Moderna’s Covid-19 vaccine is 94.5% effective in preventing the disease, preliminary data from large-scale phase three trials shows, the company announced in a press release on Monday.
- The preliminary data is based on an evaluation of 95 confirmed Covid-19 infections among the trial’s 30,000 participants.
- According to the company, 90 of the participants who got infected with Covid-19 are from the placebo group while only 5 cases of infection were seen in the group that received two doses of the vaccine.
- Of the 95 people who got infected, there were 11 severe cases, all among participants in the placebo group and none in the vaccinated group.
- The company found no “significant” safety concerns, noting that the vaccine was generally well tolerated.
- Major side effects were limited to pain at the injection site after the first shot and fatigue, muscle pain, headaches after the second shot.
Moderna’s vaccine candidate remains stable at 2°C to 8°C (36°F to 46°F) — which is the temperature of a standard home or medical refrigerator — for 30 days, the company announced in a separate release. When stored at -20°C (-4°F) the vaccine will remain stable for up to 6 months, the company added. This could turn out to be a significant advantage for Moderna’s vaccine compared to Pfizer’s vaccine, which needs to be stored at -70° C (-94°F) in specialized freezers, which may limit its availability. Moderna’s Chief Technical Operations and Quality Officer, Juan Andres, said the vaccine can be stored and shipped “at temperatures commonly found in readily available pharmaceutical freezers and refrigerator,” noting that this was “an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”
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The company plans to apply for an Emergency Use Authorization (EUA) for the vaccine with the U.S. Food and Drug Administration (FDA) in the next few weeks, and it anticipates the final decision on the EUA will be informed by final safety and efficacy data about the vaccine.
Moderna CEO Stephane Bancel said: “This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”
20 million. That’s the total number of doses that Moderna expects to have ready to ship by the end of 2020. The company also added that it was on track to manufacture 500 million to 1 billion doses globally in 2021
Moderna’s latest results mark the second set of promising vaccine data from a U.S. pharmaceutical company, after Pfizer last week announced its vaccine with Germany’s BioNTech to be around 90% effective at preventing Covid-19.