PCORI Biweekly COVID-19 Scan: Monoclonal Antibody Clinics, Vaccines for Children Under 12 Years (August 19-September 1, 2021)
This briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
On August 23, the US Food and Drug Administration (FDA) fully approved the Pfizer-BioNTech COVID-19 vaccine, under the brand name Comirnaty, for people aged 16 years or older. Many hope that this move by the FDA will influence those who identified themselves in Kaiser Family Foundation’s monthly poll as more likely to get a vaccine if one were fully approved, rather than offered only through Emergency Use Authorization (EUA).
Time has been too short since approval to know whether the observed slight uptick in vaccination rates since August 23 shows an effect of this approval. We likely will not know until another round of Kaiser’s survey and additional accumulation of vaccine-administration data in the Centers for Disease Control and Prevention’s COVID Data Tracker Weekly Review are available. And it may be difficult to tease out intention. A recent New York Times analysis suggests that communities impacted by the more-transmissible Delta virus are driving increased vaccine uptake.
Full approval has not yet been granted for use of Comirnaty in children aged between 12 and 15 years, which received a later EUA. Meanwhile, as school starts, attention veers toward possible vaccinations for children younger than 12 years (see Topics to Watch).
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.
Pop-up Monoclonal Antibody Administration Clinics to Improve Access for Outpatient Treatment of COVID-19
At a Glance
- Pop-up monoclonal antibody (mAb) administration clinics are intended to increase access to treatment for people with early known or suspected SARS-CoV-2 infection who are at high risk of serious complications.
- Clinical trials show that mAb therapies can reduce the risk of hospitalization and death, as well as significantly reduce patients’ virus levels. So greater access to early treatment might reduce virus transmission, as well as the burden from hospitalizations and costs associated with treating people who have severe COVID-19.
- The expansion of mAb administration to sites beyond emergency departments might ease the burden on hospitals and allow them to admit more patients with conditions other than COVID-19.
- Some state governments are making mAb therapies more accessible and free to eligible patients.
Pop-up mAb administration clinics aim to improve access to mAb therapies for treating people diagnosed with or who had a suspected exposure to COVID-19 and are at high risk of progressing to serious complications. Laboratory-produced mAb therapies are designed to bind a specific region of the SARS-CoV-2 spike protein, found on the virus’ surface, preventing the virus from binding or entering host cells.
The FDA has granted EUAs to 3 mAb treatments that treat early-stage infections in high-risk populations. Data from clinical trials show that mAb therapies can reduce the risk of hospitalization and death by more than 70% and significantly reduce patients’ virus levels. Laboratory studies suggest that the treatments authorized for use retain activity against the Delta strain. However, these therapies remain underutilized because of challenges with administering the infusion treatments.
Health care organizations have integrated resources from outpatient clinics (eg, urgent care, specialty clinics) to improve access to mAb therapy. For example, Pardee UNC Health Care in North Carolina has hired temporary staff licensed to safely administer outpatient treatment in nontraditional settings. Johns Hopkins Medicine and the University of Maryland Medical System are offering mAb treatments at the Baltimore Convention Center. Covington County Hospital in Mississippi has set up a pop-up mAb clinic in an old armory building. In Florida, urgent care centers and public spaces are being utilized for administering mAb therapies for free to eligible patients.
State governments are also making antibody therapies more widely available by providing resources to clinics and offering free mAb treatments. And, in Florida, eligible health care providers may give the treatment without a prescription or referral.
Pop-up mAb administration clinics might improve survival outcomes for individuals who are at high risk of progressing to severe COVID-19. The broad availability of infusion centers and free treatment might help the diffusion of mAb therapy in people at high risk of developing complications.
Early feedback from ECRI internal stakeholders suggested that these clinics can impact patient and population health outcomes, increasing access to mAb treatments by moving away from emergency departments. Pop-up administration clinics might reduce disparities for people with limited transportation access who can reach closer mAb clinics. Improved outcomes might reduce the risk of hospitalizations and deaths while freeing health care resources for conditions other than COVID-19.
Stakeholders warned that free mAb treatments might negatively impact vaccination rates and longer-term health outcomes in states with lower than the national average in vaccination rates. Stakeholders also thought that it is imperative to educate recipients that mAb therapy offers short-term passive immunity that lasts only a few months and is not a reliable substitute for vaccination. People who are treated but unvaccinated remain at greater risk of contracting COVID-19 again.
- Categories: Systems and management
- Areas of potential impact: Patient health outcomes, population health outcomes, health care delivery and process, patient management, health care disparities
Vaccines to Prevent COVID-19 in Children Younger than 12 Years
At a Glance
- Vaccines to prevent COVID-19 in children younger than 12 years are under investigation and might reduce infection spread and complications among these children and their families.
- To detect rare side effects, such as heart issues, Pfizer’s trial and Moderna’s trial both enrolled at least 3000 children between the ages of 5 and 11 years.
- The manufacturers have not reported preliminary data regarding early immune responses and tolerability of the vaccines in children younger than 12.
- Pfizer expects to have data from its trial by the end of September and is planning to submit for an EUA from the FDA soon thereafter. Moderna expects to have data by the end of 2021 and plans to seek an EUA of its vaccine for children aged between 6 and 11 years.
Although vaccines are available for adults, protection against COVID-19 remains limited to social distancing and masking for children younger than 12. From the start of the pandemic through August 26, 2021, nearly 4.8 million children tested positive for COVID-19, with case rates on the rise again.
Moderna and Pfizer are determining whether their respective COVID-19 vaccines can safely produce protective immune responses against COVID-19 in children younger than 12. At FDA’s urging, both Moderna’s and Pfizer’s study sizes were expanded to include at least 3000 children in the 5- to 11-year-old group. The larger study groups can help investigators detect rare side effects, such as heart muscle inflammation (myocarditis) and swelling of the membrane around the heart (pericarditis), occurring in vaccinated people younger than 30.
Pfizer’s phase 2/3 trial divides its group of 4500 children into 3 age groups: children aged 6 months to 2 years, 2 to 5 years, and 5 to 11 years, with 3 different dosages being given to each group. Preliminary safety and efficacy data in children younger than 12 have not been released. Pfizer expects to have data from this trial by the end of September and plans to submit for an EUA expansion into these younger age groups shortly thereafter.
Moderna is running a phase 2/3 trial in 13 275 children aged 6 months to less than 12 years to determine the safety and efficacy of its vaccine. Moderna expects to have data by the end of 2021 and plans to seek EUA for children between the ages of 6 and 11 years.
The increase in COVID-19 cases among children coupled with the back-to-school season has led to increased interest in pediatric vaccines against COVID-19. These vaccines could improve patient and population health, by decreasing the risk of infection and severe COVID-19 in children and facilitate a return to normalcy.
Early feedback from ECRI internal stakeholders suggested that a pediatric vaccine might protect children from acquiring COVID-19 in schools and might also decrease transmission risk to family members. Vaccinating children is also expected to play an important role in slowing community spread and achieving herd immunity, if possible. Having children vaccinated might allow the lifting of stringent mitigation efforts in schools and ease anxiety, allowing greater focus on education.
If available, effective vaccines would result in fewer children getting sick and reduced demands on health care resources for children, freeing resources for other medical conditions. However, stakeholders had concerns that some parents would be unwilling to vaccinate their children, and the availability of pediatric vaccines might result in public unrest or protests in areas with high vaccine hesitancy and mistrust.
- Categories: Vaccines and prophylaxis
- Areas of potential impact: Patient outcomes, population health, 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.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected]
or by mail to: Patient-Centered Outcomes Research Institute, 1828 L Street, NW, Suite 900, Washington, DC 20036.
Posted: September 13, 2021