Moderna’s COVID-19 Vaccine Provokes ‘COVID-Like Symptoms’ in Phase 3 Trial

by TVR Staff

Published October 19, 2020 | Vaccination, Risk & Failure Reports

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

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References:

  COVID-19, Department of Health and Human Services, HHS, Ian Haydon, Luke Hutchison, Marco Cáceres, Moderna, Moncef Slaoui, mRNA-1273, National Vaccine Information Center, NVIC, The Vaccine Reaction