The study – which is still in the early planning stages – is expected to include “several hundred” people with a history of severe allergic reactions, said Alkis Togias, head of the Allergy, Asthma and Respiratory Biology branch of NIAID. His department will lead the study, which the researchers hope to start in a few weeks, although the timing is not guaranteed. Although the reactions have been reported by people who were injected with Pfizer, the study may include vaccines made by both Pfizer and Moderna.
Togias said researchers at NIAID, an agency of the National Institutes of Health, became interested in the rare phenomenon after reporting that a few people had reactions to Pfizer’s vaccine which qualified as anaphylaxis, a serious and potentially fatal allergic reaction. . Last week, an Alaskan clinician suffered anaphylactic symptoms about 10 minutes after receiving the Pfizer vaccine, becoming the third health worker in the state to experience an adverse reaction to the new drug.
“We’re a little concerned that people who have had a lot of allergies and have had reactions like this to all kinds of things, not just vaccines, might be afraid of getting the shot 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 during an Operation Warp Speed briefing on Monday.
“There is now advanced planning for a study in highly allergic individuals in clinical trials to test Moderna and Pfizer vaccines and try to understand the immune mechanisms underlying any reaction,” he said.
The study comes as the federal government begins distributing nearly 8 million doses of the Covid vaccine across the country this week after shipping 2.9 million doses of the Pfizer vaccine last week. The United States is shipping 5.9 million doses of the Moderna vaccine this week as well as 2 million doses of the Pfizer vaccine, Health and Human Services Secretary Alex Azar said on Monday. As of Sunday, 556,208 Americans were vaccinated, according to the Centers for Disease Control and Prevention.
It is not known why some people have allergic reactions get vaccinated.
The Pfizer and Moderna vaccines use messenger RNA, or mRNA, technology. This 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% to 15% of volunteers participating in clinical trials reporting “significantly noticeable” side effects.
Fatigue, headaches and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as uncompromising nausea or vomiting and swelling of the face that are likely triggered by injections, according to the injections. the Food and Drug Administration. Some side effects were hard to shake off, although most resolved within a week, the FDA said.
Medical experts say allergic reactions to vaccines are rare but can sometimes occur. Still, the FDA said Thursday it was examining allergic reactions that occurred after people were given Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency will consider whether additional vaccine recommendations are needed after the investigation.
“At this point, we don’t have enough data to make a definitive recommendation one way or the other,” he told the Advisory Committee on Vaccines and Related Biologics at a meeting.
Togias said he hopes the NIAID study will shed light on allergic reactions. He said the study could include people who don’t suffer from allergic reactions so researchers can make comparisons.
Before the researchers can begin the study, the agency will need to develop a very detailed protocol that will need to be approved by the FDA, Togias said. After getting clearance from the FDA, it will then need to be reviewed and approved by an ethics committee.
“Of course everyone when they hear about a vaccine study, we try to be sensitive and act fast,” he said. “But it’s not something we can design today and start tomorrow. ”