in

US company Moderna says its Covid-19 vaccine is 95% effective

COVID-19 cure
Germany faces some issues with their issuance of the coronavirus vaccine in some states.

A new vaccine developed by the US company Moderna is nearly 95% effective in protecting against COVID-19, early data the company shows.

This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5%.

We wrote about the COVID-19 vaccine curated by the German company BioNtech and Pfizer saying their vaccine is 90% effective here>>.

A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).

Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.

As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Bancel added that they remained “committed to and focused on doing our part to help end the COVID-19 pandemic.”

Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorisations to global regulatory agencies.

Violent fire in a Berlin subway station

Violent fire in a Berlin subway station, one person suffered severe burns, three people intoxicated with smoke

German Prime ministers reject harsh restriction plan

German Prime ministers reject the harsh restriction plan backed by Merkel and present a counter-draft