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Moderna’s COVID-19 vaccine shows positive results in phase 1 clinical trials

The interim results of Moderna Therapeutics vaccine, mRNA-1273 from 4 of its first 8 patients showed good results, the company has announced.
The phase 1 study is led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The patients were given 25 and 100 microgram levels of the vaccine. They were in the age group of 18 to 55.
The results of remaining 4 volunteers are awaited.
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Dr Tal Zaks, Chief Medical Officer at Moderna.
 Dr Zaks added: “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
 The company, founded in 2010 is based in Cambridge, Massachusettes. Its 800+ employees work from a 200,000 sq ft research facility.
“With these positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA,” said Dr Stéphane Bancel, CEO, Moderna.
The company plans to  scale up manufacturing to maximize the number of doses to reach out to as many COVID-19 patients as possible in the shortest possible time, the CEO added.
Moderna has an arrangement with Switzerland based Lonza group to manufacture a billion doses of the vaccine when it gets regulatory approval. The clinical trials are funded by US government agencies.

“With these positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA,” said Dr Stéphane Bancel, CEO, Moderna.