Moderna Covid Vaccine Update: Is the Moderna Vaccine Safe? Allergic Reactions and Side Effects
- Published on: 1/5/2021
- Moderna Covid Vaccine Update: Is the Moderna Vaccine Safe? Allergic Reactions and Side Effects
How safe is the Moderna Vaccine?
Moderna enrolled over 30,000 volunteers age 18 and older in its double-blind placebo-controlled study. 11,000 were from communities of color, 7,000 were 65 and older, and 5000 were under 65 with conditions that increased their risk for severe COVID. Half received the vaccine, and half received a placebo, 15,000 in the placebo group, 15,000 who got the vaccine. Symptomatic COVID was confirmed in 185 people in the placebo group and 11 people in the vaccinated group, making the vaccine 94.1 percent effective. Researchers actively monitored the vaccine recipients for local and systemic side effects for seven days after vaccination, recorded unsolicited side-effects for 28 days, and more severe side effects and medically-attended adverse events from day 1 through 759.
Summary of The Safety Profile
Like Pfizer, those under 65 experienced more frequent mild to moderate side effects than those over age 65. However, the safety profile was similar across age groups, genders, ethnic and racial groups, participants with or without comorbid conditions, and participants with or without evidence of prior COVID infection. These systemic side-effects are unpleasant and are at a higher rate than seen in most vaccines. In most cases, they are more likely related to the lipid nanoparticles with super tiny amounts of polyethylene glycol.
Moderna reported no anaphylactic or severe allergic reactions to the vaccine, but a hypersensitivity reaction was reported in 1.5% of vaccine recipients and 1.1% of placebo recipients. The FDA's website has the list of ingredients found in all vaccines and advises that people with a history of severe allergic reactions check the list and discuss the risk of vaccination with their doctor. For example, a Boston doctor had a severe allergic reaction to the Moderna vaccine. However, he did have a history of having an allergic reaction to shellfish in the past. He was rushed to an emergency room, treated, and released. It was also initially recommended that pregnant women or those who intend to become pregnant in three months should not get the vaccine due to their inclusion in the studies. But the American College of Obstetricians and Gynecologists (ACOG) has recently released a statement supporting vaccination for pregnant and breastfeeding mothers.
Bell's palsy was observed in three people in the vaccinated group and one in the placebo group. Bell's palsy is a condition that causes temporary weakness or paralysis in the muscles on one side of the face. It is frequently a reaction to a viral infection. A recent study in Italy reported that out of 38 people presenting to a local emergency room for symptoms consistent with Bell's Palsy, 21 percent had COVID. In 2019, at the same emergency room, 22 people were treated for Bell's palsy. Bell's palsy usually resolves on its own within six months. Bell's palsy incidence as a side effect from the vaccine will be tracked compared to Bell's palsy incidence in the unvaccinated population.
Guillain-Barré Syndrome, a neurological disorder that can cause muscle weakness or even paralysis, has not been reported during coronavirus vaccine clinical trials. Therefore, in Advisory Committee on Immunization Practices (ACIP) does not list Guillain-Barré Syndrome's history as a general vaccination precaution.
With the latest guideline, the only people who should not get the vaccine are those who are known to be allergic to any of its ingredients, which is a cutoff that holds true for every single medical product. Ingredients include lipid nanoparticles and polyethylene glycol. Anaphylactic reactions can occur with any vaccine but are usually extremely rare—about one per 1 million doses. As of 19 December, the United States had seen six cases of anaphylaxis among 272,001 people who received the COVID vaccine and 2 recorded cases in the UK. As with everything we do, from driving a car to eating food that may be potentially allergenic, we weigh the risks and benefits that need to be weighed against each other. In this case, the risks and potential consequences of COVID far outweigh the risks from the vaccine.
Doctor Mike Hansen, MD
Internal Medicine | Pulmonary Disease | Critical Care Medicine
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