FDA investigates multiple reports of allergic reactions to Pfizer vaccine

WHAT YOU NEED TO KNOW:

• The Food and Drug Administration (FDA) announced on Friday that they were probing five reported cases of allergic reactions from people who received Pfizer’s COVID-19 vaccine.
• Speculations point to polyethylene glycol, a chemical included in the vaccine which triggered the reactions.
• The FDA has advised that people who have a history of experiencing severe allergic reactions to vaccines should be excluded from taking them.

On Friday, the Food and Drug Administration (FDA) revealed that the agency was investigating cases of allergic reactions to the COVID-19 vaccine developed by Pfizer and BioNTech as inoculations rolled out.

In a conversation with reporters, FDA’s Center for Biologics Evaluation and Research Director Peter Marks said that were reports of allergic reactions from Alaska and other states. The agency is currently observing five cases.

“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” he said.

Marks also said that they have the appropriate “mitigation strategy with the availability of treatment for a severe allergic reaction being at the ready” as they closely monitor the situation.

A chemical called polyethylene glycol was believed to have caused allergic reactions. Aside from Pfizer and BioNTech, Moderna’s produced vaccine also contains the said chemical substance. Marks noted that the reactions could be experienced more than usual than the initial undertaking.

“We’ll obviously be monitoring very closely what’s going on. We’re working very closely with the CDC on these, and there have been meetings between the CDC and FDA pretty much every day this week making sure we’re keeping very close track of what’s going on,” he said.

Per the agency’s vaccine guidelines, people who have allergies can still take the vaccine except for people who could potentially get severe reactions from it. They strongly advised people with a history of severe allergic reactions to refrain from getting the shots.

“FDA takes very seriously the safety of the medical products that we authorize and approve, and certainly in a vaccine setting, it’s one of the reasons Dr. Marks and his team, in collaboration with the CDC, has set up a very robust surveillance system for assessing safety,” FDA Commissioner Stephen Hahn said. 

“One of the things that FDA does very well and uniquely is really getting to the bottom of events like allergic reactions so we can completely understand the circumstances and better inform the public and also our regulatory decisions,” he added.

Last week, the reports of allergic reactions came first from Britain as they were the first country to authorize Pfizer’s vaccine use.

Source: The Hill