Positive early results from Moderna’s COVID-19 vaccine — NIH non-reviewed study

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Volunteers who received Moderna‘s COVID-19 vaccine had positive early results, according to the biotech company, which partnered with the National Institutes of Health to develop the vaccine. If future studies go well, the company’s vaccine could be available to the public as early as January, Dr Tal Zaks, Moderna’s chief medical officer, is quoted in a CNN report as saying. These early data come from the Phase 1 clinical trial, which typically studies a small number of people and focuses on whether a vaccine is safe and elicits an immune response.

The results of the study, which was led by the National Institutes of Health, have not been peer reviewed or published in a medical journal.

The report says, according to the World Health Organisation, Moderna, based in Cambridge, Massachusetts, is one of eight developers worldwide doing human clinical trials with a vaccine against the novel coronavirus. Two others, Pfizer and Inovio, are also in the US, one is at the University of Oxford in Britain, and four are in China.

Moderna has vaccinated dozens of study participants and measured antibodies in eight of them. All eight developed neutralising 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.

“We’ve demonstrated that these antibodies, this immune response, can actually block the virus,” Zaks said. “I think this is a very important first step in our journey towards having a vaccine.”

“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.

The report says while the vaccine had promising results in the lab, it’s not known if it will protect people in the real world. The US Food and Drug Administration has cleared the company to begin Phase 2 trials, which typically involve several hundred of people, and Moderna plans to start large-scale clinical trials, known as Phase 3 trials, in July. These typically involve tens of thousands of people.

Offit said before the pandemic, vaccine developers would usually test out their product in thousands of people before moving on to Phase 3, but said Moderna is “extremely unlikely” to have vaccinated that many by July, since they’ve only vaccinated dozens so far. He said it makes sense to Moderna to move into Phase 3 without vaccinating that many people, given that COVID-19 is killing thousands of people each day.

“This is a different time,” Offit is quoted in the report as saying.

Full CNN report

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