Another volunteer in the Moderna Covid-19 vaccine trial has had a serious allergic reaction – but that person was in the placebo group of the study, meaning they did not receive the vaccine, according to a presentation by the company at the Advisory Committee on Immunization Practices meeting on Saturday.
Moderna’s Dr. Jacqueline Miller said the company is investigating the incident of the allergic reaction, which happened Friday night.
At the time the company submitted for an emergency use authorization, Miller said there had been two serious allergic reactions among the clinical trial volunteers. One of those cases was also in the placebo group. The other volunteer, who did receive the Covid-19 vaccine, had an allergic reaction 63 days after receiving the second dose of the vaccine. That person reported having a history of allergies to shellfish. It’s unclear what caused the allergic reaction.
More details: Moderna said it has been examining its data to see if any of the other volunteers have had an allergic reaction within 48 hours following vaccination. Four volunteers did report some kind of allergic reaction, but none of those reactions was considered serious.
The US Food and Drug Administration said Saturday that it will alert the public if changes to the authorization of Pfizer’s Covid-19 vaccine are required following reports of allergic reactions in patients who received the vaccine.
The FDA asked the public to remain “vigilant” and to report any suspected reactions.