NIH begins Phase 1 clinical trial to test Moderna COVID-19 variant vaccine

Although it already has a successful COVID-19 vaccine in circulation, Moderna is developing a vaccine designed to address the troubling South African variant of the disease (B.1.351), and as of last week, the National Institutes of Health (NIH) began a phase one trial to evaluate it.

Known as mRNA-1273.351, the variant vaccine was developed by ModernaTX, Inc following the joint development mRNA-1273 vaccine by Moderna and the government. Its trial will focus on approximately 210 healthy adult volunteers, evaluating the candidates’ safety and immunogenicity among them. These volunteers will be split into eight cohorts, some having already received the mRNA-1273 vaccine and some not having received any COVID-19 vaccine.

“The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States,” Dr. Anthony S. Fauci, National Institute of Allergy and Infectious Diseases (NIAID) Director, said. “Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”

The trial will track the candidate’s safety, including reactions and side effects, while also charting its ability to spur an immune response in the vaccinated. This will be overseen by an independent safety monitoring committee, which will recommend that NIAID end or modify the trial if it senses a need. The trial is expected to reach full enrollment by the end of April 2021.

While the phase one trial proceeds, NIAID and Moderna will also evaluate the variant vaccine in animal models.