Press release
Wednesday, December 30, 2020
Phase 3 clinical trial data confirm that the vaccine is effective.
What
The research vaccine known as mRNA-1273 was 94.1% effective in the prevention of symptomatic coronavirus disease 2019 (COVID-19), according to the preliminary results of a phase 3 clinical trial published in New England Journal of Medicine. The vaccine also demonstrated efficacy in the prevention of severe COVID-19. The researchers did not identify safety issues and any evidence of vaccine-associated improved respiratory disease (VAERD).
The vaccine was developed jointly 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 trial. On December 18, 2020, the FDA issued an emergency use authorization that allowed Moderna to make the vaccine available for the prevention of COVID-19 in adults in the United States.
The trial was led by lead researchers 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 trial was implemented as part of the U.S. government’s Operation Warp Speed program and received support from NIAID and the Biomedical Authority for Advanced Research and Development (BARDA) from the Department of Health’s office. United States Human Services, Assistant Secretary for Preparedness 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 two doses of 100 micrograms (mcg) of the research vaccine or two shots of saline placebo 28 days apart. The average age of the volunteers is 51 years. Approximately 47% are women, 25% are 65 years of age or older, and 17% are under 65 years of age, with medical conditions presenting them with a higher risk of severe COVID-19. Approximately 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 native Hawaiian or other Pacific Islander , 2% 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 their second shot. One hundred and eighty-five cases (30 of which were classified as severe COVID-19) occurred in the placebo group and 11 cases (0 of which were classified as severe COVID-19) occurred in the placebo group. received mRNA-1273. The incidence of symptomatic COVID-19 was 94.1% lower in participants who received mRNA-1273 compared with those who received placebo.
The researchers observed 236 cases of symptomatic COVID-19 among participants at least 14 days after receiving the first shot, 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 related to vaccination. Local reactions to the vaccine were generally mild. Approximately 50% of participants receiving 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 in two days.
The researchers also found no evidence of VAERD among those receiving mRNA-1273. This rare complication was seen in individuals vaccinated with a fully inactivated respiratory syncytial virus (RSV) vaccine in the 1960s, before there was the ability to define protein structures and measure immune responses accurately. VAERD can occur when a vaccine induces an immune response that is not strong enough to protect against infection.
Although mRNA-1273 is highly effective in preventing symptomatic COVID-19, there are still not enough data available to draw conclusions about whether the vaccine may affect SARS-CoV-2 transmission. Preliminary trial data suggest that there may be some degree of prevention of asymptomatic infection after a single dose. Additional analyzes of the incidence of asymptomatic infection and viral detachment after infection are being performed to understand the impact of the vaccine on the infection.
The authors concluded by discussing the unprecedented efficiency of candidate vaccine development and noted 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 larger 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.
WHO
NIAID Director Anthony S. Fauci, MD, is available to comment on this study. John R. Mascola, MD, director of the NIAID Vaccine Research Center, is also available for comment.
Contact
To schedule interviews, contact the NIAID News & Science Writing Branch, (301) 402-1663, [email protected].
NIAID conducts and supports research, at NIH, throughout the United States and around the world, to study the causes of infectious and immune-mediated diseases and to develop better means to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other NIAID-related materials are available on the NIAID website.
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