Early Moderna Data Supports Vaccine by 2021

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The phase one trial, which was run with the USA government, included eight healthy volunteers who received two doses each of the vaccine, known as mRNA-1273, the Massachusetts-based pharmaceutical company said in a statement. And one who received a third, middle dose of the vaccine between the two doses given to the other patients showed redness around the injection site.

The company said that grant will enable it to supply millions of doses per month in 2020 and, with further investments, tens of million a month in 2021 if the vaccine proves successful. All eight developed neutralizing antibodies to the virus at levels reaching or exceeding the levels seen in people who've naturally recovered from Covid-19, according to the company. Those in the 100 microgram had antibodies that "significantly exceeded levels" in recovered patients.

By contrast, the mRNA technology being used by Moderna and several others relies on the body's own cells to produce viral proteins. One wondered what the company would need to see to gain confidence that the antibody levels produced by mRNA-1273 are truly protective.

The first participant in the Phase I study was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. Nonetheless, Zaks said the high dosage would be taken out of future studies since the lower dosage seemed to work better.

The US Food and Drug Administration already gave the company approval to begin the phase two clinical trials, which it plans to launch in July.

Phase 2 tests, with a larger number of subjects, should begin soon, and according to Moderna. Moderna said it intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) for the Phase II study, created to assess the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. There were 45 people involved in these three arms, though neutralizing antibody data are only available at this point for the first four patients each of the 25 microgram and 100 microgram cohorts.

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The study is being conducted in concert with the National Institutes of Health.

"It shows that not only did the antibody bind to the virus, but it prevented the virus from infecting the cells", said Dr. Paul Offit, a member of the NIH panel that's setting a framework for vaccine studies in the US.

"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 Tal Zaks, Moderna's chief medical officer.

The companies agreed to establish manufacturing suites at Lonza's facilities in the USA and Switzerland for the production of mRNA-1273.

"By about the end of the year, the start of next year, there's a reasonable likelihood that we'll see this vaccine on the market, at least on the American market", he said in the Channel 12 interview from Moderna's headquarters in MA.

Apple Plans To Reopen Some Of Its U.S. Stores Next Week
Apple Inc. will start reopening USA retail stores next week, beginning in Idaho, South Carolina, Alabama and Alaska. The Apple logo at the entrance to the Apple store on 5th Avenue in Manhattan, New York, on October 16, 2019.


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