FDA To Revise COVID-19 Vaccine Guidance After Reports of Side Effects

On Thursday, the US Food and Drug Administration announced that it was working with Pfizer to revise a fact sheet for recipients of the Pfizer-BioNTech COVID-19 vaccine after two people had allergic reactions.

The announcement came a day after the agency announced that an Alaskan health worker had faced a severe allergic reaction to the vaccine, similar to the one experienced by two recipients in the UK. The only odd part of the Alaskan case was that the recipient had no history of allergic reactions.

Source: The Hill

After this glitch, Doran Fink, deputy director of the FDA’s division of vaccines, said: “All of these individuals were treated with appropriate medical intervention and thankfully, all are recovered or recovering. We anticipate that there may be additional reports, which we will rapidly investigate.” Flink also added that the FDA was working in close collaboration with the UK, to find out what caused the allergic reaction in the three cases, saying, “While the totality of data at this time continues to support vaccinations under the Pfizer EUA (emergency use authorization), without new restrictions, these cases underscore the need to remain vigilant during the early phase of the vaccination campaign.”

Speaking about the new fact sheet, he said, “FDA is working with Pfizer to further revise the fact sheets and prescribing information for their vaccines to draw attention to CDC guidelines for post-vaccination monitoring and management of immediate allergic reactions.” The revision will include the current warning for people who have a history of allergic reactions to the vaccine’s ingredients to avoid getting the shot for now.

Flink also added that the sheet will include the warning that facilities, where vaccines are being administered, should ensure that medical treatment for managing serious allergic reactions is immediately available. A similar sheet or pamphlet will also be made for the Moderna vaccine with similar warnings.