More people are receiving unapproved fourth doses of the Covid-19 vaccine

If asked to show her vaccination card, Stacey Ricks can choose from three.

Ms Ricks, 49, a kidney transplant recipient who takes immunosuppressive drugs, did not develop antibodies after her first two injections of Moderna.

In June, without revealing that she had already received the Moderna injections, she received a dose of the Johnson & Johnson vaccine before federal health officials approved someone for a third injection.

Getting his fourth and fifth shots was trickier. In July, pharmacy records in the Houston area where she lives finally showed her previous shots. Armed with a doctor’s note explaining that she had not developed antibodies, Ms Ricks convinced a pharmacist to give her two doses of the Pfizer-BioNTech vaccine over the summer.

“She kept saying, ‘There is no clinical data here,’” recalls Ms. Ricks. “And I said, ‘Hey, I got the clinical data. “

Ms. Ricks is one of many people with weakened immune systems in the United States who circumvented government guidelines and received an unauthorized fourth or fifth injection.

The Food and Drug Administration and the Centers for Disease Control and Prevention are responsible for determining when additional doses should be given, but some patients and their doctors believe federal agencies have acted too slowly to protect the most vulnerable.

Israel has already started rolling out fourth injections – Prime Minister Naftali Bennett on Sunday announced the country will offer additional injections to people aged 60 and over, as well as medical staff, becoming the first country to deploy a booster additional as widely.

By comparison, the CDC updated its guidelines in late October to say that immunocompromised groups would be eligible for a fourth dose six months after a third. For those who followed the rules, the first eligibility for a fourth would be at the end of February.

But as new variants like Omicron emerge and vaccination rates continue to be slow in many areas, worrying those with weakened immune systems, many are given additional injections without being certain of their safety. or their effectiveness.

Typically, doctors have the discretion to use approved drugs outside of their recommended uses – so a fully approved vaccine like that from Pfizer could normally be prescribed as doctors see fit.

But, to receive and administer Covid-19 vaccines, providers must sign a legal agreement with the CDC – meaning that if they break agency rules, they risk being kicked out of the vaccination program and could. be prosecuted. The CDC has also previously warned that providers administering unapproved injections may not be protected against legal claims from patients if something goes wrong.

Legal experts say the government has done little to enforce the regulations and seems unlikely to impose penalties on most suppliers.

The people who take the extra hits are not doing anything illegal. They could face civil lawsuits if vaccine suppliers decide to prosecute 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 additional photos seems to have worked for some – to some extent. After Ms Ricks’ fifth injection, her doctor sent her a note stating that she had developed a “moderate” antibody response, but “still not a typical response”. She continued to take extra precautions as if she was not vaccinated.

Researchers say that some people who are immunocompromised – depending on their condition and the medications they are taking – may never generate an immune system response, no matter how many injections they receive. Doctors and extra-dose advocates say the United States has a surplus of vaccines, so the alternative is often to let them go to waste.

Higher levels of antibodies appear to correlate with better protection against the virus, but researchers aren’t sure what level of protection different numbers of antibodies provide, and the FDA doesn’t recommend people using tests. of antibodies to assess immunity.

The CDC estimates that there are around seven million immunocompromised people in the country, but it’s unclear who will benefit from additional doses, according to Dr. Robert Wachter, chairman of the Department of Medicine at the University of California at San Francisco. .

“It’s, at this point, probably more improvisation than science,” he said.

With the blessing of his transplant team, Chris Neblett, who recently moved to Indiana, Pa., Received a third injection in April.

Mr Neblett, 44, was unsure if this might help – the medications he takes for his kidney transplant suppresses his immune system and prevents him from generating antibodies after two injections of the Pfizer vaccine.

“Of course we were bending the rules, but what was the repercussions? ” he said. “There really weren’t any.

He generated low levels of antibodies after his third injection of Pfizer, but it wasn’t until his fourth injection in November that his antibody levels matched the response of a normal, healthy individual.

Mr Neblett believes his bet has served the greatest good – he’s enrolled in a Johns Hopkins Hospital study on organ transplant patients’ responses to coronavirus vaccines. His data and that of those who have also acted outside official guidelines have helped persuade the CDC and the FDA to allow third injections for vulnerable groups, according to Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who working on the study. He said hundreds of patients in his study received unauthorized injections.

“They are acting out of desperation,” he said, adding: “Rather than saying, ‘Shame on them,’ I would say, ‘Shame on the system we have created.’ “

While there may be risks for additional injections, such as overstimulating the immune system, Dr Segev said the risks can be watched carefully. Generally, he said, his data shows that additional doses of the vaccine should be safe and may work in some cases.

“If three doses didn’t work at all, we should probably be looking at something different for that fourth dose,” said Dr Segev.

One example, he said, is trying to cut back or stop immunosuppressive drugs before giving extra doses if possible. He is one of many doctors to complain that the CDC’s guidelines are too rigid and prevent healthcare professionals from treating patients on a case-by-case basis.

Karen Pearce’s doctor wrote her a note stating that the timing of her recall “MUST be done before her next chemotherapy infusion,” a treatment she needs every six months to control life-threatening inflammatory blood vessel disease.

But Ms Pearce, 69, of Gettysburg, Pa., Will not be eligible for a fourth injection until February, right after she is supposed to receive her next infusion, which she and her doctor say would render her fourth injection unnecessary. This recall took on increased importance with Omicron, but no supplier agreed to give it to it a month earlier.

“More flexibility in their advice could save lives, maybe mine,” she said.

Other experts say there are limits to the flexibility of advice. Getting extra doses too soon could be counterproductive, according to Shane Crotty, a professor at the Center for Infectious Diseases and Vaccines at the La Jolla Institute of Immunology.

This is because the immune system’s long-term memory seems to work better if it can rest between vaccines, he explained, and the body takes months to perfect its antibody-making process after an initial vaccination. .

One potential alternative to multiple injections is to use monoclonal antibodies to protect patients, said Dr. Lianne S. Gensler, rheumatologist at the University of California, San Francisco. Most treatments with monoclonal antibodies have been rare, which means that they have only been used as post-exposure treatment instead of a preventive measure. To make matters worse, Omicron has rendered some existing monoclonal antibody treatments ineffective.

The FDA approved long-term preventive monoclonal antibody therapy specifically for vulnerable populations in December, but doses may initially be limited.

Meanwhile, people with weakened immune systems are pondering their flawed options.

Patrick VanHorn, 67, of Ventura, Calif., Has chronic leukemia and needs his immunosuppressive drugs to stay alive. He did not produce any antibodies after his fourth dose of Moderna vaccine in August.

He discusses a fifth shot with his doctors but is not sure if he will.

“Right now my thought is, why bother? ” He asked. “Nothing happened in those first four shots. Why do I think a fifth hit would do anything different? “

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