Press release
Wednesday, December 30, 2020
Data from the phase 3 clinical trial confirm the efficacy of the vaccine.
What the
The investigational vaccine known as mRNA-1273 was 94.1% effective in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results of a phase 3 clinical trial reported in New England Journal of Medicine. The vaccine has also been shown to be effective in preventing severe COVID-19. Investigators found no safety concerns and no evidence of vaccine-associated improved respiratory disease (VAERD).
The vaccine was co-developed by Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. Moderna and NIAID previously shared the initial results of the COVE study. On December 18, 2020, the FDA issued an emergency use authorization that allows Moderna to make the vaccine available for the prevention of COVID-19 in adults in the United States.
The trial was led by lead investigators Lindsey R. Baden, MD of Brigham and Women’s Hospital in Boston, Hana M. El-Sahly, MD of Baylor College of Medicine in Houston and Brandon Essink, MD, of Meridian Clinical Research. The process was implemented under the US government’s Operation Warp Speed program and supported by NIAID and the Authority for Advanced Biomedical Research and Development (BARDA) in the Office of the US Department of Health and Human Services, assistant secretary for training and response.
The trial began on July 27, 2020 and enrolled 30,420 adult volunteers at clinical research sites in the United States. Volunteers were randomly assigned 1: 1 to receive either two doses of 100 micrograms (mcg) of the investigational vaccine or two shots of placebo saline 28 days apart. The average age of the volunteers is 51 years. Approximately 47% are female, 25% are 65 years of age or older and 17% are under 65 years of age, with medical conditions presenting a higher risk of severe COVID-19. About 79% of participants are white, 10% are black or African American, 5% are Asian, 0.8% are American Indian or Alaska Native, 0.2% are Hawaiian or other Pacific Islander, 2% they are multiracial and 21% (of any race) are Hispanic or Latino.
From the start of the trial until November 25, 2020, investigators recorded 196 cases of symptomatic COVID-19 occurring among participants at least 14 days after receiving the second blow. One hundred and eighty-five cases (of which 30 were classified as severe COVID-19) occurred in the placebo group and 11 cases (of which 0 were classified as severe COVID-19) occurred in the group receiving mRNA- 1273. The incidence of symptomatic COVID-19 was 94.1% lower in those participants who received mRNA-1273 compared to those who received placebo.
Investigators observed 236 cases of symptomatic COVID-19 among participants at least 14 days after receiving the first stroke, with 225 cases in the placebo group and 11 cases in the group receiving mRNA-1273. The efficacy of the vaccine was 95.2% for this secondary analysis.
According to the authors, there were no safety issues with vaccination. Local reactions to the vaccine were generally mild. Approximately 50% of participants who received mRNA-1273 experienced moderate to severe side effects – such as fatigue, muscle aches, joint pain, and headache – after the second dose, which resolved in most volunteers during two days.
Investigators also found no evidence of VAERD among those who received mRNA-1273. This rare complication was observed in people vaccinated with a fully inactivated respiratory syncytial virus (RSV) vaccine in the 1960s, before there was the ability to define protein structures and accurately measure immune responses. VAERD can occur when a vaccine induces an immune response that is not strong enough to protect against infection.
Although mRNA-1273 is extremely effective in preventing symptomatic COVID-19, there are not yet enough data available to draw conclusions about whether the vaccine may have an impact on SARS-CoV-2 transmission. Preliminary study data suggest that there may be some degree of prevention of asymptomatic infection after a single dose. Further incidence of asymptomatic infection and viral clearance after infection is being analyzed to understand the impact of the vaccine on infectivity.
The authors concluded by discussing the unprecedented effectiveness of candidate vaccine development, noting that “this process demonstrates what is possible in the context of motivated collaboration between key sectors of society, including academia, government, industry, regulators and the wider community.”
Article
LR Baden, et al. Efficacy and safety of the SARS-CoV-2 mRNA-1273 vaccine. The New England Journal of Medicine. DOI: 10.1056 / NEJMoa2035389.
Which
NIAID Director Anthony S. Fauci, MD is available to comment on this study. John R. Mascola, MD, director of NIAID’s Vaccine Research Center, is also available for comment.
Contact
To schedule interviews, please contact the NIAID News & Science Writing branch, (301) 402-1663, [email protected].
NIAID conducts and supports research – at the NIH, throughout the United States and around the world – to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing and treating these diseases. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
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