Stacey Ricks has three options when asked to show her vaccination card.
Ms. Ricks, 49, a kidney transplant recipient who takes immune suppressing medication, didn’t develop antibodies after her first two Moderna shots.
In June, without disclosing she already had received the Moderna shots, she got a dose of the Johnson & Johnson vaccine before federal health officials had approved anyone for a third shot.
It was difficult for her to get her fourth or fifth shots. Her prior shots were finally revealed by pharmacy records in Houston, where she lives. Armed with a doctor’s note explaining that she hadn’t developed antibodies, Ms. Ricks convinced a pharmacist to give her two doses of the Pfizer vaccine over the summer.
“She kept saying, ‘There’s no clinical data here,’” Ms. Ricks recalled. “And I said, ‘Hey, I am the clinical data.’”
Ms. Ricks, a person with compromised immune system in the U.S., has evaded government guidelines and received unapproved fourth or fifth shots.
The Food and Drug Administration and Centers for Disease Control and Prevention determine when additional doses should go out. However, some patients and their doctors feel the federal agencies have been slow to protect the most vulnerable.
Israel has already begun rolling out fourth shots — Prime Minister Naftali Bennett announced on Sunday that the country would offer additional shots to people age 60 and over, as well as to medical workers, becoming the first country to roll out an additional booster so broadly.
The C.D.C. In late October, the C.D.C. updated its guidelines to state that immunocompromised patients would be eligible for a fourth dose six month after the last. If you followed the rules, you would be eligible for a fourth dose as soon as possible in February.
However, Omicron is a new variant that has been developed, and the vaccination rates are slow in many areas. This is worrying for those with weak immune systems. Many are taking extra shots, without knowing if they’re safe or effective.
Typically, doctors have discretion to use approved medications outside of their recommended uses — so a fully approved vaccine like Pfizer’s could normally be prescribed as doctors see fit.
However, to be eligible for any Covid-19 vaccines, providers must agree to abide by the C.D.C. — meaning that if they break the agency’s rules, they risk being kicked out of the vaccination program and could face prosecution. The C.D.C. Also, the C.D.C. warned that providers administering unapproved shots may not have protection from patients’ legal claims if something goes wrong.
Legal experts state that the government has done little in order to enforce regulations compliance and it is unlikely to pursue penalties for most providers.
People taking the extra shots aren’t doing anything illegal. They could be sued by vaccine providers if they lie to them, but this is unlikely, according Govind Persad (an assistant professor at the University of Denver Sturm College of Law).
The F.D.A. C.D.C. C.D.C. did not respond to questions.
Getting extra shots seems to have worked for some — to a degree. After Ms. Ricks’s fifth shot, her doctor sent her a note stating that she had developed a “moderate” antibody response but “still not a typical response.” She has continued taking extra precautions as if she is unvaccinated.
Researchers say some immunocompromised people — depending on their condition and the medications they take — may never generate an immune system response, no matter how many shots they receive. Advocates for the extra doses argue that the United States has a surplus vaccines, so it is better to let them go to waste.
Higher levels of antibodies seem to correlate to better protection against the virus, but researchers aren’t sure exactly what level of protection different numbers of antibodies provide, and the F.D.A. Antibody tests are not recommended for assessing immunity.
The C.D.C. estimates that there are around seven million immunocompromised individuals in the country, but it’s difficult to know who will benefit from additional doses, according to Dr. Robert Wachter, chair of the department of medicine at the University of California, San Francisco.
“This is, at this point, probably more improv than science,” he said.
Chris Neblett moved to Indiana, Pa. in April with the blessing of his transplant team.
Mr. Neblett, 44, had no idea whether it could help him — the medications he takes for his kidney transplant suppress his immune system and stopped him from generating antibodies after two shots of the Pfizer vaccine.
“Sure, we were skirting the rules, but what were the repercussions? There weren’t really any,” he said.
He generated low levels of antibodies after his third shot of Pfizer, but it wasn’t until his fourth shot in November that his antibody levels matched a normal, healthy individual’s response.
Mr. Neblett believes his gamble served the greater good — he is enrolled in a Johns Hopkins Hospital study on organ transplant patients’ responses to the vaccine. The C.D.C. was impressed by his data and those of others who acted beyond official guidelines. C.D.C. and F.D.A. According to Dr. Dorry Segev (a Johns Hopkins University transplant surgeon who is involved in the study), third shots can be authorized for vulnerable groups. He stated that hundreds of patients were denied shots in his study.
“They’re acting out of desperation,” he said.
“Rather than say ‘Shame on them,’ I would say ‘Shame on the system we’ve created.’”
Dr. Segev acknowledged that there may be some risks associated with additional shots, such overstimulating your immune system. However, Dr. Segev suggested that you should monitor these risks carefully. He said that his data showed that additional vaccine doses are safe and effective in certain cases.
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“If three doses didn’t work at all, we probably should consider something different for that fourth dose,” Dr. Segev said.
He suggested that one example is to reduce or stop immune suppressing medication before distributing additional doses if necessary. He is one of many doctors complaining that the C.D.C.’s guidance is overly rigid and prevents medical professionals from treating patients on a case-by-case basis.
Karen Pearce’s doctor has written her a note that the timing of her booster “MUST be done prior to her next chemotherapy infusion,” a treatment she needs every six months to control a life-threatening inflammatory blood vessel disease.
But Ms. Pearce, 69, from Gettysburg, Pa., won’t be eligible for a fourth shot until February, right after she’s supposed to receive her next infusion, which she and her doctor both believe would render her fourth shot useless. Omicron has made this booster shot more important, but no providers have offered to give it to her one-month early.
“More flexibility in their guidance could save lives, maybe mine,” she said.
Experts also agree that there are limits to the flexibility of guidance. Getting additional doses too soon could be counterproductive, according to Shane Crotty, a professor at the La Jolla Institute for Immunology’s Center for Infectious Disease and Vaccine Research.
This is because the immune system’s long-term memory seems to perform better if it can rest between two vaccines, he explained, and the body takes months to perfect its antibody-making process after an initial vaccination.
Monoclonal antibody protection could be an alternative to more shots, Dr. Lianne S.Gensler, a rheumatologist from the University of California in San Francisco, said. Most monoclonal antibody treatments have been in short supply — meaning they’ve only been used as a post-exposure treatment instead of a preventive measure. Omicron rendered some monoclonal antibodies treatments ineffective, making matters worse.
The F.D.A. One long-term preventive monoclonal monoclonal antibody treatment was approved by the F.D.A. in December. However, doses may initially be restricted.
In the meantime, people with Infected immune systems Consider their imperfections.
Patrick VanHorn, aged 67, is suffering from chronic leukemia in Ventura, Calif. and requires his immune suppressing medication to keep him alive. After his fourth dose of the Moderna vaccine, he did not produce any antibodies.
He is discussing a fifth shot with his doctors, but isn’t sure if he’ll go through with it.
“Right now, my thinking is, why bother? Nothing has happened in these first four shots, why do I think a fifth shot would do something different?” he asked.
Source: NY Times