Moderna is an American biotech company that focuses on drug discovery and development based on messenger RNA (mRNA). They have developed a coronavirus vaccine, mRNA-1273, that’s showing early signs of success in the first phases of human testing.
On May 18, Moderna released the data for the interim Phase 1 of testing their coronavirus vaccine. The Phase 1 study of the vaccine was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The company issued a press release stating that: “these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
Here’s what you need to know about the Moderna coronavirus vaccine:
1. Moderna Has Announced Positive Results of the Interim Phase 1 Study
The results of the interim first phase study, a small early-stage human trial, were released on May 18. The study showed that the vaccine produced virus-neutralizing antibodies at the levels seen in patients recovered from COVID-19. The early results are based on eight patients who were administered the vaccine in two different doses (25 µg and 100 µg). The samples are not yet available for the other participants.
All participants were given different doses of the vaccine and the study found that there was a dose-dependent increase in their body’s immune response. The biotech company also indicated that the vaccine was “generally safe and well tolerated.” It indicated only one instance of what’s called a grade 3 adverse effect in one participant who experienced redness around the injection site. According to Moderna, “All adverse events have been transient and self-resolving.”
Tal Zaks, the Chief Medical Officer at Moderna, said of the results: “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg.”
2. The Company Has Received FDA Approval to Fast Track the Next Phases of the Study
On May 12, Moderna received the Food and Drug Administration (FDA)’s Fast Track designation, which will be useful in speeding up the review process of the vaccine. This means that Moderna can proceed to Phase 2 of the study, which will take place soon. The company is also working on its protocol for Phase 3, which it hopes will begin in early summer of 2020.
The Phase 2 study will look at two different dose levels, 50 µg and 100 µg, to ultimately choose the best dose for study. Based on the interim data received from Phase 1, Moderna believes that the Phase 3 study will explore doses between 25 µg and 100 µg, and will begin in July 2020. The company aims to enroll 600 healthy participants in two age groups, 18-55 years and 55 years and older. Each participant will receive a placebo or a specific dose, and they will be followed for 12 months after vaccination.
After receiving Fast Track approval, the Chief Medical Officer for Moderna said: “Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus. As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against [COVID-19].”
3. U.S. Officials Say a Vaccine Will Take From 12 to 18 Months to Be Deemed Effective & Safe, But Moderna Is Attempting to Shorten the Timeline
The news that Moderna could begin its Phase 3 trials in July 2020 puts it well ahead of the predicted timeline for a vaccine, which anticipated Phase 3 trials in the fall. The Moderna Chief Executive Officer, Stéphane Bancel, said that if the crucial Phase 3 trial in the summer is successful, they could file a BLA (biologics license application) to get permission to distribute their product in the U.S.
A 12-18 month timeline for a safe and effective vaccine has been frequently mentioned by U.S. officials. However, some experts say that this timeline is too optimistic and a vaccine won’t be ready for distribution in this time frame. Dr. Rick Bright, the vaccine scientist who formerly led the Biomedical Advanced Research and Development Authority in the U.S. government spoke to Congress last week. He said, “A lot of optimism is swirling around a 12-to-18-month time frame if everything goes perfectly. We’ve never seen everything go perfectly. I still think 12 to 18 months is an aggressive schedule, and I think it’s going to take longer than that to do so.”
However, in an interview with Business Insider, Moderna CEO Bancel said that the vaccine could potentially be ready for emergency use by the fall. Forbes believes that Moderna may be on track to get full approval for the vaccine by next year, putting it ahead of its biotech rivals developing coronavirus vaccines.
4. Moderna Has Partnered With Lonza Group to Increase Their Vaccine Production to 1 Billion Per Year Once Approved
On May 1, Moderna announced a collaboration with Switzerland-based Lonza Group to manufacture the vaccine on a large-scale so that if it gets approved they can produce as many as 1 billion doses a year. Bancel said, “We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from [COVID-19].”
The interim chairman and CEO of Lonza, Albert M. Baehny, issued a statement about the partnership:
Moderna’s technology represents a significant opportunity to change the way we protect people against disease. The current pandemic illustrates the need to combine the best science with resilient supply chains that can scale. We are fully committed to leveraging our global network and experience in manufacturing technologies to support Moderna’s manufacture of mRNA-1273 as well as collaborating on future Moderna products.
Moderna states that the reason they could develop the vaccine so quickly is because it’s an mRNA vaccine, so it’s designed using the sequence of the virus and not the virus itself. The timeline on Moderna’s website says that the genetic sequence of the COVID-19 virus was shared by Chinese authorities on January 11, and the Moderna vaccine sequence was developed two days later, on January 13.
5. Moderna Is a Biotech Company Using mRNA Science to Create New Classes of Medicines
Moderna was founded in 2010 and its mission is to “deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.” It believes that messenger RNA (mRNA) can be used to create new types of medicines that can improve patients’ lives, and that using mRNA can improve the way medicines are discovered, produced and manufactured.
The medicines developed by Moderna are supposed to help a patient’s cells produce the necessary proteins to provide the body with a therapeutic or preventative benefit. Moderna, Inc. (MRNA) is based in Cambridge, Massachusetts, and its shares spiked as much as 39% after its positive announcement on May 18.