Wednesday, July 15, 2020

Side Effects of Moderna's mRNA-1273 Vaccine for COVID-19

Moderna has released the full preliminary results of its clinical trials for its ground-breaking mRNA-1273 vaccine on the New England Journal of Medicine website dated July 14, 2020 and there appears to be some adverse reactions, particularly in the highest doses as you will see in this posting.  

The trial which is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID aka Fauci's Institute) took place with the vaccine being administered in two doses spaced 28 days apart.  The three groups received 25-microgram, 100microgram doses and 250-microgram doses.  Each group consisted of 15 individuals with the median age being between 31 years and 36.7 years and an age range of between 18 and 55 years.  The majority of the participants were white (89 percent) with 13 percent being Hispanic, 4 percent being Black and 2 percent being Asian and American Indian or Alaska Native.  Adverse reactions were ranked as mild, moderate or severe.


Here is a table showing the adverse reactions and how their severity is measured:


Let's look at the results once the second vaccination took place (in percent with some rounding errors).  Arthralgia is joint pain, myalgia is muscle pain and erythema is redness of the skin:


As you can see, in general, the adverse reactions are the worst in the highest dose group (250 microgram) and lowest in the lowest dose group (25 microgram).  That said, excluding "any local system", of the ten symptoms, there were 10 times where the administration of the mRNA vaccine resulted in more than 25 percent of the participants experiencing either moderate or severe symptoms and, in two cases, more than half of the participants experienced moderate or severe symptoms, both in the highest dosage group.

Here is a quote from the paper under "Vaccine Safety" which is rather sobering:

"No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination."

That's one out of 45 individuals that had a severe enough reaction to the first vaccination at the lowest dosage that they had to withdraw from the trial.  In case you weren't aware, urticaria are red itchy welts that result from a skin reaction.  It is better known as hives among the general public.  Uticaria results from the body's reaction to certain allergens.  Let's ask a question; do you want to be one of the one out of 45 people that suffer a severe reaction to Moderna's vaccine?  Considering that universal vaccinations are deemed necessary, in the United States, there could be up to 8 million people with severe reactions if the ratio of 1 to 45 holds across the population

As well, here is a supplemental report regarding adverse events that took place after the second vaccination in one of the members of the 250 microgram dose group as shown on screen capture from the Supplemental Study Results:


Let's close with this quote from the authors of the paper:


"Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events."


Nonetheless, the authors state that:


"These safety and immunogenicity findings support advancement of the mRNA-1273 vaccine to later-stage clinical trials."


Currently, a Phase 2 trial is taking place with 600 health adults evaluating doses of 50 micrograms and 100 micrograms.  A large phase 3 efficacy trial which is expected to evaluate a 100 microgram dose will take place during the summer of 2020.

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