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North Carolinians with compromised immune systems may now receive a third COVID-19 vaccine shot.
Late Thursday night, the U S. Food and Drug Administration expanded the emergency use authorization, and a committee for national Centers for Disease Control and Prevention voted in favor of the recommendation Friday afternoon, paving the way for the nation’s approximately 7 million immunocompromised patients to receive an additional dose of the mRNA vaccines.
FDA Director Rochelle Walensky signed the recommendation Friday afternoon.
The recommendation followed research showing patients with immunocompromised systems may not have received the same immune response as healthy individuals from the first two COVID-19 vaccinations.
“Among those who had no detectable antibody response to an initial mRNA vaccine series, 33-50% developed an antibody response to an additional dose,” Dr. Kathleen Dooling of the CDC told the Advisory Committee on Immunization Practices on Friday.
Patients with hematologic cancers saw less response than other cancer patients, and organ transplant recipients saw the lowest response, she said.
“Studies of people with solid organ transplant have the largest deficits in antibody response, ranging from zero to 79%,” she said.
Those patients are “often on immune-suppressing medications, which are lifelong to prevent rejection,” said Dr. Neil Shah, a University of North Carolina professor of medicine and transplant hepatologist.
Some patients sought antibody testing to try to determine what, if any, benefit they received from the first two doses. The CDC does not endorse this type of testing because different tests may show varying results, and it is not yet clear whether the results correlate with protection from COVID-19, according to Dooling.
Vaccine response is only part of the challenge for immunocompromised people in the pandemic.
People with weakened immune systems, including transplant recipients and cancer patients, are at higher risk for contracting coronavirus and worse outcomes than healthy individuals, Dooling said. They are also more likely to have breakthrough infections after vaccination.
Setting eligibility guidance
The CDC working group defined immunocompromised people as those “with medical conditions” or those “receiving treatments that are associated with moderate to severe immune compromise.” The category includes active or recent cancer patients, transplant recipients, active or untreated HIV patients and patients on immunosuppressing drugs.
Immunocompromised people make up about 2.7% of the adult population in the United States, according to Dooling.
The agency expects to offer additional eligibility guidance in the next few days, but “the intent is to limit this to individuals who are considered under the EUA to be moderate or severe,” Dr. Amanda Cohn, senior adviser for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases, told committee members.
“For example, it would not include long-term care facility residents or persons with diabetes, persons with heart disease,” she said. “Those types of chronic medical conditions are not the intent here.”
Dooling told the committee that individuals will self-attest to their status, and no prescription or letter from a doctor will be required.
The N.C. Department of Health and Human Services did not respond to requests for specific information about the logistics of third-dose distribution to immunocompromised patients.
“NCDHHS will be reviewing information from the federal government when we receive it, and we plan to revise our guidance accordingly and share more information next week,” a spokesperson said in a statement.
The CDC recommendation advised a third mRNA shot, either a Pfizer or Modern vaccine dose, for those with weakened immune systems, but it did not address immunosuppressed patients who received the Johnson & Johnson vaccine. CDC officials said they expect to offer recommendations for those patients in the near future, after reviewing study data.
CDC committee members debated equity concerns about the new recommendation but ultimately voted in favor of the guidance. The recommendation follows a move by several European countries, including France, Germany and the United Kingdom, for additional vaccination for immunocompromised individuals.
Earlier this month, the director-general of the World Health Organization called for a moratorium on vaccine boosters in an effort to move the flow of doses from high-wealth countries to low-wealth countries.
Hoping for protection but taking precautions
For some anxious immunocompromised patients, even without a guarantee of protection by a third shot, the possibility of an additional shield from the deadly virus is welcome news.
“I immediately had about eight to 10 messages in my inbox about this … (saying,) ‘I heard it’s approved. When can I get it?’” Shah said. “So patients obviously were very anxious about this, and they’re looking to get their booster so they can protect themselves.”
But despite patient enthusiasm for an additional dose, committee member and Vanderbilt University professor of medicine Dr. Helen Talbot reiterated the need for realistic understanding of the vaccine’s limitations and the importance of preventive measures.
“My only concern about adding a third dose for the immunocompromised is the impression that our immunocompromised population will then be safe,” she said at the committee meeting Friday.
“I think the reality is they’ll be safer, but still at an incredibly high risk for severe disease and death. And so I think there needs to be a fair amount of counseling and education that goes into this effort.”
Shah shares Talbot’s concern and said he will continue to advise patients to exercise other precautions such as masking and hand-washing.
“We’ve been telling patients to continue to mask, to continue to distance, with the fear of ‘What if they didn’t get a full response?’” he said. “They’re still at risk of getting the infection, and so until further data comes out after a booster, I think we’re going to continue to follow those same precautions.”
For Shah, vaccination is part of a larger puzzle that requires flexibility as the delta variant takes hold and scientists monitor other strains.
“This is a thing that we’re all growing with and learning,” he said.
“The challenge is that we’re trying to protect our population in general, not just our immunosuppressed patients, the best way we know how.”
Find answers to frequently asked questions about the third dose here.