Moderna Begins Phase 3 Clinical Trial of COVID-19 Vaccine Candidate

Strategic Insights -

Moderna, a Cambridge-based biotechnology company, has commenced the Phase 3 clinical trial of its coronavirus vaccine candidate, mRNA-1273, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services. The trial aims to test the safety and efficacy of the vaccine in preventing symptomatic COVID-19 disease after two doses, with a projected enrollment of 30,000 participants at nearly 100 research sites. This development marks a significant milestone in the fight against the pandemic, with the trial expected to demonstrate the potential of the vaccine to prevent COVID-19.

Key Takeaways:

  • The Phase 3 clinical trial of Moderna's COVID-19 vaccine candidate, mRNA-1273, has begun with a projected enrollment of 30,000 participants at nearly 100 research sites.
  • The trial will test the safety and efficacy of the vaccine in preventing symptomatic COVID-19 disease after two doses, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
  • The vaccine was created using the genetic sequence of the coronavirus available in a public database and uses a unique approach where the body's cells are instructed to express the spike protein, eliciting an immune response.
  • Participants will receive two injections approximately 28 days apart, with half receiving the vaccine and the other half receiving a saline placebo, in a double-blind study.
  • The trial aims to test whether the vaccine can prevent the disease without symptoms and whether one dose is enough to prevent symptomatic COVID-19.
  • Moderna is "on track" to be able to deliver approximately 500 million doses per year, possibly 1 billion doses per year, beginning in 2021, due to manufacturing capabilities and collaborations.

Statistics:

  • The trial will enroll 30,000 participants at nearly 100 research sites.
  • The vaccine was developed in 42 days, from sequence to vaccine ready for human testing, through Moderna and NIH's unique approach.
  • The trial will test whether the vaccine can prevent the disease without symptoms and whether one dose is enough to prevent symptomatic COVID-19.
  • Moderna is aiming to deliver approximately 500 million doses per year, possibly 1 billion doses per year, beginning in 2021.
  • NIH Director Francis S. Collins has stated that having a vaccine available by the end of 2020 remains their objective.

Sources:

  • Moderna press release, Monday (exact date not provided).
  • Moderna website, mRNA-1273 vaccine development.
  • National Institutes of Health press release, late March (exact date not provided).
  • FDA approval, early May (exact date not provided).
  • Moderna press release, Monday (exact date not provided), regarding manufacturing capabilities and collaborations.
  • NIH Director Francis S. Collins press release (exact date not provided).