Moderna’s COVID-19 Vaccine Enters Phase 3 Trial
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by Covid-19 Health Resource Center | 7.12.20
Moderna's mRNA-1273, an mRNA vaccine candidate, is expected to enter its Phase 3 study this month. This is exciting news—but what does it mean?
What's a phase 3 trial?
A phase 3 trial is the final stage of testing required before a drug candidate can be submitted to the FDA for approval. In a phase 3 trial, a company seeks to prove that its product works in, and is safe for, a broad spectrum of potential patients.
Moderna's phase 3 trial design
In Moderna's case, the company will test one level of its vaccine, at 100 micrograms delivered in two separate shots. This randomized, placebo-controlled trial will be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). The trial is expected to enroll 30,000 participants, mostly from the U.S.
Does it work?
Initial data is promising, but data from the phase 3 trial is needed to be sure Moderna's vaccine works.
- In the phase 2 trial, which is ongoing, 600 healthy people are being followed for post-injection reactions and safety concerns.
- Phase 3 trial data will be important for evaluating safety and efficacy, as the trial is bigger (30,000 versus 600 test subjects) and will include more people with a higher risk of exposure to COVID-19, such as health care workers and long-term care facility residents.
- The primary objective of Moderna's phase 3 trial is to show that mRNA-1273 can prevent symptomatic COVID-19 disease — if it achieves this goal, it will be considered effective, and will likely be approved by the FDA.
Who's funding this?
- As one of five vaccine developers chosen to be part of the Trump administration's Operation Warp Speed program to accelerate development of a COVID-19 vaccine, Moderna is receiving federal funding for its COVID-19 vaccine work.
- Moderna is using federal government funding to develop, test, and scale up manufacturing of its vaccine candidate.
When will it be available?
The short answer: potentially as early as the third quarter of this year, if all goes right. Moderna is ramping up production capacity in anticipation of a successful phase 3 trial.
- On Thursday, June 25, Moderna announced a partnership with Catalent Inc, a contract drugmaker, to prepare an initial dose of 100 million doses of its COVID-19 vaccine.
- Additionally, Moderna has made deals with the U.S. government and signed a 10-year collaboration with Lonza Group AG, a Swiss contract drugmaker, to produce 500 million doses a year, ramping up to one billion doses in 2021.
- Moderna's goal, assuming its vaccine is approved, is to inoculate 300 million people by early 2021.
What's the catch?
While it would be fantastic to have a a COVID-19 vaccine as soon as possible, some believe pharmaceutical companies are inadvisably cutting corners in their haste to develop a COVID-19 vaccine. If this is true, there could be significant safety issues that are missed, which could come back to haunt patients down the line.
For perspective, consider the following: the normal development timeline for a vaccine is about 10 years. Most companies, including Moderna, developing COVID-19 vaccines are looking to cut their development timelines down to only two or three by conducting simultaneous trials, such as Moderna's overlapping phase 2 and phase 3 trials (under normal circumstances, a phase 3 trial only begins after a phase 2 trial's successful conclusion).
(Image Credit: iStockphoto.com / MarianVejcik)
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