The study enrolled 30,420 adult participants at 99 locations across the United States, including over 600 participants at Brigham.
Results of the primary analysis of the ongoing phase 3 clinical trial of the US biotechnology company Moderna’s Coronavirus ((COVID-19) The vaccine has shown a 94.1% effectiveness of the therapeutic in preventing symptomatic infections and serious illnesses, according to a peer-reviewed study.
The study, published Wednesday in the New England Journal of Medicine, found that among over 30,000 participants randomly assigned to receive the vaccine or placebo, 11 in the vaccine group developed symptomatic COVID-19, compared with 185 participants who received the placebo.
The researchers said this showed 94.1% effectiveness in preventing symptomatic COVID-19, adding that cases of serious illness only occurred in participants who received the placebo.
“Our work continues. In the next few months we will have more and more data to better define how this vaccine works. However, the results so far show an effectiveness of 94.1%. These numbers are compelling, ”said Lindsey Baden, an infectious disease specialist at Brigham and Women’s Hospital in the US, where the study took place.
“And most importantly, the data suggest protection against serious illness, suggesting that the vaccine could have an impact on preventing hospitalizations and deaths for at least the first few months after vaccination,” said Baden, co-principal investigator of the study and lead author of the paper.
The study enrolled 30,420 adult participants at 99 locations across the United States, including over 600 participants at Brigham. Eligible participants were at least 18 years old and had no history of SARS-CoV-2 infection. Because of their location or circumstances, they were at significant risk of infection and a high risk of severe COVID-19, the researchers said.
They found that the proportion of race and ethnicity in the study was 79% white, 10% black or African American, and 20% Spanish or Latin American participants.
Participants received their first injection between July 27 and October 23, followed by a second shot 28 days later. Each intramuscularly administered shock was 0.5 milliliters (ml) in volume containing 100 micrograms (μg) of mRNA 1273 vaccine or saline placebo.
In the placebo group, 185 participants developed symptomatic COVID-19 disease, while in the vaccine group only 11 participants developed symptomatic COVID-19 disease.
In secondary analyzes, the vaccine’s efficacy was similar in all groups of key concern, including those who already had antibodies to SARS-CoV-2 at the time of registration and those who were 65 years of age or older, the researchers said.
30 participants had severe COVID-19 – all in the placebo group, they said. They were closely monitored for adverse events in the weeks following their injection. The researchers said the overall reactions to the vaccine were mild – about half of the recipients experienced fatigue, muscle pain, joint pain, and headache, even more after the second dose.
Mr Baden said while these results are encouraging, they are limited by the short duration of follow-up.
“Long-term data from the ongoing study may allow us to more accurately assess the effectiveness of the vaccine between different groups, determine the effects on asymptomatic infections, understand when immunity is deteriorating, and determine if vaccines affect infectivity,” she added added.
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