Federal health officials are investigating cases where people who got the new COVID-19 vaccine almost immediately suffered adverse reactions, including an Alaska health worker who spent two nights in the hospital.
“We are looking into this and I know the CDC and the FDA are very, very carefully looking into the situation to characterize these events,” Operation Warp Speed scientific chief Moncef Slaoui said Sunday. “Some of them could be anaphylactic shock—that’s dangerous. Some of them could more, let’s call them an allergic reaction—that’s important to know but less dangerous.”
The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) are two U.S. health agencies.
“The key is, we’re aware of it now,” Slaoui said. “We’ll continue to try and understand, what is it in the vaccine that induces this, if there is something that induces it that’s specific.”
No one has died after getting the vaccine but at least nine people—four in Illinois and five in Alaska—have suffered adverse effects.
Out of 272,001 people vaccinated as of Dec. 19, some 3,150 reported negative effects like an inability to work, a CDC official reported on Saturday.
Officials are looking at whether a component of the vaccine might be causing the reactions. Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, told reporters on a call that it might be polyethylene glycol, which is present in both the vaccine from Pfizer and a newly approved one from Moderna.
“So that could be a culprit here. And that’s why we’ll be watching very closely,” he said. “But we just don’t know at this point.”
Moderna’s vaccine is expected to start being administered on Monday. A Pfizer spokeswoman told The Epoch Times that the company is actively working with health authorities to assess the reports of adverse reactions.
“We will closely monitor all reports suggestive of serious allergic reactions following vaccination and update labeling language if needed,” she said in an email. “The prescribing information has a clear warning/precaution that appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.”
People with allergies to any component of the vaccines should not receive them, the FDA’s top official, Dr. Stephen Hahn, said earlier this month.
In case one of those people do end up being vaccinated, distribution sites should have medicines necessary to address reactions, he added.
Slaoui said that equipment includes EpiPens, which are used to combat severe allergic reactions, or anaphylaxis.
The healthcare worker who suffered the first known adverse reaction to Pfizer’s vaccine at Bartlett Regional Hospital was treated with an EpiPen and Benadryl before being admitted and placed on an intravenous epinephrine drip, the hospital said. The nurse has since been released and resumed working.
Adm. Brett Giroir, assistant secretary for health and part of the White House Coronavirus Task Force, said Sunday that the news of the adverse reactions shows the reporting system is working exactly as planned.
“Right now there are scattered reports. But remember, many of these are tingling and an elevated heart rate. This could be hyperventilation around the vaccine. That does not necessarily mean it’s a vaccine problem,” he said.
“We do believe there was one allergic reaction. We know that is an issue with any vaccine, generally at rates of about one in 500,000 to one in a million. But we’re going to watch these absolutely carefully. They’re immediately reported. And if there’s any change in the recommendations, they will come out,” he added.
Following the series of adverse reactions, the CDC said Saturday that it learned of the reports. The agency is now advising that people who have previously had a severe allergic reaction to any ingredient in a COVID-19 vaccine not get that vaccine.
People with severe allergic reactions to other vaccines or injectable therapies should consult with their doctor before getting a COVID-19 vaccine while people with a history of reactions to other things, such as food or pets, may still get vaccinated, the agency said.
“The CDC updated their recommendations last night, just to be sure that, if you have an allergic reaction to any vaccine, you probably shouldn’t take this one,” Giroir said, a mischaracterization of the new recommendations.
“But still, it’s widely recommended for everyone because we know it’s 95 percent effective, as much as 100 percent effective at preventing severe disease. And this is the way we end the pandemic, by getting 70 percent or 80 percent of the American people vaccinated,” he added.
Sloui was speaking on CNN’s “State of the Union.” Giroir was speaking on ABC’s “This Week.”