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Peer-reviewed report on Moderna COVID-19 vaccine publishes


#News #Release

#Wednesday, #December 30, 2020

#Data from #Phase 3 clinical trial confirm vaccine is effective.

#What

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The investigational vaccine known as mRNA-1273 was 94.1% efficacious 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 also demonstrated efficacy in preventing severe COVID-19. #Investigators 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 initial results from the COVE trial. #On #Dec. 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, M.D. of #Brigham and #Women’s #Hospital in #Boston, #Hana M. #El-Sahly, M.D. of #Baylor #College of #Medicine in #Houston, and #Brandon #Essink, M.D., of #Meridian #Clinical #Research. The trial was implemented under 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 #Human #Services’ #Office of the #Assistant #Secretary for #Preparedness 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 investigational vaccine or two shots of saline placebo 28 days apart. The average age of volunteers is 51 years. #Approximately 47% are female, 25% are 65 years or older and 17% are under the age of 65 with medical conditions placing them at higher risk for 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 through #Nov. 25, 2020, investigators recorded 196 cases of symptomatic COVID-19 occurring among participants at least 14 days after they received 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 group receiving mRNA-1273. The incidence of symptomatic COVID-19 was 94.1% lower in those participants who received mRNA-1273 as compared to those receiving placebo.

#Investigators observed 236 cases of symptomatic COVID-19 among participants at least 14 days after they received their first shot, 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 concerning safety issues with 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 aches, joint pain and headache — after the second dose, which resolved in most volunteers within two days.

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#Investigators also observed no evidence of VAERD among those who received mRNA-1273. #This rare complication was seen in individuals vaccinated with a whole-inactivated respiratory syncytial virus (RSV) vaccine in the 1960s, before there was a capacity to define protein structures and measure immune responses with precision. VAERD can occur when a vaccine induces an immune response that is not strong enough to protect against infection.

#Although mRNA-1273 is highly efficacious in preventing symptomatic COVID-19, there is not yet enough available data to draw conclusions as to whether the vaccine can impact SARS-CoV-2 transmission. #Preliminary trial data suggests there may be some degree of prevention of asymptomatic infection after a single dose. #Additional analyses are underway of the incidence of asymptomatic infection and viral shedding post-infection to understand the vaccine’s impact on infectiousness.

The authors concluded by discussing the unprecedented efficiency of the candidate vaccine’s development, noting, “this process demonstrates what is possible in the context of motivated collaboration among key sectors of society, including academia, government, industry, regulators and the larger community.”

#Article

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, M.D. is available to comment on this study. #John R. #Mascola, M.D., director of NIAID’s #Vaccine #Research #Center, is also available to comment.

#Contact

#To schedule interviews, please contact the NIAID #News & #Science #Writing #Branch, (301) 402-1663, [email protected]

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NIAID conducts and supports research — at NIH, throughout the #United #States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. #News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

#About the #National #Institutes of #Health (NIH):NIH, the nation’s medical research agency, includes 27 #Institutes and #Centers and is a component of the U.S. #Department of #Health and #Human #Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. #For more information about NIH and its programs, visit www.nih.gov.

NIH…#Turning #Discovery #Into #Health®

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[ source link ]
https://www.nih.gov/news-events/news-releases/peer-reviewed-report-moderna-covid-19-vaccine-publishes

##Peerreviewed #report ##Moderna #COVID19 #vaccine #publishes

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