CDC’s ACIP committee will further review J&J vaccine; pause to stay in place


AP photo. 4/13/2021.

ATLANTA (KNWA/KFTA) — The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) held an emergency meeting to address the pause placed on the Johnson & Johnson (J&J/Janssen) COVID-19 vaccine due to six patients who developed blood clots, and in one case, the person died.

Arkansas Secretary of Health Dr. José Romero chairs the ACIP. After a three-hour meeting, the committee decided to keep the J&J vaccination “pause” in place. The ADIC will decide by Friday when the next meeting will be held in relation to the J&J vaccine.

“There is a strong desire to reconvene as quickly as possible after reviewing the cases, and at this time ACIP would not provide, or wish to vote, for a change in the current recommendation until we meet again in a week to 10 days,” per ACIP.

In Wednesday’s meeting, April 14, more than 45 CDC representatives were on hand, and more than half-dozen doctors gave presentations — in addition to representatives from Janssen Pharmaceuticals.

ACIP further reviewed the Janssen blood-clotting cases that happened in the U.S. and the importance to get the reports of the six cases to VAERS, so follow-up can begin. “We [ACIP] need to consider implications of reported cases of thrombosis and thrombocytopenia, and the J&J vaccine vaccination policy.”

VAERS is the U.S.’s Vaccine Adverse Event Reporting System. It was established in 1990, and “is a national early warning system to detect possible safety problems in U.S.-license vaccines. It is co-managed by the CDC and FDA,” according to its website.

ACIP image.

As of April 12, more than 6.8 million doses of the J&J have been administered in the U.S. The CDC and the Food and Drug Administration (FDA) are reviewing data involving six cases of blood clots called cerebral venous sinus thrombosis (CVST) in combination with low platelets. Currently, the vaccine is in a “pause” mode as recommended by government agencies until its process is completed.

ACIP image.

Several doctors attending the ACIP video meeting leaned toward gathering more information before making a decision to “un-pause” the vaccine and mentioned that there are two other vaccine options. Other doctors would not agree to an indefinite pause.

One doctor from Massachusetts said the state had plans to use J&J use for the homebound and vulnerable population. Communities that are underserved. Another doctor from Maine expressed the same concern about not getting underserved populations vaccinated.

ACIP image.

WHAT WE KNOW ABOUT SOME OF THE CASES (note, 6 cases were mentioned, however, 1 additional case described happened during the clinical trial)

  • 25-year-old male had no previous medical history during the Phase 3 clinical trial. Had stenosis and was treated with heparin. On the ninth day after getting vaccinated he developed a headache and fever. Ten days later he had a seizure and on the 21st day, he developed CVST. He has now recovered and has been discharged from the hospital.
  • 38-year-old female. This person’s risk factor and platelet count are unknown. Also unknown if this person had COVID-19. The woman developed CVST and was treated with heparin. This person is still hospitalized.
  • 59-year-old female. COVID-19 status is unknown. Began to show significant thrombosis symptoms on her right side seven days after getting vaccinated. This person is still hospitalized.
  • 18-year-old female from Nevada. Had CVST with hemorrhaging. Her COVID-19 status was unknown. She developed symptoms 14 days after the vaccine. Initially, she was treated with heparin. She is still hospitalized.
  • 48-year-old woman from Nebraska. Developed TTP thrombosis and was initially given heparin then was switched to another medicine. She was COVID-19 negative. Her symptoms began two weeks after getting vaccinated. She is hospitalized in critical condition.
  • 26-year-old woman from the New Jersey/Pennsylvania area. She’s described as overweight, but active, and no history of clotting disorder. One week after the vaccination she went to the emergency room because of a severe headache and was treated with Benadryl. But, the headache continued and COVID-19 infection was ruled out. She was initially treated with heparin, then switched to another medication. She was hospitalized for a week and is now home.
  • 45-year-old female. Had CVST with hemorrhaging. Developed symptoms after eight days of continued fatigue, stomach pain, and headache. On the 11th day, the patient died.
Johnson & Johnson (Janssen) statement.

In the E.U., there have been 62 CVST cases, 24 cases of splanchnic vein thrombosis (SVT)/thrombocytopenia cases —18 were fatal, according to the European Medicines Agency (EMA). This data is based on the Astra Zeneca vaccine which also has a “strong association with … rare clotting events.” In the U.K., there were 79 cases of thrombosis/thrombocytopena and 19 were fatal.

In Europe, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) does not make vaccine policy for the EU, each county weighs the risks and benefits of the vaccine individually.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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