PCORI Biweekly COVID-19 Scan: Omicron-Specific mRNA Vaccines, Pediatric Recovery Programs (January 20-February 2, 2022)

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

Although several COVID-19 vaccines are clinically available, the emergence of variants has led to a decrease in their effectiveness, contributing to increased COVID-19 infections and hospitalizations around the world. The SARS-CoV-2 spike protein, expressed on the surface of the virus, helps establish infection by mediating binding of the virus to host cells and facilitating cell entry. The spike protein is the target of the currently available COVID-19 vaccines. Changes in the spike protein sequence of the highly prevalent Omicron variant, however, have negatively affected the vaccines’ effectiveness. To combat this problem, Moderna and Pfizer are both developing Omicron-specific mRNA vaccines to help prevent COVID-19.

The vaccines contain mRNA (genetic instructions) encoding the Omicron spike protein. Once in the body, the mRNA  enters antigen-presenting cells and induces the production of Omicron-variant spike protein. The presence of the spike protein elicits host immune responses such as antibody production to help prevent future infection and/or reduce disease severity.

The Pfizer Omicron-specific vaccine is being investigated in a trial enrolling 1420 adult participants aged 18 to 55 years, who will receive a 2-dose primary series and a booster dose. The company anticipates the vaccine might become clinically available by March 2022. The Moderna Omicron-specific vaccine, mRNA-1273.529, is being evaluated in a phase 2 trial enrolling 600 adult participants as a booster dose. Moderna anticipates it might become available by fall 2022.

Commentary

Increased COVID-19 cases and hospitalizations since the emergence of the Omicron variant suggest a need for a variant-specific vaccine to prevent COVID-19.

Early feedback from ECRI internal stakeholders suggested that, if effective, an Omicron-specific vaccine might slow the spread of the Omicron variant and help prevent severe COVID-19 in children and adults, thereby improving population health outcomes. Reduced transmission and hospitalizations might decrease the burden on health care workers and the health care system. An Omicron-specific vaccine might decrease health disparities if it replaces first-generation vaccines in underserved populations that have lower vaccination rates and if it is distributed more broadly and equitably. Health disparities might be increased, however, if difficulties arise in obtaining and distributing the new vaccines.

Stakeholders expressed concerns that individuals who have refused COVID-19 vaccination previously are unlikely to accept variant-specific vaccines, making it unlikely that an Omicron-specific vaccine would reduce COVID-19 spread in this population. Refusal of the Omicron-specific vaccine might, in turn, increase the risk for vaccinated people with compromised immune systems who are more vulnerable to infection and to more severe disease.

• Categories: Vaccines and prophylaxis
• Areas of potential impact: Patient health outcomes, population health outcomes, health disparities

Description

Recovery programs are being established to facilitate multidisciplinary treatment of PASC in children. Similar to PASC in adults, PASC in children encompasses a broad, multisystem range of new or worsening symptoms lasting months after mild to severe COVID-19. Common PASC symptoms in children include fatigue, cough, headaches, difficulty concentrating, joint and muscle pain, and insomnia. In addition, PASC can interfere with children’s regular daily activities, including school, sports, work, and play.

Programs to treat pediatric post-COVID conditions offer comprehensive evaluation, treatment, and management for children experiencing PASC symptoms through a multidisciplinary team of specialists, including pulmonologists, neurologists, psychologists, physical therapists, and cardiologists. Depending on the child’s needs, visits with providers may be conducted in-person or through telemedicine. These dedicated programs might increase access to coordinated care for post-COVID conditions, potentially shortening the time to resolution of symptoms and return to daily activities for children.

Children’s hospitals with pediatric post-COVID recovery programs include Yale New Haven Children’s Hospital; Children’s National Hospital in Washington, DC; Boston Children’s Hospital; Children’s Hospital Los Angeles; Cooperman Barnabas Medical Center and Children’s Hospital of New Jersey at Newark Beth Israel Medical Center; Sanzari Children’s Hospital at Hackensack University Medical Center, New Jersey; and C.S. Mott Children’s Hospital, Ann Arbor, Michigan.

Commentary

Effective recovery programs for post-COVID conditions that offer coordinated, multidisciplinary treatment are needed to improve long-term health outcomes for children experiencing PASC.

Early feedback from ECRI internal stakeholders suggested that such recovery programs might enhance symptom resolution and reduce the risk of long-term effects of PASC on children’s development and mental health.

Despite the availability of COVID-19 vaccines for children aged 5 years or older, vaccination rates have remained low in this population. Further, many states are reducing mitigation measures such as school mask use and isolation protocols. The rise in pediatric COVID-19 cases could lead to more children developing persistent symptoms, increasing the importance of these programs. However, disparities in access to these programs might arise for children who live in rural areas, have inadequate health insurance, or are socioeconomically disadvantaged.

• Categories: Systems and management, treatment
• Areas of potential impact: Patient outcomes, population health outcomes, patient management, care setting, health care disparities, health care costs, treatment models

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.