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Despite this, Sadrzadeh said he still strongly believes that the risks of COVID-19 – which has killed more than 350,000 Americans, including more than 12,000 in Massachusetts – outweigh the risks of significant allergic reactions but treatable with vaccination.
“Absolutely, I think these vaccines are safe for the general population,” Sadrzadeh said, noting that he received an injection because he was in contact with COVID-19 and wanted to protect his family and his older patients with co-morbidities. “We need to understand the value of these vaccines.”
But he underscores the need for the vaccines to be administered safely and to carefully observe those who receive them as the United States’ mass vaccination campaign intensifies. And since his fear, Sadrzadeh has written to the Food and Drug Administration, has spoken to the chief medical officer of vaccine maker Moderna, and plans to enroll in a clinical trial at Brigham and Women’s Hospital to identify common traits. in people who have had anaphylaxis.
Up to 5% of the US population has suffered from anaphylaxis, according to the National Institutes of Health, but fatal outcomes are rare. Those who have severe reactions are usually treated with epinephrine, the medicine in EpiPens.
Due to his own history of allergies, Sadrzadeh had his EpiPen handy. He said he suffered anaphylactic events six times in his life – three times in the United States and three times in his native Iran – but it was the most serious case since the age of 11. He invited independent researchers to investigate the cause of his reaction.
“I am happy to work with any research team willing to do this,” said Sadrzadeh, the first person to report having contracted anaphylaxis after taking the Moderna vaccine. “I don’t want anyone else to go through what I did. I’m a doctor and researcher myself, so I know how important vaccines are. But we need to be prepared so that people don’t get serious reactions in community settings where no EpiPens are available. “
His post is in line with the Dec. 19 guidance from the Centers for Disease Control and Prevention which, citing the small number of adverse reactions to the Pfizer-BioNTech vaccine, recommended that all people taking the new vaccines be monitored for at least 15 minutes. Previously, CDC officials debated whether people who have had severe reactions to other vaccines in the past should take COVID-19 vaccines. But they eventually recommended people with allergies get the shot if they went to their doctor and were watched for half an hour after inoculations.
Other doctors were quick to see that serious allergic incidents remain rare and should not discourage vaccination.
“People need to be sure that they get vaccinated,” said Dr Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital, who said researchers are still trying to determine if all reported incidents were true anaphylactic reactions. “There is no reason why people with allergies other than vaccine allergies should avoid getting the vaccine.”
Dr Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, said reports of anaphylaxis should be dealt with rigorously and scientifically. But he said: “The risk of getting anaphylaxis is much lower than the risk of contracting COVID.”
Anaphylaxis, which can cause rashes, rapid heart rate, drop in blood pressure and shortness of breath, has been associated with vaccines in the past. But it’s most often linked to allergies to insect bites, peanuts, or other foods.
Although no deaths have been associated with anaphylaxis after vaccinations, the rate of reactions reported after COVID-19 vaccines appears to be relatively high. Ten of the 11 cases in the United States – where only 2.6 million vaccines have been administered – involved the vaccine developed by Pfizer and BioNTech, the first to obtain US emergency clearance.
This is more than triple the historical rate of anaphylaxis from other vaccines: 1.31 cases per million doses of vaccine administered. The vast majority occur in people who have a history of allergies.
CDC officials are investigating reports that have followed COVID-19 vaccinations, noting that not all of them have been confirmed. They plan to release a morbidity and mortality report with the latest verified data on Wednesday.
“We’re going to have to monitor one of these complications, but in particular anaphylaxis, which can be life threatening,” said Dr Irwin Redlener, professor at Columbia University and director of its Pandemic Resource and Response Initiative. Based on early reports, he said, “we could end up with a lot of people with serious reactions.”
He said, however, that the safety precautions recommended by the CDC can treat people with adverse events.
“Stopping the immunization program because of this would be a big mistake,” Redlener said, “because it would mean we would lose thousands more. [unvaccinated] people with COVID. “
Some scientists suspect that the apparently higher reaction rate in the first licensed COVID-19 vaccines, both of which use new messenger RNA technology, may be attributed to a binding compound used in the lipid nanoparticles that carry the active ingredients. vaccines in human cells. The compound, polyethylene glycol, or PEG, is common in shampoos and toothpastes, but has never been used in an approved vaccine.
Researchers at the National Institute of Allergy and Infectious Diseases have started working with the FDA to study the role of PEG in new vaccines.
Vaccine makers say they monitor reports of anaphylaxis on their own and are already including warning information for those giving injections to prepare for rare anaphylactic events.
Cambridge-based Moderna officials would not specifically comment on Sadrzadeh’s account of his Christmas Eve reaction to their vaccine.
“With respect to the only report of anaphylaxis we have heard about the Moderna COVID-19 vaccine, we are evaluating the information,” said spokesperson Ray Jordan.
Robert Weisman can be reached at [email protected]. Follow him on twitter @GlobeRobW.
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