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Moderna’s COVID-19 vaccine enters pivotal phase 3 trial

Large-scale study will evaluate vaccine in 30,000 participants

Moderna

Moderna’s COVID-19 vaccine candidate has entered a late-stage phase 3 clinical trial, reinforcing its position at the forefront of the race for an effective vaccine targeting the novel coronavirus.

Moderna and the US National Institutes of Health (NIH) are collaborating on the late-stage COVE trial, which will evaluate the vaccine in 30,000 study participants. The trial will investigate two shots of the candidate, mRNA-1273, at a dosage of 100 µg.

The primary endpoint is the prevention of symptomatic COVID-19 disease, with key secondary endpoints including the prevention of severe COVID-19 disease and prevention of infection with SARS-CoV-2, which causes COVID-19, regardless of symptoms.

With its collaborators, Moderna has chosen nearly 100 clinical research sites cross the US with representative demography. The company is also working closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study.

If the vaccine can prove effective in this study, Moderna plans to be able to deliver around 500 million doses per year and up to one billon doses thereafter, beginning in 2021.

“We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic,” said Stephane Bancel, chief executive officer of Moderna.

Interim analysis from the phase 1 study of mRNA-1273 were published earlier this month, and showed that the vaccine produced rapid and strong immune responses against SARS-CoV-2 in all participants tested.

Following two doses with the vaccine, neutralising antibody levels among participants were similar to those seen in individuals who had tested positive and recovered from COVID-19. Although high levels of neutralising antibodies are not definitive proof that a vaccine is effective against a virus, it is still considered an important indicator of efficacy in early clinical trials.

Pfizer and BioNTech have also announced the initiation of a large-scale phase 2/3 study of their lead mRNA-based vaccine candidate, BNT162b2. The companies identified BNT162b2 as the most promising candidate from among four others in their vaccine programme.

Article by
Lucy Parsons

28th July 2020

From: Research

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