Vaccine race accelerates, as Moderna-NIH partnership drug induces immune responses in all Phase 1 volunteers

[E]arly results, published in the New England Journal of Medicine on [July 14], showed that [Moderna’s COVID-19] vaccine worked to trigger an immune response with mild side effects — fatigue, chills, headache, muscle pain, pain at the injection site — becoming the first US vaccine candidate to publish results in a peer-reviewed medical journal

The vaccine is expected to begin later this month a large Phase 3 trial — the final trial stage before regulators consider whether to make the vaccine available.

Moderna noted in a press release on [July 14] that, if all goes well in future studies, “the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.”

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Moderna expects to start the company’s largest study yet of its Covid-19 vaccine candidate mRNA-1237 on July 27, according to details released separately on [July 14]. It’s expected to be the first in the United States to begin Phase 3 trials.

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In Phase 2, the clinical study is expanded and the vaccine is given to people who have characteristics — such as age and physical health — similar to those for whom the new vaccine is intended, according to the US Centers for Disease Control and Prevention. In Phase 3, the vaccine is given to thousands of people and tested for efficacy and again for safety.

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Moderna’s vaccine candidate is one of 23 in clinical trials around the world, according to the World Health Organization.

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