PCORI Biweekly COVID-19 Scan: Increasing Access to Antiviral Treatments, Vaccines for Children Aged 4 and Younger (March 17-30, 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

The Test-to-Treat initiative is a federal program intended to increase access for eligible patients to antiviral COVID-19 treatments. The program is intended to enable individuals who are at high risk of developing severe COVID-19 to undergo SARS-CoV-2 testing, receive a prescription from a health care provider if appropriate, and receive the medication, all at one location. Individuals may also bring positive test results obtained through another testing site or an at-home test to be considered for treatment. A Test-to-Treat locator is available to help individuals find participating sites.

Although COVID-19-related hospitalizations and deaths are declining in the United States, the current administration noted the importance of programs and policies to better prepare for new SARS-CoV-2 variants and protect against, and treat, COVID-19. Its National COVID-19 Preparedness Plan, released in March 2022, details steps to enable the country to safely transition from crisis back to normal routines, while continuing to protect people against COVID-19. This includes the Test-to-Treat initiative. 

The US Department of Health and Human Services began distributing the oral antivirals, consisting of Paxlovid (nirmatrelvir plus ritonavir) and molnupiravir, to participating sites in early March. The “one-stop” locations include pharmacy-based clinics, federally qualified health centers, long-term care facilities, and US Department of Veterans Affairs facilities across the United States. Both antivirals have emergency use authorization (EUA) from the FDA to treat mild to moderate COVID-19 in adults at high risk for developing severe COVID-19, as well as adolescents aged 12 years or older, and should be initiated as soon as possible within 5 days of symptom onset.

Through this initiative, eligible individuals receive SARS-CoV-2 testing and antiviral treatment at no cost.

Commentary

“Test-to-Treat” might increase patient access to COVID-19 treatments during the ongoing COVID-19 pandemic.

Early feedback from ECRI internal stakeholders suggested the Test-to-Treat program might reduce health disparities for high-risk individuals by removing financial barriers to care and increasing ease of obtaining treatment, which might mitigate serious illness and death in this population.

Barriers to care could persist for high-risk individuals. Drug interactions might occur between the antivirals and certain medications patients take for chronic conditions, and individuals who have not had a recent medical exam might be unaware that they have a condition that makes them eligible to receive care through this initiative. In patients who do access treatment, the antivirals might cause side effects requiring medical attention.

However, Test-to-Treat might decrease the overall burden on the health care system by reducing COVID-19-related emergency department visits and hospitalizations. Moreover, this initiative could mitigate community SARS-CoV-2 transmission because patients are tested and treated at one location. This strategy could be effective if COVID-19 moves into an endemic phase.

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

Description

No vaccine is currently authorized to prevent COVID-19 in children aged 4 years or younger. During the Omicron predominant wave, this population was 5 times more likely to be hospitalized than during the delta predominant wave. To address this, Moderna and Pfizer-BioNTech are investigating the safety and effectiveness of their respective mRNA COVID-19 vaccines in children aged 6 months to 4 years.

In Pfizer and BioNTech’s ongoing phase 1/2/3 trial, children aged 6 months to 4 years receive 1 of 3 experimental doses of vaccine, ranging from 3 to 30 µg (lower than adult doses), given in 2- or 3-dose regimens. The companies initiated a rolling submission for EUA to the FDA in February 2022 with data on the safety and efficacy of 3 µg given in 2 of 3 planned doses. The FDA announced it will wait until additional data on a third dose in this age group are available before considering authorization. Pfizer and BioNTech expect the data will be available in early April.

In Moderna’s ongoing phase 2/3 trial, participants receive a 2-dose primary series of the vaccine with 1 of 3 varying doses. An interim data analysis reported in March found the 25-μg 2-dose series of the vaccine resulted in a significant immune response and had a favorable safety profile in children aged 6 months to under 6 years. Vaccine efficacy was 43.7% in children aged 6 months to 2 years and 37.5% in children aged 2 years to 6 years, consistent with adult observational data during the Omicron predominant wave. Moderna anticipates it will submit a request for EUA to the FDA for the 25-μg 2-dose primary series for use in this age range in the coming weeks.

All COVID-19 vaccines are currently paid for by the US government and must be administered at no cost to patients.

Commentary

Increases in COVID-19 cases due to the Omicron SARS-CoV-2 variant and recent discontinuation of mask mandates in many areas highlight the need for vaccines in children younger than 5 years to protect against COVID-19. These vaccines could improve patient and population health by decreasing the risk of SARS-CoV-2 infection and severe COVID-19 in children, their families, and communities.

Early feedback from ECRI internal stakeholders suggested pediatric COVID-19 vaccines might protect children against severe COVID-19, resulting in fewer deaths, fewer hospitalizations, and less burden on the health care system. Vaccination might also protect children against multisystem inflammatory syndrome in children (MIS-C), a serious inflammatory condition associated with COVID-19 in children, and post-COVID conditions.

Although pediatric COVID-19 vaccines might alleviate parental worry about children contracting COVID-19, stakeholders expressed concerns that, given preliminary findings of waning vaccine efficacy in children aged 5 to 11 years, parents might be hesitant to vaccinate younger children if they think the potential benefits do not outweigh the risk of adverse events.

• Categories: Vaccines and prophylaxis
• Areas of potential impact: Patient outcomes, population health, health care delivery and process, 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.