Moderna announces the analysis of preliminary efficacy findings in the results of the phase 3 trial of its COVE vaccine for the treatment of COVID-19 as well as the submission of the trial findings for emergency approval by the FDA
Moderna announces the analysis of preliminary efficacy findings in the Phase 3 trial results of its COVE vaccine for the treatment of COVID-19 as well as the submission of the trial findings for emergency approval by the FDA.
The analysis of the primary efficacy findings included 196 participants who were identified as positive for COVID-19, 30 of whom are critically ill. The effectiveness of the vaccine against COVID-19 is 94.1% (185 cases of COVID-19 were observed in the placebo group compared to 11 cases observed in the mRNA-1273 group). It was also found that none of the experimenters who nevertheless fell ill, did not deteriorate into a serious illness.
The company's report shows that the efficiency was maintained in all ages, races, ethnicity and gender. (The 196 cases of COVID-19 included 33 adults (aged over 65) and 42 participants from diverse backgrounds).
Another modern message is that mRNA-1273 continues to show high tolerance; As of this date, no significant safety incidents have been recorded.
Moderna intends to submit an emergency track marketing authorization application from the FDA. The next step is a review by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the safety and efficacy of the mRNA-1273 product, which is expected on December 17, 2020, according to the FDA notice to Moderna.
Moderna intends to submit an application for conditional marketing authorization to the European Medicines Agency (EMA) today, and the company also intends to work to obtain preliminary approval (PQ) and/or emergency use authorization (EUL) from the World Health Organization (WHO).
The company will publish information from the Phase 3 COVE Study trial in a scientific magazine
"The analysis of the positive initial results confirms the ability of our vaccine to prevent the disease of COVID-19 with an efficiency of 94.1%, and more importantly, the ability to prevent severe cases of disease of COVID-19. We believe that our vaccine will provide a new and valuable tool that may To change the way of dealing with this epidemic and help prevent serious illness, hospitalizations and death," said Stephan Bansel, CEO of Moderna.
More of the topic in Hayadan:
- Moderna's COVID-19 vaccine achieved 94.5% efficacy in the clinical trial
- Will Moderna's messenger RNA bring the news of the corona vaccine?
- Pfizer and Biontech announce success in a clinical trial of a corona vaccine - 90 percent effective
- Immune memory cells are stable over time after recovery from corona
- How to deal with corona deniers - and why it (usually) doesn't work
One response
1. This emergency approval means that the economic interest comes before the health interest. Instead of waiting all the years required for the results of clinical trials as required, marketed now and quickly, when the echoes of anxiety and panic generated by the authorities and the media are still hot, to wait as required for a few more years to see real results of this thing - means losing a huge market share
2. If anyone did not understand what and why the panic: Corona is nothing more than a mild flu and has never been more than that, 90% of the population has already been vaccinated with the herd vaccine. As happened with all the previous "epidemics", and if they wait another year or two - when almost the entire population will not need it at all (because like any flu with most people it goes away as soon as it comes) then who will agree to get vaccinated? almost no one. That's why the panic. Not any other reason. A vaccine that almost no one needs that will be worthless in a few months anyway
3. Add to this the fact that this is a dangerous game with RNA, the hereditary material of humans, with sterility risks, of a new generation that has never been tried before, and you will get a recipe for a global catastrophe. A recipe that has been cooked with great success so far by agents of panic and hysteria and must reap the fruits as quickly as possible. Push as many fools as possible, use them as guinea pigs, and the results will be studied in medical faculties, for generations to come... we. Here. now. The initial mass experiment
Who are the idiots willing to be used for this?