FDA Says "Do Not Get" COVID Vaccine If You Have This Condition
The Food and Drug Administration (FDA) approves the safety of vaccines, and their feelings about the Pfizer vaccine are clear: "FDA evaluated and analyzed the safety and effectiveness data from clinical trials conducted in tens of thousands of study participants and manufacturing information submitted by Pfizer-BioNTech" and found "clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and support that the known and potential benefits outweigh the known and potential risks of the vaccine's use." So what are those risks? Read on to see who should not get the vaccine—and to ensure your health and the health of others, don't miss these Sure Signs You've Already Had Coronavirus.
Here's Who Should Not Get the Vaccine, Says the FDA
You may have heard that a small number of people had severe allergic reactions to the Pfizer vaccine. "Severe allergic reactions, including anaphylaxis, have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of the clinical trial setting," says the FDA. Therefore: "You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
- had a severe allergic reaction after a previous dose of this vaccine
- had a severe allergic reaction to any ingredient of this vaccine."
"What the Pfizer people are saying is that if you have a history of a severe allergic reaction, you should either not take this vaccine, or if you do take it, take it in the context of a place where if you do develop an allergic reaction, it could be readily and effectively treated," said Dr. Anthony Fauci in a CNBC Healthy Returns Livestream. Keep reading to see what exactly is in the vaccine, to see if you might be allergic.
So What's in the Vaccine?
Says the FDA: "The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose." Next see what you should tell your vaccine administrator before getting yours.
What You Should Tell Your Vaccine Administrator Before Getting the Vaccine
According to the FDA, "tell the vaccination provider about all of your medical conditions, including if you:
- have any allergies
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your immune system
- are pregnant or plan to become pregnant
- are breastfeeding
- have received another COVID-19 vaccine."
Discuss Your Case With Your Doctor, if You Have Allergy Concerns
The CDC has some good advice for those unsure: "If you have had an immediate allergic reaction—even if it was not severe—to a vaccine or injectable therapy for another disease, ask your doctor if you should get a COVID-19 vaccine. Your doctor will help you decide if it is safe for you to get vaccinated," they explain. Additionally, those with an allergy to polyethylene glycol (PEG) or polysorbate should also avoid getting it. "These recommendations include allergic reactions to PEG and polysorbate. Polysorbate is not an ingredient in either mRNA COVID-19 vaccine but is closely related to PEG, which is in the vaccines. People who are allergic to PEG or polysorbate should not get an mRNA COVID-19 vaccine," they explain.
Serious Adverse Events Are Rare
The FDA says "serious adverse events, while uncommon (<1.0%), were observed at slightly higher numerical rates in the vaccine study group compared to the saline placebo study group, both overall and for certain specific adverse events occurring in very small numbers," says the FDA. "These represented common medical events that occur in the general population at similar frequency. Upon further review by FDA, these imbalances do not raise a safety concern, nor do they suggest a causal relationship to vaccination for the vast majority of reported serious adverse events.
Serious adverse events considered by FDA to be plausibly related to the vaccine or vaccination procedure were one case of shoulder injury at the vaccination site and one case of swollen lymph node in the armpit opposite the vaccination arm."
So barring any allergies, get vaccinated when it becomes available to you, and to protect your life and the lives of others, don't visit any of these 35 Places You're Most Likely to Catch COVID.