Investigational COVID-19 vaccine well-tolerated in older adults

September 30, 2020

These results, according to researchers, further support testing the investigational vaccine in older adults in this ongoing large Phase 3 trial.

An experimental COVID-19 vaccine known as mRNA-1273 was well-tolerated in older adults, according to new research in the New England Journal of Medicine. The vaccine was co-developed by the Cambridge, Massachusetts-based biotechnology company, Moderna Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).1

Beginning on March 16, 2020, the Phase 1 trial began and expanded for older-adult enrollment one month later. As previous studies have shown, older adults are more vulnerable to complications of the virus and are important when measuring the vaccine’s efficacy and safety.1

The trial enrolled 40 healthy volunteers: 20 adults aged 56 to 70 years, and 20 adults aged 71 years and older. Ten volunteers in each age group were given a lower dose of the vaccine (25 µg), and 10 volunteers in each age group received a higher dose (100 µg). After one month, volunteers received a second dose of the same vaccine at the same dosage.2

Some volunteers reported fever and fatigue after vaccination. Results indicated a positive immune response in those vaccinated, with evidence of robust binding and neutralizing antibodies against the virus.2

These results, according to researchers, further support testing the investigational vaccine in older adults in this ongoing large Phase 3 trial.3

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References

  1. NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins. News release. National Institute of Allergy and Infectious Diseases; March 16, 2020.
  2. Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults. News release. National Institutes of Health; September 29, 2020.
  3. Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins. News release. National Institute of Allergy and Infectious Diseases; July 27, 2020.