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Highlights provide a timely synopsis of selected interesting developments emerging in the last two weeks from the information universe covered by the PCORI Health Care Horizon Scanning System (HCHSS). Information covers currently emerging innovations in patient-centered care that may or may not be directly related to the Topics to Watch. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.

This winter brought both a surge in respiratory syncytial virus (RSV) and a timely advance in the clinical development of RSV vaccines. The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended the first two vaccines intended to protect older adults from lower respiratory tract disease caused by RSV: Pfizer’s PF-06928316 and GlaxoSmithKline’s RSVPreF3 OA; approvals will be decided in May. See Topics to Watch for the latest on Pfizer’s maternal vaccine to protect infants.

In another first, the FDA has granted Emergency Use Authorization to an over-the-counter test that can distinguish between influenza and COVID-19. However, the developer of this at-home test, Lucira Health, filed for bankruptcy just days before the authorization and is now seeking a financial partner to enable them to resume manufacturing.

Because the flu and COVID-19 have some symptoms in common but require very different treatments, Lucira’s test could help patients prevent progression to severe disease and potentially minimize subsequent postviral impacts (see Topics to Watch for an antidepressant that might ease post-COVID cognitive impairment, commonly known as brain fog).

Topics to Watch

ECRI Horizon Scanning has selected the topics below as those with potential for impact within the PCORI HCHSS’s focus areas in the United States within the next three years. 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.

RSVpreF (PF-06928316) Maternal Vaccine to Prevent Severe Illness from RSV Infection in Newborns and Infants

At a Glance

  • Virtually all children acquire a respiratory syncytial virus (RSV) infection by the time they are two years old. Most cases present as mild, cold-like symptoms. However, RSV can cause serious complications in children aged under six months, especially for children born prematurely and those with weakened immune systems, congenital or chronic heart or lung disease, or certain neuromuscular disorders.
  • During the final three months of pregnancy, maternal antibodies are shared with unborn children, granting passive immunity against certain infections and diseases after birth.
  • RSVpreF (PF-06928316) is an experimental vaccine designed to block RSV entry into host cells. Its administration to pregnant women is being evaluated to prevent medically attended lower respiratory tract illness (MA-LRTI) in infants up to six months of age.
  • In the phase 3 MATISSE clinical trial, RSVpreF demonstrated efficacy of 81.8 percent against RSV MA-LRTI within 90 days of birth, and of 69.4 percent up to six months of age.
  • The FDA plans to make an approval decision by August 2023.

For a description and commentary about this topic/issue, download this Innovation Brief.

Trintellix (Vortioxetine) to Treat Cognitive Impairment Associated with Post-COVID Conditions

At a Glance

  • Cognitive impairment is one of the most commonly reported post-COVID conditions (PCC), with 22 percent of patients reporting deficits in attention, memory, verbal fluency, and executive function for 12 or more weeks following COVID-19 diagnosis.
  • Trintellix (Vortioxetine ) is a multimodal antidepressant drug that is US Food and Drug Administration-approved to treat major depressive disorder (MDD) in adults.
  • One prior study reports that Trintellix given to patients with MDD improved cognitive function independent of its effects on depressive symptoms. Although more study is needed, other groups (e.g., Di Nicola et al, 2023; Vikarenko et al, 2022) have suggested Trintellix might have potential to reduce PCC–associated cognitive impairment.
  • The Brain and Cognition Discovery Foundation is currently investigating whether Trintellix might improve cognitive function and mood of patients with PCC in a phase 2, randomized, placebo-controlled study.
  • Based on the cost of Trintellix to treat MDD, it might cost about $466 per month to treat PCC.

For a description and commentary about this topic/issue, download this Innovation Brief.

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We welcome your comments on this Innovation Brief at [email protected].

Posted: March 10, 2023

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