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On Monday, Moderna, a U.S. vaccine platform company, announced that its initial trial data for the new crown vaccine mRNA-1273 Phase III trial was 94.5 percent effective( p .lt;0.0001), the first interim analysis to assess 95 percent of the COVE study of 30,000 people. For new cases of coronary pneumonia, 95 new cases included 15 seniors (over 65 years of age) and 20 participants from different communities (including 12 Hispanics or Latinos, 4 blacks or African Americans, 3 Asians and 1 multiracial).
90 Cases of Covid-19 were observed in the placebo group, while 5 cases were observed in the group receiving two doses of the vaccine.
severe cases of COVID-19 were analysed at the secondary endpoint and 11 serious cases (defined in the study programme) were included in this first interim analysis.
all 11 cases occurred in the placebo group and not in the mRNA-1273 vaccination group.
-term analysis includes DSMB's review of available Phase 3 COVE study security data at the same time, but does not report any significant security risks.
Moderna said there were no "significant" safety risks, adding that the vaccine is generally safe and well-to-do, with most adverse reactions in participants labeled mild or moderate.
side effects include pain at the injection site, as well as fatigue after the second dose, muscle pain and headaches.
Level 3 (severe) events with a frequency greater than or equal to 2% after the first dose include pain at the injection site (2.7%), fatigue (9.7%), myalgia (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%) and erythema/redness (2.0%) at the injection site.
these adverse events are usually short-lived.
data may vary depending on further and final analysis of phase III COVE study data.
Moderna intends to apply to the FDA for emergency authorization (EUA) in the coming weeks, and hopes the EUA will be based on a final analysis of 151 cases and an average follow-up time of more than two months.
also plans to submit an authorization application to regulators around the world.
the trial is part of the National Institute of Allergy and Infectious Diseases (NIAID) and the Bureau of Advanced Research and Development (BARDA) response to the new coronavirus.
Moderna is working with the CDC, Warp Warp Speed and McKesson, a COVID-19 vaccine distributor signed by the U.S. government, and with global stakeholders for the distribution of mRNA-1273 if it is granted a global license for EUA and similar.
after Pfizer said last week that its vaccine was more than 90 percent effective, investors expect Moderna's vaccine to be effective.
both the Moderna vaccine and the Pfizer vaccine use the same technology to produce the vaccine.
it is based on a molecular technique called mRNA or messenger RNA.
is a new way to stimulate immune responses using genetic material.
Moderna also said its vaccine can be stable at 36 to 46 degrees Fahrenheit (-4 degrees Celsius) (the temperature of a standard home or medical refrigerator) for up to 30 days (the general vaccine storage temperature standard is minus 36 degrees Fahrenheit to 46 degrees Fahrenheit) and can be stored for up to six months, which will simplify the distribution of the vaccine.
, Pfizer's vaccine is stored at minus 94 degrees Fahrenheit (-70 degrees Celsius).
the company says It expects to deliver about 20 million doses of the vaccine to the U.S. by the end of the year.
said it was on track to produce between 500 million and 1 billion doses worldwide by 2021.
the company has reached supply agreements in North America, the Middle East and other parts of the world.
announced in August that it had reached an agreement with the U.S. government to provide 100 million doses of the vaccine.
the agreement gives the federal government the option to buy up to 400 million additional doses.
said at the time that the U.S. had invested $955 million in moderna's new crown vaccine development, bringing its total investment to $2.48 billion.
, Moderna said it charged some customers between $32 and $37 per dose for vaccines at a lower price.
said it was discussing lower-priced, high-volume agreements.
the new mRNA-1273 coronary mRNA vaccine, which encodes a pre-fusion stable form of the Spider (S) protein and was developed by researchers at Moderna and the NIAID Vaccine Research Center in the United States.
clinical trials funded by the Alliance for Epidemiological Prevention and Innovation were completed on 7 February 2020 and analyzed and tested.
42 days from the sequence selection, it was shipped to the NIH on February 24.
the first participants in the NIAID-led mRNA-1273 phase 1 study were given the drug on March 16 (from sequence selection to phase 1 study administration).
May 12, the FDA awarded the mRNA-1273 fast-track label.
May 29, the first participants in each age group, mRNA-1273, were studied by adults aged 18-55 (n s 300) and adults aged 55 and over (n s 300).
the February study was completed on 8 July.
September 29, the New England Journal of Medicine published the results of the second interim analysis of the first phase of the study on mRNA-1273 in the NIH-led age group of 56-70 years and older.
July 28, the New England Journal of Medicine published the results of an assessment of mRNA-1273 in a preclinical virus attack study of non-human primates.
July 14 in the New England Journal of Medicine, an interim analysis of the initial queue of a NIH-led mRNA-1273 study was published.
mRNA-1273 is not currently approved for use by any regulatory authority.
rose more than 17 percent in pre-market trading on the news that CNBC and Moderna's Phase III clinical trial were up 94.5 percent.
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