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.

Download this Scan

Vaccine data are being simultaneously welcomed and questioned in the United Kingdom, Russia, China, and the United States (see Topics to Watch); distribution woes and data gaps are highlighting the possibility of increased health care disparities; and emerging coronavirus variants might alter vaccine effectiveness.

Although slow progress is being made toward herd immunity against COVID-19, many people continue to contract the 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.

Treatment development has lagged vaccine development, and treatment distribution has also been a challenge. Meanwhile, we continue to learn more about how COVID-19 affects the body.

JNJ-78436735 (Ad26.COV2-S) Vaccine to Prevent Coronavirus Infection

At a Glance

  • JNJ-78436735 is a recombinant, nonreplicating adenovirus vector vaccine. It is designed to generate protective host immune responses against the spike protein of SARS-CoV-2, the virus that causes COVID-19, from a single dose.
  • The phase 3 randomized ENSEMBLE trial, found that JNJ-78436735 was 66% effective at preventing moderate to severe COVID-19 disease and 85% effective at preventing severe COVID-19 disease 28 days after a single dose of vaccine. 
  • The vaccine was purportedly well-tolerated with no significant safety concerns or incidents of anaphylaxis reported.
  • On February 4, 2021, the company applied for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA); an FDA advisory committee meeting is scheduled on February 26, 2021. The company plans to manufacture 100 million doses for the United States by the end of June 2021, pending an EUA.

NVX-CoV2373 Vaccine to Prevent SARS-CoV-2 Infection

At a Glance

  • NVX-CoV2373 is a recombinant, nanoparticle coronavirus vaccine designed to generate protective immune responses against COVID-19 disease.
  • Primary phase 3 efficacy data from 15 000 adults in the United Kingdom showed that the vaccine was 89% effective in preventing COVID-19 from occurring at least 7 days after the second dose, with more than 50% of cases attributed to the new UK coronavirus variant. Adverse events were purportedly balanced between vaccine and placebo groups.
  • NVX-CoV2373 is also under study in a US-based phase 3 randomized trial in 30 000 participants, with primary results expected in March 2021.
  • On February 4, 2021, the company initiated rolling regulatory submissions to the FDA and international regulatory agencies. The manufacturer plans to produce up to 150 million doses per month globally by May or June 2021, pending EUA.

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.

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.


Posted: February 11, 2021

What's Happening at PCORI?

The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.

Subscribe to PCORI Emails

Image

Hand pointing to email icon