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Coronaviruses

First US Patients Dosed in mRNA Vaccine Trial to Prevent COVID-19

Strategic Insights

— 1 min read

Researchers at NYU Langone Health have begun enrolling healthy patients in a clinical trial to test four experimental mRNA vaccine candidates developed by Pfizer and BioNTech. The trial aims to determine whether the vaccines can prevent infection with the virus that causes COVID-19. The trial is being conducted at NYU Grossman School of Medicine, the University of Maryland, and other centers in the US, with Pfizer and BioNTech having already launched a similar trial in Germany. The vaccine designers at BioNTech sought to identify the protein components of the SARS-CoV-2 virus that are most recognized by the human immune system, with the goal of providing long-term protection against the virus.

Key Takeaways:

  • Four mRNA vaccine candidates are being tested in the trial, developed by Pfizer and BioNTech.
  • The trial aims to enroll healthy patients aged 18-85 years, with older adults only being immunized once testing in younger adults has provided initial evidence of safety and desired immune responses.
  • The trial will use mRNA vaccines, which are based on RNA and can be quickly designed, fabricated, and scaled up using high-speed machines.
  • The study vaccines contain viral RNA encoding the "spike proteins" used by SARS-CoV-2 to attach to human cell surfaces, which has the potential to make proteins required for viral survival visible to the human immune system.
  • The research program will proceed in stages, with the current "dose escalation phase" aiming to gather evidence on safety, best dose, and number of doses by midsummer.

Statistics:

  • 360 healthy subjects will be enrolled in the trial, divided into two groups: 18-55 years and 65-85 years of age.
  • The trial will aim to gather evidence on safety, best dose, and number of doses by midsummer.
  • The trial will expand to older adults only after initial evidence of safety and desired immune responses in younger adults has been provided.
  • The mRNA vaccines used in the trial will be delivered via small segments of mRNA injected into the arm muscles of participants.

Sources:

  • NYU Langone Health press release, May 5
  • Pfizer press release, May 5
  • BioNTech press release, May 5
  • Journal of Infectious Diseases and Immunology (no specific issue or date mentioned)
  • NYU Langone Health website (no specific date mentioned)
  • University of Maryland website (no specific date mentioned)

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