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Press release
Wednesday, December 30, 2020
Data from the phase 3 clinical trial confirm that the vaccine is effective.
What
The investigational vaccine known as mRNA-1273 was 94.1% effective in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine. The vaccine has also been shown to be effective in preventing severe COVID-19. Researchers have identified no safety concerns and no evidence of vaccine-associated enhanced 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), part of the National Institutes of Health. Moderna and NIAID previously shared the first results of the COVE trial. On December 18, 2020, the FDA issued an emergency use authorization allowing Moderna to make the vaccine available for the prevention of COVID-19 in adults in the United States.
The trial was led by principal 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 trial was implemented as part of the U.S. government’s Operation Warp Speed program and supported by NIAID and the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and the Office of the Assistant Secretary for preparation and response.
The trial began on July 27, 2020, and enrolled 30,420 adult volunteers at clinical research sites across the United States. Volunteers were randomly assigned 1: 1 to receive either two 100 microgram (mcg) doses of the experimental vaccine or two injections of saline placebo 28 days apart. The average age of volunteers is 51 years old. About 47% are female, 25% are 65 or older, and 17% are under 65 with medical conditions that put them at higher risk of severe COVID-19. About 79% of the participants are White, 10% are Black or African American, 5% are Asian, 0.8% are Native American or Alaska Native, 0.2% are Hawaiian or other Pacific Islander, 2% are multiracial and 21% (of any race) are Hispanic or Latin American.
From the start of the trial to November 25, 2020, investigators recorded 196 cases of symptomatic COVID-19 that occurred among participants at least 14 days after receiving their second injection. 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 group receiving mRNA- 1273. The incidence of symptomatic COVID-19 was 94.1% lower in participants given mRNA-1273 compared to those given placebo.
Investigators observed 236 cases of symptomatic COVID-19 among participants at least 14 days after receiving their first vaccine, with 225 cases in the placebo group and 11 cases in the group receiving mRNA-1273. The vaccine efficacy was 95.2% for this secondary analysis.
There were no safety concerns regarding the vaccination, according to the authors. Local reactions to the vaccine were generally mild. About 50% of participants receiving mRNA-1273 experienced moderate to severe side effects – such as fatigue, muscle pain, joint pain, and headaches – after the second dose, which resolved in most volunteers within two days. .
The researchers also saw no evidence of VAERD among those who received mRNA-1273. This rare complication was observed in individuals vaccinated with an inactivated respiratory syncytial virus (RSV) vaccine in the 1960s, before there was the ability to define protein structures and measure immune responses with it. precision. VAERD can occur when a vaccine induces an immune response that is not strong enough to protect against infection.
Although mRNA-1273 is very effective in preventing symptomatic COVID-19, there is not yet enough data available to draw conclusions as to whether the vaccine may have an impact on the transmission of SARS-CoV. -2. Preliminary data from the trials suggest that there may be some degree of prevention of asymptomatic infection after a single dose. Further analyzes are underway on the incidence of asymptomatic infections and viral shedding after infection 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.
Item
LR Baden, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 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 Vaccine Research Center at NIAID, is also available for comment.
Contact
To schedule interviews, please contact the NIAID News and Science Editorial Board, (301) 402-1663, [email protected].
NIAID conducts and supports research – at NIH, in the United States, and around the world – to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, comprises 27 institutes and centers and is a component of the US Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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