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Moderna completed manufacturing a version of its vaccine to prevent infection by B.1.351, a variant first identified in South Africa. The company is sending doses of this mRNA-1273.351 booster vaccine to the National Institutes of Health (NIH) for evaluation in a clinical trial, the company announced today.
The move is part of a strategy for addressing this and other variants of concern.
Moderna will compare the safety and efficacy of different boosting options, including the new booster vaccine in development; combining the booster with the existing vaccine in a single, multivalent booster; or administering a lower dose of the existing vaccine as a booster shot.
If evidence from an NIH study or the company’s internal research shows superiority of one or more of these strategies, any changes to the Moderna vaccine emergency use authorization would still require approval from the US Food and Drug Administration (FDA).
The existing or “ancestral” vaccine has been linked to production of neutralizing antibodies against the variants of concerns in preliminary data. However, Moderna is assessing these various variant vaccine options “out of an abundance of caution,” the company noted in a February 24 news release.
Moderna also announced plans to study the new booster vaccine and multivalent vaccine as a primary means of immunization for people who are seronegative.
“Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control. We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary,” Stéphane Bancel, CEO of Moderna, stated in the release.
Enhanced Manufacturing Capacity
The company also announced capital investments that will allow it to ramp up its global manufacturing capabilities. Moderna plans for greater capacity for making the existing vaccine as well as any variant vaccines deemed necessary going forward.
The enhanced capacity is expected to allow a jump from 600 million to 700 million doses globally this year. In 2022, the company predicted its capacity worldwide will reach 1.4 billion doses, assuming the 100-microgram dose remains the same.
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and neurology. Follow Damian on Twitter: @MedReporter.