Is the Moderna Vaccine Safe? Allergic Reactions and Side Effects
Allergic Reactions. Bell’s Palsy. Side effects. Pregnant Women. Breastfeeding mothers. 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-19. Half received the vaccine, and half received a placebo, so 15,000 in placebo group, 15,000 who got the vaccine. Symptomatic COVID-19 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 the age of 65 experienced more frequent mild to moderate side effects than those over age 65. 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-19 infection. These systemic side-effects are unpleasant and are at a higher rate than seen in most vaccines, and in most cases, they are more likely related to the lipid nanoparticles that have 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. A Boston doctor had a severe allergic reaction to the Moderna vaccine. He did have a history of having allergic reaction to shellfish in the past as well. He was rushed to an emergency room, treated, and released. Also, it was initially recommended that pregnant women or those who intend to become pregnant in three months should not get the vaccine due to lack of their inclusion in the studies. But the American College of Obstetricians and Gynecologists (ACOG) has recently released a statement supporting vaccination for both 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-19. 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. The incidence of Bell’s palsy as a side effect from the vaccine will be tracked and compared to the incidence of Bell’s palsy in the unvaccinated population.
Guillain-Barré Syndrome, which is a neurological disorder that can cause muscle weakness or even paralysis, has not been reported during coronavirus vaccine clinical trials and in general the Advisory Committee on Immunization Practices (ACIP) does not list a history of Guillain-Barré Syndrome 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-19 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 need to be weighed against each other, and in this case, the risks and potential consequence from getting COVID-19 far outweigh the risks from the vaccine.