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A group of independent advisers from the Centers for Disease Control and Prevention on Thursday urged federal regulators to act quickly to determine whether people with weakened immune systems should receive an additional dose of the Covid-19 vaccine to boost their response to the shots.
The exhortations came after a presentation by the CDC to the outside group, called the Advisory Committee on Immunization Practices, on the latest research into how immunocompromised patients may – or may not – respond to Covid-19 vaccines.
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Doctors say it is increasingly clear that many such patients remain largely vulnerable to Covid-19 after vaccination. This is because people with weakened immune systems may not develop an effective immune response against the coronavirus after vaccination.
An estimated 2.7% of adults in the United States are immunocompromised, the CDC said.
These patients “are doing everything they can, getting vaccinated, getting their close contacts vaccinated. And that is not enough. They are still unprotected, ”said Dr. Sandra Fryhofer, physician in internal medicine and member of the association’s American Medical Board of Trustees, at Thursday’s meeting.
Indeed, those on the front lines treating the sickest Covid-19 patients say those with compromised immune systems remain at risk.
“All of the fully vaccinated patients that I admitted to the ICU were immunocompromised. All of them,” said Dr. Todd Rice, director of the medical intensive care unit at Vanderbilt University Medical Center in Nashville, Tennessee. . Rice, who was not in the meeting, said her patients hospitalized with Covid-19 would not have been vaccinated otherwise.
Rice is a co-author of a study that found that 44% of Covid-19 cases hospitalized in the United States – that is, those who are fully vaccinated but are still infected and sick enough to go to hospital – are people with weakened immune systems.
The study was posted on a preprint server and has yet to be peer reviewed, but the CDC highlighted it at Thursday’s meeting.
Studies examining the safety and efficacy of an additional injection of Covid-19 in vulnerable populations are ongoing, and it remains unclear whether low levels of immunity to the coronavirus in immunocompromised people can be corrected with an additional dose.
Dr Sara Oliver, a medical epidemiologist at the CDC, pointed to research which found that among immunocompromised patients who did not have a detectable antibody response after a full vaccination, only 33-50% responded to a third dose, developing antibodies.
“The immunosuppressed community is certainly aware of its risk,” said Dr. Camille Kotton, ACIP member and infectious disease clinician specializing in solid organ transplantation at Massachusetts General Hospital in Boston. But that awareness, she said, resulted in patients deciding for themselves whether they should receive booster shots.
“Many have taken matters into their own hands and many are proceeding with additional doses of the vaccine as they see fit,” Kotton said. “I am concerned that they are doing this in an unsupervised manner, but as is currently the case due to regulatory issues, we are not in a position to recommend additional doses.”
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All Covid-19 vaccines used in the United States are given under emergency use authorizations by the Food and Drug Administration. The guidelines state that these drugs or treatments can only be used as directed, meaning doctors are unable to decide for themselves which of their patients might need additional protection.
Doctors can only recommend off-label drugs – or, in this case, a vaccine – if the treatment is fully approved by the FDA. Moderna and Pfizer-BioNTech have requested full approval, but it has yet to be granted to either of the drug makers.
But the CDC appears to be looking for ways to bypass emergency use permits, by providing additional vaccines to immunocompromised patients.
“We are actively looking for ways to potentially provide access earlier than any potential change in regulatory decisions,” said Dr Amanda Cohn, chief medical officer of the CDC’s Covid-19 Vaccine Working Group. This could include, for example, enrolling patients in studies.
Dr Doran Fink, deputy clinical director of the vaccines and related product applications division at the FDA, said the agency “is actively exploring all regulatory options to provide access to additional doses of authorized vaccines in situations where the data suggests that the benefits outweigh the risks. “
“It is eluding us. Time is running out,” said Fryhofer. “I appreciate how closely the FDA is reviewing the safety and the amount of research going into this decision. But I wish it all went faster.”
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