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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Updated booster shots targeting the BA.4 and BA.5 subvariants of the Omicron variant as well as the parent strain of SARS-CoV-2 were authorized by the FDA on August 31, 2022 (see Topics to Watch). This marks the first time that a COVID-19 vaccine was evaluated on mouse data instead of human trial results. However, this is standard practice for annual updates to the flu vaccine. Expediting variant-specific vaccines could offer more nimble protection while fulfilling the early promises of mRNA vaccines’ quick adaptability. Although the models share similarities, some uncertainty remains over how precise the extrapolation of mouse data is for COVID-19 compared with its use for quadrivalent influenza vaccination and whether the added benefit of a bivalent vaccine will be a game-changer or simply offers incremental improvement.

Not getting COVID-19 remains the only sure way to prevent post-COVID conditions (PCC). A recent estimate finds that such conditions are keeping about 4 million people from working, and there are many accounts of how people are suffering. New treatment options (see Topics to Watch) are slowly emerging but require better understanding of the mechanisms that are causing PCC symptoms. Micro-clots have been posited as a possible mechanism, among others. A new funding program from the Patient-Led Research Collaborative will prioritize research that looks specifically at knowledge gaps identified by patients.

Omicron BA.4/BA.5-Adapted Bivalent Booster Vaccines to Prevent COVID-19

At a Glance

  • Decreased COVID-19 vaccine efficacy against symptomatic disease from the highly prevalent Omicron variant of SARS-CoV-2 has led the FDA to urge vaccine manufacturers to add an Omicron BA.4/BA.5 component to their COVID-19 vaccines to improve efficacy.
  • Moderna’s mRNA-1273.222 vaccine and Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted vaccine are two bivalent COVID-19 vaccines being developed to target the Omicron subvariants BA.4 and BA.5 in addition to the original SARS-CoV-2 strain.
  • Pfizer and BioNTech submitted their BA.4/BA.5-adapted bivalent vaccine candidate to the FDA for emergency use authorization (EUA) on August 22, 2022, and Moderna submitted its vaccine a day later, both citing preclinical and manufacturing data of the BA.4/BA.5-specific vaccines, as well as data from clinical trials of their BA.1-adapted bivalent vaccine candidates.
  • Both vaccines were authorized by the FDA on August 31, 2022. The US Centers for Disease Control and Prevention (CDC) recommended the use of the updated boosters for people aged 12 years and older to target the BA.4/BA.5 Omicron subvariants.
  • Moderna and Pfizer have entered into supply agreements with the US government to supply 66 million and 105 million doses, for about $26 and $30 per dose, respectively.

Rintatolimod (Ampligen) to Treat Post-COVID Conditions

At a Glance

  • Rintatolimod is an investigational RNA-based immunomodulatory treatment for post-COVID conditions (PCC) and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)—two poorly understood, often debilitating conditions that share severe fatigue as a hallmark symptom.
  • Nearly one-third of patients diagnosed with COVID-19 develop PCC, according to estimates. The lack of FDA-approved treatments for PCC represents a major unmet medical need for effective treatments.
  • A recent pilot study, performed within an expanded access program (EAP), suggested that rintatolimod was associated with a decrease in fatigue-related measures in 4 patients with PCC.  
  • Based partly on these data, the developer intends to submit an investigational new drug (IND) application to the FDA for a phase 2, randomized, controlled trial to investigate rintatolimod to treat PCC.

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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 horizonscan@pcori.org.


Posted: September 8, 2022

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