COVID-19 & HIV

Health authorities strongly recommend that everyone living with HIV receive a COVID-19 vaccine to protect themselves against SARS-CoV-2, the virus that causes COVID-19.

There is no evidence that COVID-19 vaccines have more side-effects in people living with HIV who are on effective antiretroviral (ARV) therapy than people with no underlying health conditions. However, people living with HIV should let the healthcare staff giving the vaccine know if they have any other health-related conditions, such as allergies, that may put them at risk of more serious side-effects when immunized.

Patient information leaflets, as well as public health authorities’ guidelines for COVID-19 vaccines, list a weakened immune system as a precaution for use. This warning is not based on concerns about the safety of the vaccine, but reflects the fact that there is limited information on vaccine efficacy in people with immune deficiency and/or HIV. Efficacy refers to how effective a vaccine is in a clinical trial.

Many countries have published guidelines on health conditions that may lead to vaccination side-effects. For example, some require people who have had previous allergies – particularly severe allergies or allergies following previous vaccination – to remain in the facility for about an hour after vaccination for monitoring.

A vaccine is a biologically active substance that causes the body to trigger a defence response against harmful pathogens, such as viruses and bacteria. Many vaccines contain weakened or inactive protein parts of the pathogen (called antigens) that trigger an immune response in the body. Newer vaccines contain the blueprint to help the body produce these antigens, rather than introduce the antigen into the body directly.

Regardless of whether the vaccine is made of the antigen itself or the blueprint to produce it, this weakened version will not cause disease in the person receiving the vaccine. Instead, it prompts their immune system to respond in much the same way as if it was naturally exposed to a pathogen. Multiple vaccine doses can help the immune system learn to recognize and defeat the pathogen before it has a chance to take hold; this can result in stronger immunity that may last longer.

Before a vaccine is allowed to be tested in humans, it must show potential for triggering an immune response; this is done in pre-clinical testing in a laboratory. Human (clinical) testing then has three stages to ensure that the vaccine is safe and effective:

• Phase 1 is a safety study that involves giving the vaccine to a small group of healthy people (around 100) to ensure that there is no harm and to see if it triggers an immune response.
• Phase 2 is a larger safety study with hundreds of people to learn more about safety in diverse populations and the most appropriate dosage.
• Vaccines can be studied in a Phase 2b trial to see more quickly if there is any efficacy before committing to a more costly and much larger Phase 3 study.
• Phase 3 is a final study (which establishes efficacy) where the vaccine is compared against a placebo to measure how effective it is at preventing disease and also possibly other outcomes that are less of a priority, like preventing infection or transmission of the virus. These studies enroll thousands of people and can detect rarer side-effects in addition to measuring efficacy.

Although they were developed very quickly, the clinical trials of COVID-19 vaccine candidates have been carried out to the same standards, including safety standards, as other clinical trials. All COVID-19 vaccines authorized for use have completed the Phase 3 study stage and shown to be safe and effective. Stringent regulatory bodies have approved them for use in the general population.

People living with HIV have taken part in trials of most COVID-19 vaccine candidates, including those developed by Pfizer-BioNTech, Moderna and the National Institutes of Health, AstraZeneca and the University of Oxford, Johnson & Johnson, and Novavax and Sanofi-GlaxoSmithKline. Most trials that have not included people living with HIV as participants are studying similar vaccines to ones that have been tested in people living with HIV already. They are therefore assumed to be safe for people living with HIV.

The currently approved vaccines have been shown to be safe and effective at preventing disease. This means that the vast majority of vaccinated people did not become ill with COVID-19. However, no vaccine is 100% efficacious, and efficacy levels have varied in the clinical trials of the different vaccines. Most vaccines also require two doses to achieve this effectiveness and to ensure longer durability of vaccine-induced immunity. Some vaccines under review currently use one dose.

People living with HIV being treated effectively with ARV therapies may have subtle immune deficiencies and chronic inflammation that could affect susceptibility to SARS-CoV-2, risk of severe disease from COVID-19 and response to SARS-CoV-2 vaccines.

The British HIV Association (BHIVA) says that people with HIV, whether being treated with ARVs or not, might not respond as well to COVID-19 vaccines, possibly because people living with HIV might have a weaker immune response than people who are HIV negative. BHIVA is monitoring all evidence around COVID-19 and HIV and will update its advice if needed.

There are no safety concerns with COVID-19 vaccines interacting with ARVs or around ARVs affecting COVID-19 vaccines.

The clinical trials of COVID-19 vaccines have been set up principally to measure their effect on preventing disease (not infection). Effectiveness at preventing disease varies between the vaccines as they are tested in different populations, at different times and are different types of vaccines.

We do not yet know whether the vaccines being used actually prevent transmission of SARS-CoV-2. This means that we cannot say whether vaccinated people will not be infected and then transmit the virus to others. However, while we do not yet have evidence, it is highly likely that COVID-19 vaccines will lower the risk of transmission, but the level at which they do so may also vary between vaccine types.

In addition to efficacy, countries must also consider differences between vaccines in terms of cost, the number of doses required and ease of vaccine storage with some vaccines needing storage at different temperatures.

Most of the COVID-19 vaccines already approved fall into one of three types of vaccines, all of which are considered to be safe for people living with HIV:

• Vaccines based on mRNA
• Vaccines based on a genetically modified adenovirus 
• Vaccines based on inactivated viruses.

Vaccines based on mRNA

The Pfizer-BioNTech and Moderna vaccines are called mRNA vaccines. They contain a blueprint – a synthetic portion of the genetic material from SARS-CoV-2, encased in fat bubbles so that it can enter cells. When the vaccine is injected, the cells of the body first produce and excrete viral proteins from the blueprint (in this case, a specific protein called the spike protein) using the normal process of making proteins from mRNA. The viral spike protein then stimulates an immune response. The mRNA degrades quickly and does not change human genes. In fact, RNA cannot affect your DNA.

Vaccines based on a genetically modified adenovirus

The Oxford-AstraZeneca vaccine is based on a genetically modified adenovirus, similar to the virus that causes the common cold, but which has been weakened. This technology has been used before for other vaccines. Importantly, as with the mRNA vaccine, a copy of some genetic material from SARS-CoV-2 has been inserted into the adenovirus genetic code. This means that when the vaccine is injected, the body produces the spike protein using the same natural process of making proteins and then goes on to mount an immune response against the viral protein.

Vaccines based on inactivated viruses

Most COVID-19 vaccines don’t contain live virus; no COVID-19 vaccines made from live virus have been approved for use so far. Two COVID-19 vaccines produced in China, which are reaching approval stage, use inactivated virus.

“Inactivated” in this case means that the vaccines have been treated with chemicals to inactivate them so they do not contain live virus. It is not known if the inactivated virus vaccines will be safe for all people living with HIV. People living with HIV with CD4 counts of below 200 cells/mm³ and immunocompromised people are not usually offered vaccines made from live bacteria or viruses. This is because they contain a weak form of the pathogen that may cause a mild case of the disease.

Depending on the public health approaches implemented in different countries, some people living with HIV may be offered a COVID-19 vaccine earlier than other people of the same age.

For example, in some countries, this might apply to people living with HIV with CD4 cell counts of below 50 cells/mm³ or to people living with HIV with CD4 counts of 50-200 cells/mm³ who also have other health conditions that may increase the risk of becoming very ill with COVID-19.

Herd immunity is the level at which the virus can no longer easily spread in a population. Modelling suggests that giving a COVID-19 vaccine to 60% to 70% of the population of a country may provide herd immunity if the vaccine has 90% to 95% efficacy.

If a vaccine has a lower level of efficacy, more than 60-70% of the population would have to be vaccinated to reach herd immunity.

At present, no COVID-19 vaccines are approved for people under the age of 18 years. Some studies are underway to assess both the safety and efficacy of vaccines in children and adolescents.

Aside from the problem of access to vaccines in low- and middle-income countries, many of these countries have a substantial proportion of their population under the age of 18 years. For example, close to half of Africa’s population is under the age of 18 years compared with 24% of the population in the UK. Achieving herd immunity through vaccination in countries with a young population will therefore be further compounded until COVID-19 vaccines are approved and available for children and adolescents.

Additionally, the emergence of new variants highlights the importance of vaccinating people around the world as rapidly as possible to help ensure that the virus does not have the opportunity to grow and generate more mutations. If other variants that escape the vaccine’s effects do emerge, we need to be in a position to rapidly develop and administer new vaccines.

COVID-19 requires global attention to stop outbreaks. Viruses do not respect borders and in an interconnected world, it is essential that vaccine rollout scales up everywhere. Due to lack of access to vaccines in many countries, achieving global population immunity may not be reached soon – at a time when new variants and strains are emerging, effectively disrupting health systems, lives and livelihoods everywhere.

Based on current evidence from clinical trials, some researchers have raised concern that people given vaccines based on a type of adenovirus called Ad5 may have increased susceptibility to HIV-1. This increased susceptibility was seen in men (but not women) who were given experimental HIV-1 vaccines in areas of high HIV prevalence. One COVID-19 vaccine in development uses Ad5 and, if it were to be approved, researchers have cautioned against its use in high HIV-prevalence areas.

SARS-CoV-2 – like influenza (which causes the flu), HIV and other viruses – can and does mutate. These genetic variations may change the infectiousness of viruses, for example, making them more transmissible, and the severity of the disease, making them able to cause more severe illness by evading the immune system or to cause different symptoms.

New SARS-CoV-2 variants have recently emerged, including those first found in the UK, South Africa and Brazil. Concerns have been raised about whether the currently approved vaccines will be effective against them. Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases in the United States, recently stated that the evidence so far suggests that the vaccines currently being used will still be effective against the COVID-19 viral variants that have recently emerged. However, there are signs that they may be less efficacious. New data from a relatively small study in healthy adults found that the Oxford-AstraZeneca vaccine offered limited protection against mild and moderate disease caused by the 501Y.V2 variant, first identified in South Africa.

Research is ongoing to understand the nature of the new variants and to identify and manage their impact. New vaccines that are adapted for these new coronavirus variants may have to be developed, approved and used to keep up with coronavirus mutations and manage their impact. Already, some manufacturers of approved vaccines are developing revised versions to respond to newly emerging variants. Every year, new vaccines against the circulating strains of the influenza virus are rolled out based on surveillance done beforehand to understand how to design the vaccine. Such approaches – including new vaccines and annual doses – may be used in future for SARS-CoV-2.

Most early studies showed no clear evidence for a higher COVID-19 viral infection rate or different disease pattern in people with and without HIV. However, as more data become available, most studies are now reporting a higher risk of poorer outcomes among people living with both HIV and COVID-19.

A recent European study of people who developed symptoms of COVID-19 showed that those with a CD4 count of below 350 cells/mm³ had a three-fold increased risk of severe COVID-19. Another study in South Africa showed that those with a CD4 count of below 200 cells/mm³ had an increased risk of dying from COVID-19.

Regardless of HIV status, it remains important for everyone to continue to wash their hands regularly, wear a mask, follow guidance about physical distancing, avoid crowded and badly ventilated settings and self-isolate when appropriate. It also highlights the importance of people continuing to have safe access to options for HIV testing so that anyone can be aware of their status.

If you have an HIV test and the results are positive, you should access treatment services to ensure that your viral load remains undetectable and your CD4 count high to protect yourself as far as possible from the effects of both HIV and COVID-19.

Coronaviruses are a large family of viruses, which may cause illness in animals or humans. COVID-19 is the name given to the infectious disease caused by the most recently discovered novel coronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. Not everyone who is infected with SARS-CoV-2 will end up getting sick with the disease, COVID-19, and people can have anything from no symptoms at all to being mildly sick or severely ill.

How COVID-19 affects people living with HIV is not fully known yet. As more data becomes available, it appears that people living with HIV may be at increased risk of worse outcomes from COVID-19 if they are not adhering to treatment or live with certain co-morbidities than people without HIV.

More recent data also highlights that worse outcomes, including increased risk of severe disease from COVID-19, hospitalization and death, are more likely in people living with HIV who are immunocompromised. These are people living with HIV and other co-morbidities, with low CD4 cell counts and/or advanced HIV disease, which may make them more vulnerable to more severe illness. This is yet another reason for immunocompromised people living with HIV to adhere to antiretroviral therapy to suppress the virus. They should also take the same precautions as anyone else to reduce their risk of exposure to SARS-CoV-2. These precautions are called non-pharmaceutical interventions and they include wearing a mask, washing hands, keeping a physical distance and avoiding crowded spaces.

It is thought that COVID-19 affects people living with HIV who have achieved viral suppression and do not have a low CD4 count the same way as the general population. This is based on other coronavirus-caused disease outbreaks, such as SARS (caused by SARS-CoV-1) and MERS (caused by MERS-CoV), where only a few cases of mild disease among people living with HIV were reported.

People living with HIV are advised to take the same precautions as the general population and adhere to their specific government recommendations. Things people can do to protect themselves and others from COVID-19 include:

• Regular and thorough hand-washing with soap and water or an alcohol-based hand rub. Download a practical guide on how to support community-level handwashing, particularly in resource-limited settings. Access more resources on handwashing.
• Wear a mask to protect yourself and others from the virus. The Centers for Disease Control and Prevention has clear advice on why and how to wear a mask.
• Maintain physical distancing of at least 1 metre between yourself and other people.
• Cover your mouth and nose with a tissue, your sleeve or your elbow (not your hands) when you cough or sneeze. Wash your hands and dispose of the tissue immediately afterwards.
• Avoid touching eyes, nose or mouth with unwashed hands.
• If you become sick, even with mild symptoms, stay home and away from work, school, public spaces and other people until you recover. 
• Continue to take your HIV treatment regularly, as prescribed, to keep your immune system as strong as possible.
• If you need to access health services, it is recommended that you follow national guidance and, where possible, call your healthcare provider before arriving at a health facility.

People living with HIV who know their status and are not yet on antiretroviral treatment should start treatment without delay.

People living with HIV who are on treatment should ensure that they have at least 30 days of antiretrovirals (ARVs) with them and, where possible, a three- to six-month supply of ARVs. Access more information on strategies for extending the duration of ARV therapy refills and reducing contact with health facilities.  

People living with HIV should stay socially connected with networks and communities using technology where possible to address any stress or anxiety with friends and their healthcare provider.

There is no evidence that pre-exposure prophylaxis (PrEP) prevents you from getting COVID-19 or that PrEP will help you recover quicker from COVID-19.

Current clinical data suggest that older people and people with other co-morbidities, including cardiovascular disease, diabetes, chronic respiratory disease and hypertension, are at an increased risk of developing severe COVID-19 illness compared with others.

If you are living with HIV and are older and/or have other co-morbidities, such as those listed in the previous paragraph, then it is particularly important that you keep taking any prescribed chronic medication.

While there is limited evidence on how COVID-19 impacts people living with both HIV and TB, people living with HIV who are also living with TB or who are TB survivors often have lung damage. Therefore, they may be more susceptible to COVID-19 and may develop serious illness. They should pay particular attention to guidance on infection control practices, such as physical distancing. 

Given that both pulmonary TB and COVID-19 affect the lungs, high TB-burden countries will need to protect people living with TB and TB survivors from SARS-CoV-2 exposure (SARS-CoV-2 is the virus that causes the coronavirus disease, COVID-19). They will also need to differentiate between those with respiratory illness caused by TB and by COVID-19, which would require different clinical management.  

For more information on service delivery to TB clients during the COVID-19 pandemic, read the position statement of the Southern Africa HIV Clinicians Society.

People living with HIV who are on treatment should ensure that they have at least 30 days of ARVs with them and, where possible, three to six months’ supply of ARVs.

Before the COVID-19 outbreak, the World Health Organization already recommended that clinically stable adults, children, adolescents and pregnant and breastfeeding women, as well as members of key populations (men who have sex with men, people who inject drugs, sex workers and transgender people), could benefit from multi-month prescriptions and refills.

Multi-month refills are where three to six months of HIV medication are dispensed to reduce the frequency of visits to clinical settings. With longer prescriptions, people living with HIV can access longer ART refills and/or receive ART refills from community-based services. This will limit unnecessary visits to healthcare facilities, thereby reducing the risk of SARS-CoV-2 exposure and of treatment interruption that could result from possible lockdowns and disruptions to clinic schedules during the COVID-19 outbreak. Access more information on strategies for extending the duration of ART refills and reducing contact with health facilities.

People who think that they may have been exposed to HIV should get tested and seek medical advice as quickly as possible.

Currently, there is no evidence that any type of antiretroviral therapy is effective for treating COVID-19. A study published in the New England Journal of Medicine showed that a combination of lopinavir and ritonavir (both antiretrovirals used to treat and prevent HIV) was not associated with clinical improvement or mortality in seriously ill patients with COVID-19 compared with standard of care alone. The question of whether earlier treatment or different combinations of antiretrovirals and other drugs could have clinical benefit is important and requires further study. A Journal of the International AIDS Society (JIAS) article systematically reviewed the clinical outcomes of using antiretroviral drugs for the prevention and treatment of coronaviruses.

In the Solidarity clinical trial, four existing antiviral drugs already on the market to treat other diseases were assessed to determine their relative effectiveness on morbidity and mortality from COVID-19. Led by the World Health Organization (WHO), this multi-country, multi-arm study randomized patients hospitalized with COVID-19 to receive: (1) remdesivir; (2) hydroxychloroquine; (3) lopinavir (without interferon); (4) interferon (including some plus lopinavir); and (5) no trial drug. The peer-reviewed results from the trial have been published: none of the drugs had a meaningful impact on reduced mortality, initiation of ventilation or duration of hospital stay.

Find out more information and get the latest guidance from WHO on COVID-19, HIV and antiretrovirals.

While resources and services are being disrupted and diverted to work on COVID-19, it is critical that essential health services are maintained. These include services for people living with and affected by HIV to protect against HIV disease progression and complications from any other co-infections or co-morbidities, such as prevalent chronic conditions like hypertension and diabetes.

The World Health Organization published guidance, titled Maintaining essential health services: operational guidance for the COVID-19 context, in June 2020 and included a specific section (2.3.1) on HIV, viral hepatitis and sexually transmitted infections. Maintenance of HIV testing, prevention and continuity of HIV treatment are highlighted as essential during the COVID-19 crisis. Additional guidance is given on how to adapt services to be safely delivered during the COVID-19 pandemic, and how to transition towards the restoration of activities.

COVID-19 is also impacting global health product supply chains, including logistics and shipping. Many global agencies are working closely with suppliers and partners to assess the impact on core health product supplies and provide recommendations for implementing partners on how to manage that impact. You can find the most recent assessment and recommendations from the Global Fund here.

Where public health measures are still imposed to respond to COVID-19 outbreaks, national governments should ensure that these do not threaten human rights, as evidenced by the HIV response. Criminalization of non‐disclosure, exposure or transmission of HIV is an example: its public health impacts include stigmatizing people living with HIV and discouraging people from learning their HIV status. Such a strategy should clearly not be applied to COVID-19.

Where there are COVID-19-related restrictions on people’s travel, it is important to ensure that people living with and affected by HIV have access to HIV and other essential health services. This includes being able to access uninterrupted HIV treatment anonymously.

During the COVID-19 pandemic, it is important to ensure that key populations, including men who have sex with men, people who inject drugs, sex workers and transgender people, have access to HIV prevention and other health services, including condoms, pre-exposure prophylaxis (PrEP), sterile needles and syringes and/or opioid substitution therapy, and gender-affirming hormone therapy. See How is COVID-19 affecting the HIV response? for more details on maintaining essential health services.

Download a guide to preventing and addressing social stigma associated with COVID-19

The global health community is monitoring the COVID-19 pandemic and is working to ensure that healthcare systems, supply chains and communities are prepared. This is especially important in resource-limited settings, especially sub-Saharan African, with high burdens of HIV and other chronic co-infections and co-morbidities.

Previous outbreaks have demonstrated that when health systems are overwhelmed, deaths from vaccine-preventable and other treatable conditions can also increase dramatically, including those related to HIV and AIDS and TB. Countries will need to balance responding directly to the COVID-19 pandemic and maintaining essential health services. The World Health Organization has published updated guidance on a set of targeted immediate actions that countries should consider at national, regional and local levels to reorganize and maintain access to high-quality essential health services for all. Read the guidance.

In addition to maintaining essential healthcare services, governments must support those most vulnerable, including the homeless and those living in informal settlements, to ensure access to shelter, food and clean water, especially during government-enforced movement restrictions.

To ensure physical distancing, policies should be in place that limit the number of times people living with HIV visit a health facility. Health facilities must be set up in ways that support appropriate triaging and infection control measures. Where possible, unnecessary visits to health facilities for people living with HIV should be reduced. For example, if someone tests positive for HIV, they should be supported to immediately initiate ART on the day of diagnosis to reduce unnecessary follow-up appointments. People living with HIV who are on treatment should ensure that they have at least 30 days of ARVs with them and, where possible, a three- to six-month supply of ARVs. Get more information on strategies for extending the duration of ART refills and out-of-facility HIV treatment support and reducing contact with health facilities.