Is the moderna vaccine safe? What are the side effects, allergic reactions, guillain-barre syndrome bell's palsy. let's break it down in this article. So the modern, they took the genetic code from the sars coronavirus 2, virus. They identify the section that codes for the spike protein. The protein that binds to human ace2 receptor and they use this mrna sequence for its vaccine short additional genetic sequences were added to both ends to help stabilize. This mrna the mrna strands are encapsulated in a lipid nanoparticle, what is especially nice about messenger.
Mrna vaccines is that there are no weakened, killed or gutted viral particles in the vaccine. Making it much safer for those who are immunocompromised and this vaccine is 95 effective so like the pfizer bio and tech vaccine. There are two doses with the moderna vaccine, they're administered on days 1 and day 29 so it's a little bit different from pfizer. Pfizer's first one and then you get the second one three weeks later so very similar.
Once the messenger mrna vaccine is injected human cells that used the mrna code to produce a viral spike protein, but not the other 28 proteins required to make a sars cov2 virus. Without the complete genetic code the sars-kov2 virus can't be manufactured in a human being once the viral spike protein is produced the human immune system recognizes.
it as foreign then there's a series of complicated immune processes including the production of antibodies, that are triggered and that's what allows your body to fight off that virus in the future. So in the new England journal medicine moderna enrolled over 30 000 volunteers, age 18 and older and it's a double-blinded placebo-controlled study. Eleven thousand were from communities of color, seven thousand were 65 and older and there were 5000 that were under the age of 65. But they had conditions that were considered, risk factors for severe covid half. The people received the vaccine half the people received placebo. So 15000 and placebo group 15000 who got the vaccine, symptomatic covid 19 was confirmed in 185 people in the placebo group and only 11 in the vaccinated group, that's a 94.1 percent efficacy.
Now researchers actively monitored the vaccine recipients for local and systemic side effects for seven days after vaccination and they recorded unsolicited side effects for 28 days. More severe side effects and medically attended adverse events from day one all the way through day 759 which means it's continuing to be monitored. Let's first start off by talking about the local side effects, so injection site reactions in the seven days.
After the first vaccination dose, that occurred in 84 of the vaccinated group and that's compared to 20 percent in the placebo. After the second dose 89 of the vaccinated group and 19 of the unvaccinated group recorded injection side effects. Overall the vaccine side effects were rated as mild to moderate in severity and lasted an average of 2.6 and 3.2 days. After the first and second vaccine doses respectively, the most common local side effect was injection site pain that was reported 84 percentage and 88 percentage in the vaccinated group. After the first and second vaccine dose respectively injection site pain was reported by 20 percent and 17 of the placebo group.
After the first and second dose the average duration of pain was two days, after the first dose and three days. After the second swollen axillary lymph nodes meaning lymph nodes and your armpits, they were swollen. 21 of people under the age of 65 and 12 percent of people over the age of 65 in the vaccine group and then it was about five percent in four percent of individuals in the placebo group. The median duration of swelling was one day after the first dose in two days, after the second other local side effects were uncommon such as redness and swelling at the injection site.
What about systemic side effects just like with the pfizer vaccine systemic side effects were more common after the second vaccine with 55 percentage reporting a systemic side effect. After the first dose and 79 after the second dose in the vaccine group in the placebo group, 42 percentage had side effects that were systemic after the first dose and 37 after the second dose.
The most commonly reported systemic adverse event was fatigue that was at 69 percent of the vaccine group and 36 of the placebo. That fatigue lasted for about a couple days, headache was reported in 63 in the vaccine group and then 37 at the placebo group. Muscle pain was reported 60 in the vaccine 20 in the placebo group.
Now in the vaccine group 45 reported joint pain compared to 17 and placebo then there was other things that occurred less frequently, but more commonly in the vaccine group, such as chills and fever about half of those in the vaccinated group reported systemic side effects starting at 15 hours after vaccination, with no long-term side effects systemic reactions lasting longer than seven days were about 12 percent in the vaccine. That's compared to 10 percent in the placebo, so about the same in both groups severe adverse reactions defined as those that prevent normal.
Daily activities that was 0.2 to 7.7 percent of participants overall fewer than one percent of vaccine recipients reported fever over 102 degrees fahrenheit. Severe fatigue was reported in 7.7 of vaccine recipients muscle pain and 6.1 joint pain in 3.7 and headache in 4.4. Severe adverse reactions were more frequently reported after the second vaccine dose and less commonly in the groups that were over 65 years old, systemic side effects are expected as the immune system responds to foreign viral proteins. So a decrease in reactorgenicity is expected in older adults as aging brings about a gradual deterioration in the immune response.
However the immune response or reactogenicity of the immune system to the moderna vaccine, it may be more than most people have previously experienced with other vaccines. So in summary just like with pfizer, those who were younger less than the age of 65 they had more frequent mild to moderate side effects compared to the older groups.
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 and in most cases, they're 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 percent of vaccine recipients and that's compared to 1.1 percent 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 own doctor. So there was a boston physician, who had a severe allergic reaction to the moderna vaccine. He did have a history of having allergic reaction to shellfish and he was rushed to the emergency room.
He was 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 the lack of their inclusion in the studies. But the american college of obstetricians and gynecologists 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's frequently a reaction to a viral infection a recent study in italy reported that out of 38 people presenting to a local er for symptoms that were consistent with bell's palsy 21 had covid 19 in 2019 at that same er 22 people were treated for bell's palsy.
Bell's palsy usually resolves on its own within 6 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 beret 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 does not list a history of guillain-barre 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 his ingredients, which is a cut off 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 one. Million doses as of december 19th the united states has seen six cases of anaphylaxis among 272 000 people who received the covid 19 vaccine and there were two recorded cases in the uk as with everything. We do whether it's driving a car, to eating a food that could potentially be allergenic. We have to weigh the risks versus the benefits and when it comes to covid 19 the risks of getting covid 19 and the potential consequences that come with that far outweigh the risks that come from the vaccine itself.
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