Covid Vaccine trials, associated clots in women and if the FDA should spend more time on increasing women in related trials.
On April 13, 2021, the CDC and FDA recommended a pause in the use of Johnson & Johnson’s COVID-19 Vaccine. Of the nearly 7 million doses administered so far in the United States, a small number of cases of a rare and severe type of blood clot have been reported in people after receiving the J&J/Janssen COVID-19 Vaccine. All reports occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.
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Because these adverse events have, thus far, solely impacted women, there is a renewed focus on the impact of biological sex on vaccine efficacy.
Using online resources, please
1. Provide a brief overview on whether biological sex is an examined variable in vaccine trials and describe any FDA requirements related to biological sex in vaccine trials.
2. Please take a position regarding whether the FDA should create more requirements or reduce the number of requirements in vaccine trials related to biological sex with supporting information and references for the position taken.
