Is Denver Health offering the Johnson & Johnson vaccine?
Based on guidance from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Colorado Department of Public Health and Environment (CDPHE), Denver Health has resumed administration of the Johnson & Johnson (Janssen) COVID-19 vaccine. A brief pause of the vaccine was previously recommended after reported cases of Thrombosis with Thrombocytopenia Syndrome (TTS), a rare but serious type of blood clot that occurs in the brain and/or in the abdomen.
What is TTS?
TTS is a rare syndrome that involves acute venous or arterial thrombosis and new onset thrombocytopenia in patients with no recent known exposure to heparin. Although the mechanism of TTS is not fully understood, it appears to be similar to heparin-induced thrombocytopenia.
What are the symptoms of TTS?
Individuals who received the Johnson & Johnson vaccine more than a few weeks ago are at very low risk of serious side effects. Anyone who received the Johnson & Johnson vaccine within the last three weeks who develops severe headache, difficulty breathing, leg pain, or stomach pain should be evaluated. These symptoms are different from the flu-like symptoms people may experience after receiving a COVID-19 vaccine. Providers should maintain a high index of suspension for symptoms that might represent blood clots or low platelets in patients who received the vaccine within the past three weeks.
Who is at highest risk of developing TTS?
To date, about 8 million doses of the Johnson & Johnson vaccine have been administered in the United States. Among individuals who received the vaccine, there have been 15 reported cases of this type of blood clot. Thirteen TTS cases occurred in women aged 18-49 years and two occurred in women aged ≥50 years; no cases occurred in men. Among subgroups by age, the highest reported rate was in women aged 30-39 years with incidence of 11.8 TTS cases per 1 million Johnson & Johnson vaccinations. No cases occurred in women who were pregnant or had given birth in the previous 12 weeks. None had a documented history of previous thrombotic events, a known diagnosis of an underlying clotting disorder, or a family or personal history of clotting disorder.
Should I recommend the Johnson & Johnson vaccine to women between ages 18-49 years?
The Johnson & Johnson vaccine is highly effective at preventing hospitalization, ICU admission, and death due to COVID-19. Modeling studies performed by the CDC suggest that resumption of the Johnson & Johnson vaccine in patients aged ≥18 years would prevent 1,000 to 2,000 ICU admissions and 500 to 1,500 deaths with an estimated 26 cases of TTS. For women who are ages 18-49 years and able to return for a second vaccine, an mRNA vaccine would be preferable. However, the Johnson & Johnson vaccine is still recommended for women who are unwilling or unable to return for a second vaccine as the absolute risk of TTS is very small even in the highest risk group of women.
References and further information can be found HERE