Moderna had already achieved one landmark feat in the race to find a vaccine against the novel coronavirus when it became the first company to deliver its potential vaccine in humans after it dosed its first recipient in March.
The company, which reached this stage in just 63 days, has now taken another landmark by being able to post positive Phase I results from the study.
The results of the trial, led by the National Institutes of Health (NIH), was based on eight people who were given two doses of the vaccine, which revealed that levels of binding antibodies were equivalent or higher than those seen in the blood samples of recovered patients.
Overall, the study tested three dose strengths, 25 µg, 100 µg, and 250 µg – at the ‘middle’ strength dose, 100 µg, the levels of antibodies ‘significantly exceeded’ levels in convalescent sera.
The company reported that three participants at the 250 µg level had exhibited grade three adverse events, following a second dose of vaccine. As a result, Phase II studies will only carry forward two dose levels of 50 µg and 100 µg.
Moderna announced plans to initiate a large-scale Phase III trial in July of this year, with the readouts ultimately determining whether the potential vaccine will be viable for widespread use.
Yesterday, on an investor call, Tal Zaks, CMO of Moderna, was asked what he anticipates the hurdles will be at the pivotal Phase III stage.
Zaks answered, “The challenge for me shifts to how do I ensure I have enough cases to be able to demonstrate [efficacy] as quick as possible?”
He explained that there will be a need to have a trial large enough to provide an adequate sample of protection.
In addition, it will need to be demonstrated that the vaccine protects people who are ‘at risk’ of getting the disease in the months following being dosed to maintain the pace of development, which places an importance on the location of those recruited for trials.
He added, “If there is no circulating virus in the places that I chose to vaccinate, then we won’t have the cases and it’d be a long time before we know [efficacy].”
The importance of in-house production
Speed is paramount both to clinical testing and to the possibility of scaling manufacture for a global rollout.
Stéphane Bancel, CEO of Moderna, was questioned on how rapid early development of its vaccine candidate had been possible and he answered that one of the answers was related to in-house knowledge of the manufacturing process for an mRNA vaccine.
Bancel cited the work the company had previously done developing a vaccine for the H10 flu virus, which had given Moderna more than four years of experience developing and manufacturing mRNA vaccines.
Further than this, Bancel highlighted the ‘strategic advantage’ of possessing its own Norwood, US, facility, which was opened in 2018 and remains the company’s sole manufacturing facility.
As to how the facility confers an advantage, he explained that having teams that understand the manufacturing process “from raw materials to shipping vials to clinical trials” is a fundamental part of the company’s decision-making process.
He compared this situation to if Moderna had worked with a contract manufacturing organization (CMO) from the beginning: “If we had contract manufacturers, we could never have been so fast, because one has to call four or five CMOs around the world and the chance they all had an empty slot for us, waiting, was of course very slim.”
By contrast, he noted, “With our own team on equipment, on facility, [this] allows us to tell the team: ‘this is very important, this one needs to move through the system much faster than usual.’”
Partnering to scale production
With the vaccine candidate progressed quickly and its potential established, Moderna was comfortable then forming a partnership with a contract manufacturer to take production to the next level.
Earlier this month, the company announced a partnership with Lonza with the aim of scaling production to allow for the creation of one billion doses of the vaccine annually.
The technology transfer will take place next month and Lonza will then be able to produce batches of the vaccine through its US facilities by July.
Once Lonza is able to contribute to production, Bancel outlined that the plan is to continue to ramp production from millions of doses per month to tens of millions and then to a point where one billion doses are possible over the course of a year.
Alongside utilizing Lonza’s worldwide network, Bancel also confirmed that the company’s Massachusetts facility would also be expanded.