On December 11, the Food and Drug Administration (FDA) granted emergency use authorization for the first COVID-19 vaccine in the United States, after an expert advisory panel voted overwhelmingly that its benefits of outweigh the risks.
That vaccine, from Pfizer and BioNTech, is currently being rolled out nationwide. A second vaccine, from Moderna and the National Institutes of Health, is expected to receive authorization within days.
Today, FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of #COVID19 caused by SARS-CoV-2 in individuals 16 years of age and older. The emergency use authorization allows the vaccine to be distributed in the U.S. https://t.co/1Vu0xQqmCB pic.twitter.com/c8maeePP9O— U.S. FDA (@US_FDA) December 12, 2020
Many people living with HIV are wondering whether the vaccines are appropriate for them and where they will end up in the queue. Reassuringly, current evidence indicates that vaccination is safe for this population, and advocates are asking that HIV-positive people be considered a priority group.
COVID-19 vaccines have been developed with unprecedented speed. Early in the pandemic, National Institutes of Health director Anthony Fauci, MD, predicted that a vaccine could be available in 12 to 18 months, but the authorization beat even that optimistic timeline.
But as often happens when things move this quickly, misinformation can spread as fast as the virus. For example, On December 12, Business Insider published an article suggesting that people with HIV should wait to get the vaccine due to potential safety concerns.
But most experts disagree.
“There is no reason to believe that people with HIV should not get the vaccine. It is not a live vaccine, and it is safe and efficacious across diverse groups,” Monica Gandhi, MD, MPH, medical director of the Ward 86 HIV clinic at Zuckerberg San Francisco General Hospital, told POZ. “I will be encouraging my patients with HIV, especially those on antiretroviral therapy, to get the vaccine. I totally recommend it.”
Vaccine Safety and Effectiveness
Both the Pfizer/BioNTech and Moderna vaccines employ a novel messenger RNA (mRNA) approach that uses nanoparticles, or fat bubbles, to deliver bits of genetic material that encode instructions for making the SARS-CoV-2 spike protein, which the coronavirus uses to enter human cells. When injected into a muscle, the cells produce the protein, triggering an immune response. The mRNA degrades quickly in the body, and it does not alter human genes.
In a Phase III clinical trial of more than 43,000 volunteers, the Pfizer/BioNTech vaccine was 95.0% effective at reducing the risk of symptomatic COVID-19, according to findings published recently in The New England Journal of Medicine. A total of 170 cases were observed seven days or more after the second dose: 162 in the placebo group and just eight in the vaccine group.
Another Phase III trial, which included about 30,000 people, showed that the Moderna vaccine was 94.1% effective, according to FDA briefing documents released ahead of a public advisory committee meeting on December 17. In this study, there were 196 cases of symptomatic COVID-19 observed at least 14 days after the second dose: 185 in the placebo group and 11 in the vaccine group. What’s more, Moderna presented additional data showing that the vaccine also appears to reduce asymptomatic infection by two thirds.
Both trials enrolled people with stable HIV. Advocates successfully pressured Moderna to change eligibility criteria that initially excluded HIV-positive people and asked Pfizer to clarify that people with HIV were eligible.
The Pfizer trial included 120 people with HIV; they entered the study late and therefore were not included in the primary efficacy and safety analysis. The Moderna trial included 176 people with HIV. In that study, one HIV-positive person in the placebo group and none in the vaccine group developed symptomatic COVID-19. No unusual safety concerns were reported for people with HIV.
Trials of other COVID-19 vaccine candidates, including those being developed by AstraZeneca and the University of Oxford, Johnson & Johnson, Novavax and Sanofi/GlaxoSmithKline, also include people living with HIV.
Considerations for People With HIV
Although these numbers are small, these findings are reassuring. The Pfizer vaccine is indicated for people living with HIV, and it is likely that the Moderna vaccine will be as well.
The FDA’s fact sheet for the Pfizer vaccine notes that people who are “immunocompromised or are on a medicine that affects your immune system” should mention this condition to their vaccine provider. The Centers for Disease Control and Prevention (CDC) states in its interim clinical considerations for the Pfizer vaccine: “Immunocompromised individuals may still receive COVID-19 vaccination if they have no contraindications to vaccination. However, they should be counseled about the unknown vaccine safety profile and effectiveness in immunocompromised populations, as well as the potential for reduced immune responses and the need to continue to follow all current guidance to protect themselves against COVID-19.”
About two-third of people with HIV in the U.S. have a suppressed viral load, and most these days do not have AIDS or advanced immune suppression. But even people with well-treated HIV may have more subtle immune deficiency and chronic inflammation that could affect coronavirus susceptibility, risk of severe COVID-19 and response to vaccines.
The mRNA approach is thought to be safe for people with HIV. These vaccines do not contain weakened or inactivated SARS-CoV-2, just genetic instructions for making one of its key proteins. There is no way the vaccine can cause COVID-19, even in immunocompromised people, who generally should not receive live vaccines. But a vaccine from the Chinese company Sinopharm, which was recently approved in the United Arab Emirates, does use inactivated SARS-CoV-2.
In October, Susan Buchbinder, MD, of the University of California at San Francisco, and colleagues published a letter in The Lancet expressing concern about the use of an adenovirus vector in COVID-19 vaccines. This type of vaccine uses a common cold virus to deliver genes for SARS-CoV-2 proteins.
More than a decade ago, an HIV vaccine using adenovirus type 5 (Ad5) as a vector appeared to actually increase the risk of HIV acquisition among men in the STEP and Phambili trials who had preexisting immunity to Ad5 due to prior exposure. The authors suggested that preexisting Ad5 antibodies activated by the vaccine might enhance HIV replication in CD4 T cells or make CD4 cells more susceptible to HIV infection.
“On the basis of these findings, we are concerned that use of an Ad5 vector for immunization against [SARS-CoV-2] could similarly increase the risk of HIV-1 acquisition among men who receive the vaccine,” they wrote. “This important safety consideration should be thoroughly evaluated before further development of Ad5 vaccines for SARS-CoV-2.”
The Pfizer/BioNTech and Moderna mRNA vaccines do not use adenovirus vectors. The AstraZeneca/University of Oxford vaccine uses a chimpanzee adenovirus, so preexisting immunity in humans would not be a concern. However, a vaccine being developed by the Chinese company CanSino Biologics does use human Ad5 as a vector, and the Russian Sputnik V vaccine uses both Ad5 and Ad26.
Referring to the Pfizer and AstraZeneca/University of Oxford vaccines, guidance from the British HIV Association (BHIVA) and the Terrence Higgins Trust states:
“There is no reason to think these vaccines will be less safe for people with HIV. Both include some of the genetic material from SARS-CoV-2 (the virus that causes COVID-19) but not the whole virus. This means they are not live vaccines and so are no less safe in people with damaged immune systems. It is possible that people with HIV might not respond as well to the vaccine. This means that the vaccine might trigger a weaker response in people with HIV.”
Should People With HIV Be Prioritized?
Some experts argue that people with HIV should be prioritized to receive COVID-19 vaccines.
Health care workers and residents of long-term care facilities will be first in line. After that, other groups vying for priority include frontline essential workers, people over age 65 and those with comorbidities, or underlying health conditions that raise the risk for severe COVID-19 and death.
A National Academies of Sciences, Engineering, and Medicine committee has issued a framework to help policymakers plan for equitable vaccine allocation.
Their proposed Phase 1b includes people with two or more underlying conditions that put them at “significantly higher risk,” for example, cancer, chronic kidney or lung disease, serious heart conditions, type 2 diabetes, obesity or immunosuppression due to an organ transplant. Many people living with HIV fall into this category because of coexisting conditions.
Phase 2 consists of people with underlying conditions that put them at “moderately higher risk,” including any one of the Phase 1b conditions. Other conditions that “might put individuals at increased risk” should also be considered for prioritization, including asthma, hypertension, immunosuppression due to a bone marrow transplant, HIV/AIDS, liver disease, use of corticosteroid medications and pregnancy.
In the United Kingdom, people with HIV fall into priority group 6 (out of 9), which includes those up to age 64 with “underlying health conditions which put them at higher risk of serious disease and mortality.” (People over 65 are in in a higher priority group regardless of HIV status.) However, BHIVA notes, some HIV-positive people may be at higher risk and eligible for priority group 4 (“clinically extremely vulnerable individuals”), including those with a current CD4 count below 50, those who have ever had a very low CD4 count, those with a CD4 count below 200 plus other risk factors such as a detectable viral load or comorbidities, and those with recent serious HIV-related illnesses.
In light of this new evidence, and acknowledging “the intersectionality of factors that put people at higher risk for COVID-19 that are so prevalent among people living with HIV,” a coalition of advocates—including AVAC, the Black AIDS Institute, Let’s Kick ASS (AIDS Survivor Syndrome), NASTAD, the Prevention Access Campaign, SisterLove, the Treatment Action Group and the Well Project—are issuing an open letter urging the CDC’s Advisory Committee on Immunization Practices to consider people living with HIV a priority group for the receipt of COVID-19 vaccines.
In addition, NASTAD is calling for state and local vaccination plans to include community networks and trusted providers that are best able to reach communities disproportionately impacted by COVID-19, including health department HIV and hepatitis programs, community-based organizations and harm reduction service providers.
“A vaccine presents an incredible opportunity to stem the tide of the COVID-19 pandemic, but only if federal, state, and local governments commit to addressing the systemic racism and inequality that are driving the disproportionate impact of the pandemic on communities of color,” NASTAD executive director Stephen Lee said in a statement. “COVID-19 has shone a spotlight on the many ways our healthcare system is profoundly broken, including for individuals living with and at risk for HIV and hepatitis.”
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