Moderna released its final data on its coronavirus vaccine on Monday, saying its candidate has been shown to be almost 94.1% effective in protecting people from the disease.
The pharmaceutical company also said the vaccine has a 100% effectiveness rate against severe cases of coronavirus.
Moderna plans to apply for emergency use authorization from the United States Food and Drug Administration (FDA) on Monday and conditional approval from the European Medicines Agency (EMA).
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Ranking games ModernThis product is the second vaccine likely to receive US emergency use authorization (EUA) this year. On November 20, pharmaceutical company Pfizer filed for EUA after claiming its coronavirus was 95% effective in preventing mild to severe COVID-19 disease in a large, ongoing study.
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Data from the Phase 3 trial showed that the vaccine is “generally well tolerated” and that no serious safety issues have been identified to date, the company said in a press release.
Moderna has been making its mRNA-1273 vaccine for several months and says around 20 million doses will be available by the end of the year.
The company also remains on track to manufacture 500 million to one billion doses worldwide by 2021, he said.
Canada signed an agreement in September for 20 million doses to be delivered in early 2021, with the possibility of increasing the supply to 56 million doses.
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The vaccine, which is given as two injections 28 days apart, has been studied in 30,000 volunteers who have been given either the real thing or a placebo.
Data released on Monday indicates that out of 196 coronavirus cases, 185 cases were in the placebo group and 11 received the vaccine. This means the vaccine has an efficacy rate of 94.1%, the company said.
The latest data is slightly lower than an interim analysis released on November 16 on an efficiency of 94.5%.
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There were also 30 severe cases of COVID-19, and each case was identified in the placebo group and none in the vaccinated group.
There has been one COVID-19-related death in the study to date, which occurred in the placebo group, the company added.
The safety of the phase 3 trial is still ongoing, but the most adverse reactions to the vaccine are pain at the site, fatigue, myalgia, headache, and redness at the injection site.
Moderna said the effectiveness rate was also constant across age, race, ethnicity and gender, Moderna said.
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The 196 cases of coronavirus involved 33 older adults (65 years and older) and 42 participants identified as being from various communities (including 29 Hispanics, six black or African Americans, four Asian Americans and three multiracial participants).
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with an efficiency of 94.1% and, above all, the ability to prevent severe COVID-19 disease. We believe our vaccine will provide a powerful new tool that could change the course of this pandemic and help prevent serious illnesses, hospitalizations and deaths, ”said Stéphane Bancel, CEO of Moderna.
Modern plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another trial in even younger volunteers in early 2021. The company hopes the vaccine will be available to adolescents in the early 2021 years. ‘by September of next year, Zaks said.
– With files from Reuters
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