A first interim analysis of the trial findings included 95 participants who were infected with Corona, 90 of whom are from the control group * All five who got sick despite the vaccine were asymptomatic or in a mild condition * Israel is among the first in line when the vaccine is approved
a week later The report of the pharmaceutical company Pfizer About 90% success for the vaccine it developed, another company announced a similar success. Moderna, a biotechnology company that develops vaccines using messenger RNA (mRNA) technology, the same technology with which Pfizer develops its vaccine - and which is different from all other vaccines being developed today, announced yesterday (Sunday) that an independent testing team examined the clinical trial (phase 3) of The mRNA-1273 vaccine, its vaccine candidate against the corona virus (COVID-19) confirmed that the trial met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
More than 30,000 participants in the USA participated in this study. It was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services.
The primary endpoint of the Phase 3 COVE study is based on an analysis of confirmed COVID-19 cases starting two weeks after the second dose of the vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 1273 cases observed in the mRNA-94.5 group, resulting in a point estimate of vaccine efficacy of 0.0001% (p < XNUMX).
11 of the subjects developed severe disease. All occurred in the placebo group and none in the mRNA-1273-immunized group.
The 95 COVID-19 cases included 15 adults (aged 65+) and 20 participants identifying as diverse communities (including 12 Hispanic or Latino, 4 Black or African American, 3 Asian American, and 1 multiracial).
Short-term side effects
The interim analysis included a concurrent review of the available safety data from the phase 3 COVE study by the DSMB, which did not indicate any significant safety concerns. A review of side effects indicated that the vaccine was generally tolerable. Most side effects were mild or moderate in severity. Among other things, pain at the injection site was reported (2.7%) and starting from the second dose also fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain elsewhere in the body (4.1%) and erythema /redness at the injection site (2.0%). These side effects were usually short-lived. These data are subject to change based on ongoing analysis of additional Phase 3 COVE study data and final analysis.
Moderna says preliminary analysis indicates a broadly consistent safety and efficacy profile across all subgroups evaluated.
As more cases accumulate towards the final analysis, the company expects that the evaluation of the points for the effectiveness of the vaccine may change. The company plans to submit data from the full Phase 3 COVE study for peer-reviewed publication.
"We have been chasing the vaccine since January"
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since the beginning of January, we have been chasing this virus with the intention of protecting as many people as possible around the world. All along, we knew that every day was important. This positive interim analysis from our Phase 3 study gave us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," said Stefan Bansel, CEO of Moderna.
"I want to thank the NIH, especially the NIAID, for their scientific leadership in supporting basic research of potential pandemic threats at the Center for Vaccine Research that led to the discovery of the best way to make antibodies to the spike (crown) protein used in our vaccine and others."
As I recall, the Israeli government purchased an option and participated in financing the development of the vaccine. Moderna's chief physician promises to provide Israel with vaccines as soon as possible: Dr. Tal Zaks said today (Monday) In an interview with the Marciano Foundation on News 12, that since Israel was one of the first countries to sign an agreement with the company for the purchase of vaccines, it is expected to supply Israel with vaccines against Corona soon - probably as early as early 2021.
"The expectation is that the supply to Israel will arrive from the first shipment that will come off the European production line, we have established production lines in Switzerland," said Dr. Sachs, who emphasized: "I hope this will happen at the beginning of 2021."
More of the topic in Hayadan:
