PCORI Biweekly COVID-19 Scan: Digital Immunization Records, Variant-Specific Vaccines (February 20-March 3, 2021)

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

After receiving a COVID-19 vaccine, people are issued a written card that includes their protected health information (eg, name, date of birth), which vaccine they received, and when the next dose is due. Several smartphone apps are under development that are intended to help the public maintain a digital record of their vaccination status to facilitate return to work, school, and travel, while protecting other sensitive information.

The VCI is a coalition of health and technology industry leaders seeking to develop a secure, verifiable method to digitize vaccination cards. The SMART Health Cards initiative would provide individuals with access to their COVID-19 vaccination records and laboratory results via digital wallet apps such as Apple Wallet or Google Pay.

Users can add their health records by linking the app directly to laboratory or health care provider websites, which developers say will provide a verifiable source of vaccination status and/or laboratory test results. Users can share information from their digital card with third parties seeking verification of immunization status or test results. Platforms such as CommonPass might facilitate sharing data.

For people without smartphones, VCI is developing a paper printout (PDF) of a QR code containing verifiable credentials aligned with Fast Healthcare Interoperability Resources standards.

Commentary

Smartphone applications that keep a digital record of vaccination status might provide convenient access and secure sharing of verifiable vaccination records. This initiative could ease the process for individuals who require documentation to safely return to work, school, or travel.

Early feedback from ECRI internal stakeholders suggested that SMART Health Cards can provide portability of data for some. However, it could increase disparities for individuals—such as older adults who might lack access to a cellphone or might be uncomfortable with technology—because users must link to provider sites and have a printer.

Stakeholders also expressed concerns regarding data privacy and security because these apps might be hacked. Even with the verifiable credentialing system that allows individuals to manage their health information and control what they share, providers might not permit clinical data sharing because of obstacles around electronic health record data integration across platforms (eg, different laboratories and health systems).

• Categories: Systems and management
• Areas of potential impact: Population health, health care delivery and process, health care disparities 

Description

Coronavirus genetic mutations are inevitable, leading to successful viral variants that can emerge and persist around the world. The emergence of some SARS-CoV-2 variants has prompted researchers to evaluate whether modified COVID-19 vaccines specific to the new variants will be needed to ensure protection against COVID-19. Variants harboring certain mutations in the SARS-CoV-2 spike protein, which the virus uses to bind and enter human cells, are of particular concern because some mutations might nullify protective antibody responses from the first generation of vaccines. 

Initial studies have found that Moderna’s mRNA-1273 vaccine has a 6-fold reduced neutralization against the B.1.351 variant, first identified in South Africa. The ability of serum from people vaccinated with Pfizer and BioNTech’s BNT162b2 to neutralize the variant was reduced by 3-fold, compared with early COVID-19 isolates. Moderna, the developer of mRNA-1273, has announced a phase 1 trial to determine the neutralizing ability of a vaccine candidate (mRNA-1273.351) specific for B.1.351. Pfizer and BioNTech, the developers of BNT162b2, are also discussing with regulatory authorities initiating a study using an mRNA vaccine with a variant sequence, which would lead to an adaptable vaccine platform and regulatory process for use against B.1.351 or other emerging variants.

Commentary

COVID-19 vaccines have allowed many individuals to gain protection against severe disease. However, the emergence of more contagious variants or those that might reduce vaccine efficacy is a major obstacle to ending the pandemic.

Early feedback from ECRI internal stakeholders suggested that, if authorized vaccines are shown to be less effective against COVID-19 variants, variant-specific vaccines could improve patient and public health outcomes. Initial variant vaccines might play a key role in defining expectations about periodic vaccine adjustments needed for emerging variants and for defining regulatory pathways if COVID-19 becomes a seasonal disease. Variant vaccines might still have moderate impact because they will not yet replace the authorized vaccines and are intended as boosters.

Concern remains over the long-term safety and adverse effects from being exposed to 2 or more doses of mRNA vaccine lipid nanoparticles (eg, allergic reactions, hypersensitivity, and toxicity). Stakeholders also raised concerns that misperceptions of variant-strain infectivity as well as initial vaccine-rollout missteps might reduce variant vaccine or booster shot uptake.

• 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.