Experts have been in a race against the clock since the beginning of the pandemic: First, to develop vaccines and treatments, and now to keep up with the rapidly evolving virus.
That’s why it comes as no surprise that the efficacy of preventive measures such as Evusheld may shrink as the virus changes, too. Evusheld is a drug produced by AstraZeneca that contains tixagevimab and cilgavimab — monoclonal antibodies packaged and administered together, per the U.S. Food and Drug Administration.
“All viruses can mutate and escape the immune system, which is how they try to get ahead,” says Camille Kotton, MD, Clinical Director of Transplant and Immunocompromised Host Infectious Diseases at Massachusetts General Hospital. “We see this with many different viruses, including COVID-19.”
In a recent statement, the National Institutes of Health (NIH) noted that the COVID-19 subvariants BA.4.6, BA.2.75.2, BA.5.2.6, BF.7, BQ.1, and BQ.1.1 are likely to be resistant to Evusheld.
These subvariants are currently estimated to cause more than 45 percent of COVID-19 infections in all regions of the United States.
“I’m definitely seeing breakthrough infections from people who have been well-vaccinated, on Evusheld, and are immunocompromised,” says Dr. Kotton. “I think it’s going to be a potentially hard winter for immunocompromised patients, especially with the three different viruses circulating — COVID-19, influenza, and RSV.”
The recent update on Evusheld’s efficacy is of particular importance to those who are immunocompromised, since these individuals may have relied on it as another layer of protection against COVID-19.
“This news has a big impact, because up until this point, immunocompromised patients had this back-up plan in case their immune systems weren’t robust enough to reflect an effective antibody response against the virus,” says Priya Nori, MD, Associate Professor in the Department of Medicine (Infectious Diseases) at Montefiore Health System. “Although the vaccines exert their impact in a number of ways, not just antibodies, the antibody response is what we can measure — and that’s what Evusheld was providing. It had been doing a great job until very recently.”
Here’s what this news means for you if you are immunocompromised — and the four steps you should take next.
Still Talk to Your Doctor About Getting Evusheld
Although the efficacy of Evusheld is waning with the evolution of new variants, some protection is still better than none. The NIH COVID-19 Treatment Guidelines Panel continues to recommend the use of Evusheld for individuals who are eligible — including those with medical conditions or treatments that may result in moderately to severely compromised immune systems.
This includes patients actively being treated with high-dose corticosteroids (i.e., 20 or more milligrams of prednisone or equivalent per day when administered for two or more weeks), tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory, per the U.S. Centers for Disease Control and Prevention (CDC).
Here’s how monoclonal antibodies work: The lab-made proteins mirror the immune system’s ability to fight off viruses and other harmful pathogens. In particular, Evusheld targets the spike protein of SARS-CoV-2, blocking the virus’ attachment to and invasion of your cells.
Currently, Evusheld is the only preventive agent authorized by the FDA for use in those who are not expected to mount an adequate immune response to COVID-19 vaccination (or for those who have contraindications for the vaccines, like an allergy).
“If I told you your seatbelt in your car was half as effective this week as it was a month ago, you’d still wear your seatbelt, because it seems reasonable,” says Dr. Kotton. “Evusheld still covers some strains.”
However, depending on your condition and how accessible Evusheld is for you, your doctor can provide more detailed guidance on if it is worth it for you at this time. A health care provider may take into account the regional prevalence of the resistant subvariants, your individual risks, and available resources.
Get the Bivalent Booster Shot
This year, the FDA authorized bivalent formulations of the COVID-19 vaccine for use as a single booster dose at least two months after a primary or booster vaccination.
Bivalent means a vaccine works by stimulating an immune response against two different antigens. The bivalent COVID-19 boosters contain the original SARS-CoV-2 strain and another strain common between the BA.4 and BA.5 lineages of the omicron variant, per the FDA.
The CDC recommends getting the updated COVID-19 bivalent booster from Pfizer (for those ages 12 and older) or Moderna (for those ages 18 and older). Although these booster shots are from Pfizer and Moderna, you can still receive them if you got a Novavax or Johnson & Johnson primary series.
“If you have not gotten the bivalent booster yet, now is absolutely the time, because we’re looking at a pretty bad winter respiratory viral season,” says Dr. Nori.
In a new study published in the CDC’s Morbidity and Mortality Weekly Report, researchers looked at symptomatic adults who received testing for SARS-CoV-2 infection at pharmacies nationwide from September 14 to November 11, 2022. They found that bivalent mRNA vaccines provided additional protection against infection compared with previous vaccination with two, three, or four monovalent vaccines alone.
What’s more, the relative benefits of a bivalent booster (compared to the previous vaccine doses alone) increased with time since the receipt of the last monovalent dose. These results are the first published estimates of vaccine effectiveness for the newly authorized bivalent mRNA booster vaccines.
“There’s no question in my mind that it’s effective,” says Dr. Kotton. “Everybody who hasn’t had COVID-19 in the past three months or hasn’t had a vaccine in the last two months needs the vaccine.”
Talk to Your Doctor About Treatment Options
Given you may have less protection from Evusheld as an immunocompromised patient, it’s more important than ever to have a clear plan of action in place with your doctor should you get infected with COVID-19.
For the treatment of mild to moderate COVID-19 in non-hospitalized adults who are at high risk of progressing to severe COVID-19, the NIH continues to recommend Paxlovid (first preference) and Remdesivir. Paxlovid is an antiviral pill from Pfizer that inhibits the SARS-Cov-2 protein from replicating, while Remdesivir is an intravenous drug that requires infusions for three consecutive days.
Alternative therapies should only be used when neither Paxlovid or Remdesevir are available, feasible to use, or clinically appropriate, per the NIH. These alternative drugs include bebtelovimab (only for when the majority of circulating Omicrons subvariants in the region are susceptible), which is a monoclonal antibody developed by AbCellera and Eli Lilly, and molnupiravir — an antiviral pill created by Merck.
Continue Taking Standard COVID-19 Precautions
You still have plenty of control over the individual steps you take to protect yourself from infection this winter — which are the standard mitigation efforts you’ve heard about since the beginning of the pandemic.
“We’re going to have to stick with the basics for the next couple months to ride out this potentially rough winter with multiple viruses — and hope that newer antibody-based therapies may at some point be available,” says Dr. Nori.
Continue to wear high-quality face coverings like N95 or KN95 masks (it’s especially important for you to do this on an individual level, since much of the general population is no longer masking), avoid crowded or poorly ventilated spaces, and maintain hand hygiene. Read more about how to protect yourself against COVID-19 during the 2022 holiday season.
“What immunocompromised individuals now have are the vaccines, including the updated bivalent booster, and their own autonomy to continue to mask and avoid certain crowded situations or conditions,” says Dr. Nori. “You have to fall back on those, especially during a time now in which most other people have abandoned those basic public health interventions.”
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CDC Recommends the First Updated COVID-19 Booster. CDC Newsroom. U.S. Centers for Disease Control and Prevention. September 1, 2022. https://www.cdc.gov/media/releases/2022/s0901-covid-19-booster.html.
Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose. U.S. Food & Drug Administration. August 31, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use.
Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals. U.S. Food & Drug Administration. December 8, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure.
The COVID-19 Treatment Guidelines Panel’s Statement on Omicron Subvariants, Pre-Exposure Prophylaxis, and Therapeutic Management of Nonhospitalized Patients With COVID-19. COVID-19 Treatment Guidelines. National Institutes of Health. November 10, 2022. https://www.covid19treatmentguidelines.nih.gov/therapies/statement-on-omicron-subvariants/.
Interview with Camille Kotton, MD, Clinical Director of Transplant and Immunocompromised Host Infectious Diseases at Massachusetts General Hospital.
Interview with Priya Nori, MD, Associate Professor in the Department of Medicine (Infectious Diseases) at Montefiore Health System.
Link-Gelles R, et al. Effectiveness of Bivalent mRNA Vaccines in Preventing Symptomatic SARS-CoV-2 Infection — Increasing Community Access to Testing Program, United States, September–November 2022. Morbidity and Mortality Weekly Report (MMWR). November 22, 2022. doi: http://dx.doi.org/10.15585/mmwr.mm7148e1.
Pre-exposure Prophylaxis with EVUSHELD™. COVID-19. U.S. Centers for Disease Control and Prevention. October 19, 2022. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/pre-exposure-prophylaxis.html.