A study on the third dose of COVID-19 vaccine brings “hope” to people with immunodeficiency

A Research A third dose of the Moderna or Pfizer vaccine, published Wednesday in the New England Journal of Medicine, was found to have “significantly improved” its efficacy in organ transplant recipients taking immunosuppressive drugs. It was.

Doctors at the University Hospital of Toulouse in France evaluated transplant recipients to see if the third dose increased the level of antibodies that fight COVID-19. Of the 59 patients who had no detectable antibody after the second dose, 44% showed antibody after the third dose. In the second subset of patients who produced some antibodies after the second dose, all 40 showed elevated levels after the third dose.

Lead author Dr. Nasim Kamal said this was the largest study supporting the hypothesis that three doses would be better for organ transplant patients. “I think it’s probably the same for all other immunocompromised patients.”

Performed by Segev at Johns Hopkins, Annual report of internal medicine The result was similar last Tuesday. Of the 24 patients who had no detectable antibody after the second dose, 33% showed an increase in antibody after the third dose. All 6 Patients with low antibody levels after the second dose showed high levels after the third dose.

Calling the result “incredibly exciting and encouraging,” Segev said the message was “one of the hopes” for immunocompromised individuals who did not respond after two doses.

In France, health officials start in April Advised the third shot For severe immunodeficiency, including transplant recipients, dialysis patients, and some individuals with autoimmune diseases.

However, the third dose is not currently permitted in the United States. The Food and Drug Administration’s Emergency Use Authorization for the Coronavirus Vaccine only allows individuals to receive Johnson & Johnson once and Pfizer and Moderna twice.

Johns Hopkins researchers did not provide their study participants with a third dose, Segev said. Patients received their own third dose prior to the study. He explained that some people traveled to areas that were “less compliant” with federal guidelines.

FDA spokesman Abigail Capobianco says vaccine manufacturers need to submit data demonstrating the safety and efficacy of a third dose before regulators consider changing recommended doses for immunocompromised patients. Said.

Dr. Robert Finberg, who led Pfizer’s vaccine trial at the University of Massachusetts School of Medicine, said the results were promising, but emphasized that they were in the early stages of the research process. He also warned people trying to get a third dose of the vaccine without the supervision of a clinician.

For transplant patients, there is a potential risk from vaccines, including organ rejection, Kamal said. The person who recently published the case Kidney International Photograph of a kidney transplant recipient who experienced organ rejection after the second dose.

“Our main concern is that when we boost our immune system several times, we’re dealing with organ transplant patients, so we’re a little afraid of getting accurate rejection,” Kamal said. Told.

Segev is aware of the risks and this year to study the efficacy of third and even fourth doses in a controlled situation where both the transplanted organ and the patient’s immune response can be carefully monitored. I would like to start clinical trials in the second half of the summer.

“Everyone is cautiously optimistic and will eventually find a way to reach the defensive immunity of the majority of immunosuppressed people in this country,” Segev said. “But … Before we make these types of vaccination strategies publicly available, we need to carefully understand their risks.”

Some patients may simply not respond to the vaccine. Dr. Dan Barouch, director of the Virology and Vaccine Research Center at the Beth Israel Deaconess Medical Center, said there are always vaccine non-responders, even among individuals. People who are not immunocompromised.

“I find it difficult to get into 100%, but the fact that a simple third dose gives a good response in one-third to one-half of previous non-responders is very encouraging. Will be, “he said.

Sam Dey, 52, who received a heart transplant in 2015, said his body did not produce the antibodies needed to fight COVID-19, despite two doses of Pfizer. As a result, he “lives as if the pandemic had just begun.”

Dey is wary of studies on a third dose due to the small sample size and lack of diversity among participants. But he said he was happy to know that someday he could produce antibodies while taking immunosuppressive drugs. “There is always hope.”

In the meantime, and sometimes even after producing antibodies, immunocompromised people need to continue to take health precautions.

Segev said the transplant patients would be “vaccinated but act unvaccinated.” That is, keep wearing the mask, keep a distance of 6 feet, and follow all other recommendations that the US Centers for Disease Control and Prevention have for unvaccinated individuals.

Glenda Daggert, 75, received a kidney and pancreas transplant in 1999. She was vaccinated as soon as she qualified, but “continued to be as vigilant as ever.” It was only recently discovered that Daggert was one of a subset of immunosuppressive drug transplant patients who developed antibodies after two doses.

“I feel very lucky,” she said. “I was very relieved to get confirmation.” Nevertheless, Mr. Daggert said she was still wearing the mask indoors and “very rarely” took it off outdoors.

Her husband, Ira Copperman, co-chairman of the transplant support organization, said:

Dr. Daniel Kritzkes, an infectious disease physician at Brigham and Women’s Hospital, confirmed the importance of strict precautions for people with immunodeficiency.

This is most true for individuals with the highest levels of immunosuppressive drugs and the lowest levels of vaccine response. Cancer patients receiving aggressive chemotherapy and all transplant recipients, including organs, stem cells, and bone marrow.

People with low levels of immunosuppressive drugs to treat autoimmune diseases such as inflammatory bowel disease, lupus, and arthritis, he said, responded to the vaccine in the “gray area.” “They really need to talk to their healthcare providers to find out where they are in the immunosuppressive spectrum,” Kuritzkes said.

For individuals living with HIV, he said, most people could be “reasonably comfortable” with a “good response” to the vaccine, especially if they are taking antiretroviral drugs. Stated.

Camille Caldera can be reached at [email protected]..