Biotechnology firm Moderna, Inc. of Cambridge, Massachusetts began a Phase 3 human clinical trial to test the safety and efficacy of its experimental mRNA-1273 COVID-19 vaccine on July 27, 2020. The randomized, placebo-controlled trial involves giving two 100-microgram doses of the vaccine to 28,618 volunteer participants over 18 years of age, including some elderly people aged 71 and older.1 2 3
The first dose of the vaccine, which has been given to all participants, was followed up 28 days later with a second dose. As of Oct. 9, 22, some 194 participants have received the second dose. In August, some of the participants reportedly experienced adverse events such as fatigue, chills, headaches and injection site pain.1 2 3
Moderna has indicated that preliminary results of its Phase 3 trial may be available by the end of November 2020, in accordance with expectations by former Modern executive Moncef Slaoui, head of the U.S. government’s Operation Warp Speed program to develop a COVID-19 vaccine in record time.1 4 5
Phase 3 Trial Participants Have Serious Reactions
In September, three participants in the Phase 3 trial reported suffering reactions such as high fever, headaches, body aches and exhaustion. One of these participants, 44-year-old Luke Hutchison of Utah, suffered a fever (over 100°F), chills, a bad headache and shortness of breath after getting the second dose of the vaccine.6 7
Another of the trial participants, a woman from North Carolina in her 50s, suffered a migraine that “left her exhausted and struggling to focus.”7 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.7
Hutchinson compared the symptoms he experienced following the second dose of the mRNA-1273 vaccine to “full-on COVID-like symptoms.”7 He added:
I’m obviously an isolated case, but since all indications point to this vaccine being approved, I feel like people should know that the side effects may be severe, especially after the second shot.7
Phase 1 Trial Participants Had Grade 3 Reactions
During Moderna’s Phase 1 trial on the mRNA-1273 vaccine, eight of the 45 participants experienced adverse events following vaccination, including four participants who suffered serious Grade 3 reactions. One of those four participants, 29-year-old Ian Haydon of Seattle, Washington, suffered Grade 3 “systemic symptoms” after getting a second dose of 250 µg of the vaccine.8 9
In an article earlier this year, The Vaccine Reaction reported:
Haydon said he came down with a fever of over 103 degrees [Fahrenheit] and that he felt sicker than he ever has before. He sought medical care at an urgent care center. After he was released from the center and returned home, he fainted.9
The U.S. Department of Health and Human Services (HHS) describes a Grade 3 adverse event as “severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care” such as “bathing, dressing and undressing, feeding self, using the toilet, taking medications.”9
1 Neilson S. Moderna’s coronavirus vaccine just started its phase 3 trial — the first in the US. Here’s how it’ll work. Business Insider July 27, 2020.
2 Enrollment Update: 28,618 participants enrolled. Moderna.
3 Lovelace B. Moderna says its coronavirus vaccine shows promising results in small trial of elderly patients. CNBC Aug. 26, 2020.
4 Khemlani A. Coronavirus update: Moderna targets Thanksgiving for vaccine results as pressure mounts on Pfizer. Yahoo! Finance Oct. 1, 2020.
5 Wilkie C. White House coronavirus vaccine advisor Moncef Slaoui to divest $12.4 million of Moderna holdings. CNBC May 18, 2020.
6 Farr C, Lovelace B. Coronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it. CNBC Oct. 1, 2020.
7 Salo J. COVID-19 vaccine trial participants report aches, fevers and chills. New York Post Oct. 6, 2020.
8 Cáceres M. Healthy Clinical Trial Subjects Suffer Grade 3 Side Effects to Moderna’s mRNA COVID-19 Vaccine. The Vaccine Reaction May 24, 2020.
9 Cáceres M. Volunteer Describes His Serious Reaction in Moderna’s mRNA COVID-19 Vaccine Trial. The Vaccine Reaction May 30, 2020.