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Another decisive step in the search for vaccine COVID-19. After AstraZeneca and the University of Oxford, theMom (European Medicines Agency) has begun to analyze data from the anti-Covid mRna-1273 vaccine developed by Modern Biotech Spain, a subsidiary of American Moderna. As the EMA points out on its website, it was decided to start with the continuous review procedure, the first step in the approval process, based on the preliminary results of non-clinical studies and the first clinical studies carried out in adults, which seem to indicate that the the vaccine stimulates the production of antibodies and immune T cells against the SarsCov2 virus. Quick procedure for the subsidiary in Spain. The vaccine has «an efficacy for 94.5% “remains stable at a temperature between 2 ° and -8 ° C” the temperature of a normal domestic or medical refrigerator, for 30 days, “the same company announced.
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“Up to 1 billion doses in 2021”
The American company Moderna expects to have around 20 million doses of the Covid vaccine by the end of 2020 for the US The company also says it is on track for full production of 500 million to 1 billion doses in 2021.
The evaluation
The EMA Committee for Medicinal Products for Human Use (CHMP) has begun to evaluate the first batch of data on Moderna Biotech Spain’s vaccine, which comes from laboratory tests. Larger-scale clinical trials are currently underway in thousands of people, the results of which are expected soon and should indicate the effectiveness of the vaccine in protecting against Covid-19. The results emerge from a phase 3 study called Cove ‘that enrolled more than 30 thousand participants in the United States ”, conducted in collaboration with the National Institute of Allergy and Infectious Diseases, the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health.
Moderna says its COVID-19 vaccine is 94.5% effective, making it better than Pfizer’s https://t.co/UZPVsGwSPx pic.twitter.com/TPTBs51jrR
– Daily Mail US (@DailyMail) November 16, 2020
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All available data on the safety of the vaccine and its quality (ingredients, production method, stability and storage conditions) will be reviewed by the EMA as soon as they are available. Ongoing review will continue until there is sufficient data to support an application for authorization to sell the vaccine. The Ema, specifies in a note, evaluate the vaccine according to the usual standards of efficacy, safety and quality, but the process should be shorter than normal thanks to the time gained from continuous review. The European Agency had already activated this procedure in early October for the anti-Covid-19 vaccine developed by AstraZeneca and the University of Oxford.
Fantastic news. He has just published the preliminary results of the Moderna vaccine, also in this case with an efficacy greater than 90%. Soon details about @MedicalFacts
– Roberto Burioni (@RobertoBurioni) November 16, 2020
Bags fly
The European stock exchanges began to run on the news that the vaccine developed by Moderna turned out to be 94.5% effective. Madrid (+ 3%) leads the race followed by Paris and Milan (both + 2.2%). Moderna’s title is waiting to be listed on Wall Street 12% jump in pre-commercialization, while Pfizer (-1.6%) and Biontech (-5.6%) are being sold after the good results that emerge from the vaccine trial of the American company, which follows the one developed by the German Biontech together with the US group Pfizer.
Vaccine monitoring
The European Medicines Agency (Ema) and the national regulatory agencies of European countries have drawn up a special plan for security monitoring of anti-Covid vaccines, on how to collect and analyze the information that will arise once it is authorized. companies must submit monthly safety reports.
Job analysis
The work illustrated today also analyzed serious cases of Covid-19: they were included in particular 11 severe cases (as defined in the study protocol) in this first interim analysis. “All 11 cases occurred in the placebo group and none in the mRna-1273 group.” The 95 Covid-19 cases included 15 over 65s and 20 minority participants.
Biden’s reaction and Trump’s tweet
“Today’s news of a second vaccine is another reason to be confident,” the president-elect of the United States wrote on Twitter. Joe biden – What happened with the first vaccine is still true with the second: there are still many months. Until then, Americans should continue to practice social distancing and wear masks to keep the virus under control. “After the news of the experimental vaccine from Pfizer and BioNTech, Biden had recalled that he will have to wait several months before he can have a vaccine, inviting Americans to continue protecting themselves with the mask and maintaining social distancing.
Not even the outgoing American president, Donald trump, did not intervene. Always on Twitter: “Another vaccine has just been announced. This time from Moderna, 95% effective. For those great ‘historians’, remember that these great discoveries, which will end the Chinese plague, were made under my supervision. “
Last updated: 15:44
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