Moderna’s COVID-19 vaccine candidate moves into late-stage trial

Moderna, which has never brought a vaccine to market, has received almost $1 billion from the United States government, which is helping bankroll several vaccine candidates under its Operation Warp Speed program.

Moderna CEO Stephane Bancel in a statement on Monday said that "we are grateful to the efforts of so many inside and outside the company to get us to this important milestone", adding that "we look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic".

With its collaborators, Moderna has selected almost 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study.

Phase-three trials began on Monday of a candidate vaccine against the novel coronavirus in the USA, with an expected enrollment of 30,000 volunteers, the National Institutes of Health announced. The Moderna vaccine uses ribonucleic acid or RNA, which is a chemical messenger that contains instructions for making proteins to fight the coronavirus infection. British drugmaker AstraZeneca Plc said it will begin large-scale U.S. trials this summer of its vaccine under development with Oxford University researchers. This response is in a similar range to that in individuals who have recovered from Covid-19, providing encouragement that the vaccine will be able to protect the majority of people against infection.

As part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, NIH and other HHS agencies and government partners, in collaboration with representatives from academia, philanthropic organizations and numerous biopharmaceutical companies, advised on the trial protocol design and endpoints to ensure a harmonized approach across multiple vaccine efficacy trials. The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives. The randomised, placebo-controlled trial is expected to include approximately 30,000 participants in the USA, testing an mRNA-1273 dosage of 100 µg.

Volunteers for the Moderna trial will not know whether they are getting the real shot or a dummy version.

The vaccination here was conducted after the volunteers had undergone a rigorous screening procedure.

If a participant is suspected to have COVID-19, the participant will be asked to provide a nasal swab for testing within 72 hours. An independent data and safety monitoring board (DSMB) will review blinded and unblinded data-including safety data and cases of COVID-19 in both groups-at scheduled data review meetings. ClinicalTrials.gov includes a complete listing of study locations.

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