A federal vaccine safety review panel announced today that it recommends lifting the pause on the use and distribution of the Johnson & Johnson COVID-19 vaccine for people 18 and older. The Food and Drug administration has followed the recommendation and lifted the pause, adding a warning about the potential for rare blood clots for women under age 50.

State health experts will review the federal decisions and will participate as part of Western States Scientific Safety Review Workgroup that will be assessing the Centers for Disease Control and Prevention and FDA decision today based on the panel’s recommendation. Once that review is completed, the Oregon Health Authority will share its recommendations to clinicians and vaccine providers on plans for the resumption of the vaccine’s use and distribution in Oregon.

Dr. Dean Sidelinger, Oregon’s state health officer said, “Today’s federal actions are encouraging news as we confront the latest surge in COVID-19 hospitalizations and deaths. This thorough scientific review found that the benefits of the Johnson & Johnson outweigh the risks. And the prompt and rigorous safety examination can give us all confidence that adverse events are carefully scrutinized.”


Background

The pause was implemented on April 13 after reports of six cases of an unusual, severe syndrome of blood clots in major veins, along with low platelet count occurred among six women who received the Johnson & Johnson’s COVID-19 vaccine. The syndrome is named “thrombosis thrombocytopenia syndrome” (“TTS”), and it resembles cases of clotting reported in Europe following administration of AstraZeneca’s adenovirus-vectored COVID-19 vaccine. It also shares features with heparin-induced thrombocytopenia (HIT), including the presence of antibody to platelet factor 4 and rebound of platelet count following intravenous immune globulin (IVIG) administration. Since then, CDC and FDA have been investigating possible cases of TTS and reviewing additional data.

Today, the CDC’s Advisory Committee on Immunization Practices (ACIP) met to review the data accumulated since then and to weigh the benefits of the vaccine against its risks.

  • After nearly 8 million doses of the Johnson & Johnson vaccine were administered, 15 cases of TTS have now been confirmed. All were women: 13 of the cases were 18–49 years of age, and two were 50+ years old. Three have died (including a woman in Oregon).
  • The risk of this syndrome was found to be seven cases per million doses in women 50 years of age or younger, based on the cases reviewed.
  • The risk in women older than 50, the risk was found to be 0.9 cases per million.
  • Less than one per million doses in men were identified, based on a case history of a man who developed this syndrome during the clinical trial.
  • Even assuming moderate transmission of COVID-19, the panel estimated that in women 18–49 years of age, Johnson & Johnson vaccine would prevent far more deaths and intensive care unit admissions than the potential number of TTS cases incurred. One million doses in this age group, at current US COVID-19 exposure risk, might be associated with 13 cases of TTS but prevent 657 hospitalizations, 127 ICU admissions, and 12 deaths. The benefits outweigh the risks even further for women 50 years of age and older and for men.

For these reasons, ACIP voted that the Johnson & Johnson vaccine again be recommended for persons 18 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization. Prior to any resumption of use and distribution of the Johnson & Johnson vaccine in Oregon, the Western States Scientific Safety Review Workgroup will also be assessing the ACIP recommendation. The Oregon Health Authority will consider its recommendations before advising clinicians and vaccine providers on plans for the resumption of the vaccine’s use and distribution.

OHA recommends that those who received or will receive the Johnson & Johnson vaccine to be aware of this rare potential risk within the first three weeks of vaccination. Clinical characteristics include clots in the cerebral, extremity, pulmonary or splanchnic vasculature. Symptoms may include severe or unusual headache, leg pain, shortness of breath, or abdominal pain; petechiae in the arms and shins indicating thrombocytopenia. Those who develop such symptoms should be advised to seek medical attention immediately.

Clinicians are advised to review the American Society of Hematology guidelines for recognition and treatment of HIT the appropriate evaluation and management of patients presenting with symptoms consistent with TTS.. Additionally, clinicians are advised to report this and any other adverse events following any immunization to the Vaccine Adverse Events Reporting System (VAERS).