The chief scientist for the U.S. government’s Operation Warp Speed (OWS) program aimed at facilitating development of COVID-19 vaccines confirmed on Dec. 1, 2020 that 10-15 percent of the volunteers, who participated in clinical trials to test the safety and effectiveness of experimental vaccines developed by Pfizer, Inc. (in partnership with BioNTech SE) and Moderna, Inc. (in partnership with National Institute of Allergy and Infectious Diseases), reported “significantly noticeable” side effects.1
Dr. Moncef Slaoui, who leads OWS, which is a partnership involving private industry and agencies of the federal government,2 said that side effects suffered by clinical trial participants given Pfizer/BioNTech’s messenger RNA (mRNA) BNT162b2 vaccine and Moderna’s mRNA-1273 vaccine have included redness and pain at the injection site, along with fever, chills, muscle aches and headaches.1 3 4
Some Reactions Have Been Serious and Severe
Some of those reactions have been serious, including the case of 44-year-old Luke Hutchison of Utah who suffered a fever (over 100°F), chills, bone and muscle aches, a bad headache and shortness of breath after getting the second dose of the mRNA-1273 vaccine during a Phase 3 trial. Hutchison compared his symptoms “full-on COVID-like symptoms.”5
“I started shaking. I had cold and hot rushes. I was sitting by the phone all night long thinking: ‘Should I call 911?’” Hutchison said. “Nobody prepared me for the severity of this.”6
Another Phase 3 trial participant (a woman in her 50s) who received the mRNA-1273 vaccine suffered a migraine that “left her exhausted and struggling to focus.5 She said:
If this proves to work, people are going to have to toughen up. The first dose is no big deal. And then the second dose will definitely put you down for the day for sure. You will need to take a day off after the second dose.5
In one of the earlier trials for the Pfizer COVID-19 vaccine, more than half of the 45 participants experienced side effects, including two severe reactions—a Grade 3 fever of over 101.3°F two days after vaccination, and sleep disturbance one day after vaccination.7
Severe reactions were also suffered by several individuals in an early trial for Moderna’s COVID-19 vaccine consisting of 45 participants—including the case of 29-year-old Ian Haydon of Seattle, Washington. Within 12 hours of receiving a second dose of mRNA-1273, Haydon came down with a fever of over 103°F. He sought medical care at an urgent care center.8
Vaccine Reactogenicity: The “Elephant” in the Room
“Somebody needs to address the elephant: What about vaccine reactogenicity?” asks Deborah Fuller, PhD, professor of vaccinology at the University of Washington in Seattle. “I feel like it’s being glossed over.”5
An independent analysis of Moderna’s Phase 3 trial determined that 9.7 percent of the participants suffered severe fatigue following vaccination, 8.9 percent suffered severe muscle pain, 5.2 percent suffered severe joint pain and 4.5 percent suffered severe headaches. An analysis of the Pfizer/BioNTech Phrase 3 trial found that 3.8 percent of participants suffered from severe fatigue and 2 percent of participants suffered severe headaches.5
Arnold Monto, MD, professor of epidemiology at the University of Michigan School of Public Health notes that these rates of severe reactions are higher than the public is used to. “This is higher reactogenicity than is ordinarily seen with most flu vaccines, even the high-dose ones,” Dr. Monto says. With Pfizer and Moderna planning to supply their COVID-19 vaccines to some 35 million people around the world by the end of this year, hundreds of thousands of people may experience severe reactions to these two vaccines alone.5
ACIP Calls for Transparency on Vaccine Side Effects that “Are not a walk in the park”
At a Nov. 20 meeting of the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention (CDC) on medical issues, doctors urged the CDC and vaccine manufacturers to be transparent about the “rough side effects” people may experience after getting the initial dose of COVID-19 vaccines so that they are not scared away from getting the second dose.1
ACIP liaison from the American Medical Association (AMA) Sandra Fryhofer, MD stressed:
We really need to make patients aware that this is not going to be a walk in the park. They are going to know they had a vaccine. They are probably not going to feel wonderful. But they’ve got to come back for that second dose.1
What Will Be the Long-Term Side Effects?
Perhaps the biggest question concerning the Pfizer/BioNTech and Moderna vaccines, as well as others, may be, “What will be the long-term side effects of these vaccines?” While Dr. Slaoui observed that the vaccines have produced short- to medium-term reactions, he indicated that there is no way to know what longer-term side effects such as autoimmune diseases may be. “[T]he very long-term safety [of the vaccines] is not yet understood by definition,” Dr. Slaoui said.1
As a recent article in USA Today pointed out, medical experts “still don’t know the long-term effects of the vaccines and won’t know until after the trials are completed and researchers monitor participants in the real world for years after.”9
Click here to view References:
1 Lovelace B. Trump Covid vaccine czar says side effects ‘significantly noticeable’ in 10% to 15% of recipients. CNBC Dec. 1, 2020.
2 Fact Sheet: Explaining Operation Warp Speed. U.S. Department of Health and Human Services.
3 Press release. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. Pfizer Nov. 18, 2020.
4 Webull Financial. Moderna Announces Primary Efficacy Analysis In Phase 3 COVE Study For Its COVID-19 Vaccine Candidate; Vaccine Efficacy Against COVID-19 Was 94.1%, Vaccine Efficacy Against Severe COVID-19 Was 100%. Nov. 11, 2020.
5 TVR Staff. Moderna’s COVID-19 Vaccine Provokes ‘COVID-Like Symptoms’ in Phase 3 Trial. The Vaccine Reaction Oct. 19, 2020.
6 Wadman M. Public needs to prep for vaccine side effects. Science Nov. 27, 2020.
7 TVR Staff. Pfizer/BioNTech’s COVID-19 Vaccine Causes Adverse Reactions in Over Half of Clinical Trial Volunteers. The Vaccine Reaction July 18, 2020.
8 Cáceres M. Volunteer Describes His Serious Reaction in Moderna’s mRNA COVID-19 Vaccine Trial. The Vaccine Reaction May 30, 2020.
9 Rodriguez A, Hauck G. Will there be side effects from a COVID-19 vaccine? When can you get it? We answer your vaccine questions. USA Today Dec. 2, 2020.