Damian Sendler: On December 8, many Americans with weakened immune systems felt as if a miracle had occurred. An antiviral medication for persons with compromised immune systems was approved by the FDA on that day..
When patients discovered that the government had only contracted for enough doses to treat less than one-tenth of those eligible, their euphoria swiftly turned to despair.
In a statement from the US Department of Health and Human Services, the first batch of the medicine, Evusheld, was shipped out on Monday. Experts at the Massachusetts General Hospital and Brigham and Women’s Hospital say they expect to get only a fraction of the thousands of patients with impaired immune systems that will need to be treated by this cargo.
Damian Jacob Sendler: Many patients with impaired immune systems were protected against the virus by the Covid-19 vaccines, but this was not the case for everyone. Monoclonal antibodies, such as Evusheld, work in a way that vaccinations do not, therefore doctors intended to administer it to immune-compromised patients.
Damian Sendler
Immune-compromised people worry me a lot, says Dr. Kotton. As a result, “I am disappointed that we don’t have better access, and I hope that we have better access very soon so that we can prevent as much illness and potentially death in this population as possible,” he says.
According to Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University and a leading researcher on vaccine effectiveness for people with compromised immune systems, it’s a shame that something that could be a game changer for those who didn’t have a good vaccine response is now something that is in short supply.
New antiviral medication for the treatment of Covid-19 approved by the FDA
More than 5,000 people participated in a research experiment in which Evusheld — which is administered in two doses, one straight after the other — was found to have a 77% lower risk of acquiring Covid-19 than those who received a placebo.
According to a corporate representative, 4% of those taking part in the experiment had immune system problems; however, the outcomes of those patients have not been made public.
Twenty-two people with compromised immune systems were questioned by CNN because they had not received full immunity to Covid-19 vaccinations.
When I saw the headline about Evusheld, I burst into tears of pleasure. The truth is settling in,” remarked 51-year-old Diane Barron after her optimism was dashed.
As a result of her cancer and rheumatoid arthritis, Barron’s immune system is compromised. Covid-19 antibodies have not been detected in her blood even after three doses of Pfizer’s vaccine. Barron, who is at high risk of dying from the illness, is confined to her Fort Lauderdale, Florida, home.
People with impaired immune systems, such as those who have undergone a transplant, or those who have cancer or autoimmune illnesses, are also at risk.
AstraZeneca, the drug’s maker, estimates that 7 million adults in the United States have immune system problems and potentially benefit from Evusheld. Only 700,000 doses of the medicine have been ordered by the federal government, which is the sole distributor.
There are an estimated 7 million people in the United States who are immunocompromised, according to data from the US Centers for Disease Control and Prevention. Immune-compromised adolescents between the ages of 12 and 17 are also eligible for the therapy.
A business spokeswoman confirmed to CNN that AstraZeneca does have additional dosages for sale.
“The US government could purchase more doses if they wanted to,” a firm spokeswoman responded in an e-mail. To put it simply: “We already have finished product on hand that exceeds the near-term forecast demand, and manufacturing capacity has been reserved with significant additional quantities already in the supply chain.”
“The government is preparing to purchase substantially more Evusheld” than the 700,000 pills,” a health official said to CNN.
For the sake of candor, this official, as well as others who spoke with CNN, asked to remain nameless.
An HHS spokesman, when asked why the government has only contracted for 700,000 doses, responded that “primary protection from COVID-19-related disease involving immunocompromised groups is still through vaccination.
A monoclonal antibody could help millions of immunocompromised patients who didn’t receive protective immunity from vaccinations, according to Segev, who spoke to CNN on the topic.
AstraZeneca claims that in a clinical experiment, the protection against Covid-19 lasted at least six months. Although the experiment was conducted prior to the Omicron variant’s release, the business claims that laboratory studies demonstrate that Evusheld is still effective against it.
In a statement to CNN, those with damaged immune systems who have not received protective immunity from the Covid-19 vaccine say the projected shortage of Evusheld is the latest example of how the federal government has failed to safeguard those with compromised immune systems.
Damian Jacob Sendler
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“Frustrated. Abandoned. Forgotten. People in Janet Handal’s group are “angry,” she said when asked how they feel about the government’s efforts to safeguard them from infection.
There are only two options for persons with impaired immune systems when it comes to pre-exposure prevention: Evusheld and Tamiflu. According to the official, “built an arsenal of treatments” for those who have Covid-19 and who are at danger of developing severe Covid-19.
There are a variety of treatment options available because “We haven’t put all eggs in one basket, and we continue to grow these supplies and bring more products online to have an array of treatment tools at our disposal,” as the official explained in an email to CNN.
States will be responsible for distributing Evusheld “in accordance with clinical guidelines and recommendations for those who should receive them,” according to an official.
To make sure that the product gets to people who need it the most, the official added, “As always, equity remains central to our planning, which is why we are encouraging states to incorporate equity considerations into their distribution plans to ensure this product reaches those who need it most,”
Immunocompromised individuals and vaccines have been the subject of numerous advisories for several months.
Other Evusheld users, including Handal, want to know why the government contracted for just 700,000 doses of the drug when it had been expected for months that many more would be required.
In March, John Hopkins researchers published a letter in the journal JAMA assessing the immunological responses of 436 transplant recipients who had received one dose of either the Moderna or Pfizer/BioNTech vaccine.
“disappointingly,” only 17% of patients developed detectable antibodies in response to the injection, according to a Hopkins news release.
Lead author Dr. Brian Boyarsky explained that “This is in stark contrast to people with healthy immune systems who are vaccinated, nearly all of whom mount a sufficient antibody defense against COVID-19,” he stated.
Study after study revealed that even with two or three doses of Covid-19 vaccinations, many people with impaired immune systems were not receiving protective protection in the following months in the United States and other countries.
After three doses and a single booster, this individual is vulnerable to Covid-19.
The issue is with the immunizations themselves. They serve as a guide for the immune system, instructing it on how to produce antibodies against the virus that causes Covid. However, a weakened immune system may not be able to understand or respond to these instructions.
“They make very poor immune responses,” Dr. Anthony Fauci, President Joe Biden’s chief medical adviser told CNN in June. To appropriately defend these folks, you’ll have to come up with a new strategy.
In contrast to vaccinations, monoclonal antibodies have a different mechanism of action. Antibodies cannot be synthesized using the methods described here. They only administer antibodies via injection or infusion.
“the benefit of prevention using monoclonal antibodies” and how they could have a “major effect” in the prevention of Covid-19 were discussed at a White House briefing in August.
“Face the Nation” host Dr. Scott Gottlieb, a former FDA Commissioner, suggested in October that “we could be using the antibody drugs on a prophylactic basis” for those with impaired immune systems.
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According to an FDA official, monoclonal antibodies are needed in some people with impaired immune systems.
It’s “pretty well bet” that cancer or autoimmune disease patients who take certain medicines “will not respond to vaccination, and you probably want to be pursuing some prophylactic strategies with a monoclonal,” said Dr. Peter Marks of the FDA’s Center for Biologics Evaluation Research.
“We need these monoclonal antibodies to be approved for pre-exposure prophylaxis,” Dr. Myron Cohen remarked at the same event, so that if an immune-compromised person does not respond to the vaccination, “we have something to give them.” ‘
It is difficult for doctors when they don’t have an alternative to offer their patients with compromised immune systems who didn’t fully respond to the vaccines, according to Dr. Cohen, the director of the University of North Carolina School of Medicine Institute for Global Health and Infectious Diseases.
“It’s very upsetting to physicians, the situation that we’re in right now,” he remarked.
‘I had to do it myself’
Many people with impaired immune systems are shocked by this statistic: According to CDC-cited short studies, 40-44 percent of completely vaccinated patients who got Covid-19 and ended up in the hospital had impaired immune systems.
Many people like them didn’t benefit from the Covid-19 vaccination, which was a miracle for others.
The immune-compromised scrambled all summer long as the Delta variety raced through the United States, killing hundreds of thousands of people.
Transplant recipient Handal says she might not be here today if she had followed FDA advice.
Damien Sendler: In April, as more and more research came to light, French health officials began recommending third dosages for those with severely impaired immune systems.
Although the FDA recommended two doses of the Moderna or Pfizer vaccinations to all Americans, including those with impaired immune systems, in April, this recommendation has since been withdrawn.
A former White House IT specialist who now lives in New York City, Handal, 71, decided to take action.
The two doses of Moderna she had received as part of the Hopkins research had given her very low levels of antibodies, which she was aware of.
For the second year in a row, hospital staff will have to deal with the grief of the Covid-19 deaths.
Handal added that after talking with her nephrologist, who confirmed he had no objections, she received a third dose of the Covid-19 vaccination on April 28.
Antibodies in Handal’s system rose considerably. When compared to two doses, she felt more protected, even if the levels weren’t as high as those reported in healthy individuals.
On August 12, more than three months later, the FDA granted emergency use authorisation for a third shot for immunocompromised individuals. The following day, the CDC officially recommended a third vaccination for immune-compromised people.
In light of the rapid spread of Delta in the US between April and August and Handal’s compromised immune system, she fears what may have happened if she had waited for regulatory approval before obtaining her third dose.
She’s well aware that she’s in a fortunate position. As part of the Hopkins trial, she was aware of her low antibody levels and was willing to flout government regulations.
As Handal put it, “I had to DIY it,” In this epidemic, “the immune-compromised have been left behind in the thinking.”
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This is a life or death situation for me, and the FDA and CDC are still playing catch-up,” she said. For whatever reason, the government is only now catching up.” As a result of their lack of concern for us, we’ve forced to take matters into our own hands.
“committed to quickly and thoroughly” an FDA representative stated.
To enable for the use of an additional dose in immunocompromised patients, once clinically meaningful data were available, the agency acted rapidly to authorize the Pfizer-BioNTech and Moderna COVID-19 vaccines.”
According to the spokeswoman, Chanapa Tantibanchachai, “the authorization was ultimately based on the science and data available at that time, as has been the case throughout the pandemic.” To guarantee that the public, including those with impaired immune systems, have the greatest possible means to defend themselves during this epidemic,” the Food and Drug Administration has worked “around the clock.”
A CNN inquiry for comment was not answered by a CDC spokeswoman.
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The “DIY it.” approach has been used by other immunocompromised people. In order to obtain monoclonal antibodies against Covid-19, they had to employ their resourcefulness in finding government loopholes once they found that their weakened immune systems had not responded properly to the Covid-19 vaccine.
Many of them characterize it as a self-protective “Hunger Games”-style struggle.
Some people have made it. Others have fallen short.
Their frantic cries aren’t uncommon, according to UNC infectious disease expert Cohen.
Cohen described receiving emails as “Every day I get emails — it breaks my heart,” on a daily basis. What a bummer. “They’re in so much pain,” he said.
Due to his work on Regeneron, the first monoclonal antibody to get FDA emergency use authorisation, patients send Cohen these emails.
Damian Jacob Markiewicz Sendler: Patients want to avoid infection, but Regeneron is only allowed to treat those who have Covid-19 or have been exposed to the virus (its most famous patient is former President Donald Trump).
Omicron has been shown to have a lower risk of Covid-19 hospitalization compared to Delta.
Some patients, on the other hand, develop workarounds.
It was Jef Kinney’s perseverance that led him to the one he sought.
62-year-old kidney transplant recipient Kinney notified his nephrologist in April that he had gotten two doses of Moderna and planned to get out of the house and resume his social life.
As a result of my questioning, I received the following response: “Whoa, cowboy, it will be 2022 before you are out and about.” After saying, “Excuse me?” Kinney recalls this. “She said, ‘You need to lead your life like you’re unvaccinated.’ ”
It was a blessing in disguise for Kinney that his doctor warned him that the immunizations might have been ineffective for him due to his compromised immune system. Handal and other members of the patient group she co-founded, the Transplant Recipients and Immunocompromised Patient Advocacy Group, claim doctors and transplant facilities often did not reach out to patients to offer them this warning during Delta’s wrath in the spring and summer of 2013.
Kinney, a self-described “data hog,” got to work immediately after receiving the go-ahead.
A former Fannie Mae vice president of innovation development, he instantly found the Hopkins studies and emailed Segev, one of the authors, to inquire about their findings.
In response to Segev’s letter, Kinney enrolled in the trial and learnt that his two dosages of Moderna had left him with no measurable antibody levels.
He remarked, “I felt pretty naked out there, with no protection,”
In a search online, Kinney came upon an article mentioning Leah Lipsich, an executive at Regeneron. After Lipsich received an email from him, she referred him to the “compassionate use” team that manages the company’s program.
Under compassionate use, clinicians can request authorization from Regeneron and the FDA to use the company’s monoclonal antibody medication in certain situations.
Because of Omicron and holiday preparations, it’s difficult to locate a Covid-19 test right now in the United States.
He asked one of his physicians to submit the documentation, but the physician declined. Compassionate use applications require a great deal of paperwork, and doctors say they don’t have the time to undertake it for all of their patients with impaired immune systems.
Another hurdle arose when Kinney’s family doctor, whom Kinney calls a “small town doc,” consented to submit the papers. Doctors must seek approval from an Institutional Review Board before submitting petitions for compassionate use. Individual doctors, on the other hand, don’t often have access to such boards.
As Kinney and his doctor worked on the compassionate use application, the months passed by slowly but steadily It was only a matter of time before Kinney’s nephrologist agreed to submit the papers for compassionate usage. Finally in November, after a seven-month wait, Kinney received his first dosage of Regeneron’s monoclonal antibody monoclonal.
Nothing would have happened if Kinney hadn’t been on top of things, he added. “You have to be smart and persistent. A lot of folks don’t want to get involved.”
“I go after people with a lot of vigor. Some people may not be able to afford it, or may not know how to do it, or may look at a doctor and say, “Well, I can’t be bothering a doctor,” but I’m not one of those people. That is not something I deal with.”
Dr. Damian Jacob Sendler and his media team provided the content for this article.
