Recommendations for Pfizer Covid-19 vaccines injection
What allergic reactions mean for Pfizer vaccine?
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| Photo: FinancialTímes.com |
The warning by Britain's regulators over the Pfizer-BioNTech COVID-19 vaccine is only directed at people with a history of certain significant allergic reactions.
And it comes after UK officials reported a small number of adverse reactions in people who received the jab on their first day of its rollout.
Two cases of anaphylaxis and one possible allergic reaction were recorded, prompting a revision of guidelines.
Put simply, Anaphylaxis is a condition can cause throat swelling, breathing difficulty and problems swallowing. The UK’s National Health Service even describes it as severe and sometimes life-threatening.
Late on Wednesday, the UK regulator said anyone with a history of anaphylaxis to a vaccine, medicine or food should not get the vaccine.
An expert from the London School of Hygiene & Tropical Medicine advised Reuters that anyone who’s ever needed to use an EpiPen should delay having this vaccine, at least until a reason for the adverse reaction has been clarified.
Severe allergies are very rare, however. That's according to London's Queen Mary University, which also told us that in 2012 there were only seven hospital admissions per 100,000 people for severe allergies, they said.
Some experts Reuters spoke with praised UK regulators' caution, while others -- such as a representative of the Mayo Clinic in the US -- said these added restrictions in Britain were "overdoing it".
The vaccines maker Pfizer had excluded people with a history of significant adverse reaction from late-stage trials of it’s COVID-19 vaccine, according to Yahoo.
The CDC Guidelines for Allergic Reactions to COVID-19 Vaccines
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| Photo: Healthline.com |
The Centers for Disease Control and Prevention (CDC) released new guidelines. This past weekend advising people in the United States who are severely allergic to the ingredients in the COVID-19 vaccines to not get the inoculation.
The guidelines come after at least six adults experienced a significant allergic reaction, called anaphylaxis, after getting the vaccine.
The reactions, which included elevated heart rate, shortness of breath, and lightheadedness, occurred within 30 minutes of vaccination. In Alaska, two healthcare workers developed symptoms within 10 minutes of being inoculated.
Severe reactions to COVID-19 vaccines appear to be isolated with only a small handful of serious reactions occurring out of the hundreds of thousands of people who’ve been vaccinated in the United States.
The CDC recommends all adults be monitored for 15 minutes after getting vaccinated. People with a history of severe allergic reactions should be observed for 30 minutes in a medical facility that can provide quick treatment if an adverse event occurs.
The CDC is advising that people who have a history of allergic reactions to any of the ingredients included in the shots talk with their doctor before getting vaccinated.
The full list of ingredients — which include sodium chloride, potassium chloride, and a number of lipids — can be found on the Pfizer vaccine’s prescribing information chart.
Moderna’s vaccine prescribing information chart also lists the ingredients, which include various lipids, sodium acetate, and tromethamine.
Another ingredient in question is polyethylene glycol, a laxative commonly used with colonoscopies. Few cases of anaphylactic reaction have been linked to polyethylene glycol, but the reaction has been reported in the past, cites healthline.
The Moderna and Pfizer vaccines don’t include preservatives, and the vial stoppers are not made with latex.
People who’ve had a serious allergic reaction to any injectable medicine or vaccine in the past should consult their doctor.
These individuals can still get the vaccine, but they’ll be monitored for a longer period of time, according to Dr. William Schaffner, an infectious disease expert at Vanderbilt University in Tennessee.
Those with other allergies not related to vaccines — including “allergies to food, pet, venom, environmental, or latex” — should still get vaccinated, the CDC recommends.
“They can get their vaccine, and we’ll watch them for 15 minutes,” Schaffner told Healthline.
You should still plan to get vaccinated if:
- You’ve had a serious allergic reaction to oral medications.
- You have a family history of severe allergic reactions to vaccines.
- You’ve had mild reactions to vaccines.
Dr. Henry Bernstein, a pediatrician at Northwell Health’s Cohen Children’s Medical Center and a member of the CDC Advisory Committee on Immunization Practices (ACIP), said the CDC and the Food and Drug Administration (FDA) are closely monitoring reactions to the vaccine.
“Safety is being closely monitored as always with all vaccines, and especially now with the COVID-19 vaccines,” Bernstein told Healthline.
The system is working, Schaffner said.
The cases are under careful investigation to determine the nature of these problems, Schaffner noted.
“It’s still very early days, but we know it’s very unusual,” Schaffner said.
Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions
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| Photo: Science.com |
Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).
PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine.
Others are skeptical of the link. Still, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) was concerned enough to convene several meetings last week to discuss the allergic reactions with representatives of Pfizer and Moderna, independent scientists and physicians, and the Food and Drug Administration (FDA).
NIAID is also setting up a study in collaboration with FDA to analyze the response to the vaccine in people who have high levels of anti-PEG antibodies or have experienced severe allergic responses to drugs or vaccines before. “Until we know there is truly a PEG story, we need to be very careful in talking about that as a done deal,” says Alkis Togias, branch chief of allergy, asthma, and airway biology at NIAID.
Pfizer, too, says it is “actively seeking follow-up.” A statement emailed to Science noted it already recommends that “appropriate medical treatment and supervision should always be readily available” in case a vaccinee develops anaphylaxis.
Anaphylactic reactions can occur with any vaccine, but are usually extremely rare—about one per 1 million doses. As of 19 December, the United States had seen six cases of anaphylaxis among 272,001 people who received the COVID-19 vaccine, according to a recent presentation by Thomas Clark of the U.S. Centers for Disease Control and Prevention (CDC); the United Kingdom has recorded two. Because the Pfizer and Moderna mRNA vaccines use a new platform, the reactions call for careful scrutiny, says Elizabeth Phillips, a drug hypersensitivity researcher at Vanderbilt University Medical Center who attended an NIAID meeting on 16 December. “This is new.”
| News reports about the allergic reactions have already created anxiety. “Patients with severe allergies in the US are getting nervous about the possibility that they may not be able to get vaccinated, at least with those two vaccines,” Togias wrote in an invitation to meeting participants. “Allergies in general are so common in the population that this could create a resistance against the vaccines in the population,” adds Janos Szebeni, an immunologist at Semmelweis University in Budapest, Hungary, who has long studied hypersensitivity reactions to PEG and who also attended the 16 December gathering, reports sciencemag. Scientists who believe PEG may be the culprit stress that vaccination should continue. “We need to get vaccinated,” Phillips says. “We need to try and curtail this pandemic.” But more data are urgently needed, she adds: “These next couple of weeks in the U.S. are going to be extremely important for defining what to do next.” |
