Federal regulators have lifted the recommended pause on administering the Johnson & Johnson vaccine, giving states the license to use the shot that has proven to be a lifeline for remote communities unable to properly transport and store it.
The independent panel of vaccine experts at the Centers for Disease Control and Prevention on Friday recommended lifting the pause on the Johnson & Johnson vaccine, with many committee members saying that the benefits outweighed the risks. The panelists also recommended that the Food and Drug Administration consider adding a warning label for women under 50.
The Food and Drug Administration and the Centers for Disease Control and Prevention, which initiated the pause on April 13, are expected to follow the ACIP recommendation, meaning that the vaccine will likely soon be back in use. On Thursday, Dr. Rochelle Walensky, the CDC’s director, said she was “really hopeful” that the Johnson & Johnson vaccine could “be used again soon.”
ACIP is the body within the CDC charged with making recommendations on vaccines.
During the ACIP meeting, the CDC presented findings that 15 women had experienced blood clots linked to the Johnson & Johnson vaccine. When ACIP met on April 14, 7 cases of blood clots had been discovered.
JOHNSON & JOHNSON PAUSE MAKES IT HARDER TO VACCINATE RELUCTANT, HARD-TO-REACH PATIENTS
A dozen of the clots occurred in the brain. Thirteen occurred in women under age 30, and two occurred in women between age 50 and 64. All of the blood clots happened within 15 days of receiving the vaccine.
Over 1.8 million women age 18-49 have received the Johnson & Johnson vaccine, which means that blood clots happen in that age group at a rate of seven per million. The rate for women over 50 is less than one per million.
A presentation by Dr. Sara Oliver from the CDC showed that the benefits of the vaccine outweigh the risks. If the use of the Johnson & Johnson vaccine was resumed at a rate of 50% of what it was before the pause for everyone over age 18 over six months, there would be 26 cases of blood clots. But 1,435 COVID-19 deaths would be prevented, as would 2,236 admissions to intensive care units.
Most voting members of the ACIP seemed persuaded that the benefits of resuming the Johnson & Johnson vaccine outweighed the risks, with at least one arguing that the benefits were greater than those discussed by the committee.
“I think it is possible that [ACIP] is underestimating the benefits of vaccination,” said Dr. Matthew Daly, a senior investigator at the Institute for Health Research at Kaiser Permanente Colorado.
Daley noted that the committee overlooked that vaccination would cut down on more transmissible variants of the virus and that fewer infections would likely mean less health problems later on.
But others were concerned that the public would not be adequately informed about the risks.
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“What I worry we can’t do is educate the entire medical force and every American with enough detail and understanding that they can determine the risk factors for themselves,” said Dr. Helen Talbot, an associate professor of medicine and health policy at Vanderbilt University.
