February 25, 2021 -- Moderna is pursuing two strategies against emerging SARS-CoV-2 variants. The company is evaluating booster vaccine doses and is increasing vaccine manufacturing capacity to meet global demand.
Moderna has developed messenger RNA (mRNA)-1273.351 against the SARS-CoV-2 variant known as B.1.351 (South African variant). The company will evaluate booster doses of vaccine to increase neutralizing immunity against the variants of concern. These include mRNA-1273.351, mRNA-1273 and mRNA-1273.351 (multivalent booster "mRNA-1273.211"), and a third dose of authorized mRNA-1273. These options would all be administered at a dose of 50 µg of lower.
Moderna has completed the manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, and has shipped the doses to the U.S. National Institutes of Health (NIH) for a phase I clinical study led by the National Institute of Allergy and Infectious Diseases (NIAID).
Second, Moderna plans to evaluate its mRNA-1273.351 and mRNA-1273.211 candidates as primary vaccinations in seronegative individuals, given in a two-dose series at the 100-µg dose level and lower. The company plans to evaluate immunogenicity and safety in participants who have not received a COVID-19 vaccine, as well as participants in clinical studies who previously received the mRNA-1273 vaccine.
In a separate statement, Moderna announced that it is investing to increase capacity at its manufacturing facilities, a move that it expects will increase global 2022 capacity to approximately 1.4 billion doses of its COVID-19 vaccine based on 100-µg dosage. According to the company, this will allow it to increase current production of vaccines and to accommodate production of potential booster vaccines. The company estimates that up to 12 months may be necessary before the additional production is available.
Moderna is boosting its 2021 manufacturing from 600 million doses to 700 million doses globally and is exploring ways to potentially deliver up to 1 billion doses in fiscal year 2021.
Around 60 million doses have been shipped globally, including approximately 55 million doses shipped to the U.S. government. Another 33 million doses have been produced in the U.S. and in the final stages before release.
Moderna expects to complete delivery of the first 100 million doses to the U.S. government by the end of the first quarter of 2021, the second 100 million doses by the end of May 2021, and the third 100 million doses by the end of July 2021.