January 12, 2021; Joseph P. McGowan, MD, Chair; Christopher J. Hoffmann, MD, MPH, Director, JHU-NYSDOH AI Guidelines Program; Charles J. Gonzalez, MD, Medical Director, New York State Department of Health NYSDOH AIDS Institute (NYSDOH AI), on behalf of the Medical Care Criteria Committee (MCCC) of the NYSDOH AI Clinical Guidelines Program
|Priority COVID-19 Vaccine Status for People With HIV|
|The MCCC of the NYSDOH AI Clinical Guidelines Program advocates COVID-19 vaccination for people with HIV, regardless of CD4 cell count or viral load, given the apparent safety of the available vaccines and the increased risk, in some reports, of more severe COVID-19 disease in people with HIV [Braunstein, et al. 2020; CDC 2020; Hoffmann, et al. 2020; Tesoriero, et al. 2020; Triant and Gandhi 2021].|
Vaccine availability: The available vaccines against SARS-CoV-2, the virus that causes COVID-19 disease, which have received expedited FDA authorization, were developed in accordance with rigorous standards for safety, effectiveness, and manufacturing quality. The FDA Emergency Use Authorization (EUA) is based on recommendations of the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), which comprises medical and public health experts.
The first 2 authorized vaccines were developed by Pfizer-BioNTech and Moderna. They are messenger RNA (mRNA) vaccines that encode the part of the spike protein of SARS-CoV-2 that the virus uses to gain entry into human cells. The mRNA is translated in the human cell cytoplasm into the spike protein and then degraded. It does not enter the cell nucleus and does not become part of a person’s genetic material. Neither of these mRNA vaccines contain live virus or other microorganisms.
Vaccine safety in people with HIV: To date, the vaccine clinical trials (both vaccines combined) included approximately 300 participants with HIV, a number too small to determine efficacy specifically in people with HIV [Baden, et al. 2020; Polack, et al. 2020]. Nonetheless, to date, there has been no evidence of decreased vaccine efficacy in people with HIV, and there have been no reports of increased vaccine adverse effects in people with HIV. Conducting implementation research in conjunction with vaccine access programs may provide additional data related to SARS-CoV-2 vaccine benefits and the optimal vaccine prioritization strategy for people with HIV.
Eligibility: The Pfizer-BioNtech vaccine is authorized for use in people ≥16 years old; the Moderna vaccine is authorized for use in people ≥18 years old. For more information, see CDC > Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States.
- Pfizer-BioNtech vaccine: 2 doses; the second is administered 21 days after dose 1
- Moderna vaccine: 2 doses; the second is administered 28 days after dose 1
- For each vaccine, a 4-day grace period is acceptable, and there is no maximal interval; therefore, there is no need to restart a series for late dosing.
Maintain adherence to ART: People with HIV who are vaccinated against COVID-19 should maintain their adherence to prescribed antiretroviral therapy (ART) to maintain viral suppression. Viral suppression confers many benefits, including health maintenance and HIV transmission prevention.
Maintain COVID-19 prevention: Before and after vaccination, current guidelines to prevent the spread of COVID-19 should be followed:
- Wear a mask.
- Avoid crowds and maintain social distance of at least 6 feet from others.
- Wash hands with soap and water for 20 seconds or use hand sanitizer with at least 60% alcohol.
- Follow the NYS travel advisory and CDC travel guidance.
- Follow guidance for quarantine after exposure to COVID-19.
- Follow applicable workplace guidance.
Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med 2020:[Epub ahead of print]. [PMID: 33378609]
Braunstein SL, Lazar R, Wahnich A, et al. COVID-19 infection among people with HIV in New York City: A population-level analysis of linked surveillance data. Clin Infect Dis 2020:[Epub ahead of print]. [PMID: 33252620]
CDC. Vaccination considerations for persons with underlying medical conditions. 2020 Dec 29. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html [accessed 2021 Jan 6]
Hoffmann C, Casado JL, Härter G, et al. Immune deficiency is a risk factor for severe COVID-19 in people living with HIV. HIV Med 2020:[Epub ahead of print]. [PMID: 33368966]
Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020;383(27):2603-2615. [PMID: 33301246]
Tesoriero JM, Swain CE, Pierce JL, et al. Preprint: Elevated COVID-19 outcomes among persons living with diagnosed HIV infection in New York State: Results from a population-level match of HIV, COVID-19, and hospitalization databases. medRxiv 2020. [PMID: 33173901]
Triant VA, Gandhi RT. When epidemics collide: Why people with HIV may have worse COVID-19 outcomes and implications for vaccination. Clin Infect Dis 2021:[Epub ahead of print]. [PMID: 33395474]