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FDA, Pfizer revising COVID-19 vaccine guidelines on side effects

FDA, Pfizer revising COVID-19 vaccine guidelines on side effects

The US Food and Drug Administration (FDA) together with Pfizer Inc. have informed on revising the information on recently-developed COVID-19 vaccine. As Bloomberg News reports, there were a few new side effects previously unknown.

The FDA has approved the information for the use and monitoring of Pfizer’s COVID-19 vaccine developed with BioNTech SE, said Doran Fink, deputy director of FDA’s division of vaccines and related products applications.

Following the first mass vaccinations in the different countries, some recipients have reported the new side effects like rare allergic reactions. Under the protocol, any body’s reaction should be listed in the datasheet attached to the drug.

The revisions reflect guidelines from the Centers for Disease Control and Prevention for following vaccine recipients and managing potential reactions,

On Thursday, the FDA advisory panel meeting called to consider whether to recommend Moderna Inc.’s coronavirus vaccine for emergency use authorization. The experts believe that the focus should be on allergic reactions after two COVID-19 vaccine recipients in Alaska suffered the reactions, which have also seen in vaccine recipients in the UK.

“At this point, we and CDC are continuing to investigate these cases and consider data,” Fink said and promised to continue to evaluate and investigate the data.