More Info on the J&J COVID-19 Vaccine Thrombosis Scare

Production Woes

Another setback that Johnson & Johnson faces is the suspension of production at Emergent BioSolutions, a manufacturing partner for the COVID-19 vaccine in Baltimore at the request of the FDA after an inspection of the facility.⁹ Two months ago, contamination of Johnson & Johnson’s vaccines with ingredients from a coronavirus vaccine made by AstraZeneca ruined 15 million doses. The halt in production could lead to a delay in millions of doses being distributed. The Johnson & Johnson vaccines distributed in the U.S. are manufactured in a facility in the Netherlands and were not part of the quality control inspection.

Practical Implications

While effective and safe vaccines are essential tools for both public health and personal health of patients, clinicians must be aware of symptoms that could represent serious thrombotic events or thrombocytopenia in patients who have recently received the Johnson & Johnson COVID-19 vaccine, including severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, petechiae, or new or easy bruising.⁶ Platelet counts should be obtained, and patients should be screened for evidence of immune thrombotic thrombocytopenia.

Unless heparin-induced thrombocytopenia (HIT) testing is negative, clinicians should not treat patients with thrombotic events and thrombocytopenia following receipt of the Johnson & Johnson vaccine with heparin.⁶ Should HIT testing be positive, non-heparin anticoagulants and high-dose intravenous immunoglobulin should be strongly considered.

Health officials have full confidence the vaccine is safe and effective in preventing COVID-19. Including the six reported cases, 15 cases in total of thrombosis-thrombocytopenia syndrome (TTS) have been reported to VAERS. All these reported cases occurred in women between the ages of 18 and 59, with a median age of 37 years old.

Healthcare providers are asked to report adverse advents in patients following receipt of COVID-19 vaccines, as required under the Emergency Use Authorizations for COVID-19 vaccines, to VAERS. More information about the Johnson & Johnson vaccine is available on the company’s website.

Mary Choy, PharmD, BCGP, FASHP, is a medical writer and editor living in New York City. Dr. Choy is director of pharmacy practice at the New York State Council of Health-System Pharmacists. She is also the author of Healthcare Heroes: The Medical Careers Guide.

References

1. Centers for Disease Control and Prevention. COVID-19 vaccinations in the United States. 2021.
2. FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 vaccine use following thorough safety review [press release]. Centers for Disease Control and Prevention. 2021 Apr 23.
3. Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine. [press release]. Centers for Disease Control and Prevention. 2021 Apr 13.
4. Vogel G, Kupferschmidt. Concerns over rare clotting disorders halt use of Johnson & Johnson’s COVID-19 vaccine. Science. 2021 Apr 13.
5. Food and Drug Administration. Joint media call: FDA & CDC to discuss Janssen COVID-19 vaccine. YouTube. 2021 Apr 13.
6. ACIP presentation slides. April 2021 meeting. Centers for Disease Control and Prevention. 2021 Apr 14.
7. Sadoff J, Davis K, Douguih M, et al. Thrombotic thrombocytopenia after Ad26.COV2.S vaccination—response from the manufacturer. NEJM. 2021 Apr 16.
8. Strasburg J, Hopkins JS, Loftus P. J&J privately asked rival COVID-19 vaccine makers to probe clotting risks. The Wall Street Journal. 2021 Apr 16.
9. Rowland C. Johnson & Johnson suffers another setback as FDA tells Md. Vaccine maker to suspend production. The Washington Post. 2021 Apr 19.