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Allergy Issues Amid Pfizer’s Vaccine Approval in the U.S.
Posted
December 12, 2020
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December 12, 2020
1,561
69
14
5.32%
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1:50Now PlayingFollowing a Thursday vote by an advisory panel of outside experts backing the vaccine for use in people 16 and older, the FDA was weighing how to address reports of serious allergic reactions in the U.K., where the vaccine was approved earlier this month. Officials there have since told people with a history of significant allergic reactions not to get the vaccine.
In a fact sheet for patients, the FDA said “there is a remote chance” the vaccine could cause a severe allergic reaction and told doctors in a similar document they should have medical interventions on hand to help treat such a side effect. The CDC, which is helping states with the vaccine rollout, will ensure each site has medication on hand to treat any allergic reactions, FDA’s Marks said Saturday.
While serious allergic reactions were not seen in Pfizer’s clinical trials and Marks said the FDA is “comfortable” giving the vaccine to Americans, he added: “We’ll be monitoring very closely for them. I think we still need to learn more.”
Many Americans have expressed skepticism about the vaccines being developed to fight the coronavirus. A wider campaign to convince the hesitant to get inoculated is expected in the weeks and months ahead.
“As a physician, I have no hesitation recommending that my parents and my patients’ families receive the vaccine, and I encourage all Americans to get vaccinated in the order recommended by the CDC,” said Richard Besser, the president and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC. “When my group is called, I will gladly roll up my sleeve.”
Side effects in Pfizer’s clinical trial were mild and developed more frequently in younger participants in the study, specifically those aged 55 and younger, with no signs of serious safety concerns, according to an FDA staff report on the vaccine’s safety and efficacy.
After the second injection, fatigue and headache were the most common systemic reactions, occurring in 59% and 52% of the younger participants, compared with 51% and 39% in those over age 56.
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