Jen Laws, President & CEO Jen Laws, President & CEO

One Shot or Two? Necessity of COVID-19 Vaccination Among People Living with HIV and/or Chronic Liver Disease

At the time of this writing, the United States’ Food and Drug Administration (FDA) has provided Emergency Use Authorizations (EUAs) to 3 COVID-19 vaccines, with Novavax’s product potentially leading the race to become the fourth. While some have fretted over “which vaccine” is “the best”, governors and clinicians have resoundingly adopted a simple answer: “which ever vaccine you can get”. While President Biden has pushed to expand eligibility to all adults in the US by May 1st, as we’re all too familiar with in patient advocacy, eligibility does not necessarily equate to access and, in this respect, demand still vastly outstrips vaccine supply domestically.

The debate on who should get a vaccine and when began well before the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations in December 2020. ACIP’s recommendations focused primarily on constructing an ethical model based on hospitalizations and mortality, with an eye toward those performing duties most necessary to meet the health care demands of the moment. Ultimately, outside of this job-based prioritization, ACIP gave top priority via age-based allocation and then ascertaining those at-risk for these outcomes based on pre-existing conditions. Most states adopted some version of these prioritized populations. The debate on the efficacy of this model continues to rage on – what about those in marginalized communities more impacted by COVID-19 than more affluent communities? What about younger people with comorbidities? Which health conditions should be prioritized?

Regardless of where one’s local government falls on this debate, evidence catalogued by the CDC indicates a very real need for people living with HIV and those with chronic liver diseases to seek a vaccine as readily as possible as these cohorts are at increased risk for complications related to a COVID-19 infection. Studies have found PLWH experiencing an acute COVID-19 infection may see as much as 50% drop in CD4 T-cells compared to their historical levels, a condition known as lymphopenia – of which, is also an indicator for severe COVID-19 and protracted recovery or death. Additionally, the same study found key clinical metrics used to measure inflammation were similarly increased among PLWH. Another study out of Wuhan, examining people with chronic, yet controlled Hepatitis B infections may see a reactivation of viral activity and/or potentially face significant progression of liver cirrhosis during and after a COVID-19 diagnosis. Another study found SARS-CoV-2 may target certain cells in the bile tract and cause focused damage to the systems serving a person’s liver, with another study suggesting the need for health care providers to emphasize liver repair post COVID diagnosis.

While Janssen ensured PLWH were enrolled in phase 3 clinical trials for their product, none of the currently authorized products included solid organ transplant recipients in their trials. While the American Society of Transplantation notes COVID-19 vaccine administration recommendations for solid organ transplant recipients remains the same as other vaccines (either completed at least 2 weeks prior to transplant or initiated at least 1 month after transplant). Which may pose a problem according to a study published in March showing transplant recipients having received the first shot in the series mounted an antibody response just 17% of the time. While antibody responses are not necessary to confer immunity, they are the leading indication of an immune response. The authors of this study will be seeking to answer that question later this year.

Furthermore, additional research is needed in assessing post-acute COVID-19 infections and the implications of “long COVID”. Most research at this moment on long-COVID is tied to assessing symptom presentation and frequency of health care needs. However, there is a minor bit of information regarding organ function post-hospitalization with COVID-19 – none of it is “good news”. In particular, people experiencing chronic liver diseases were almost 2 times as likely to experience “major adverse events” after being released from the hospital due to COVID-19.

All of this information culminates with a sense of urgency some states are heeding in expanding vaccine access “ahead of schedule” to include people living with HIV or specific programming targeted to provide vaccines to these communities.

Brandon Macsata, CEO of ADAP Advocacy Association, recently penned a blog addressing any hesitancy among people living with HIV around getting their vaccines: “Vaccines are an important element of the journey, along with proven public health strategies (i.e., wearing masks, remaining social distant, washing hands). For the HIV-positive community, it is even more important for us to do our collective part to protect ourselves, as well as the people around us. Get your Covid-19 vaccine!

With the CDC’s guidance on prioritizing our communities in vaccination schemes, I couldn’t agree more.

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