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Covid restrictions fuel anger from far-left and far-right in Europe. Doctor: South Africa has seen 'uncoupling' of Omicron infections and deaths. How do Ghanaians feel about travel restrictions? Hear from public health expert. Travel restrictions continue around the globe due to Omicron variant. In April, Kinney, 62, a kidney transplant recipient who lives in Oxford, Maryland, told his nephrologist he'd received two doses of Moderna and planned to get out of the house and start being social again.
Kinney was lucky that his physician advised him that because of his weak immune system, the vaccines might not have been very effective for him. Handal and many other members of the patient organization she co-founded, the Transplant Recipients and Immunocompromised Patient Advocacy Group, say last spring and summer, as Delta raged, doctors and transplant centers typically did not reach out to patients to give them this warning.
Fully advised, Kinney, a self-described "data hog," got to work. A retired vice president at Fannie Mae of innovation development, he's accustomed to doing research, and quickly found the Hopkins studies, and emailed Segev, one of the authors.
Segev wrote back, and Kinney joined the study and learned he did not have any detectable antibodies from his two doses of Moderna. Kinney found an article online that mentioned Leah Lipsich, an executive at Regeneron. He sent her an email, and Lipsich connected him to the team that runs the company's "compassionate use" program. Under compassionate use, doctors can ask Regeneron and the FDA for permission to use the company's monoclonal antibody drug under certain circumstances. Finding a Covid test is a struggle right now in the US as Omicron and holiday plans collide.
Kinney asked one of his doctors to submit the necessary paperwork, and the doctor declined. Other immune-compromised people said their doctors also turned them down because compassionate use applications involve paperwork, and the doctors told them they did not have time to do it for all their immune-compromised patients.
Kinney's family physician, whom he describes as a "small town doc," agreed to submit the paperwork, but then he hit another snag. For compassionate use applications, doctors are required to get permission from an Institutional Review Board.
While medical centers have such boards in-house, typically individual doctors don't. Months passed as Kinney and his doctor worked on the compassionate use application.
Then Kinney received an email that his nephrologist, who works at a large medical center, had agreed to submit his paperwork for compassionate use. Kinney finally received his first dose of Regeneron's monoclonal antibody in November, after a seven-month effort to get the drug.
It's a hard slog to get people to engage. I realize there are people who don't have the resources to do that, or who don't know how to do that, or would look at a doctor and say, 'Well, I can't be bothering a doctor.
Cancer patient finds another loophole. Lisa Wiest managed to get monoclonal antibodies to prevent Covid because she knows how to think on her feet. Wiest, who has chronic lymphocythic leukemia, learned last spring that her Covid vaccinations had given her barely detectable levels of antibodies.
While her friends and family were getting protection from their vaccines, Wiest, who was 50 at the time, felt vulnerable and unprotected. In August, Wiest, a federal employee who lives in Rochester, New York, heard that the state of Florida had set up clinics to give monoclonal antibodies. On a trip to visit a friend there in September, she went to a clinic in Clearwater that was offering Regeneron's antibodies to qualified patients.
Wiest told the nurse at the clinic that she had a blood cancer and had received very little antibody response to her first two shots. She thought that would be enough to get the Regeneron infusion. It wasn't. In the US, Regeneron is only authorized to treat certain people who have Covid or who have been exposed to the virus, meaning they have been within six feet of someone with Covid for a total of 15 minutes or more. Wiest didn't fall into either category. Cleveland-area hospitals battling latest Covid surge put ad in local paper that reads: 'Help'.
But the FDA left some wiggle room, and Wiest jumped on it. The FDA allows someone to get Regeneron if they are immune-compromised and are "in the same institutional setting" as people who have Covid, "for example, nursing homes or prisons. The wiggle room patients have found is in the phrase "for example" -- someone doesn't have to actually be in a nursing home or prison to be eligible to get the drug.
Wiest explained to the nurse that her husband is a pastor, and since Covid was rampant in their community, potentially she was exposed every Sunday in church.
That didn't cut it. Then she told the nurse that she'd just gotten off a three-hour flight. Wiest says that did the trick. The nurse gave her an infusion of Regeneron's monoclonal antibodies. While relieved to get the medicine, Wiest wishes the federal government would make it easier for people like her to get protected against Covid Omicron prompts new confusion over what's safe and what's not. We're a small group, but we're genuinely upset that the vaccine didn't work for many of us.
Even with Evusheld, we're going to have to fight and advocate for ourselves," she said. The state of Florida did not return emails from CNN asking about standards at the state-run clinics. In early June, Regeneron asked the FDA to expand its emergency use authorization to include prevention for everyone who is immune-compromised, according to Dr. George Yancopolous, Regeneron's president and chief scientific officer. Chanapa Tantibanchachai, the FDA spokesperson, said the agency is "committing to quickly and thoroughly reviewing all submitted applications, including requests for Emergency Use Authorization, to speed patient access to medicines to prevent or treat COVID provided they meet the agency's rigorous standards.
A Christmas miracle. Much has changed since Kinney and Wiest fought to get monoclonal antibodies this summer and fall. Evusheld, however, retains neutralizing ability against the highly transmissible variant, according to AstraZeneca.
As immune-compromised patients wait to see if they'll be one of the relatively few to get a dose of Evusheld, all doctors can do is tell their immune-compromised patients to be careful about masking and social distancing -- and to get vaccinated.
In October, the CDC told the immune-compromised they may get a fourth shot at least six months after their third shot of Pfizer or Moderna. Even though immune-compromised people often don't have a robust antibody response to the vaccine, it's still important to get vaccinated because the shots could help improve other parts of the immune system besides antibodies that are more difficult to measure, Segev said.
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