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efficacy, side effects … data from New England


#France —#Interim results of the phase 3 trial COVE on #Moderna’s mRNA-1273 anti-Covid vaccine were published yesterday in the #New #England #Journal of #Medicine[1].

“The COVE #Trial #Provides #Evidence of the #Short-Term #Effectiveness of the mRNA-1273 #Vaccine in the #Prevention of #Symptomatic SARS-CoV-2 #Infection in a #Diverse #Adult #Trial #Population […] The mRNA-1273 vaccine has shown 94.1% effectiveness in preventing #Covid-19 disease, including severe forms. #Apart from transient local and systemic reactions, no safety problem has been identified ”, indicate the authors, #Dr #Lindsey R. #Baden (infectious disease specialist, #Dana #Farber #Institute, #United #States) et al.

These data support the good results obtained with the RNA vaccine from #Pfizer / #BioNTech.

30,420 adult participants

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#In this phase 3 trial, 30,420 participants over the age of 18 were recruited from 99 centers in the #United #States. They had never had #Covid-19 disease and were randomized to receive either the vaccine (n = 15,210) or saline (n = 15,210).

#Two injections were administered 28 days apart, in the deltoid, in a volume of 0.5 ml containing 100 μg of mRNA-1273 or of a saline placebo. #Overall, 96% of participants received both doses.

#Vaccine mRNA-1273 was stored at 2-8 ° C at sites prior to preparation and vaccination. #No dilution was required. #Doses can be stored in syringes for up to 8 hours at room temperature before administration. #Caregivers and patients did not know what product they were receiving. #In contrast, a few #Moderna employees were familiar with the products administered to patients.

#What do we know about the trial population?

The average age of the participants was 51.4 years, 47.3% of the participants were female, 24.8% were 65 or older, and 16.7% were under 65 and had co-morbidities that exposed them to a risk of serious illness. #In total, 50% of participants were considered at risk of severe #Covid. #In detail, 5% had heart disease, nearly 5% had chronic lung disease, 6.5% severe obesity, 9.5% diabetes, 0.6% liver disease and 0.6% were affected. AIDS.

The majority of participants were white (79.2%), 10.2% were black or #African-American, and 20.5% #Hispanic or #Latino.

#Entry-to-study SARS-CoV-2 infections were detected in 2.3% of participants in the mRNA-1273 group and in 2.2% in the placebo group.

94.1% efficiency

#As of #November 25, 2020, participants had a median follow-up time of 64 days (range 0-97) after the second dose, with 61% of participants having more than 56 days of follow-up.

The primary efficacy endpoint was the prevention of #Covid-19 disease with onset of symptoms at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2.

#Symptomatic disease of #Covid-19 was confirmed in 185 participants in the placebo group and in 11 participants in the mRNA-1273 group; vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P <0.001).

#Severe #Covid-19 occurred in 30 participants, with one death; all 30 were in the placebo group.

The researchers indicate that efficacy was similar in the different subgroups, especially in participants who were baseline SARS-CoV-2 positive and in participants 65 years of age or older.

#For participants younger than 65, the effectiveness was 95.6%, and for those 65 or older, the effectiveness was 86.4%.

#As with the #Pfizer #BioNTech vaccine, the #Moderna vaccine began to protect approximately 10 days after the first dose, with maximum protection after the second dose.

#Good short-term tolerance

The safety profile of mRNA-1273 vaccine at median follow-up of 2 months is good. The frequency of serious adverse events 28 days after injection was similar in the vaccine and placebo groups.

#Adverse events at the injection site, mainly pain, occurred more frequently with the vaccine than with placebo, after the first dose (84.2% vs. 19.8%) and the second dose (88.6% against 18.8%). They lasted on average 2 to 3 days.

#Delayed injection site reactions (those occurring from day 8) were observed in 244 participants (0.8%) after the first dose and in 68 participants (0.2%) after the second dose. The reactions were characterized by erythema, induration, and tenderness, and resolved over the next 4 to 5 days.

#Moderate to severe systemic side effects, such as fatigue, myalgia, arthralgia, and headache, were seen in approximately 50% of participants in the 1273 mRNA group after the second dose. These side effects were transient, starting approximately 15 hours after vaccination and resolving in most participants on day 2, with no sequelae.

The severity of systemic events increased after the second dose in the mRNA-1273 group, with an increase in the proportions of grade 2 events (from 16.5% after the first dose to 38.1% after the second dose) and grade 3 events (from 2.9% to 15.8%).

#Injection site and systemic adverse events were more common in younger participants (18 to <65 years) than in older participants (≥ 65 years).

#Hypersensitivity reactions were reported in 1.5% and 1.1% of participants in the vaccine and placebo groups, respectively. #Bell’s palsy occurred in the vaccine group (3 participants [<0,1%]) and the placebo group (1 participant [<0,1%]) during the trial observation period (more than 28 days after injection).

“The anecdotal finding of a slight excess of #Bell’s palsy in this trial and in the BNT162b2 vaccine trial raises concerns that this is not a fortuitous event, and this possibility calls for close monitoring. », #Indicates the authors.

#Overall, 0.5% of participants in the placebo group and 0.3% in the mRNA-1273 group had adverse events that prevented them from receiving the second dose, and less than 0.1% of participants in both groups discontinued their participation in the trial due to adverse effects.

#Note: three deaths occurred in the placebo group (one from intra-abdominal perforation, one from cardiopulmonary arrest and one from severe systemic inflammatory syndrome in a participant with chronic lymphoid leukemia and diffuse bullous rash) and two in the group vaccinated (one by cardiopulmonary arrest and one by suicide).

#Limitations of the study

#This preliminary publication has several limitations mainly related to the median follow-up of only two months. #Longer-term data (a two-year follow-up is planned) will be required to answer a number of questions. “The apparently high efficacy of the mRNA-1273 vaccine is based on short-term data, and a decrease in efficacy over time has been demonstrated with other vaccines,” the researchers say in their discussion. The nature and duration of the protective immune response to SARS-CoV-2 must therefore be specified. “#In addition, the efficacy of the vaccine has been tested within a framework of national recommendations combining barrier measures and social distancing, which may have resulted in lower levels of infectious inoculum,” the researchers specify.

#Long-term follow-up for rare adverse events is also necessary, particularly in #Bell’s palsy.

#Finally, the trial was not designed to determine whether mRNA-1273 could protect against asymptomatic infection with SARS-CoV-2, a critical issue in controlling the pandemic. #Studies to answer this question are in progress or planned.

“#That the mRNA-1273 #Covid-19 and BNT162b2 #Covid-19 vaccines protect with an almost identical vaccine efficacy of 94 to 95% – and that the two vaccines were developed and tested in less than a year – are scientific triumphs and extraordinary medical ”, indicates #Barton F. #Haynes (#Duke #Human #Vaccine #Institute, #Duke #University #School of #Medicine, #Durham, USA) in an editorial accompanying the article[2]. “The next challenge is to get these vaccines and the next #Covid-19 vaccines to those most at risk as quickly as possible,” he concludes.

The next challenge is to get these vaccines and the next #Covid-19 vaccines to those most at risk as quickly as possible.
#Barton F. #Haynes

The trial was funded by the #Biomedical #Advanced #Research and #Development #Authority and the #National #Institute of #Allergy and #Infectious #Diseases. #Vaccine maker #Moderna was responsible for the overall trial design (with input from the #Biomedical #Advanced #Research and #Development #Authority, NIAID, #Covid-19 #Prevention #Network, and trial cochairs), screening and site monitoring, data analysis. A #Moderna-funded medical writer helped write the manuscript. The authors guarantee the accuracy and completeness of the data and the reliability of the trial to the protocol.

#Find the latest information on COVID-19 in the #Medscape #Coronavirus #Resource #Center





[ source link ]
https://francais.medscape.com/voirarticle/3606730

#efficacy #side #effects #data ##England

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