Inside This Issue: Updated guidance for fully vaccinated people; pause lifted on J&J COVID-19 vaccine; benefits of continuing HIV services during the COVID-19 pandemic; funding opportunities from HOPWA and NIAID; updated pediatric HIV treatment guidelines; and more.
CDC: Fully Vaccinated People May Safely Go Without Masks for Most Outdoor Activities
At the end of April, the number of Americans who had been fully vaccinated for COVID-19 reached about 100 million – 30% of the nation’s population. On April 27, the U.S. Centers for Disease Control and Prevention (CDC) issued updated guidance indicating that, “Fully vaccinated people can participate in many outdoor activities without a mask at low risk to themselves or to others.” In particular, fully vaccinated people can safely:
- walk, run, or bike outdoors;
- attend small outdoor gatherings with fully vaccinated and unvaccinated people; and
- dine at an outdoor restaurant with friends from multiple households.
“While [it is] generally safe for vaccinated people to be outdoors without a mask, CDC continues to recommend requiring masking in crowded settings and venues where there is a decreased ability to maintain physical distance until widespread vaccination coverage is achieved,” according to the guidance. These crowded outdoor settings include live performances, parades, and sports events.
CDC considers people to be fully vaccinated for COVID-19 two weeks after they have received the second dose in a 2-dose series (Pfizer-BioNTech or Moderna vaccines), or two weeks after they have received a single-dose vaccine (Johnson and Johnson vaccine). CDC has produced a poster/infographic that summarizes current COVID-19 safety guidance for vaccinated and unvaccinated people in a variety of outdoor and indoor settings.
FDA and CDC Lift Pause on the Use of J&J Vaccine After Safety Review
On April 23, the U.S. Food and Drug Administration (FDA) and CDC determined that the recommended pause regarding the use of the Janssen/Johnson & Johnson (J&J) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume in persons aged 18 years or older. In April, FDA and CDC had recommended a pause in the use of the J&J vaccine in the wake of case reports of thrombosis with thrombocytopenia syndrome (TTS) – a rare and severe type of blood clot – in individuals after receiving that vaccine.
After a thorough review of the safety data, FDA and CDC recommended that the use of the J&J vaccine resume, concluding that the benefits of the vaccine outweighed its risks in all population groups. “The summary of evidence showed that the single-dose Janssen COVID-19 vaccine is a highly effective and flexible (e.g., stored at refrigerator temperatures) prevention tool that can be useful in communities with increasing COVID-19 incidence and emerging variants of SARS-CoV-2, the virus that causes COVID-19,” CDC noted.
CDC concluded that limiting the J&J vaccine use to specific population groups – such as by age or sex – could reduce numbers of rare blood clot cases “but could also challenge public health implementation, limit personal choice, and disproportionately affect populations with barriers to vaccine access or who have difficulty returning for a second dose.”
However, to guide decision-making, the agency also emphasized the need for patient and provider education about the risk for TTS with the J&J vaccine, especially among women under 50 years old, as well as the availability of other COVID-19 vaccines. For those seeking more information, FDA has created a web page with answers to frequently asked questions about the J&J vaccine.
HIV and COVID-19
Study Finds Benefits of Continuing HIV Services During the COVID-19 Pandemic Far Outweigh Risks
UNAIDS and the World Health Organization (WHO) have supported mathematical modelling to evaluate the expected benefits of continuing HIV services during the COVID-19 pandemic versus the potential harm of additional SARS-CoV-2 transmission by providing these services. In a recent study, researchers from Avenir Health and New York University reported on the results of mathematical modelling of the projected risks and benefits for four HIV services: voluntary medical male circumcision, HIV diagnostic testing, viral load testing, and programs to prevent mother-to-child transmission.
In their analysis, the researchers compared COVID-19 deaths in 2020 and 2021 among health workers and clients due to keeping HIV services open with averted AIDS-related deaths occurring now and projected over the next 50 years due to maintenance of HIV services. They applied the mathematical models to countries with HIV and COVID-19 epidemics of varying severity.
The researchers found that maintaining HIV services would avert between 19 and 146 AIDS-related deaths per 10,000 people over a 50-year period, while the additional COVID-19-related deaths from exposures related to HIV services would be 0.002 to 0.15 per 10,000 people. The analysis demonstrates that the benefits of continuing to provide HIV services during the COVID-19 pandemic outweigh the risk of additional COVID-19-related deaths by a factor of at least 100 to 1.
“Ministries of health take into account many factors in deciding when and how to offer essential health services during the COVID-19 pandemic,” noted Meg Doherty, director of WHO’s Global HIV, Hepatitis, and Sexually Transmitted Infections Programs. “This work shows that taking the longer view, the benefits of continuing key HIV services are far larger than the risks of additional COVID-19 transmission. Innovative and safe delivery of services must continue as the pandemic is brought under control.”
HOPWA Funding Opportunity: Housing as an Intervention to Fight AIDS
The U.S. Department of Housing and Urban Development (HUD) Office of HIV/AIDS Housing recently announced the release of a new Notice of Funding Opportunity (FR-6400-N-11) through the Housing Opportunities for Persons With AIDS (HOPWA) program. Through this competitive grant, “Housing as an Intervention to Fight AIDS,” HUD is making a total of $41 million available to states, local governments, and non-profits for housing assistance and supportive services for low-income people living with HIV and their families, coordination and planning activities, and grants management and administration.
“This funding will provide communities an opportunity to create and implement new projects that align with initiatives aimed at ending the HIV/AIDS epidemic, and elevate housing as an effective structural intervention in ending the epidemic,” according to HUD. Grantees will “prioritize sustainable, effective, and equitable approaches to providing housing and services to persons living with HIV and their families that can be continued past the funded project’s period of performance.” The agency expects to make 18 awards available with an award ceiling of $2.25 million each. The closing date for applications is July 6.
NIAID Funding Opportunities: Research to Help End the HIV Epidemic
The National Institute of Allergy and Infectious Diseases (NIAID) recently published funding opportunity announcements (FOAs) to promote the goals of the U.S. Ending the HIV Epidemic (EHE) initiative. For your review, we are providing brief descriptions of these opportunities, the application deadlines, and links for further information.
RFA-AI-21-023: Respond: Epidemiology to End the HIV Epidemic (RESPOND: EEE) – According to NIAID, “The objective [of this funded research] is to better understand HIV susceptibility and ongoing transmission in the U.S. using local and population-level epidemiology in collaboration with implementing partners. Data generated through this research will inform intervention approaches and facilitate more timely evaluation of context-specific HIV control strategies towards the goal of ending the HIV epidemic in the U.S.” NIAID and its partners intend to commit a total of about $4.5 million to fund five or six awards. The application deadline is July 30.
RFA-AI-21-024: Multidisciplinary Treatment Approaches to End the HIV Epidemic – “The purpose of this FOA is to utilize implementation science to develop, implement, and evaluate creative, multidisciplinary approaches to healthcare delivery that more effectively engage and retain individuals in HIV care and treatment so that they achieve durable viral suppression,” according to NIAID. Supported research will seek “to achieve more rapid and sustained viral suppression and improved outcomes for people with HIV through better healthcare engagement.” NIAID and its partners intend to commit a total of about $5 million to fund five or six awards. The application deadline is August 4.
RFA-AI-21-025: Prevention Strategies to End the HIV Epidemic – The purpose of this FOA “is to support projects to improve use of evidence-based HIV prevention interventions among populations in priority areas identified as highly impacted by HIV,” according to NIAID. “Creative, multidisciplinary approaches are needed to meet the needs of specific populations and localities.” NIAID and its partners intend to commit a total of about $5 million to fund five or six awards. The application deadline is July 30.
HHS Releases Updated Pediatric HIV Treatment Guidelines
An HHS expert panel recently updated the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Key updates to the guidelines include:
- guidance on the use of telemedicine visits and telehealth communication in the care of children with HIV;
- changes to recommendations regarding what antiretroviral drugs (ARVs) to use when starting antiretroviral treatment (ART) for the first time, as well as ART options in the management of treatment-experienced children; and
- updates to the guidelines’ pediatric ARV information appendix to include recently approved medications.
New AIDSVu Resources Focus on HIV Among Transgender People
In commemoration of National Transgender HIV Testing Day on April 18, AIDSVu published a blog item and five updated infographics highlighting HIV among transgender people. The blog post highlights challenges in transgender HIV surveillance and CDC’s plans to improve its HIV data among transgender populations in the United States. AIDSVu’s updated transgender persons and HIV infographic series includes the following:
- Transgender Women of Color Are Disproportionately Impacted by HIV
- Five States with the Highest Number of Transgender Women with HIV
- High Poverty Levels Among Transgender Women and Men with HIV
- Growing Numbers of Transgender Women Served by the Ryan White HIV/AIDS Program
- One-Third of Transgender Women with HIV Are Between 25 and 34 Years Old
CDC Guides and Toolkits Address COVID-19 Vaccine Equity
In a recent Dear Colleague letter, Dr. Deron Burton, acting director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention noted, “It is our responsibility to ensure equitable distribution and administration [of COVID-19 vaccines], especially for those most at risk for this disease and most affected by the barriers of lack of access and information, stigma, distrust, and fear.” He noted that CDC has recently developed several materials to ensure that no one is left behind in the nation’s vaccination efforts, which are described below.
COVID-19 Vaccine Equity: Best Practices for Community and Faith-based Organizations – This fact sheet describes approaches for ensuring vaccine access, taking into consideration cultural appropriateness, language sensitivity, community involvement, and support.
A Guide for Community Partners – This 22-page resource includes guidance on how to increase COVID-19 vaccine uptake among members of racial and ethnic minority communities. It includes: information on potential strategies and interventions; ready-made messages and materials; and guidance on who and how to connect with others in efforts to increase vaccine access, confidence, and uptake.
Toolkit for Correctional and Detention Facilities – This web page features guidance and tools to help administrators of correctional and detention facilities make decisions and protect and communicate with staff, people who are incarcerated, and their communities about COVID-19.
COVID-19 Research Reports
Recent COVID-19 Studies Published in MMWR
CDC’s Morbidity and Mortality Weekly Report (MMWR) is continuing to provide extensive coverage of COVID-19-related research. The reports are aggregated on a page devoted to studies about COVID-19 and summarized in a podcast. For your convenience, we have compiled links to recent MMWR papers below:
- COVID-19 Outbreak Among Farmworkers – Okanogan County, Washington, May-August 2020
- COVID-19 Among Workers in the Seafood Processing Industry: Implications for Prevention Measures – Alaska, March-October 2020
- Linked Clusters of SARS-CoV-2 Variant B.1.351 – Maryland, January-February 2021
- Postvaccination SARS-CoV-2 Infections Among Skilled Nursing Facility Residents and Staff Members – Chicago, Illinois, December 2020-March 2021
- COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage Variant in a Skilled Nursing Facility After Vaccination Program – Kentucky, March 2021
- Health Care Utilization and Clinical Characteristics of Nonhospitalized Adults in an Integrated Health Care System 28-180 Days After COVID-19 Diagnosis – Georgia, May 2020-March 2021
- Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients – United States, April 2021
- Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years – United States, January-March 2021
- Airport Traveler Testing Program for SARS-CoV-2 – Alaska, June-November 2020
- COVID-19 Outbreaks in Correctional Facilities with Work-Release Programs – Idaho, July-November 2020
- Laboratory Modeling of SARS-CoV-2 Exposure Reduction Through Physically Distanced Seating in Aircraft Cabins Using Bacteriophage Aerosol – November 2020