NIH devising study on rare allergic reactions to coronavirus vaccine

 Officials at the National Institutes of Health are rushing to design a study to find out why people rarely have severe allergic reactions to the Pfizer coronavirus vaccine.

The goal is to determine which component of the vaccine is most likely to be responsible for these life-threatening incidents, known as anaphylaxis. No case has yet been linked to the other recently licensed vaccine, which is made by Moderna, but it is being given to the general public for the first time this week and contains ingredients similar to those developed by Pfizer and its partner BioNTech.

This is a challenging task for researchers hoping to have an answer within weeks. The study will recruit volunteers with a history of severe allergic reactions who will receive the vaccine under close clinical supervision, according to Daniel Rotrosen, director of the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases.

 

 "This is not a simple study design," Rotrosen told the Washington Post. We hope to look for people with severe allergies. Recruiting them won't necessarily be that easy. There is still a lot of work to be done to ensure that we have the optimal study design. Having said that, we are trying to move forward as quickly as possible for obvious reasons. "

Pfizer and Moderna vaccines have passed strict safety reviews. During randomized trials, volunteers had no serious allergic reactions, although people with a history of anaphylaxis were excluded.

Government officials and medical experts say these rare reactions should not stop the public from being vaccinated, although the standard guideline is that people who receive the vaccine should stay in the clinic or doctor's office for 15 minutes, 30 minutes. If they have a history of severe allergies. Interactions. Anaphylaxis can be quickly reversed with adrenaline and other medications.

As of Sunday afternoon, 556,000 people had received a dose of the vaccine in the United States, according to the Centers for Disease Control and Prevention. As of Saturday, the CDC had identified six cases of anaphylaxis in people who received the Pfizer-BioNTech vaccine under review.

The vaccines do not contain the coronavirus itself, rather they contain the synthetic messenger RNA that sends signals to cells to make a protein similar to the coronavirus elevation protein. In turn, the immune system responds by producing antibodies against this protein, which creates guards against infection with the actual virus. RNA does not interact with or change a person's DNA.

Milder side effects, such as headache, fatigue or injection site pain, are common and disappear within a day or two, and are a sign that the vaccine is boosting the immune system.

One of the main suspects for adverse reactions is a chemical widely used in drugs, cosmetics, and other household products, and part of the vaccine formula: polyethylene glycol, Peter Marks, director of the FDA's Center for Biological Research and Assessment, said Friday. More than 2 in 3 people have antibodies to PEG, as it is known, but allergic reactions are extremely rare.

They are so rare that, according to Rotrosin, there would be no practical way to collect enough PEG-sensitive volunteers to conduct the proposed study. Therefore, volunteers will be from a larger group of people who will experience severe allergic reactions to anything.

The Rotrosen Institute, led by Anthony S. Fauci, has held a series of Zoom meetings in recent days with representatives from the Food and Drug Administration, as well as Pfizer and Moderna. Also participating in the calls are academic and scientific researchers with knowledge of allergic reactions, including PEG and lipid nanoparticles, which are used in vaccines.

In an email on Sunday, Rotrosen said the study will likely involve several hundred volunteers at clinical sites across the country.

He wrote, "Such a study will include clinical and laboratory laboratory assessments of the participants, administration of the vaccine (vaccines) under close monitoring, and clinical and laboratory follow-up to assess the immune or allergic reaction."

N. said. Franklin Adkinson, professor of allergy and immunology at Johns Hopkins University School of Medicine who has participated in the planning sessions, PEG is the most obvious suspect because it is known for its ability to trigger a severe allergic reaction. One possibility is that these reactions are underreported, and thus are more common than doctors think.

The topic of anaphylaxis made headlines almost immediately after healthcare workers in the United Kingdom began receiving a Pfizer vaccine shortly after it was approved. Each of the healthcare workers who experienced severe reactions had a history of anaphylaxis.

It was the third case of anaphylaxis, involving an Alaskan health worker, that many experts focused on. The woman, who is described only as middle-aged and working at Bartlett Regional Hospital in Juneau, has not only experienced one but several stages of anaphylaxis, each requiring medical treatment with adrenaline and other medications before a full recovery. The first symptoms began 10 minutes after receiving an injection of the Pfizer vaccine. Most importantly, he did not have a history of allergic reactions.

Adkinson described the case as "a very severe reaction that is clearly not an excessive interpretation of the facts because she had to be hospitalized."

This issue is under close scrutiny.

Adkinson suggested that healthcare workers who routinely handle "PEGylated" drugs may have unusually high levels of the antibodies against them.

He said that his patients suffering from allergies called him to ask if they should be vaccinated.

"I tend to be on the reservation and wait until we explore this a little bit more," he said. As a physician with an interest in public health, I am very interested in providing a balanced and accurate view so that patients are not afraid to get vaccinated. We already know that the vast majority of patients will be able to cope with it without any difficulty. "