Variant Specific COVID-19 Vaccines Coming Soon
With the number of confirmed reports of the SARS-CoV-2 coronavirus variant known as Omicron increasing, many people are seeking protection from COVID-19 vaccines.
As of November 27, 2021, media reports indicate 95 Omicron virus infections, and about 1,004 probable cases have been reported in eight countries.
However, there is good news as variant targeted mRNA vaccines could become available in early 2022.
For example, Massachusetts-based Moderna, Inc. announced updates to its strategy on November 26, 2021, to address SARS-CoV-2 variants of concern, given the recent emergence of the Omicron (B.1.1.529) virus variant.
Currently, Moderna’s SpikeVax vaccine is a global success story, with hundreds of millions of vaccines delivered in less than one year.
However, Moderna began preparations in early 2021 to advance a comprehensive strategy anticipating new variants of concern could evolve.
This strategy includes three levels of response should the currently authorized 50 µg booster dose of mRNA-1273 proves insufficient to boost waning immunity against the Omicron variant.
First, Moderna has already tested a higher dose booster of mRNA-1273 (100 µg) in healthy adults.
Moderna has completed the dosing of 306 participants in a safety and immunogenicity study of this high dose (100 µg) booster. The 100 µg dose of mRNA-1273 has also recently been studied by the U.S. National Institutes of Health.
It has generally resulted in the highest neutralizing titers against prior SARS-CoV-2 strains. Moderna is rapidly testing sera from its high dose booster recipients in neutralizing assays to determine if the 100 µg dose provides superior neutralizing protection against Omicron.
Second, Moderna is already studying two multi-valent booster candidates in the clinic designed to anticipate mutations such as those that have emerged in the Omicron variant.
The first candidate (mRNA-1273.211) includes several mutations in the Omicron variant that was also present in the Beta variant of concern. The Company has completed dosing in a potentially pivotal safety and immunogenicity study of mRNA-1273.211 at the 50 µg (N=300) and 100 µg (N=584) dose levels.
A second multi-valent candidate (mRNA-1273.213) includes many of the mutations in the Omicron variant that was also present in the Beta and Delta variants.
The Company has completed dosing at the 100 µg (N=584) dose level and plans to explore the 50 µg dose level in approximately 584 participants. Moderna will rapidly expand testing of sera from completed and ongoing multi-valent booster studies to determine if these multi-valent candidates can provide superior neutralizing protection against Omicron.
Third, Moderna will rapidly advance an Omicron-specific booster candidate (mRNA-1273.529).
This candidate is part of the Company’s strategy to advance variant-specific candidates for a subset of variants of significant concern. By 2021 this has already included Beta- and Delta-specific boosters.
The Company has repeatedly demonstrated the ability to advance new candidates to clinical testing in 60-90 days.
“From the beginning, we have said that as we seek to defeat the pandemic, it is imperative that we are proactive as the virus evolves. The mutations in the Omicron variant are concerning. For several days, we have been moving as fast as possible to execute our strategy to address this variant,” commented Stéphane Bancel, CEO of Moderna, in a press statement issued on November 26, 2021.
“We have three lines of defense that we are advancing in parallel.”
In the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, Cambridge MA-based Moderna has a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation and an integrated manufacturing plant that allows for both clinical and commercial production at scale and unprecedented speed.
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