ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.

Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.

Description

JNJ-78436735 (Johnson & Johnson) is a recombinant, nonreplicating adenovirus vector vaccine. It is designed to express the SARS-CoV-2 spike protein in cells at the immunization site and invoke protective anti–SARS-CoV-2 host immune responses from a single dose.

A company news release announced that in the randomized phase 3 ENSEMBLE trial enrolling 43 783 volunteers, JNJ-78436735 was 66% effective at preventing moderate to severe disease and 85% effective at preventing severe disease 28 days after a single dose of vaccine. Efficacy in preventing moderate to severe disease across geographic regions was 72% in US participants, 66% in Latin America, and 57% in South Africa. No significant safety concerns or anaphylactic incidents were reported. A 2-dose protocol is also being studied in the phase 3 ENSEMBLE 2 trial, with primary completion in May 2022.

On February 4, 2021, the company submitted an EUA application, and a Vaccines and Related Biologic Products Advisory Committee meeting is scheduled on February 26, 2021. The company plans to manufacture 100 million doses for the United States by end of June 2021, pending approval or EUA.

Commentary

Safe and effective COVID-19 vaccines are key to ensuring long-term public health and might enable relaxed social distancing protocols. JNJ-78436735’s single-dose preliminary efficacy coupled with the company’s plan to manufacture 100 million doses might substantially help achieve herd immunity in the United States. The vaccine’s varied efficacy in preventing moderate to severe disease across geographic regions suggests that the vaccine might be somewhat less effective against some variants than against the original strain. Reduced efficacy against variant strains might delay or inhibit achieving herd immunity, without the use of revised boosters.

Early feedback from ECRI internal stakeholders revealed that, although vaccine efficacy was lower than the Pfizer or Moderna vaccines, JNJ-78436735’s efficacy and single-dose administration might help mitigate disparities by increasing the feasibility of vaccination efforts for people with limited access to care. Administration cost, logistics, scheduling, and personnel requirements will also be simplified because of single-dose administration. However, stakeholders raised concerns that the lower efficacy against variant strains might eventually result in the need for a booster dose or doses to ensure sustained protection. 

• Categories: Vaccines and prophylaxis
• Areas of potential impact: Patient outcomes, population health, clinician and/or caregiver safety, health care delivery and process, health care disparities, health care costs

Description

NVX-CoV2373 (Novavax, Inc) is a coronavirus vaccine that consists of special recombinant multimeric nanoparticles. These nanoparticles present the full-length SARS-CoV-2 spike protein, which is essential for host receptor binding, viral fusion, and viral entry. The spike protein nanoparticles are seen by the body as foreign antigens and purportedly trigger protective immune responses. NVX-CoV2373 nanoparticles do not contain polyethylene glycol, which has been linked with anaphylaxis concerns. NVX-CoV2373 is coadministered with the proprietary Matrix-M1 adjuvant to enhance immune responses. The vaccine is administered twice, 21 days apart.

Primary efficacy data announced through a company news release of a phase 3 randomized trial involving 15 000 adults in the United Kingdom found that the vaccine was 89% effective in preventing mild through severe COVID-19 occurring at least 7 days after the second vaccination. More than 50% of cases in the analysis were attributed to the UK variant. Severe adverse events purportedly occurred at low levels and were balanced between vaccine and placebo groups. In a South African phase 2b trial, the vaccine was 60% effective in preventing mild through severe COVID-19. A phase 3, US randomized trial is enrolling 30 000 participants, with primary completion expected in March 2021.

On February 4, 2021, the company initiated rolling regulatory submissions to the FDA and international regulatory agencies. The manufacturer plans to produce up to 150 million doses per month globally by May or June 2021.

Commentary

Safe and effective COVID-19 vaccines are key to ensuring long-term public health and might enable relaxed social distancing protocols. NVX-CoV2373’s encouraging preliminary efficacy and the company’s plan to rapidly scale manufacturing might substantially facilitate herd immunity in the United States. The vaccine’s efficacy profile across geographic regions suggests that it might be somewhat less effective against some variants than against earlier strains.

Early feedback from ECRI internal stakeholders revealed that the representation of trial participants older than 60 years was encouraging. NVX-CoV2373’s efficacy and scale-up might increase access to vaccines in the United States and abroad. Some stakeholders were encouraged that the vaccine might provide some efficacy against variants, but others remained cautious about the reduced efficacy against variants. The vaccine’s adjuvant helps to increase the number of doses available. Rapid scale-up of the vaccine might improve health care delivery by reducing supply bottlenecks currently being experienced with Moderna and Pfizer vaccine distribution.

• Categories: Vaccines and prophylaxis
• Areas of potential impact: Patient outcomes, population health, clinician and/or caregiver safety, health care delivery and process, health care disparities, health care costs

Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.

The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.

In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.

The HCHSS COVID-19 supplement produces 3 main outputs:

• Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
• Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
• High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.