Is COVID Vaccine Safe for the Millions of Americans Who Use EpiPens?

It will be safe for most people who carry medication used to treat severe allergic reactions to take the Pfizer-BioNTech vaccine, scientists say.

With the first batches of the COVID vaccine now rolling out across the U.S., experts say anyone with common allergies to medications, foods, inhalants, insects and latex are unlikely to suffer a life-threatening allergic reaction as a result of the drug.

Health officials have stressed the only people currently being advised against taking the Pfizer-BioNTech vaccine are those with extreme allergies to its components.

"While those with severe allergies to the ingredients of the vaccine should not receive it at this time, many people with severe allergies to other things can safely receive the vaccine when it is available," Boris Lushniak, MD, preventive medicine physician and the Dean of the University of Maryland School of Public Health, told Newsweek.

Lushniak said many people who carry auto-injectable devices used to deliver the drug epinephrine in the event of a life-threatening allergic reactiom—known as anaphylaxis— will not be allergic to any ingredients of the Pfizer-BioNTech vaccine and should not be deterred from seeking the vaccine when it becomes available to them.

He noted the vaccine does not have ingredients "particularly unsafe compared to many other medications" but said patients should be made to feel comfortable talking to their doctors as many of the compounds have "long and confusing names."

The U.S. Food and Drug Administration (FDA) issued emergency use authorization (EUA) for the Pfizer-BioNTech vaccine on December 11, saying it can be given to people over the age of 16. It said testing showed "clear evidence" it may be effective in preventing COVID, the respiratory illness responsible for more than 300,000 U.S. deaths.

On December 12, the Advisory Committee on Immunization Practices (ACIP), which is a division of the U.S. Centers for Disease Control and Prevention (CDC) reiterated advice about severe allergies to the vaccine ingredients and noted that facilities used to administer the vaccine must also have treatments for anaphylactic reactions to hand.

Its report said medical staff should observe patients after they are given the vaccine to monitor for adverse reactions. The ACIP said people should be watched for 15 minutes, extended to at least 30 minutes for anyone who has a history of anaphylaxis.

The reaction is common and believed to impact about one in 50 people in the U.S., Niraj Patel, MD, chair of the American College of Allergy, Asthma and Immunology COVID-19 Task Force, told Newsweek via email, noting statistics suggest millions of people in the U.S. carry an epinephrine auto-injector due to risk of anaphylaxis.

An Asthma and Allergy Foundation of America study printed in the Journal of Allergy and Clinical Immunology (JACI) in 2014 suggested that while anaphylaxis is estimated to occur in one in 50 Americans, some believed it was closer to one in 20.

In any case, Dr. Patel stressed it is "very uncommon" to have an allergy to a vaccine and there is no reason to get tested for allergies before taking the COVID medication.

"Allergy to a specific vaccine component is very rare," Dr. Patel said. "There have been components of other vaccines associated with allergic reaction including egg, gelatin, neomycin [but] none of these components are present in the Pfizer vaccine."

The American College of Allergy, Asthma, and Immunology has said allergic reactions to vaccines causing anaphylaxis are estimated at 1.31 in one million doses given.

Anaphylaxis can occur in seconds of a severe allergic reaction, causing the immune system to "release a flood of chemicals that can cause you to go into shock," leaving blood pressure dropping and blocking breathing, the Mayo Clinic says online.

Epinephrine is the only drug recommended to treat anaphylaxis because it works on the entire body and its organs, according to Atlanta Allergy & Asthma.

EpiPen is one of the most recognizable brands of the injectors used to deliver the drug epinephrine, and is not without controversy. The devices have faced shortages and severe price hikes, with the cost of a two-pack surging by nearly 550 percent to reach more than $600 in recent years, health news website Stat reported in 2016.

EpiPen is a brand of the pharmaceutical company Mylan, which on July 29 combined with Upjohn, a division of Pfizer, which manufactures the devices. In the U.S., an EpiPen package which contains two auto-injectors costs roughly $650 cash, according to an article on drugs.com. In the United Kingdom, for comparison, the same shots cost £49.99 ($67).

The FDA approved the first generic version of EpiPen in August 2018, brought into the U.S. market via Teva Pharmaceuticals U.S., it announced at the time.

Worries about the safety of the Pfizer-BioNTech vaccine increased this month after two people in the U.K. with severe allergies reported anaphylactic reactions after taking the vaccine. British health officials updated their guidance to say anyone with a history of anaphylaxis to a vaccine, medicine or food should not receive the jab.

Dr. Peter Marks, a director of the FDA's Center for Biologics Evaluation and Research, said in a briefing on December 12 that the Pfizer-BioNTech trials included people with common allergies but not anyone who had severe allergies to vaccines.

"We're telling people that unless they've had a severe allergic reaction to the vaccine or one of its components, they can receive it," Marks said, Business Insider reported. And Marks' point has been echoed by the wider scientific community in the days since.

Mary Beth Fasano, MD, President of the American Academy of Allergy, Asthma, and Immunology, said: "A person who needs an epinephrine auto-injector because of a history of an allergy to food, insects, venoms—are able to proceed with vaccination. There would be no need to advise against receiving the vaccine 'just in case.'

"For those few individuals who have a known history of severe allergic reaction to any of the ingredients, they would be advised to await the roll-out of another vaccine."

What are the Pfizer BioNTech vaccine ingredients?

The FDA has said you should tell your vaccine provider about any existing allergies and should only not take it if you have had a severe allergic reaction after a previous dose of the vaccine or had a severe allergic reaction to any ingredient of the vaccine.

Per the FDA documentation, the COVID-19 vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate and sucrose."

Pfizer-BioNTech
Occupational Nurse Melissa Valentin prepares a dose of Pfizer-BioNTech COVID-19 vaccine at the Ashford Medical Center in San Juan, Puerto Rico, on December 15. RICARDO ARDUENGO/AFP/Getty