People with some allergies should not get the newly approved COVID-19 vaccine, a top health official said Sunday.
“Our conditions for use, is what we call them, specifically states that, if you have an allergy to any component of the Pfizer/BioNTech vaccine, you should not receive it,” Dr. Stephen Hahn, commissioner of the Food and Drug Administration (FDA), said on CNN’s “State of the Union.”
Hahn’s administration on Friday authorized the vaccine for emergency use and administration of the shots is expected to begin Monday.
British drug regulators approved it earlier last week and began administering shots soon after.
Two people fell ill after getting the vaccine in the United Kingdom, prompting authorities to advise that people “with a significant history of allergic reactions do not receive this vaccination.”
“We did not see, within the clinical trial, significant allergic reactions among the subjects of the trial. However that was seen in U.K. rollout and distribution,” Hahn said on ABC’s “This Week.”
“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. However, we also, out of abundance of caution, have asked at the distribution sites [for] the available dose of medicines that might be necessary to address it,” he added.
The risk for allergic reactions appears to be low but authorities want to be careful, the doctor said.
According to a fact sheet (pdf) from the FDA for healthcare providers, no one who has a known history of a severe allergic reaction, or anaphylaxis, to any component of the newly approved vaccine should get injected.
The components are listed as follows: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), polyethylene glycol, N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, cholesterol, potassium chloride, sodium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, and sucrose.
Moncef Slaoui, President Donald Trump’s vaccine czar, said last week that because people with a history of severe allergic reactions were not included in clinical trials, the illnesses in Britain were “new news.”
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“The expectation will be that subjects with known severe allergic reactions should not take the vaccine, until we understand exactly what happened here,” Slaoui said at a press briefing.
While officials said people with some allergies should avoid the vaccine, Dr. Francis Collins, director of the National Institutes of Health, said many people should get injected.
“I would like to plead just to people who are listening to this this morning, to really hit the reset button on whatever they think they knew about this vaccine that might cause them to be so skeptical. The data is out there now. It’s been discussed in a public meeting. All the details of the safety and the efficacy for anybody who wants to look. This is a very powerful outcome of this incredibly intense year long experience to develop this. And I think all reasonable people, if they had the chance to sort of put the noise aside and disregard all those terrible conspiracy theories, would look at this and say, ‘I want this for my family. I want it for myself,’” he said on NBC’s “Meet the Press.”
An FDA advisory panel met before the emergency authorization to go over issues including the allergy problems.
The panel recommended the FDA approve the vaccine.
Collins, who didn’t mention the allergy issue, challenged critics who believe the development of the vaccine has been too quick, arguing that the vaccines were designed and tested in a way that is actually more rigorous than what most vaccine candidates undergo.
Still, experts remain unclear about whether someone who gets the vaccine is still able to contract and pass on the CCP (Chinese Communist Party) virus, which causes the disease COVID-19.
“That is an urgent question to discover. It will take us a couple of months to figure that out. And there’s still some debate about the ideal design of the studies to do that,” Collins said. “What that means is, if you’ve had the vaccine, and people are going to start getting it this week, you still need to wear the mask, you still need to think of yourself as potentially contagious, even though you are protected from getting sick at a very high percentage of certainty.”