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Moderna Demonstrates Positive Results from Phase 3 Trial of its Next-Generation COVID-19 Vaccine


This week, Moderna announced interim results from its NextCOVE phase 3 trial that showed the latest generation of its COVID-19 vaccine, mRNA-1283, induced a more robust immune response compared to its previous COVID-19 vaccine, mRNA-1273.222 (Spikevax). “mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much needed vaccine to market,” Moderna CEO Stéphane Bancel, said in a statement.1

What the Data Showed
The NEXTCove clinical trial is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older in the United States, United Kingdom and Canada.1

Moderna reported its mRNA-1283 elicited a higher immune response against both the Omicron BA4/BA5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222 according to data results from its phase 3 trial. This result was most acutely seen in participants over the age of 65 years.1

What You Need to Know

The interim results from Moderna’s NextCOVE phase 3 trial indicate that mRNA-1283 induced a more robust immune response compared to its predecessor, mRNA-1273.222 (Spikevax). This heightened immune response was observed against both the Omicron BA.4/BA.5 and original strains of the SARS-CoV-2 virus, particularly among participants over the age of 65.

Despite the enhanced immune response, mRNA-1283 showed similar safety profiles to the older vaccine. Common adverse events included injection site pain, headache, fatigue, myalgia, and chills. This suggests that the new vaccine maintains a favorable safety profile comparable to the previous version.

One potential added benefit of mRNA-1283 is the improvement in storage requirements. Moderna is working on new storage requirements that could extend the shelf life and enable the vaccine to be stored in pre-filled syringes, potentially easing distribution challenges, especially in low and middle-income countries where access to ultra-cold freezers may be limited

In terms of safety, the mRNA-1283 saw similar effects as the older vaccine. The most commonly solicited local adverse event was injection site pain. The most common solicited systemic adverse events included headache, fatigue, myalgia, and chills.1

A Potential Added Benefit?
One of the challenges of the mRNA vaccine platforms for both Moderna and the Pfizer-BioNTech COVID-19 vaccines has been the storage requirements for them. Specifically, these requirements can limit their shelf life.

According to the Centers for Disease Control and Prevention (CDC), the mRNA vaccines can be stored at ultra-cold frozen temperatures until their expiration dates. For the Pfizer-BioNTech vaccines, the freezer recommendations are -90°C and -60°C (-130°F and -76°F),2 and the recommendations for the Moderna vaccines are between-50°C and -15°C (-58°F and 5°F).3 To keep the vaccines at these temperatures requires special ultra-cold freezers.

The vaccines can also be stored at typical refrigeration temperatures (between 2°C and 8°C (36°F and 46°F) for up to 10 weeks.

However, without access to these freezers, it can make it more difficult to serve populations in low and middle income countries for long periods of time who may not have such resources.

According to Moderna’s latest statement, the company is working on improving its storage requirements, thus elongating the mRNA-1283 vaccine’s shelf life. The company is looking to deliver on a pre-filled syringe presentation, which could potentially increase access into new settings such as those in LMIC.1

References
1. Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine. Moderna press release. March 26, 2024. Accessed March 29,2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Achieves-Positive-Interim-Results-from-Phase-3-Trial-of-Next-Generation-COVID-19-Vaccine/default.aspx

2. Pfizer-BioNTech COVID-19 Vaccine Storage and Beyond-Use Date Tracking Labels. CDC. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-handling-label.pdf

3. Vaccine Storage and Beyond-Use Date Tracking Labels. CDC. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/Moderna-Storage-Labels.pdf



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