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FDA and CDC lift pause on Johnson & Johnson one-dose COVID-19 vaccine

CDC and FDA announced lifting of pause on Johnson & Johnson vaccine
CDC and FDA announced lifting of pause on Johnson & Johnson vaccine

NORTHWEST MIAMI-DADE, Fla. – A Centers for Disease Control and Prevention advisory panel on Friday recommended that the Johnson and Johnson COVID-19 vaccine be resumed.

Soon after, the CDC announced that the U.S. Food and Drug Administration and the CDC determined that the pause be lifted and the use of the vaccine resume.

“The FDA AND CDC are lifting the recommended pause on the Johnson & Johnson, or Janssen, COVID-19 vaccine,” said FDA Director Janed Woodcock.

The recommendation, which was adopted 10-4 with one abstention, by the CDC’s Advisory Committee on Immunization Practices, said their decision came from weighing benefits over risk.

This opens the door for Johnson & Johnson vaccine distribution to start up again and make the one-dose vaccine available to all Americans 18 years of old and older.

(Below, Friday’s Press Conference discussing the decision about reinstating the Johnson & Johnson vaccine)

United States health officials suddenly paused the vaccine last week after at least six women got sick with rare blood clots following the shot.

“One of the reasons for the pause was to get a better handle on how many real cases there have been,” Dr. Aileen Marty, Florida International University’s infectious disease expert said.

Part of the risk-benefit analysis conducted by the panel, according to Dr. Rochelle Walensky, the director of the CDC, included looking at who would prefer or who might not have access to a two-dose vaccine.

During Friday’s meeting, officials learned that there were 15 confirmed reports of blood clot complications, many near the surface of the brain, and all involving women.

Marty said the majority of issues reported have been in the younger population and that the priority in recent days has been educating healthcare providers on recognizing these cases and how to treat them.

Some who voted no on Friday did express concerns since in at least three cases women died from these complications and some of those experts felt that stronger warnings were needed to inform people of these risks.

During the pause, medical and scientific teams at the FDA and CDC examined available data from the blood clots. According to the CDC, teams there and at the FDA also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for adverse events.

They wanted to ensure that there was enough education and information to properly manage and recognize these events due to the unique treatment required for blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

According to the CDC, the two agencies have determined the following:

  • Use of the Janssen 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 show 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 suggest that the chance of 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 Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine

About the Authors:

Amy Viteri is an Emmy Award-winning journalist who joined Local 10 News in September 2015. She's currently an investigative reporter and enjoys uncovering issues facing South Florida communities. A native of the Washington, D.C., area, she's happy to be back in South Florida, where she earned a masters degree at the University of Miami.

Saira Anwer joined the Local 10 News team in July 2018. Saira is two-time Emmy-nominated reporter and comes to South Florida from Madison, Wisconsin, where she was working as a reporter and anchor.