Moderna releases positive early vaccine data, signs fill-finish deal
Moderna holds one of the leading efforts to develop a vaccine against COVID-19 in its portfolio.
In mid-May, the biotech posted brief results from its Phase I trial into mRNA-1273, which outlined the positive data recorded but without adding full detail.
This week, Moderna provided a more thorough update on the interim analysis in The New England Journal of Medicine, alongside the National Institutes of Health (NIH).
In the results, the company revealed that MRNA-1273 produced binding antibodies in all patients after the first vaccination, with those receiving two 100 µg doses producing 4.1-fold titer levels above those seen in reference convalescent sera.
In terms of T-cell response to the vaccine, it managed to create a Th1-biased CD4 T-cell responses without significant elevation of TH2-biased CD4 T-cell responses.
The major question now is how long the raised antibody levels will remain in participants and the duration of immune response to the virus. Moderna noted that recipients of the vaccine will be followed for one year after receiving the second vaccination.
The next step for the biotech is the Phase III study, using the 100 µg dose strength, in approximately 30,000 participants, which is scheduled to begin initiation on July 27.
As Moderna begins to scale the vaccine up to commercial levels, the biotech sealed a fill-finish manufacturing agreement with Laboratorios Farmacéuticos Rovi.
The European company will provide contract manufacturing for the vaccine out of its Madrid, Spain, facility. Rovi will provide vial filling and packaging capacity to enable the production of hundreds of millions of doses to supply the ex-US market.
The deal will begin in 2021, with Rovi hiring additional staff members and procuring a production line and equipment for compounding, filling, automatic visual inspection and labeling to meet Moderna’s requirements.
During the same announcement on the Phase I results, the biotech stated that it has secured the capacity to produce 500 million doses per year, and possibly up to one billion doses, in 2021.
In order to achieve this capacity, Moderna previously partnered with Lonza and Catalent to allow it to rapidly scale the manufacture of its vaccine, after having worked on the vaccine in-house up until securing the assistance of Lonza in May.