![]() All women experienced symptom onset no sooner than 6 days post-vaccination, but no later than day 15, and all reported headache, fatigue, and abdominal pain. Of the 15 women, 3 died, 5 were recovered or recovering at home, and 7 remained hospitalized, including 4 in the intensive care unit. Seven of the 15 cases were in obese women, and two women were taking oral contraceptives. As of Apr 21, Shimabukuro said the CDC was investigating fewer than 10 additional possible cases. ![]() Seven of the 16 cases were in women ages 30 to 39. "TTS is rare but clinically serious and potentially life threatening and a potentially life threatening adverse event that has been observed in association with the Janssen COVID-19 vaccine," Shimabukuro said.Īll 15 of the cases involved women, all but 2 of whom were under the age of 50. The cases had been detected using the Vaccine Adverse Event Reporting System (VAERS). CDC: 15 TTS cases, 3 deathsĪCIP members heard from Tom Shimabukuro, MD, MPH, MBA, the deputy director of the Immunization Safety Office at the CDC, who said the agency had detected a total of 15 TTS cases, including 3 fatalities, up from 6 when the pause was first instated. Following the ACIP ruling, the FDA and CDC announced that use of the vaccine should resume in the United States.Īt the time of the pause, the Johnson & Johnson (J&J, or Janssen) vaccine made up only 5% of immunizations given in the United States, but it has been considered an important tool in reaching patient populations that would benefit from the single-dose COVID-19 vaccine. The pause began after rare blood clots, called thrombosis with thrombocytopenia syndrome (TTS), were detected in a handful of patients in the weeks following vaccination. This ends a 10-day pause on use of the vaccine. One member abstained from voting because of a conflict of interest. Today the Advisory Committee on Immunization Practices (ACIP), the independent group of experts that advises the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), recommended in a 10-to-4 vote that the Johnson & Johnson COVID-19 vaccine be reinstated in the United States' vaccination campaign.
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