Empty vials that contained a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus lie on a table as South Africa proceeds with its inoculation campaign at the Klerksdorp Hospital on February 18, 2021.
Phill Magakoe | AFP | Getty Images
Two trial participants suffered severe allergic reactions shortly after getting Johnson & Johnson’s Covid-19 vaccine, a J&J scientist told an FDA panel on Friday.
J&J was first informed on Wednesday about the allergic reactions, Macaya Douoguih, head of clinical development and medical affairs for J&J’s vaccines division Janssen, told the FDA’s Vaccines and Related Biological Products Advisory Committee.
One of the people was participating in an ongoing trial in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction, after getting the vaccine, she said.
She did not give details on the second person’s reaction.
“We will continue to closely monitor for these events,” she told the panel.
There were previously no reports of anaphylaxis in J&J’s clinical trial. The Centers for Disease Control and Prevention is currently monitoring for such events as states and pharmacies roll out Pfizer’s and Moderna’s vaccines.
There have been 46 reports of anaphylaxis in those who received Pfizer’s vaccine and 16 cases in those who received Moderna’s, according to a CDC report published Feb. 16. The agency said the occurrence of the reaction is in the range of those reported for the influenza vaccine.
The CDC is asking health-care providers to monitor patients for 15 minutes after vaccination and 30 minutes for those who have a history of allergic reactions.
If someone has a severe allergic reaction after getting the first dose of Covid-19 vaccine, the CDC recommends that they do not get the second dose, even if the allergic reaction was not severe enough to require emergency care.