Briefing

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.

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The National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Tech program has initiated a faster genotyping method for SARS-CoV-2 variant detection that might supplement next generation sequencing of virus samples. The data are available on a free dashboard and the materials needed to reproduce the method are detailed in a free, peer-reviewed paper so that other public and private labs can make use of the technique.

Tracking variants is crucial to decisions regarding future vaccine formulations, and the recent FDA Vaccines and Related Biological Products Advisory Committee meeting recommended the use of bivalent vaccines that also target the BA.4 and BA.5 subvariants of Omicron (see Topics to Watch for a booster that addresses the Beta and Omicron variant). Looking ahead, Pfizer and BioNTech announced that they, too, are investigating a next generation, pan-coronavirus shot, and will join Moderna and others to develop a pipeline of potentially variant-proof vaccines.

Extension of Regulatory Flexibilities for Telehealth Utilization and Reimbursement Beyond the COVID-19 Pandemic

At a Glance

  • Before the COVID-19 pandemic, telehealth utilization and reimbursement were limited to specific zip codes, health care settings, and technologic modalities (e.g., audio-only services were generally not covered).
  • As a result of loosened restrictions on telehealth, the provision and utilization of health care services for Medicare and Medicaid beneficiaries using telehealth increased during the pandemic. Federal and state regulations are now covering some costs of telehealth services beyond the duration of the COVID-19 pandemic.
  • Federal extensions include an additional year of Medicaid funding through the American Rescue Plan Act, through March 31, 2025, and an additional 5 months of Medicare reimbursement after the end of the public health emergency, through the Consolidated Appropriations Act, 2022.
  • States’ legislations include the H 654 VT 2021-2022, extending regulatory flexibilities in the state of Vermont through June 2023, and others.

Sanofi-GSK Next-generation Booster Vaccine to Prevent COVID-19

At a Glance

  • Waning efficacy is seen in the months after vaccination with available COVID-19 vaccines despite booster doses. The FDA recently announced it advises manufacturers to add an Omicron-variant-specific component to their booster vaccines, with the aim of having updated vaccines ready for fall 2022.
  • Sanofi and GSK have collaborated to develop a “next generation” COVID-19 vaccine that generates antibodies to target the spike proteins of the original virus, plus the Beta and Omicron variants to prevent COVID-19.
  • Preliminary data from phase 2/3 and phase 3 trials suggest the vaccine, given as a booster, significantly increased the number of neutralizing antibodies against multiple SARS-CoV-2 variants, including Omicron, compared with available vaccine boosters.
  • The companies are planning to submit the clinical trial data to regulatory authorities, with the aim of making the booster vaccine available later this year.

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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: July 13, 2022

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