FDA is investigating allergic reactions to Pfizer vaccine in multiple states – as one Chicago hospital pauses its program after four workers suffer ill-effects
- CDC confirms at least six have had adverse reactions to COVID-19 vaccine
- So far, some 272,000 shots of Pfizer-BioNTech vaccine have been given in US
- In Alaska, three health care workers needed medical attention after getting shot
- In Chicago suburb, hospital stopped inoculations after four had severe reaction
- FDA official says allergic reactions could be due to polyethylene glycol (PEG)
- PEG is a chemical compound present in both Pfizer and Moderna vaccines
- PEG is also found in laxatives as well as creams, ointments, and solvents
- In industrial use, PEG is also a binding agent that can be found in antifreeze
- FDA insists most Americans with allergies should be safe to get the vaccine
US health officials closely tracking possible side effects of the first authorized COVID-19 vaccine said on Saturday they have seen at least six cases of severe allergic reactions out of more than a quarter million shots given – prompting one Illinois hospital to pause vaccinations.
Medical experts said that a chemical called polyethylene glycol (PEG), a compound most commonly used in laxatives, ‘could be the culprit’ causing the reactions.
PEG is an ingredient in the Pfizer vaccine as well as the Moderna Inc vaccine authorized on Friday.
But the Food and Drug Administration has said that most Americans with allergies should be safe to receive the vaccine. It said only people who have previously had severe allergic reactions to vaccines or ingredients in this particular vaccine should avoid getting the shot.
A frontline health care worker at Garfield Medical Center receives his first dose of Pfizer COVID-19 vaccine in a pop-up tent outside their main facility in Monterey Park, California, on Friday
The Centers for Disease Control and Prevention said that it has seen at least six cases of severe allergic reactions to the COVID-19 vaccine developed by Pfizer and BioNTech. Vials of the vaccine are seen above in Pinellas Park, Florida, on Friday
The Centers for Disease Control and Prevention said more than 272,000 shots of the Pfizer vaccine were given nationwide as of Saturday morning.
The half-dozen cases of allergic reaction were reported as of Friday night, and included one person with a history of vaccination reactions.
Vaccines paused at Illinois hospital
A suburban Illinois hospital paused vaccinations on Friday after four employees suffered adverse reactions.
The unnamed employees experienced tingling and elevated heart rates almost immediately after receiving the shot.
The hospital, Advocate Condell Medical Center, will resume vaccinations on Sunday.
A medical facility in Illinois temporarily stopped COVID-19 vaccinations after four healthcare workers experienced adverse reactions to the shots.
Advocate Condell Medical Center in Libertyville stopped the vaccinations on Friday and will resume them on Sunday.
The unidentified employees experienced reactions that included tingling and elevated heart rate just moments after taking the vaccine, ABC 7 reports.
‘These four team members represent fewer than 0.15% of the approximately 3,000 who have so far received vaccinations across Advocate Aurora Health,’ a statement reads.
While three of the staff are recovering at home a fourth is receiving additional treatment.
Advocate shared that it would be using the time to help determine what may have caused the reactions.
The vaccinations are still taking place at the eight other Advocate Aurora Health locations in Illinois and in the three locations in Wisconsin.
Advocate Condell Medical Center in Libertyville, Illinois, stopped the vaccinations on Friday and will resume them on Sunday after four medical workers reported adverse reactions
Three health care workers in Alaska needed medical treatment after being administered the vaccine earlier this week while a hospital in suburban Chicago halted inoculations after four staffers reported adverse reactions.
Health officials are keeping close watch for such side effects.
US vaccine recipients are supposed to hang around after their injections in case signs of an allergy appear.
The CDC said all cases occurred within the recommended observation window and were promptly treated.
The numbers were discussed at a meeting of a committee that advises the CDC on vaccines.
The group on Saturday endorsed Moderna’s COVID-19 vaccine, which was granted emergency authorization on Friday.
Less severe side effects have also been rare.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a press conference that allergic reactions to PEG could be somewhat more common than previously understood.
Among the first 215,000 people to get vaccinated in the United States, fewer than 1.5 per cent of them had problems that left them unable to perform their normal activities or required medical care.
Medical experts said that a chemical called polyethylene glycol (PEG), a compound most commonly used in laxatives, ‘could be the culprit’ causing the reactions
Many vaccines can cause temporary discomfort, such as a sore arm or certain flu-like symptoms.
COVID-19 vaccines tend to cause more of those reactions than a flu shot, and some hospitals are staggering the times their employees get vaccinated to avoid staffing problems.
A clinician based in Fairbanks, Alaska, suffered anaphylactic symptoms after being given the Pfizer coronavirus vaccine, a hospital said on Friday, becoming the third health care worker in the state to suffer an adverse reaction to the new drug.
The clinician, whose name was not released, started showing symptoms about 10 minutes after being inoculated on Thursday, according to Foundation Health Partners, operator of the Fairbanks Memorial Hospital.
The health care worker was treated in the hospital´s emergency room with epinephrine and released about six hours later, Foundation Health Partners said in a written statement.
Two health care workers in Juneau suffered adverse reactions to the medication earlier this week.
One was briefly hospitalized in that city for anaphylaxis after she was vaccinated on Tuesday.
The second had a milder reaction on Wednesday and was treated at the hospital emergency room and released.
‘Allergic reactions, though uncommon, can occur with injections of medications and vaccines,’ Foundation Health Partners´ Chief Medical Officer Dr. Angelique Ramirez said in the statement.
The Fairbanks clinician issued her own statement that was included in the Foundation Health Partners release.
‘I would get the vaccine and recommend it to anyone, despite my reaction, to help our country get immunized which is needed for the health of all Americans, for the economy, get families hugging again, for getting children back to schools, and to get the country on the other side of this pandemic,’ the health worker said.
Alaska received its first shipments of the Pfizer vaccine on Sunday evening, state officials said.
Batches have been sent around the state, including by floatplane and boat to more remote sites.
The cases in Alaska were similar to two cases reported last week in Britain.
Britain’s medical regulator has said that anyone with a history of anaphylaxis, or severe allergic reactions to a medicine or food, should not be given the Pfizer-BioNTech COVID-19 vaccine.
On Friday, the FDA said the Moderna vaccine should not be given to individuals with a known history of a severe allergic reactions to any components of the shot.
The regulator is also requiring that appropriate medical treatments for immediate allergic reactions must be available when the shot is administered in case of an anaphylactic reaction.
Pfizer could not be immediately reached for comment.
WHAT ARE THE KNOWN SIDE EFFECTS OF THE PFIZER VACCINE?
UK medicines regulator advised that anyone who has a history of ‘significant’ allergic reactions to medicines, food or vaccines should not get the Pfizer coronavirus jab.
Dr June Raine, the chief executive of the MHRA, told Parliament’s Science and Technology Committee that this was not identified in the trials.
‘We know from very extensive clinical trials that this wasn’t a feature,’ she said.
Allergic reactions to the vaccine are ‘very rare’, according to the trials involving more than 40,000 people.
Pfizer found a ‘very small number’ during its phase three clinical studies, which found 137 out of 19,000 people. This compared to a comparable 111 in a group of the same size who didn’t get the vaccine.
They also identified 12 possible side-effects from the vaccine, with seven identified as ‘very common’ meaning they are likely to affect more than one in ten people. Below are the known side effects.
The patient safety leaflet for the vaccine cautions that anyone with an allergy to any of the active substances in the vaccine should not receive the jab.
It adds: ‘Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.’
Allergic reactions to the vaccine are:
Very common (Likely to affect more than one in ten people)
- Pain at injection site
- Muscle pain
- Joint pain
Common (Likely to affect up to one in ten people)
- Injection site swelling
- Redness at injection site
Uncommon (May affect one in 100 people)
- Enlarged lymph nodes
- Feeling unwell
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