J&J Vaccine Pause Lifted

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J&J Vaccine Pause Lifted

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On Friday, April 23, the US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) allowed the Johnson & Johnson’s coronavirus vaccine to be administered again.


The vaccine had been put on pause because of a side effect that caused an extremely rare case of blood clots. 


15 women, most of them under the age of 50, of the 8 million people given the J&J shot, were affected by this rare blood clot. Three of the women died, five were discharged and seven still remain hospitalized.


According to information presented by the CDC panel’s safety subgroup on April 23, women who are under 50 have the highest risk for this side effect, but the risk is one in 7 million doses for men and women who are over 50.


The decision to lift the pause on the vaccine was announced after the CDC advisory panel voted 10-4 on the continuation of the vaccine.


The CDC and FDA announced that they would control the risk of the rare case of blood clots by giving out warnings to let younger women decide whether they would get the J&J shot or a different one.


During the meeting, acting FDA Commissioner Dr. Janet Woodcock said, “We have concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18-years- and older.” 


However, Dr. Sarah Long of Drexel University College of Medicine voted against the proposal because she felt that it did not do enough to warn women about the serious side effect. “This is an age group that is most at risk [of the clotting] that is getting vaccines predominately to save other people’s lives and morbidity, not their own. And I think we have a responsibility to be certain that they know this,” she said.


Despite concerns, the vaccine is set to continue administration and the CDC, FDA, and the European Medicines Agency, which had also previously found a similar side effect in the AstraZeneca vaccine, is working with doctors to treat this rare blood clotting efficiently.


“We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine,” said J&J’s chief scientific officer, Paul Stoffels."We will continue to collaborate with the CDC, FDA, and health authorities around the world, including the European Medicines Agency and the World Health Organization, to ensure this very rare event can be identified early and treated effectively.”


By Alexandria Kim 

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