Reports of possible allergic reactions to the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, both recently approved for emergency use by the U.S. Food and Drug Administration, have raised public concern. But a team of experts led by allergists at Massachusetts General Hospital has now examined all relevant information to offer reassurance that the vaccines can be administered safely even to people with food or medication allergies. The group's review is published in the Journal of Allergy and Clinical Immunology: In Practice.
In response to accounts of potential allergic reactions in some people following COVID-19 vaccination in the United Kingdom, that country's medical regulatory agency advised that individuals with a history of anaphylaxis to a medicine or food should avoid COVID-19 vaccination.
After closer review of the data related to allergic reactions, however, the FDA recommended that the vaccines be withheld only from individuals with a history of severe allergic reactions to any component of the COVID-19 vaccine, and the Centers for Disease Control and Prevention advised that all patients be observed for 15 minutes post-vaccination by staff who can identify and manage such reactions. The U.S. agencies do not recommend that people with food or medication allergies avoid vaccination.
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WHAT'S THE IMPACT
To provide insights from allergists' perspectives, Dr. Aleena Banerji, clinical director of the Allergy and Clinical Immunology Unit at MGH and associate professor at Harvard Medical School, and her colleagues have summarized what's currently known about allergic reactions to vaccines like those developed against COVID-19, and they have proposed detailed advice so that individuals with different allergy histories can safely receive their first COVID-19 vaccine.
They also outline steps on safely receiving the second dose in individuals who develop a reaction to their first dose of COVID-19 vaccine.
The goal is to reassure not just the general public but those charged with administering the vaccine. The guidelines are built on the recommendations of U.S. regulatory agencies, and provide steps to the medical community on how to safely administer both doses of the vaccine to those with histories of allergic reactions.
The experts note that allergic reactions to vaccines are rare, with a rate of about 1.3 per 1 million people. They also determined that the Pfizer-BioNTech and Moderna COVID-19 vaccine allergic reactions will have a similarly low rate of occurrence. They stress that vaccine clinics will be monitoring all patients for 15 to 30 minutes and can manage any allergic reactions that occur.
Banerji and her co-authors recommend that individuals with a history of anaphylaxis to an injectable drug or vaccine containing polyethylene glycol or polysorbate speak with their allergists before being vaccinated. They stress that patients with severe allergies to foods, oral drugs, latex or venom can safely receive the COVID-19 vaccines.
THE LARGER TREND
Just days before Christmas, the Department of Health and Human Services and Department of Defense announced they will purchase another 100 million doses of Pfizer's COVID-19 vaccine. Officials are confident that this deal will ensure that there are enough vaccines available for every American who wants one by June 2021.
Under the agreement, Pfizer will manufacture and distribute the 100 million doses to government-designated locations. At least 70 million doses will be delivered by the end of June 2021, with the remaining doses to be delivered by the end of July.
This week, CareFirst BlueCross BlueShield announced that costs associated with all FDA-authorized COVID-19 vaccines will be fully covered for all members, including members in self-insured plans.
Initial vaccine supplies are expected to be limited. Most states will distribute the vaccines in phases, using Centers for Disease Control and Prevention recommendations to determine which populations will be vaccinated during each phase. As vaccines become more widely and readily available, each state will communicate when and where vaccinations will occur.
Throughout the public health emergency, it's important to continue practicing social distancing behaviors such as wearing a mask, staying at least six feet apart and washing one's hands, according to CareFirst.