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With New COVID-19 Variant on the Rise, Vaccine Manufacturers Test Fall 2023 Monovalent Shots


Immunization Awareness Month

Eris, or EG5, is of Omicron lineage and accounts for ~17% of reported COVID-19 cases; mRNA vaccine producers are confident in the new shots to protect against it.

With New COVID-19 Variant on the Rise, Vaccine Manufacturers Test Fall 2023 Monovalent Shots image credit virus variants  ©PX Media/stock.adobe.com
©PX Media/stock.adobe.com

The COVID-19 variant, Eris (EG5), has become the dominant strain in the United States, now accounting for 17.3% of the reported cases, according to the CDC’s latest reporting.1

As variants evolve, the question of their ability to evade current vaccine protection becomes relevant. The current mRNA vaccine formulations should provide protection against EG5, as well as other emerging variants in the Omicron lineage, according to William Schaffner, MD, professor of infectious diseases and preventive medicine at Vanderbilt University Medical Center in Nashville, TN.

“The Food and Drug Administration, and the manufacturers have gotten together, and they will produce yet another updated vaccine, which will be ready for use sometime this fall. It will provide protection against all of these Omicron variants…” Schaffner said in a recent interview with Patient Care partner site Contagion. Although he was speaking specifically about the EU11 variant, which was emerging at the time, it also is in the Omicron lineage, which means the updated mRNA formulations will protect against the dominant and these emerging strains.

COVID-19 vaccine manufacturer Moderna confirmed this in an announcement yesterday.2 The company reported preliminary clinical trial data showing that its mRNA COVID-19 vaccine for the 2023-2024 respiratory virus season elicited a “significant boost in neutralizing antibodies against EG5 and another emerging variant, FL151 (Fornax).2

“These new results show that our updated COVID-19 vaccine generates a robust immune response against the rapidly spreading EG5 and FL 151 strains and reflects our updated vaccine's ability to address emerging COVID-19 threats," said Stephen Hoge, MD, president of Moderna, said in a statement.2

Moderna previously presented clinical trial data with its updated COVID-19 vaccine that demonstrated robust human immune responses across the key circulating XBB strains at the June 2023 FDA VRBPAC meeting. With this new trial data, Moderna has now confirmed an antibody response against current strains of concern.

Every year, public health officials decide upon an annual influenza vaccine schedule, and US federal officials decided to expand this to include COVID-19 vaccines. As such, they will host an annual meeting to discuss the dominant COVID-19 variants circulating and which should be included in the season’s formulation. Participants in the June VRBPAC meeting, recommended that the 2023-2024 vaccines be monovalent and contain proteins protecting against the XBB lineage.

In a recent quarterly filing, BioNTech reported it along with their partner, Pfizer, have manufactured Omicron XBB15-adapted monovalent COVID-19 vaccine doses at risk to ensure readiness ahead of the fall and winter seasons in various regions worldwide. The companies plan to prepare shipments of Omicron XBB15-adapted monovalent COVID-19 vaccine doses for fast delivery following potential regulatory approval. According to a report by Reuters,3 the Pfizer-BioNTech vaccine showed neutralizing activity against EG5 in a preclinical trial.

This article first appeared on our partner site Contagion and has been lightly edited.

1. CDC. COVID-19 Data Tracker. Variant proportions. Accessed August 18, 2023. https://covid.cdc.gov/covid-data-tracker/#variant-proportions
2. Moderna clinical trial data confirm its updated COVID-19 vaccine generates robust immune response in humans against widely circulating variants. Moderna. News release. August 17, 2023. Accessed August 18, 2023. https://investors.modernatx.com/news/news-
3. Pfizer's updated COVID shot effective against 'Eris' variant in mice study. Reuters. August 17, 2023. Accessed August 18, 2023. https://www.reuters.com/business/healthcare-pharmaceuticals/pfizers-updated-covid-shot-effective-against-eris-variant-mice-study-2023-08-17/

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