#And only 11 participants in the vaccination group developed symptomatic COVID-19 vs. 185 control participants who received a placebo. #Admittedly, these are still provisional results because the trial must continue for 2 years, however these initial data are very promising. #Especially since the serious cases of COVID-19 identified at this stage only occurred in the participants who received the placebo.
“A significant impact for the prevention of hospitalizations and deaths, at least in the first months following vaccination”
#Brigham and #Women’s #Hospital is the primary site for this phase III trial supported by the US #National #Institutes of #Health. The trial is being led by #Dr #Lindsey #Baden, an infectious disease specialist at BWH and an expert in vaccine development for viral diseases, who comments on the first data in a statement: “We are continuing the trial. #Over the next few months, we will have more and more data to better define how this vaccine works, but the results at this stage show an efficacy of 94.1%. These figures are convincing and suggest protection against severe forms, and therefore a significant impact on the prevention of hospitalizations and deaths, at least in the first months following vaccination ”.
The trial recruited precisely 30,420 adult participants from 99 US sites, with no known history or particularly high risk of SARS-CoV infection, including more than 600 participants enrolled in BWH. The representativeness of the different ethnic origins in the #American population has been respected. #Participants received their first injection between #July 27 and #October 23, 2020, followed by a second injection 28 days later. #Each injection, administered intramuscularly, was in volume of 0.5 mL containing 100 μg of mRNA-1273 or a saline placebo. 50% of participants (n = 15,210) received the vaccine candidate. #Preliminary analysis shows that:
- in the placebo group, 185 participants developed a symptomatic form of COVID-19;
- in the vaccine group, 11 participants developed a symptomatic form;
- the efficacy of the vaccine appears similar in the different analysis groups (participants already having antibodies against SARS-CoV-2 at the time of inclusion and participants aged 65 years and over);
- 100% of participants who developed severe COVID-19 were in the placebo group.
- all cases of symptomatic COVID-19 and severe COVID-19 are still under close surveillance;
#Some side effects: #Also under surveillance are participants who developed side effects which, the researchers write, “on the whole were mild: about half of the participants experienced fatigue, muscle pain, joint pain and headache. head, more frequent after the second dose. #In most cases, these effects started around 15 hours after vaccination and disappeared after 2 days without leaving any damage.
A similar number of adverse events were reported in the placebo and vaccine groups.
#Very encouraging results but which will still have to be confirmed over a longer follow-up period. The #European #Medicines #Agency (EMEA) is expected to publish its assessment of the vaccine candidate around #January 12
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#COVID19 #published #high #efficacy #data ##Modernas #vaccine