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Moderna, Inc. (Cambridge, MA, USA) has said that it is all set to report the first data from the last stage of the trial of its experimental COVID-19 vaccine in November that will reveal whether it is effective.
A Reuters report claims Moderna expects an independent data monitoring committee to carry out a mid-term review of its currently ongoing trial of 30,000 people in November. The company expects two-month follow-up safety data, as required by the US Food and Drug Administration, in the second half of November, after which it will file an emergency use authorization. Moderna is preparing to distribute its COVID-19 (mRNA-1273) vaccine and expects to produce 20 million doses by the end of 2020, and between 500 million and 1 billion doses in 2021. Moderna has said infection rates in the trial were in line with expectations, according to the Reuters report.
“Since we follow the zip codes (geographic areas of the US) and the counties these participants come from, we have pretty sophisticated models of what to expect, and I think we are on the right track to meet those expectations,” he said. medical director Tal Zaks told Reuters.
In addition, the UK Medicines and Health Products Regulatory Agency (MHRA) has started the ongoing review process of Moderna’s experimental COVID-19 vaccine. This announcement follows the positive results of a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the phase 1 study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+). Interim Phase 1 analysis showed that mRNA-1273 was generally well tolerated in all age groups and induced strong and rapid immune responses against SARS-CoV-2.
Moderna has initiated ongoing submission of 1273-mRNA data for ongoing review, in consideration of possible clearance from the MHRA, provided the candidate vaccine meets the rigorous MHRA standards for safety, effectiveness, and quality. This ongoing review process allows the MHRA to begin its independent evaluation using the information submitted by Moderna and accept new evidence as it becomes available until the application is deemed complete. This process can reduce authorization time while maintaining the usual high standards of safety, efficacy, and quality.
“We appreciate the collaboration we have had to date with regulatory authorities around the world and the process established by the MHRA to address this ongoing public health emergency,” said Stéphane Bancel, CEO of Moderna. “This is a great example of what is being done to support efforts to deliver a safe and effective vaccine to the citizens of the UK in the safest and most efficient way possible.”
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