• Johnson and Johnson COVID-19 Vaccine Update

    As of 4/27/21

    On April 23, the CDC’s ACIP voted to reaffirm its recommendation for the administration of the Janssen (Johnson & Johnson) vaccine under the FDA’s EUA for individuals aged 18 and older. The administration of the vaccine had been paused to allow for further analysis of cases of Thrombosis with Thrombocytopenia Syndrome (TTS) that were associated with individuals of the J&J vaccine. These events are rare with only 15 cases identified in almost 7 million doses of the vaccine.

    The ACIP determined the potential benefits of vaccination to prevent morbidity and mortality from COVID-19 outweighed the potential risk of TTS. No cases have been reported among individuals who have received the Pfizer/BioNTech or Moderna vaccines. The CDC has updated its clinical considerations for the Janssen vaccine and the EUA fact sheets for clinicians and patients have been revised to include information on TTS. An MMWR was published with details on the identified cases of TTS, in addition to a benefit-risk analysis that informed the CDC in reaffirming the recommendation for use of the Janssen vaccine under the EUA. The AAFP has a revised safety and efficiacy overview.

    If Patients Have TTS Symptoms: While these events are infrequent, CDC is recommending individuals who receive the Janssen vaccine seek urgent medical care if they have symptoms including severe or persistent headache, blurred vision, severe abdominal pain, chest pain, shortness of breath, leg swelling, petechiae or bruising. Treatment with non-heparin products is recommended for individuals with TTS who received the vaccine. Detailed guidance for clinicians can be found in the CDC’s clinical considerations.

    Frequently Asked Questions

    Q: Can I get the Johnson and Johnson vaccine?
    A: Yes, the Janssen (Johnson & Johnson) vaccine is recommended for individuals 18 years and older following a temporary pause in administration. The pause allowed a thorough review of the data surrounding a rare adverse event of Thrombosis with Thrombocytopenia Syndrome (TTS). To date, this event has been reported in 7 per 1 million vaccine recipients. A thorough review of the data showed that the potential benefits of the Janssen vaccine greatly outweigh the potential risks. The CDC has updated tthe clinical considerations for this vaccine and will continue to update information as it becomes available. 

    Q: What is TTS? 
    A: Thrombosis with Thrombocytopenia Syndrome is the presence of a blood clot(s) combined with low platelet counts. Almost all cases reported so far have been in women under 50 years of age. Symptoms were reported to have started between 6 and 15 days after vaccination.

    There are no known risk factors for developing this rare event representing a reporting rate of 7 such events per 1 million vaccinations among women 18 through 49 years old and a rate of 0.9 per 1 million vaccinations among women 50 years and older. For all women, this is a rare adverse event and for women 50 years and older and men of all ages, the event is even more rare. Additionally, use of heparin in individuals with suspected TTS may be harmful, clinicians are advised to use non-heparin therapies unless HIT testing is negative. 

    Q: What symptoms are related to these rare blood clots?
    A: CDC has identified the following symptoms as those to be watching for following vaccination with J&J vaccine: severe or persistent headache, backache, chest pain, severe abdominal pain, shortness of breath, leg swelling, petechiae or bruising. As with any adverse reaction to vaccines, patients and clinicians are strongly encouraged to report symptoms to v-safe and the Vaccine Adverse Event Reporting System (VAERS).

    Q: Are there risk factors for getting TTS?
    A: Right now, there have been no factors identified that were consistent across all of the cases. The median age of individuals was 37 years and the median time to symptom onset was 8 days. Some individuals had underlying medical conditions that increase risk for clotting (e.g., obesity, hypothyroidism, and hypertension). Only two patients were taking combination birth control pills and there were no cases among individuals who were pregnant or had recently given birth. None of the individuals had documented history of previous thrombotic events, a known diagnosis of an underlying clotting disorder, or a family or personal history of clotting disorders. 

    Q: What about the other two COVID-19 vaccines?
    A: No cases of TTS have been reported among individuals who have received the Pfizer/BioNTech or Moderna vaccines.  

    Q: What should clinicians do if they suspect a patient has a blood clot after getting the vaccine?
    A: The CDC and the FDA have issued the following guidance:

    • Evaluate patients initially with a screening PF4 enzyme-linked immunosorbent (ELISA) assay as would be performed for autoimmune heparin-induced thrombocytopenia (HIT). Consultation with a hematologist is strongly recommended.
      • Based on similar cases associated with the AstraZeneca COVID-19 vaccine in Europe, the pathogenesis of these rare adverse events may be associated with platelet-activating antibodies against platelet factor-4 (PF4).
    • CDC is recommending that clinicians do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine with heparin, unless HIT testing is negative.
      • In cases of HIT, the use of heparin may be harmful, and alternative treatments need to be given.
    • If HIT testing is positive or unable to be performed, non-heparin anticoagulants and high-dose intravenous immune globulin should be strongly considered.
    • Detailed guidance is also available from the American Society of Hematology
       

    Read More from the CDC and FDA