Briefing for January 23-February 5, 2021 - PCORI
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BIWEEKLY
PCORI HEALTH CARE HORIZON SCANNING SYSTEM
COVID-19 SCAN VOLUME 1, ISSUE 19
Briefing for January 23-February 5, 2021 Treatment development has lagged vaccine development, and
treatment distribution has also been a challenge. Meanwhile, we
This briefing provides an at-a-glance view of some important
continue to learn more about how COVID-19 affects the body.
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. Topics to Watch
Vaccine data are being simultaneously welcomed and ECRI Horizon Scanning has selected the topics below as those with
questioned in the United Kingdom, Russia, China, and the potential for impact relative to COVID-19 in the United States within
United States (see Topics to Watch); distribution woes and data the next 12 months. All views presented are preliminary and based
gaps are highlighting the possibility of increased health care on readily available information at the time of writing. Because
disparities; and emerging coronavirus variants might alter vaccine these topics are rapidly developing, we cannot guarantee the
effectiveness. accuracy of this information after the date listed on this publication.
In addition, all views expressed in the commentary section are solely
Although slow progress is being made toward herd immunity
those of ECRI Horizon Scanning and have not been vetted by other
against COVID-19, many people continue to contract the
stakeholders. Topics are listed in alphabetical order.
disease. Recent models predict that, although overall case
numbers are decreasing, 440 000 to 1.1 million new cases are
likely in the United States by the end of February.
JNJ-78436735 (Ad26.COV2-S) Vaccine AT A GLANCE
to Prevent Coronavirus Infection
f JNJ-78436735 is a recombinant, nonreplicating
Categories: Vaccines and prophylaxis adenovirus vector vaccine. It is designed to generate
Areas of potential impact: Patient outcomes, population protective host immune responses against the spike
health, clinician and/or caregiver safety, health care delivery protein of SARS-CoV-2, the virus that causes COVID-19,
and process, health care disparities, health care costs from a single dose.
Description: JNJ-78436735 (Johnson & Johnson) is a f The phase 3 randomized ENSEMBLE trial, found that JNJ-
recombinant, nonreplicating adenovirus vector vaccine. It 78436735 was 66% effective at preventing moderate to
is designed to express the SARS-CoV-2 spike protein in cells at severe COVID-19 disease and 85% effective at preventing
the immunization site and invoke protective anti–SARS-CoV-2 severe COVID-19 disease 28 days after a single dose of
host immune responses from a single dose. vaccine.
A company news release announced that in the randomized f The vaccine was purportedly well-tolerated with no
phase 3 ENSEMBLE trial enrolling 43 783 volunteers, JNJ- significant safety concerns or incidents of anaphylaxis
78436735 was 66% effective at preventing moderate to reported.
severe disease and 85% effective at preventing severe f On February 4, 2021, the company applied for Emergency
disease 28 days after a single dose of vaccine. Efficacy in Use Authorization (EUA) to the US Food and Drug
preventing moderate to severe disease across geographic Administration (FDA); an FDA advisory committee
regions was 72% in US participants, 66% in Latin America, meeting is scheduled on February 26, 2021. The company
and 57% in South Africa. No significant safety concerns or plans to manufacture 100 million doses for the United
anaphylactic incidents were reported. A 2-dose protocol is States by the end of June 2021, pending an EUA.
also being studied in the phase 3 ENSEMBLE 2 trial, with
primary completion in May 2022.
RESEARCH DONE DIFFERENTLY®
On February 4, 2021, the company submitted an EUA the original strain. Reduced efficacy against variant strains
application, and a Vaccines and Related Biologic Products might delay or inhibit achieving herd immunity, without the
Advisory Committee meeting is scheduled on February 26, use of revised boosters.
2021. The company plans to manufacture 100 million doses Early feedback from ECRI internal stakeholders revealed
for the United States by end of June 2021, pending approval that, although vaccine efficacy was lower than the Pfizer or
or EUA. Moderna vaccines, JNJ-78436735’s efficacy and single-dose
Commentary: Safe and effective COVID-19 vaccines are administration might help mitigate disparities by increasing
key to ensuring long-term public health and might enable the feasibility of vaccination efforts for people with limited
relaxed social distancing protocols. JNJ-78436735’s single- access to care. Administration cost, logistics, scheduling, and
dose preliminary efficacy coupled with the company’s plan personnel requirements will also be simplified because of
to manufacture 100 million doses might substantially help single-dose administration. However, stakeholders raised
achieve herd immunity in the United States. The vaccine’s concerns that the lower efficacy against variant strains might
varied efficacy in preventing moderate to severe disease eventually result in the need for a booster dose or doses to
across geographic regions suggests that the vaccine might be ensure sustained protection.
somewhat less effective against some variants than against
NVX-CoV2373 Vaccine to Prevent AT A GLANCE
SARS-CoV-2 Infection
f NVX-CoV2373 is a recombinant, nanoparticle
Categories: Vaccines and prophylaxis coronavirus vaccine designed to generate protective
Areas of potential impact: Patient outcomes, population immune responses against COVID-19 disease.
health, clinician and/or caregiver safety, health care delivery f Primary phase 3 efficacy data from 15 000 adults in
and process, health care disparities, health care costs the United Kingdom showed that the vaccine was
Description: NVX-CoV2373 (Novavax, Inc) is a coronavirus 89% effective in preventing COVID-19 from occurring
vaccine that consists of special recombinant multimeric at least 7 days after the second dose, with more than
nanoparticles. These nanoparticles present the full-length 50% of cases attributed to the new UK coronavirus
SARS-CoV-2 spike protein, which is essential for host receptor variant. Adverse events were purportedly balanced
binding, viral fusion, and viral entry. The spike protein between vaccine and placebo groups.
nanoparticles are seen by the body as foreign antigens and f NVX-CoV2373 is also under study in a US-based phase
purportedly trigger protective immune responses. NVX- 3 randomized trial in 30 000 participants, with primary
CoV2373 nanoparticles do not contain polyethylene glycol, results expected in March 2021.
which has been linked with anaphylaxis concerns. NVX-
f On February 4, 2021, the company initiated rolling
CoV2373 is coadministered with the proprietary Matrix-M1
regulatory submissions to the FDA and international
adjuvant to enhance immune responses. The vaccine is
regulatory agencies. The manufacturer plans to
administered twice, 21 days apart.
produce up to 150 million doses per month globally by
Primary efficacy data announced through a company news May or June 2021, pending EUA.
release of a phase 3 randomized trial involving 15 000
adults in the United Kingdom found that the vaccine was
89% effective in preventing mild through severe COVID-19 On February 4, 2021, the company initiated rolling regulatory
occurring at least 7 days after the second vaccination. More submissions to the FDA and international regulatory agencies.
than 50% of cases in the analysis were attributed to the The manufacturer plans to produce up to 150 million doses per
UK variant. Severe adverse events purportedly occurred at month globally by May or June 2021.
low levels and were balanced between vaccine and placebo Commentary: Safe and effective COVID-19 vaccines are key
groups. In a South African phase 2b trial, the vaccine was to ensuring long-term public health and might enable relaxed
60% effective in preventing mild through severe COVID-19. A social distancing protocols. NVX-CoV2373’s encouraging
phase 3, US randomized trial is enrolling 30 000 participants, preliminary efficacy and the company’s plan to rapidly scale
with primary completion expected in March 2021. manufacturing might substantially facilitate herd immunity
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.
2 Biweekly COVID-19 Scan | Volume 1, Issue 19in the United States. The vaccine’s efficacy profile across provide some efficacy against variants, but others remained
geographic regions suggests that it might be somewhat less cautious about the reduced efficacy against variants. The
effective against some variants than against earlier strains. vaccine’s adjuvant helps to increase the number of doses
Early feedback from ECRI internal stakeholders revealed that available. Rapid scale-up of the vaccine might improve health
the representation of trial participants older than 60 years care delivery by reducing supply bottlenecks currently being
was encouraging. NVX-CoV2373’s efficacy and scale-up might experienced with Moderna and Pfizer vaccine distribution.
increase access to vaccines in the United States and abroad.
Some stakeholders were encouraged that the vaccine might
About Horizon Scanning diagnostics, preventive measures, management strategies,
and systems changes with potential for high impact to
Horizon scanning is a systematic process that serves as
patient outcomes—for individuals and populations—in the
an early warning system to inform decision makers about
United States in the next 12 months.
possible future opportunities and threats. Health care
horizon scanning identifies technologies, innovations, and The HCHSS COVID-19 supplement produces 3 main outputs:
trends with potential to cause future shifts or disruptions— • Biweekly COVID-19 Scans (eg, this document) provide ECRI
positive or negative—in areas such as access to care, care Horizon Scanning with a vehicle to inform PCORI and the
delivery processes, care setting, costs of care, current public in a timely manner of important topics of interest
treatment models or paradigms, health disparities, health identified during ongoing scanning and topic identification
care infrastructure, public health, and patient health or through the ECRI stakeholder survey process.
outcomes.
• Status Reports (quarterly) briefly list and describe all
The PCORI Health Care Horizon Scanning System (HCHSS) COVID-19–related topics identified, monitored, and
conducts horizon scanning to better inform research recently archived.
investments at the Patient-Centered Outcomes Research
Institute (PCORI). Initially, PCORI defined the HCHSS project • High Impact Reports (every 4 months) highlight those
scope to focus on interventions with high potential for topics that ECRI internal stakeholders (eg, physicians,
disruption in the United States in 5 priority areas: Alzheimer’s nurses, allied health professionals, public health
disease and other dementias, cancer, cardiovascular professionals, first responders, health systems experts,
diseases, mental and behavioral health conditions, and clinical engineers, researchers, business and finance
rare diseases. In addition, the system captures high-level professionals, and information technology professionals)
disruptive trends across all clinical areas, which may lead have identified as having potential for high impact relative
PCORI to expand the project scope to include other priority to COVID-19 in the United State.
areas in the future. We welcome comments on this document. Send comments
In early 2020, the COVID-19 pandemic created a fast- by email to horizonscan@pcori.org.
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,
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.
3 Biweekly COVID-19 Scan | Volume 1, Issue 19About This Report Financial Disclosure Statement
The PCORI Health Care Horizon Scanning System is operated None of the individuals compiling this information has any
by ECRI under contract to PCORI, Washington, DC (Contract affiliations or financial involvement that conflict with the
No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12). The findings and material presented in this report.
conclusions in this document are those of the authors, who All statements, findings, and conclusions in this publication
are responsible for its content. No statement in this report are solely those of the authors and do not necessarily
should be construed as an official position of PCORI. represent the views of PCORI or its Board of Governors. This
A representative from PCORI served as a contracting officer’s publication was developed through a contract to support
technical representative and provided input during the PCORI’s work. Questions or comments may be sent to
implementation of the horizon scanning system. PCORI does PCORI by email at info@pcori.org or by mail to Suite 900,
not directly participate in horizon scanning or assessing leads 1828 L Street, NW, Washington, DC 20036. ©2021 Patient-
or topics and did not provide opinions regarding potential Centered Outcomes Research Institute. For more information,
impact of interventions. see www.pcori.org.
Public Domain Notice
This document is in the public domain and may be used and
reprinted without special permission. Citation of the source is
appreciated.
Suggested citation: Lynch M, De Lurio J, Patel P, et al. PCORI
Health Care Horizon Scanning System: Biweekly COVID-19
Scan. Washington, DC: Patient-Centered Outcomes Research
Institute; February 5, 2021. Prepared by ECRI under Contract
No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12.
Prepared for:
Patient-Centered Outcomes Research Institute
1828 L St., NW, Suite 900, Washington, DC 20036
Phone: 202-827-7700 | Fax: 202-355-9558 | www.pcori.org
Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12
Prepared by:
ECRI
5200 Butler Pike, Plymouth Meeting, PA 19462
Phone: 610-825-6000 | Fax: 610-834-1275 | www.ecri.org
Investigators
Marcus Lynch, PhD, MBA Prital Patel, MPH Andrew Furman, MD, MMM, FACEP
Jennifer De Lurio, MS Randy Hulshizer, MA, MS
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.
WWW.PCORI.ORG | INFO@PCORI.ORG | FOLLOW US @PCORI © 2021 Patient-Centered Outcomes Research Institute. All Rights Reserved.You can also read
