Judy Salins is a smart and empowered patient. But, until this week she didn’t know that the medication she takes to protect herself from Covid-19 wasn’t as effective as it once was.
Salins stated, “I was shocked to learn this.” Salins said, “What should I do now?”
Evusheld is the name of the medicine. Its effectiveness is declining dramatically as new Covid-19 subvariants take center stage. The drug does not neutralize all of them.
More than half of all new Covid-19 infections occurred in the week that ended November 5.
Salins stated that she had not heard of the fact that Evusheld was less protective than previously acknowledged by government health officials for over a month.
Salins, a former high school teacher, said that “I believe this is shameful.” “Getting Covid-19 for immune-compromised individuals like me can be a death sentence. So I am appalled that nobody told me.”
Evusheld is all that stands between Salins and the virus. Her blood tests revealed that her vaccines did not produce antibodies. This is not an unusual problem for people with a weak immune system.
Evusheld is a preventive medicine that helps to prevent Covid-19 infection in approximately 7 million Americans.
The group’s advocates claim that the government has not done enough to spread the word about the group and that many vulnerable people are unaware of the fact that the medicine’s effectiveness is declining in the face of the new subvariants. People who use Evusheld may need to take extra precautions to avoid crowds and wear masks regularly as the power of Evusheld is decreasing.
“I am concerned that there are a large number of people who don’t know the changes in the world. “I’m very worried about that,” Dr. Brian Koffman said, chief medical officer at the CLL Society. The society serves patients with chronic lymphocytic leukemia.
He said, “The tide is coming and we have to let people know that they are no longer as protected”
Koffman is so concerned that Covid-19 could cause a “winter” of discontent in immune-compromised patients, he says.
Another advocate for the immune-compromised claims that health officials aren’t taking seriously their responsibility to the immune-compromised as public health officials.
Janet Handal, co-founder, and president of Transplant Recipients & Immunocompromised Patients Advocacy Group said that “This is a perfect storm”: People will travel and want to be with each other and won’t realize they aren’t protected by their Evusheld.
She referred to the US Centers for Disease Control website, where she briefly mentioned that Evusheld is less protective.
A spokesperson for the US Department of Health and Human Services stated that Evusheld’s declining efficacy was shared by the US Food and Drug Administration with “more than 350 organizations representing health professionals, patient advocates and pharmacies and key contacts in fighting COVID-19”. The information was posted on the US Department of Health and Human Services’ Twitter and Facebook accounts.
CDC Director Dr. Rochelle Walensky and Dr. Ashish Jha (White House coronavirus response coordinator) have briefly discussed the fact that Evusheld’s effectiveness has declined over the past weeks during public events.
“We should do better”
Salins stated that she does not keep her eyes on the FDA’s social media accounts, or watch White House briefings. Salins claims that her family doctor who prescribed Evusheld has not gotten in touch with her to tell her it isn’t working as well as she didn’t hear anything from her rheumatologist.
Salins is a Missouri resident, and the new subvariants Evusheld cannot neutralize are quickly taking over. According to CDC data, those subvariants are increasing rapidly in New York City and New Jersey.
Ten large hospitals were contacted, five in New York City and five in New Jersey. Only one of them said that it is reaching out to patients who have received Evusheld to inform them that their medicine is not working.
According to a Northwell spokesperson, Northwell Health is reaching out to patients by phone and in writing “to inform them of the diminishing efficacy” of Evusheld. Patients are also being told by Northwell Health that while the treatment may not offer as much protection, it is better than none at all. This message was repeated by the FDA.
Salins, 70 years old, stated that she is lucky to attend church with Robyn Bramble, director of scientific affairs at the CLL Society. Brumble, who wrote about Evusheld’s declining efficacy is the one who warned Salins.
Salins now knows her medication isn’t working as well, and she can take steps toward being more cautious. Salins might cancel a planned trip to Mexico with her husband. She may not be able to attend the indoor sporting events of her grandchildren or attend church. If she does, she will wear an N95 mask.
Salins is concerned about immune-compromised friends who might not be so lucky to have an expert friend.
She said that many people in the US are immune-compromised like her and that they have let us go about, flitting around, and not knowing” about Evusheld’s declining effectiveness.
Dr. S. Shahzad Mustafa is an allergist and clinical immunologist at the University of Rochester Medical College. He said that the whole health care system needed to do a better job of informing patients with compromised immune systems that many of the subvariants are not Evusheld.
Mustafa stated, “It’s not a service.” “We should do more.”
Mustafa works as a consultant for AstraZeneca (the company that produces the drug) and is paid for his services.
A spokesperson for AstraZeneca stated that the company was “developing a next-generation monoclonal antibody to neutralize currently circulating and future variants of concern.”
“Scrabble variants” are dominating
The National Institutes of Health revised its Covid-19 treatment guidelines on October 19. It stated that five subvariants were “likely to resist” Evusheld. These five subvariants, namely BA.4.6, BA.2.75.2, and BF.7 respectively, were responsible for approximately 55% of all new infections in the US over the last week.
Evusheld is also possible in BA.5, a subvariant. According to the CDC, it was responsible for 39% of all infections in the US during the week ending November 5.
BA.5 is fast disappearing. It was responsible for 51% of all infections the week before.
According to CDC data, 69% of new infections occurred in New York and New Jersey where the “Scrabble” variants are taking over. BA.5 – the subvariant in which Evusheld still has power – is responsible for 25% of all new infections. It has been dropping steadily each week.
“My alarm bells wouldn’t go off”
Evusheld’s decline in power has been well-reported by government officials.
A spokesperson for HHS said that the FDA sent its first warning to patients on October 3, and then shared it with other advocacy and medical groups. HHS’s Administration for Strategic Preparedness and Response has shared this information with its weekly engagements, which include healthcare providers, medical organizations, and advocates for the immune-compromised. The Evusheld information has been shared by the HHS Office of Intergovernmental and External Affairs with both state and local governments, as well as medical providers and advocacy organizations.
The CDC has made available information on Evusheld, as well as the new variants, to healthcare providers and patients via its website. Walensky, director of the agency, stated that some Covid subvariants “do not evade our monoclonal antibody,” which included Evusheld, at a US Chamber of Commerce event on November 1.
Jha, White House Covid coordinator, stated that some of the tools used to protect immunocompromised patients, such as Evusheld and the other main tools, might not be effective in the future. That’s a big challenge.
However, Handal, the co-founder of the immune-compromised support organization, says that is not enough.
She pointed out the CDC page on patients. “Evusheld is protective, but may offer less protection for certain strains Omicron variant.”
“If I read this, it would make my alarm go off.” She said that this is not something a patient would read and then say, “I have to change my Christmas plans.” “The CDC must explain to patients in layman’s terms the changes and what it means for them.
Handal, a technology specialist who worked in the White House during Clinton’s administration, criticized the CDC page for healthcare providers as too complicated and indirect.
This page informs providers that Evusheld could have reduced efficacy against Omicron BA.4.6, BF.7, and BA.2.75 Sublineages with substitutions for spike protein 346.”
She stated that “Regular doctors won’t understand the spike and blah blah blah,”
Handal provided an alternative plan. Because many people are immune-compromised due to the medications they take, and pharmacies and insurance companies are aware of patients’ prescriptions, the government needs to ask these groups to inform people that Evusheld is no longer as powerful.
Medicare, the federal insurance program for health, covers a large number of immune-compromised patients. A spokesperson for the Centers for Medicare & Medicaid Services responded to an inquiry by sending a statement. It includes a link that takes you to a CMS website that links to an FDA factsheet for healthcare providers. It states on page 18 that there is a risk of treatment failure because of the resistance to [Evusheld]. When considering prophylactic treatment options, prescribing healthcare providers must consider the presence of SARS-CoV-2 variants within their locality.
A depressing message
For the immuno-compromised, it gets worse
If their Evusheld is not able to protect them and they contract Covid-19 they will need to stop taking the antiviral drug Paxlovid. This is because they could be allergic to other drugs.
According to the FDA, there is a second Covid-19 treatment. It is a monoclonal anti-mouse antibody called bebtelovimab. However, it is not expected to neutralize BQ.1 or BQ.1.1 subvariants. According to the CDC, those two strains accounted for 35% of all new infections in the US during the week ending November 5.
New treatments won’t be coming any time soon.
Jha stated last month that even if we had money now, it would take many months to bring monoclonals on the market. And we don’t have any money right now.”
Koffman, CLL Society’s medical director, is now trying to spread the message to immuno-compromised patients that they must “go back to basics” to “mask up” since “no variant can outsmart anN95 mask.”
He said that it was not easy to hear his message.
Many people with immune problems found relief when Evusheld was made available at the beginning of last year. After two years of lockdown, they finally felt secure enough to leave their home and visit family and friends.
Koffman stated that it was a “get out of jail free” card for the immune-compromised population.
He said that now those immune-compromised patients have learned that the medicines that used to work so well for them are no longer effective, they’re “crestfallen”.
He is concerned about the physical health and well-being of those with immune problems who don’t realize they need to be more cautious, but he also worries about their mental health.
He said, “They become depressed because of their inability to do things.” “So now, I worry about both.”