For some, three COVID shots not enough
If asked to show her vaccine card, Stacey Ricks can choose from three.
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.
Getting her fourth and fifth shots was trickier. By July, pharmacy records in the Houston area where she lives finally showed her prior shots. Armed with a doctor’s note explaining that she hadn’t developed antibodies, 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,’ ” Ricks recalled. “And I said, ‘Hey, I am the clinical data.’ ”
Ricks is one of many people with compromised immune systems in the U.S. who have sidestepped government guidelines and received unauthorized fourth or fifth shots.
The Food and Drug Administration and the Centers for Disease Control and Prevention are in charge of determining when additional doses should be administered, but some patients and their doctors feel that federal agencies have acted too slowly to protect the most vulnerable.
As new variants like omicron arise and vaccination rates continue to be sluggish in many areas, worrying those with weak immune systems, many of them are getting extra shots without being certain of whether they are 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.
But, in order to receive and administer any COVID-19 vaccines, providers must sign a legal agreement with the CDC — meaning that if they break the agency’s rules, they risk being kicked out of the vaccination program and could face prosecution. The CDC also previously warned that providers administering unapproved shots may not have protection from patients’ legal claims if something goes wrong.
Legal experts say the government has done little to enforce compliance with regulations and seems unlikely to pursue punishments for most providers.
People taking the extra shots aren’t doing anything illegal. They could face lawsuits if vaccine providers decide to go after them for lying, but that is extremely unlikely, according to Govind Persad, an assistant professor at the University of Denver Sturm College of Law.
The FDA and CDC did not respond to questions.
Getting extra shots seems to have worked for some — to a degree. After Ricks’ 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 immuwhat nocompromised people — depending on their condition and the medications they take — may never generate an immune system response, no matter how many shots they receive. Doctors and advocates for the extra doses say the United States has a surplus of vaccines, so the alternative is often letting them go to waste.
Higher levels of antibodies seem to correlate to better protection against the virus, but researchers aren’t sure exactly level of protection different numbers of antibodies provide, and the FDA does not recommend that people use antibody tests to gauge immunity.
The CDC estimates that there are around 7 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.
With the blessing of his transplant team, Chris Neblett, who recently moved to Indiana, Penn., got a third shot in April.
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.
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. His data and that of those who also acted outside of official guidelines helped convince the CDC and FDA to authorize third shots for vulnerable groups, according to Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who works on the study. He said hundreds of patients in his study got unauthorized shots.
“They’re acting out of desperation,” he said.
“Rather than say ‘Shame on them,’ I would say ‘Shame on the system we’ve created.’ ”
One potential alternative to more shots involves using monoclonal antibodies to protect patients, said Dr. Lianne S. Gensler, a rheumatologist at the University of California, San Francisco. 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. To make matters worse, omicron rendered some existing monoclonal antibody treatments ineffective.
The FDA approved one longterm preventive monoclonal antibody treatment specifically meant for vulnerable populations in December, but doses may initially be limited.
Meanwhile, people with compromised immune systems ponder their imperfect options.
Patrick VanHorn, 67, of Ventura, Calif., has chronic leukemia and needs his immune suppressing medication to stay alive. He produced no antibodies after his fourth dose of the Moderna vaccine in August.
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.