PCORI Biweekly COVID-19 Scan: Booster Vaccine, Targeted Information Campaigns (July 21-August 3, 2022)
The 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.
The FDA has decided to delay expanding boosters to children and adults aged up to 50 years in favor of waiting for updated bivalent boosters that protect against both the original virus and the currently dominant Omicron variant of SARS-CoV-2 (see Topics to Watch for one such vaccine expected in September).
On July 26, 2022, the White House hosted the “Summit on the Future of COVID-19 Vaccines." One of the speakers, Akiko Iwasaki (a professor at Yale University), recently published a call for an “Operation Nasal Vaccine” to bring the successful tactics of Operation Warp Speed to the production of a vaccine delivered by nose spray. Such a vaccine could incite mucosal immunity; that is, block the virus at the nose and throat where it first enters the body. Clinical trials are underway and results in mouse studies are promising.
A group at the University of Pennsylvania hopes to create another innovative method to reduce the transmission of SARS-CoV-2 from infected individuals to others: CTB-ACE2 release chewing gum. The chewing gum would reduce the viral load in the chewer’s mouth using plant-cell-derived ACE2 receptors that would cause the free virus to aggregate in clumps to the proteins in the gum. Recent lab results offered proof of concept ahead of a clinical trial planned to begin in August 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.
BNT162b5 Booster Vaccine to Prevent COVID-19
At a Glance
- Mutations in the Omicron variant of SARS-CoV-2 have resulted in increased infections and COVID-19–related hospitalizations, prompting the FDA to advise vaccine manufacturers to develop COVID-19 bivalent booster vaccines containing a component against Omicron.
- Pfizer (New York, New York) and BioNTech (Mainz, Germany) are investigating a bivalent messenger RNA (mRNA) vaccine, BNT162b5, that targets the spike protein from the original SARS-CoV-2 virus as well as the Omicron variant to prevent COVID-19.
- BNT162b5 is being investigated in a phase 2 trial of 200 adults who have already received a booster dose of an authorized COVID-19 vaccine.
- The companies plan to evaluate multiple vaccine candidates to create vaccines that generate longer-lasting immunity against SARS-CoV-2 infections.
- On June 29, 2022, the company announced that the US government agreed to purchase the first 105 million doses of an Omicron specific vaccine from Pfizer for about $30 per dose.
Although several COVID-19 vaccines are available, emerging SARS-CoV-2 variants such as Omicron can evade the antibody responses produced by these vaccines. This has contributed to an increase in SARS-CoV-2 infections and COVID-19–related hospitalizations. On June 30, 2022, the FDA advised manufacturers to develop modified bivalent vaccines that add the Omicron variant spike protein component to their current booster vaccine composition that can be used starting in early to mid-fall 2022.
Pfizer and BioNTech are developing an Omicron-specific mRNA booster vaccine, BNT162b5, intended to protect against both the Omicron variant and the original strain of SARS-CoV-2. The bivalent vaccine contains mRNA (genetic instructions) encoding the recombinant spike proteins modeled on the Omicron SARS-CoV-2 BA.2 variant and the original SARS CoV-2 strain. BNT162b5 enters antigen-presenting cells and induces the production of both spike proteins to elicit host immune responses to help prevent future infection and/or reduce disease severity.
BNT162b5 is being investigated in a phase 2 trial in 200 adults that has an estimated completion date of January 2023. The vaccine is given as a second booster dose for adults who received a booster dose of an FDA-authorized COVID-19 vaccine at least 90 days prior. The companies will be evaluating multiple enhanced vaccines in the future to generate longer-lasting and broader immune responses against COVID-19. On June 29, 2022, the company announced that the US government agreed to purchase the first 105 million doses of an Omicron-specific vaccine from Pfizer for $3.2 billion or about $30 per dose.
Reduced effectiveness of COVID-19 vaccines against SARS-CoV-2 variants has led to a need for updated COVID-19 vaccines to boost the population’s immunity against SARS-CoV-2 infections.
Early feedback from ECRI internal stakeholders suggested that, if effective, BNT162b5 might be able to reduce hospitalizations and deaths due to COVID-19. However, changes to the parent vaccine formulation might cause the public to question its effectiveness and result in reduced uptake, especially since oral drugs, such as Paxlovid, are already widely available to treat those at risk of severe illness due to COVID-19. Misinformation regarding COVID-19 vaccine boosters might cause individuals to question the need for another booster. Less than optimal uptake of Omicron-targeted boosters could contribute to an endless cycle in which more variants emerge that are capable of evading current vaccines in circulation, therefore leaving vaccine developers continually behind the pace of SARS-CoV-2 variants.
- Category: Vaccines and prophylaxis
- Areas of potential impact: Patient health outcomes, population health outcomes, health disparities
Targeted Information Campaigns to Equitably Improve Maternal COVID-19 Vaccination Rates and Child Health Outcomes
At a Glance
- Despite evidence that COVID-19 vaccination is not associated with increased risk of adverse maternal or fetal outcomes, misinformation remains widespread, and vaccination coverage among pregnant women varies significantly by race and ethnicity.
- Infection during pregnancy is also associated with worse outcomes for children, including increased risk of preterm birth and neurodevelopmental issues.
- Multiple academic and government health organizations have developed toolkits that use evidence-based behavior change theories and social media tools to promote vaccination among pregnant women.
- Dissemination of culturally relevant, scientifically informed health information might beneficially alter behaviors regarding COVID-19 vaccination and reduce disparities in maternal and child health outcomes.
Pregnant women are at increased risk for severe illness from COVID-19, and maternal COVID-19 vaccination has been linked to reduced risk of critical COVID-19 and hospitalization for their infants. Despite the growing evidence that vaccination is not associated with increased risk of adverse maternal or fetal outcomes, misinformation remains widespread, and vaccination coverage among pregnant women varies significantly by race and ethnicity (see figures 2 and 3 in the CDC link).
Recent evidence suggests that SARS-CoV-2 infection during pregnancy is associated with worse outcomes for children, including the increased risk of preterm birth and neurodevelopmental effects, which might further exacerbate existing health disparities. Therefore, there is a need for targeted information campaigns and community-based programs to increase vaccine literacy and support individual decision-making.
Multiple academic and government health organizations have developed toolkits that use behavior change theories and social media tools to promote vaccination among pregnant women, including the Department of Health & Human Services, the American College of Obstetricians and Gynecologists, and the California Department of Health. Notably, the University of Washington’s “One Vax, Two Lives” campaign targets the 5 dimensions of vaccine uptake (ie, access, affordability, awareness, acceptance, and activation) and aims to broadly disseminate scientifically informed health information that addresses population-specific vaccine concerns. Expanding the advertising to a 4-week campaign nationally might cost about a half million dollars.
Effective strategies to communicate evidence-based information regarding the safety and effectiveness of COVID-19 vaccination and the risk of infection for pregnant women are needed to reduce vaccine hesitancy and improve health outcomes for pregnant women and their infants.
Early feedback from ECRI internal stakeholders suggested that communication toolkits to increase vaccine literacy might beneficially alter pregnant women’s attitudes and behaviors regarding COVID-19 vaccination. Broadly disseminating scientifically backed information on familiar social media platforms might combat vaccine misinformation, reduce the stigma around mRNA vaccines, and increase awareness of vaccine options. In addition, culturally relevant content in multiple languages might promote equitable access to current vaccine information and resources.
Preventing SARS-CoV-2 infection can potentially decrease the burden on the health care system and caregivers by reducing COVID-19 complications in pregnancy and in infants postpartum. However, public distrust in the health care system and government might diminish the effectiveness of these public health interventions.
- Category: Public health
- Areas of potential impact: Patient health outcomes, population health outcomes, health 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.
In May 2021, the COVID-19 supplement was modified and merged with the HCHSS. The Biweekly COVID-19 Scans continue, while the Status Reports and High Impact Reports were folded into the PCORI Horizon Scanning Database and High Potential Disruption Reports.
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].
Posted: August 11, 2022
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