U.S. plans to study allergic reactions from Pfizer shots
The US is investigating why a handful of people suffered severe allergic reactions shortly after taking Pfizer’s coronavirus vaccines, an official from the National Institute for Allergies and Infectious Diseases told CNBC on Monday.
The study, which is still in the early stages of planning, is expected to include “several hundred” people who have had severe allergic reactions in the past, said Alkis Togias, director of NIAID’s allergy, asthma and respiratory biology department. His department will lead the study, which researchers hope to begin in a few weeks, although the timing is not guaranteed. While reactions have been reported by people who received Pfizer’s shot, the study may look at the vaccines made by both Pfizer and Moderna.
According to Togias, researchers at NIAID, an agency of the National Institutes of Health, became interested in the rare phenomenon after it was reported that some people reacted to Pfizer’s vaccine, which qualified as anaphylaxis, a serious and potentially life-threatening allergic reaction. Just last week, a clinician in Alaska suffered anaphylactic symptoms about 10 minutes after being vaccinated with Pfizer, making it the third state health worker to have a side effect on the new drug.
“We’re a bit concerned that people with a lot of allergies who have reacted to things like this, not just vaccines, might be afraid to get vaccinated now,” Togias told CNBC. “We just don’t want that to happen. We want to find a way they can get vaccinated,” he added.
President Donald Trump’s coronavirus vaccine czar Moncef Slaoui mentioned the study at a briefing on Operation Warp Speed on Monday.
“We are currently planning a study in highly allergic people in clinical trials to test Moderna and Pfizer vaccines and understand the immune mechanisms underlying the reactions,” he said.
The study comes as the federal government starts distributing nearly 8 million doses of Covid vaccine across the country this week after sending out 2.9 million doses of Pfizer’s vaccine last week. The US is shipping 5.9 million doses of Moderna’s vaccine and 2 million doses of Pfizer’s vaccine this week, Health and Welfare Secretary Alex Azar said Monday. As of Sunday, 556,208 Americans had received shots, according to the Centers for Disease Control and Prevention.
It is unclear why some people have allergic reactions.
Both Pfizer’s and Moderna’s vaccines use messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response against the virus. US health officials say the vaccines are safe. Only 10% to 15% of the volunteers in the clinical trials reported side effects that were “significantly noticeable”.
Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the Food and Drug Administration says were likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.
Medical experts say allergic reactions from vaccines are rare but can occur sometimes. Still, the FDA said Thursday it was investigating allergic reactions that occurred after people received Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s Vaccines and Allied Product Applications division, said the agency will consider whether additional recommendations about the vaccines are needed after the investigation.
“Right now we don’t have enough data to make a final recommendation one way or another,” he told the Advisory Committee on Vaccines and Related Biological Products during a meeting.
Togias hopes the NIAID study will shed some light on the allergic reactions. He said the study could include people who don’t have allergic reactions so researchers can make comparisons.
Before researchers can begin the study, the agency needs to create a very detailed protocol that needs to be approved by the FDA, Togias said. After it gets an OK from the FDA, it needs to be reviewed and approved by an ethics committee.
“Of course, when they hear a study related to the vaccine, everyone tries to be sensitive and move forward quickly,” he said. “But we can’t design that today and start tomorrow.”