Investigational COVID-19 vaccine well-tolerated in older adults

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.