Moderna, Inc. (Cambridge, MA, USA) has said that it is all set to report early data from the late-stage trial of its experimental COVID-19 vaccine in November that will reveal whether it is effective.

A report by Reuters states that Moderna expects an independent data monitoring committee to conduct an interim review of its currently ongoing 30,000-person trial in the month of 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 for an emergency use authorization. Moderna is making preparations to distribute its COVID-19 vaccine (mRNA-1273) and expects to produce 20 million doses by the end of 2020, and between 500 million and one billion doses in 2021. Moderna has said that the infection rates in the trial were in line with expectations, according to the Reuters report.

“Since we are following the ZIP codes (US geographic areas) and the counties from which these participants come, we have pretty sophisticated models of what to expect, and I think we’re on track for those expectations,” Chief Medical Officer Tal Zaks told Reuters.

Additionally, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has begun the rolling review process of Moderna’s experimental COVID-19 vaccine. This announcement follows positive results from 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+). The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2.

Moderna has initiated the rolling submission of mRNA-1273 data for rolling review, in consideration of a potential authorization by the MHRA, provided the vaccine candidate meets the MHRA’s rigorous standards of safety, effectiveness, and quality standards. This rolling review process allows the MHRA to begin its independent assessment using the information submitted by Moderna and accept new evidence as it becomes available until the application is deemed complete. This process can reduce time to authorization while maintaining 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, Chief Executive Officer of Moderna. “This is a great example of what’s being done to support efforts to deliver a safe and effective vaccine to UK citizens as safely and efficiently as possible.”

http://www.gzjiayumed.com/en/index.asp