Are COVID-19 vaccines safe for people living with HIV?
Many of the COVID-19 vaccines studies have included a small number of people living with HIV in their trials. Despite limited data, available information suggests current WHO recommended COVID-19 vaccines ( AstraZeneca/Oxford, Johnson and Johnson, Moderna, Pfizer/BionTech, Sinopharm and Sinovac) are safe for people living with HIV. The currently available vaccine products are not live vaccines, they include genetic material from SARS-CoV-2 which cannot replicate. Therefore, these vaccines are not expected to be less safe in people who are immunocompromised. In addition to this, no pharmacological interactions have been reported between COVID-19 vaccines and antiretroviral medications which people living with HIV should continue to take after vaccination to maintain health.
Recently, a debate in the scientific literature has led to broader concerns about a potential association observed more than a decade ago between adenovirus vector-based vaccines and an increased risk of acquiring HIV infection among men who received this type of vaccine[1]. This unexpected finding was detected in two HIV vaccine trials that used adenovirus vector containing products[2],[3]. The reason for this observed HIV risk remains uncertain, although several follow-up studies have suggested a possible interference in the HIV specific vaccine response or in the CD4 cell susceptibility to HIV infection induced by this kind of vaccine[4],[5]. However, a third study using another adenovirus vector-based vaccine, conducted more recently has not reported this finding[6]. Specific studies on this topic with COVID-19 vaccines are needed. Despite these potential concerns, it is important to highlight that the benefits of all authorized COVID-19 vaccines in a pandemic context currently outweigh the potential risks. WHO will continue to monitor the situation as new data become available and SAGE recommendations will be updated accordingly.
Do COVID-19 vaccines provide protection for people living with HIV?
It is theoretically possible that people living with HIV with low CD4 cell counts might have a weaker immune response to vaccines. However, in practice this has not been documented for all vaccines and there is no evidence to support a less robust immune response to COVID-19 vaccines among people living with HIV and low CD4 cell counts. WHO is reviewing new evidence as it emerges and will provide updates. More importantly, advocacy is needed so that no one person is left behind and that national COVID-19 vaccination programmes do not exclude people from key and vulnerable populations, at risk of HIV, who may have limited access to health services. It is also important to advocate for the inclusion of people living with HIV, including those with more advanced disease, in COVID-19 vaccine trials to provide information to confirm efficacy.
Should people living with HIV get vaccines early in the roll out?
WHO recommends that countries refer to the WHO SAGE Roadmap For Prioritizing Uses Of COVID-19 Vaccines In The Context Of Limited Supply[7] which was created under the assumption that there would not be substantive differences in vaccine efficacy among subgroups (for example, in people with comorbidities that increase the risk of severe COVID-19 such as HIV-positive status). Therefore, countries can make plans for people to receive the vaccine in order of priority based on their age, health, occupation and other factors such as people in living in care or residential homes, or closed settings such as prisons.
Some countries are prioritizing vaccination for all people living with HIV or for those who are immunocompromised (as indicated by having a CD4 cell count <200/mm3) [8],[9]. An informal poll of more than 100 countries from all regions revealed at least 40 that have an immunization policy that prioritizes vaccinations for people living with HIV. These policies are supported by recent literature which suggests that people living with HIV at any CD4 cell count appear to be at increased risk for severe outcomes and death due to COVID-19 compared with people without HIV [10],[11],[12]. Independent of immune status, many people living with HIV have one or more comorbidities that may put them at increased risk for a more severe COVID-19.
A new WHO report confirms that HIV infection is a significant independent risk factor for both severe/ critical COVID-19 presentation at hospital admission and in-hospital mortality. Overall, nearly a quarter (23.1%) of all people living with HIV who were hospitalized with COVID-19, died [13]. The report is based on clinical surveillance data from 37 countries regarding the risk of poor COVID-19 outcomes in people living with HIV (PLHIV) admitted to hospital for COVID-19. And found that the risk of developing severe or fatal COVID-19 was 30% greater in PLHIV compared to people without HIV infection. Underlying conditions such as diabetes and hypertension are common among PLHIV. Among male PLHIV over the age of 65 years, diabetes and hypertension were associated with an increased risk of more severe and fatal COVID-19. These conditions are known to put people at increased risk of severe disease and death [13].
Therefore, all people living with HIV should be prioritized for early vaccination. And people living with HIV with co-morbidities (such as chronic pulmonary disease, diabetes, hypertension, obesity, kidney disease, liver disease, Parkinson’s disease, multiple sclerosis, motor-neuron disease) should be prioritized for early vaccination and management of their co-morbidities. People living with HIV should not be excluded from COVID-19 vaccine access plans regardless of their immune status, and countries should include people living with HIV as a priority group for COVID-19 vaccination according to their epidemiological context.
What can WHO and the world do to support people living with HIV to live a healthy life?
While WHO is working with countries to ensure fair and equitable access to safe and effective COVID-19 vaccines, it is important to continue actions to prevent SARS-CoV-2 transmission and to reduce COVID-19 deaths. Alongside the response to COVID-19, it is critical to maintain access to essential health services. This includes:
- Supporting people living with HIV to continue taking antiretroviral therapy (ART) and adapting services to make this easier and more efficient during the COVID-19 response.
- Continuing to provide HIV prevention and testing services with linkage to ART initiation as a priority.
- Ensuring those who start ART can remain on it to reduce health risks and complications during COVID-19, including maintaining viral load suppression. This must be classified as an essential service, together with prevention, diagnosis and treatment of co-morbidities and co-infections.
- Monitoring all people living with HIV and SARS-CoV-2 infections, especially those with advanced HIV disease or with co-morbidities.
Although there may be an increase in the risk of developing severe disease from COVID-19 among people living with HIV, making sure that people have access to effective ART and other health care they need will help to minimize this risk.
For further information on COVID-19 vaccines and all WHO guidance related to COVID-19 see https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance.
For community friendly resources please see: https://i-base.info/covid-19/
[1] Buchbinder SP, McElrath MJ, Dieffenback C, Corey L. Use of adenovirus type-5 vectored vaccines: a cautionary tale. Lancet. 2020, 396 (10260): E68-E69, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32156-5/fulltext#articleInformation.
[2] Buchbinder SP Mehrotra DV Duerr A, Fitzgerald DW, Mogg R, et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008; 372: 1881-1893.
[3] Gray GE, Allen M, Moodie Z, Churchyard G, Bekker LG, et al. Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study. Lancet Infect Dis. 2011; 11: 507-515.
[4] Frahm N, DeCamp AC, Friedrich DP, Carter DK, Defawe OD, et al. Human adenovirus-specific T cells modulate HIV-specific T cell responses to an Ad5-vectored HIV-1 vaccine. J Clin Invest. 2012; 122: 359-367.
[5] Perreau M, Pantaleo G, Kremer EJ. Activation of a dendritic cell-T cell axis by Ad5 immune complexes creates an improved environment for replication of HIV in T cells. J Exp Med. 2008; 205: 2717-2725.
[6] Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, et al. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013; 369: 2083-2092.
[7] WHO SAGE Roadmap For Prioritizing Uses Of COVID-19 Vaccines In The Context Of Limited Supply. https://www.who.int/publications/m/item/who-sage-roadmap-for-prioritizing-uses-of-covid-19-vaccines-in-the-context-of-limited-supply
[8] SARS-CoV-2 vaccine advice for adults living with HIV: British HIV Association (BHIVA) & Terrence Higgins Trust (THT) guidance. https://www.bhiva.org/SARS-CoV-2-vaccine-advice-for-adults-living-with-HIV-plain-english-version-update.
[9] Guidance for COVID-19 and Persons with HIV (last updated February 26, 2021): National Institutes of Health, Office of AIDS Research. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/HIV_COVID_19_GL__2021.pdf.
[10] Bhaskaran K, Rentsch CT, MacKenna B, Schultze A, Mehrkar A et al. HIV infection and COVID-19 death: a population-based cohort analysis of UK primary care data and linked national death registrations within the OpenSAFELY platform. Lancet HIV. 2021 Jan;8(1):e24-e32. doi: 10.1016/S2352-3018(20)30305-2. Epub 2020 Dec 11. PMID: 33316211; PMCID: PMC7773630. https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(20)30305-2/fulltext
[11] Geretti AM, Stockdale AJ, Kelly SH, Cevik M, Collins S, et al. Outcomes of COVID-19 related hospitalization among people with HIV in the ISARIC WHO Clinical Characterization Protocol (UK): a prospective observational study. Clinical Infectious Diseases, 2020, ciaa1605. https://doi.org/10.1093/cid/ciaa1605.
[12] Boulle A, Davies MA, Hussey H, Ismail M, Morden E, et al. Risk factors for COVID-19 death in a population cohort study from the Western Cape Province, South Africa. Clinical Infectious Diseases, 2020; ciaa1198. https://doi.org/10.1093/cid/ciaa1198
[13] Bertagnolio S, Thwin SS, Silva R, Ford N, Baggaley R, Vitoria M, Jassat W, Doherty M, Diaz J. Clinical characteristics and prognostic factors in people living with HIV hospitalized with COVID-19: findings from the WHO Global Clinical Platform. July 2021. https://theprogramme.ias2021.org/Abstract/Abstract/2498.
