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The United States is looking into why a handful of people have suffered severe allergic reactions shortly after receiving Pfizer coronavirus vaccine injections, an official with the National Institute of Allergy and Infectious Diseases told CNBC on Monday.
The study, which is still in the early planning stages, is expected to include “several hundred” people who have a history of severe allergic reactions, said Alkis Togias, chief of the Division of Allergy, Asthma and Airway Biology. NIAID Airs. His department will lead the study, which the researchers hope to begin in a matter of weeks, although the timing is not guaranteed. While reactions have been reported by people who received the Pfizer injection, the study can look at vaccines made by both Pfizer and Moderna.
Togias said researchers at NIAID, an agency within the National Institutes of Health, became interested in the rare phenomenon after reports that some people had reactions to the Pfizer vaccine that they called anaphylaxis, a serious and life-threatening allergic reaction. . Last week, a doctor in Alaska suffered anaphylactic symptoms about 10 minutes after receiving the Pfizer vaccine, becoming the third healthcare worker in the state to suffer an adverse reaction to the new drug.
“We are a little concerned that people who have had a lot of allergies and who have had reactions like this to all kinds of things, not just vaccines, may be afraid to get vaccinated now,” Togias told CNBC. “We just don’t want that to happen. We want to find a way for them to get vaccinated,” he added.
President Donald Trump’s coronavirus vaccine czar Moncef Slaoui mentioned the study in an Operation Warp Speed briefing earlier Monday.
“There is now advanced planning for a study in highly allergic individuals in clinical trials to test the Moderna and Pfizer vaccines and try to understand the immune mechanisms behind any reactions,” he said.
The study comes as the federal government begins distributing nearly 8 million doses of the Covid vaccine nationwide this week after shipping 2.9 million doses of the Pfizer vaccine last week. The United States is shipping 5.9 million doses of Moderna’s vaccine, as well as 2 million doses of Pfizer’s vaccine this week, Health and Human Services Secretary Alex Azar said Monday. As of Sunday, 556,208 Americans have received vaccinations, according to the Centers for Disease Control and Prevention.
It is not clear why some people experience allergic reactions when receiving the injections.
Both Pfizer and Moderna vaccines use messenger RNA or mRNA technology. It is a new approach to vaccines that uses genetic material to elicit an immune response against the virus. US health officials say the vaccines are safe, with only 10-15% of volunteers in clinical trials reporting side effects that were “significantly noticeable.”
Fatigue, headaches and muscle pain are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as intractable nausea or vomiting and facial swelling that are likely triggered by injections, according to the Food and Drug Administration. Medicines. Some side effects were difficult to eliminate, although most resolved within a week, the FDA said.
Medical experts say that allergic reactions to vaccines are rare, but can sometimes occur. Still, the FDA said Thursday it was investigating allergic reactions that occurred after people received the Pfizer vaccine. Doran Fink, deputy director of the FDA’s division of vaccines and related product applications, said the agency will consider whether additional recommendations on vaccines are needed after the investigation.
“At this point, we don’t have enough data to make a definitive recommendation one way or another,” he told the Advisory Committee on Vaccines and Related Biologicals during a meeting.
Togias said he hopes the NIAID study will shed some light on allergic reactions. He said the study may include people who do not have allergic reactions so researchers can make comparisons.
Before the researchers can begin the study, the agency will have to create a very detailed protocol that will need to be approved by the FDA, Togias said. After obtaining FDA approval, it will need to be reviewed and approved by an ethics committee.
“Of course, everyone when they hear a study that relates to the vaccine, we try to be sensitive and act fast,” he said. “But it is not something we can design today and start tomorrow.”
