Briefing

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.

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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).

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.

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. 

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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: September 13, 2021

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