On December 8, 2021, the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for Evusheld (formerly AZD7442) for emergency use in the United States for pre-exposure prevention of COVID-19. The EUA approval seems to provide long-awaited hope for adults and children 12 years of age and older who are moderately to severely immunocompromised and may not mount an adequate immune response and for those who have been advised against the available COVID-19 vaccines due to severe allergies with components of the vaccine or a history of adverse reactions. However, over the last month, many people have expressed frustration and disappointment with the lack of access to Evusheld and transparency about the distribution process.
Evusheld is for people not currently infected by or exposed to COVID-19. It is a combination of two long-acting monocolonal antibodies given in one intramuscular dose, consisting of two separate injections (tixagevimab and cilgavimab).
“About seven million people in the US are immunocompromised and may benefit from Evusheld for pre-exposure prophylaxis of COVID-19.” “AstraZeneca has agreed to supply the U.S. government with 700,000 doses of Evusheld. The U.S. government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis.” Therefore, only 10% of people who could benefit from Evusheld will have access to it.
Even more alarming, there is no streamlined plan for how to distribute Evusheld. “Evusheld will be distributed by states, which will in turn distribute them to health care providers ‘in a manner consistent with clinical guidelines and recommendations for those who should receive them.’” Health care providers will need to develop their own prioritization guidelines, likely in a similar manner to the state COVID-19 vaccine distribution plans in the beginning of 2021. Patients in 2022 who seek Evusheld stand to be even more confused than 2021, as distribution plans get even further complicated because individual health care providers (rather than states) will determine Evusheld prioritization guidelines—meaning qualifications to access Evusheld could vary within states.
Some healthcare systems, like UPMC in Pittsburgh began administering doses to eligible patients on December 30, 2021. But many healthcare systems have yet to begin Evusheld distribution.
On Twitter, #Evusheld has generated some noise with many people expressing their disappointment in lack of access to the treatment. Dr. Vivian G. Cheung (@Vivian_Cheung2) has been vocal about her frustration with Evusheld distribution plans in Maryland. On December 27 she tweeted, “I’m a doctor and an immunocompromised patient. I called every site that supposedly got an allocation of Evusheld but no one was able to tell me their process of distribution. @ChristyINSW @VanHollenForMD @BenCardinforMD.” On January 4, 2022, she tweeted: “I called all the hospitals that received #Evusheld again. They still do not have plans on how to distribute Evusheld. It is so wrong to keep life-saving meds in storage rather than giving them to immunocompromised pts now. @POTUS @GovLarryHogan @MDHealthDept.”
Patients face similar frustrations in California. Tania Daniels (@TaniaDaniels3), a healthcare advocate with 9 Lives Health Advocacy, LLC, tweeted on January 6, 2022 where she also shared the list for California health care centers who had received Evusheld: “[emoji] scary & [emoji] insulting to #immunocompromised who really need #Evusheld. Even scarier, my #transplant ctr told me Mon they hadn’t received any yet. But looking at the data tells another story. @CedarsSinai why? Just tell us your prioritization so we’ll know. #transplanttwitter.”
In what has become a frustrating and scary two years for many, people who are immunocompromised or unable to get the COVID-19 vaccine have yet another barrier to face in access to prophylactic prevention for COVID-19.
Tracy Waller, Esq., MPH, is an attorney with the Maryland Center for Developmental Disabilities (MCDD) at Kennedy Krieger Institute as part of the MCDD’s grant to develop a Center for Dignity in Healthcare for people with Disabilities (CDHPD).