
U.S. Food and Drug Administration, FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine, Feb. 27, 2021
U.S. Food and Drug Administration, Emergency Use Authorization for Vaccines Explained, accessed March 25, 2021
Bloomberg Businessweek, Inside Operation Warp Speed’s $18 Billion Sprint for a Vaccine, Oct. 29, 2020
Government Accountability Office, OPERATION WARP SPEED, Accelerated COVID19 Vaccine Development Status and Efforts to Address Manufacturing Challenges, February 2021
Moderna, mRNA Platform: Enabling Drug Discovery & Development, accessed March 25, 2021
Nanotoday, Three decades of messenger RNA vaccine development, October 2019
Nature Reviews, mRNA vaccines — a new era in vaccinology, Jan. 12, 2018
CDC, Vaccines & Immunizations, accessed March 25, 2021
CDC, DES History, accessed March 25, 2021
National Institutes of Health, Exposure to Diethylstilbestrol during Sensitive Life Stages: A legacy of heritable health effects, Nov. 5, 2013
FDA, Kefauver-Harris Amendments Revolutionized Drug Development, accessed March 25, 2021
The Washington Post, A gamble pays off in ‘spectacular success’: How the leading coronavirus vaccines made it to the finish line, Dec. 6, 2020
Email exchange with Tyler Longsine, research assistant for Rep. Edming, March 25, 2021
The Associated Press, Pfizer and Moderna did not skip animal trials, Nov. 25, 2020
Vox YouTube channel, mRNA vaccines, explained, Feb. 2, 2021
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