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If You Have This Condition, You "Should Not Receive" the COVID Vaccine, Warns FDA

The Pfizer-BioNTech COVID-19 vaccine may not be 100% safe for people with a history of severe allergic reactions.
Female doctor or nurse giving shot or vaccine to a patient's shoulder. Vaccination and prevention against flu or virus pandemic.

The "light at the end of the tunnel" is here—the coronavirus vaccine, and with it, the possible end of the pandemic. Although it will be months before we have herd immunity, the first shots will likely be administered this week. But is it safe? Public health experts from the FDA to the CDC to advisory panels to Dr. Anthony Fauci have said yes, it's safe. However, the head of the FDA, Stephen Hahn, noted yesterday on This Week that it may not be 100% safe for those who have a history of severe allergic reactions; in fact, they "should not receive" the vaccine, out of an abundance of caution. Read on to hear his warning, and to ensure your health and the health of others, don't miss these Sure Signs You've Already Had Coronavirus.

The Head of the FDA Says Those Who Have Had an Allergic Reaction to the Vaccine Ingredients Should Not Take It

On Wednesday, UK health authorities warned that anyone with a "significant history of allergic reactions" should not be given the Pfizer/BioNTech vaccine. The guidance was issued by the National Health Service England after two health care workers "responded adversely" to their initial dose of the vaccine on Tuesday. According to the group, the two staff members had a history of allergic reactions, with both carrying adrenaline auto injectors. Each of them demonstrated symptoms of anaphylactoid reaction.

Dr. Hahn said the findings meant the process was working—and that  he didn't see any cases like this in the trials. "This is why we do a line by line assessment of the data, and I don't know if you saw any of the advisory committee public discussion of this. But we did not see, within the clinical trial, significant allergic reactions among the subject of trial. However, that was seen in U.K. rollout and distribution," he told host Martha Raddatz. "So, what we said, we're, first of all, taking this very seriously, that safety is very important. We put in our label that those who have any evidence of severe allergy to any component of this Pfizer-BioNTech vaccine should not receive it."

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The FDA's Official Recommendation About Who Should Not Take the Vaccine

Officially, the FDA says "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."

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."

If you get the vaccine and have an allergic reaction, Hahn says doctors have been instructed to prepare for such an event. "Out of abundance of caution, [we] have asked at the distribution sites the available dose of medicines that might be necessary to address it. So, again, because the clinical trial data, the risk appears to be low, but we need to be very careful about this and make sure that we administer this appropriately," said Hahn.

RELATED: If You Feel This, You May Have Already Had COVID, Says Dr. Fauci

Skepticism of the Vaccine Endangers Herd Immunity

Raddatz wondered how the " skepticism of the vaccine" might be an issue—"no matter how many times you talked about it being safe, or you delivered it, despite reassurances about that, many in the U.S. continue to voice skepticism. Recent polling shows between one-quarter and one-third of Americans do not want to receive a shot," she said. "What kinds of problems do those numbers present?"

"That is a significant problem," said Hahn. "I mean, if you think about how we get out of this pandemic, we have to continue our mitigation efforts right now. That is so important, mask wearing, et cetera. But the way we see light at the end of the tunnel, the way we get through this is to achieve herd immunity. And that means we need to vaccinate a significant number of people in this country, including those who are hesitant.

And we need to address their fears and concerns. We need to roll this out in a way that provides confidence to people. But we also need to be transparent. What do we know? What do we don't know?

And our process—this is our contribution to the transparency. We want the data to be known. We wanted that advisory committee to be public. Because we wanted everyone in America—around the world, frankly, to see what information was available and why we made the judgment we made about the safety and efficacy of the vaccine. And as you can see, the experts on the panel also gave, with their vote, a thumbs up to that authorization process as well. So I think that level of transparency and information helps us."

As for yourself, follow the fundamentals and help end this surge, no matter where you live—wear a face mask, social distance, avoid large crowds, don't go indoors with people you're not sheltering with (especially in bars), practice good hand hygiene and to protect your life and the lives of others, and don't visit any of these 35 Places You're Most Likely to Catch COVID.