Moderna
Tablets allow Moderna employees to monitor daily operations.
- The upstart biotech Moderna believes it can have a coronavirus vaccine ready for emergency use this fall.
- Business Insider spoke Wednesday with the company's founder and chairman, Noubar Afeyan, about the ambitious plan to get to that point.
- A small trial testing the vaccine in humans is ongoing. Moderna CEO Stephane Bancel expects that study to start producing data this spring.
- Moderna will run additional trials to test the vaccine in more people, while building out its manufacturing power to produce millions of doses each month.
- Visit Business Insider's homepage for more stories.
With many public health experts warning for the potential of a second coronavirus outbreak in the fall, one biotechnology company is aiming to have a vaccine ready for emergency use by then.
The first human trial of the experimental vaccine, from the biotech Moderna, is already underway. CEO Stephane Bancel laid out the next steps for testing the vaccine, as well as ramping up production, in an MIT lecture series on Wednesday.
Business Insider spoke on Wednesday with Noubar Afeyan, the chairman and co-founder of Moderna, about what comes next for the biotech's vaccine. Afeyan is founder and CEO of the Boston biotech VC firm Flagship Pioneering, which helped start Moderna.
Together, the two Moderna leaders shared an ambitious strategy aimed at having a vaccine ready by the fall. Vaccines can take years to develop, and they're shortening the timeline significantly.
Moderna is far from alone in the sprint to develop a vaccine. Pharma giants like Johnson & Johnson, Sanofi, and Pfizer have vaccine projects, as do a wide range of small biotechs.
But Moderna is the leader out of the gate, as one of only two companies to have started human testing. The other is a Chinese biotech called CanSino Biologics.
Moderna expects human data to start coming in the spring, with more studies rapidly following
Right now, researchers in Atlanta and Seattle are recruiting healthy volunteers to participate in the first clinical trial of Moderna's vaccine. That study is trying three dose strengths - 25 micrograms, 100 micrograms, and 250 micrograms - in 45 people.
Bancel said he expects to get data about the vaccine's safety in the spring. Additional data showing how well the vaccine triggers an immune response, known as immunogenicity, should come in the late spring or early summer, the CEO added.
This first study of the vaccine is called a Phase 1 trial, and is aimed at determining whether the vaccine is safe for people to get. Drug development is divided into three phases, and these trials are usually done sequentially, with each study informing the design of the next one. But the pandemic's urgency has Moderna eyeing a quicker approach.
The biotech wants to start a Phase 2 study in late spring. In order to do this, the biotech will design the study based solely off of the safety results and plans to test multiple dose strengths, according to the CEO.
"We do not expect to wait for the immunogenicity data," Bancel said, adding the motivation is to shorten the testing timeframe as much as possible.
A Phase 3 trial will start in the summer or early fall, Bancel said. That will start after there is immunogenicity data that can guide the design, particularly on the best dose to use going forward.
Afeyan acknowledged the unknowns surrounding the vaccine and these future trials, but said the pandemic requires urgency.
"There's a lot of things that we don't know about this disease," Afeyan said, later adding, "That may be problematic as we enter advanced clinical trials. We just don't know what we don't know. But the need is such, and the technology is efficient and testable enough that we thought we had to do this."
Manufacturing is revving up, with plans for 24/7 production
Moderna is now making vaccine doses for the Phase 2 and 3 studies, even without having seen any in-human data for the candidate.
Bancel said his team just ordered new equipment to build out its plant in Norwood, Massachusetts. The company is hiring and training more workers to soon have the plant up and running 24/7.
The short-term goal is to produce millions of doses per month and get to dozens of millions per month in 2021, he said.
This hinges on a huge unknown: what dose strength will be needed. The first trial is testing a low dose of 25 micrograms and a high dose of 250 micrograms - a 10-times difference in strength and material needed.
The US Biomedical Advanced Research and Development Authority (BARDA) said Monday it is providing an undisclosed amount of funding to Moderna to boost its vaccine manufacturing capabilities.
"That will gives us resources to scale up and advance enough to be in a position to make large quantities come this fall," Afeyan said on the BARDA agreement. "And then the question will be what is the status of the crisis and what does the data suggest as it relates to any consideration for emergency use."
While Afeyan declined to provide a specific estimate on the number of doses Moderna could have available in the fall in an emergency, he said "it would be commensurate with the need."
Additionally, Moderna is considering adding additional sites in the US and outside the US to build supply for other countries and markets, Afeyan said.
A commercially-available vaccine is still at least a year out
While Moderna is acknowledging the potential for an emergency use of its vaccine in the fall, Afeyan said the timeline for bringing its vaccine to market as an FDA-approved product is in line with the 12 to 18 months timeline.
On commercial pricing, Bancel previously told Business Insider in March that they will set a reasonable price for its vaccine.
On Wednesday, he compared vaccine pricing to what we are currently seeing for diagnostic testing: free to the end consumer, with insurers and governments picking up the bill.
Thinking further ahead, another critical unknown is how this novel coronavirus may change over time, with researchers already noticing some mutations.
Moderna's vaccine, along with most of the other vaccine research efforts, is targeting the spike protein of the coronavirus. Bancel said researchers are closely watching to see if there are any mutations to that protein, which could cause a vaccine to lose some efficacy.
But the CEO also said Moderna is well-suited to make quick changes to its vaccine, given its technology. He recalled it took 42 days to go from sequencing the virus' genetics to shipping a vaccine to US health officials.
"I believe we can go faster," he said.
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