By Samuetta Hill Drew
Last week’s article reviewed the Johnson & Johnson’s Jassen COVID-19 vaccine cases which prompted the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to recommend a “pause” until further review. The “pause” was initiated by the CDC and the FDA on April 13 and lifted April 23 by these same agencies. So, what exactly is a pause and what happens during a pause?
The CDC emphasizes that COVID-19 vaccine safety is a top priority for the federal government, and all reports of health problems following COVID-19 vaccinations are taken seriously. Therefore, the CDC and FDA recommended the “pause” to communicate with and prepare the healthcare system to recognize and treat patients appropriately. Communication with healthcare providers will also emphasize the importance of reporting and how to report severe events in people who have received this vaccine. The pause also allowed the CDC’s independent advisory committee, the Advisory Committee on Immunization Practices (ACIP), to meet, review these cases, and assess their potential significance.
The ACIP is made up of 15 members. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members following an application and nomination process. Fourteen of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine; one member is a consumer representative who provides perspectives on the social and community aspects of vaccination.
In addition to the 15 voting members, ACIP includes eight ex officio members who represent other federal agencies with responsibility for immunization programs in the U.S. and 30 non-voting representatives of liaison organizations that bring related immunization expertise. Members and representatives serve on the Committee voluntarily.
The agency acted quickly after a vote by the CDC’s ACIP recommended lifting the pause. “Above all else, health and safety are at the forefront of our decisions,” said CDC Director Dr. Rochelle P. Walsensky. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Jassen COVID-19 administered – and we paused to examine them more carefully.”
The FDA and CDC have determined the following based on the FDA News Release:
• Use of the Jassen COVID-19 Vaccine should be resumed in the United States.
• The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
• The FDA has determined that the available data shows that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
• At this time, the available data suggests that the chance of thrombosis-thrombocytopenia (TTS) occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
• Health care providers administering the vaccine and vaccine recipients, or caregivers should review the Jassen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers).
The FDA updated its fact sheets accompanying the vaccine, indicating that women under the age of 50 should be aware of the risk of a rare blood clotting syndrome (TTS) associated with the vaccine. Therefore, to Keep an Eye on Safety consult with your healthcare provider if you plan on using this particular COVID-19 vaccine.