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The candidate vaccine from the American company Moderna demonstrated 94.1% effectiveness against Covid-19 and also demonstrated 100% effectiveness in severe cases. These are the data that come from the efficacy analysis of the Phase 3 Cove study on the coronavirus vaccine candidate developed by Moderna, which involved 30,000 volunteers, including 196 cases of Covid-19, of which 30 serious.
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The mRna-1273 vaccine “continues to be generally well tolerated,” the company continues: “To date, no serious safety concerns have been identified.” The Cove study exceeded the median follow-up of 2 months after vaccination, as required by the US FDA for emergency use authorization.
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At this point Moderna announces that today it will request an emergency use authorization and a conditional marketing authorization from the European Medicines Agency (Ema) from the FDA and that it will continue with the continuous reviews (rolling review), already initiated with international regulatory agencies. . The phase 3 study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (Niaid) led by Anthony Fauci, part of the National Institutes of Health (NIH), and with the Authority for Advanced Biomedical Research and Development. (Barda). The efficacy of the vaccine was demonstrated in the first interim analysis in 95 cases.
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Today’s analysis is based on 196 Covid cases, of which 185 in the placebo group versus 11 cases in the mRna-1273 group. Therefore, the precise estimate of the efficacy of the vaccine is 94.1%. A secondary endpoint looked at severe cases of Covid-19. All 30 occurred in the placebo group and none in the mRna-1273 vaccinated group. “To date, one Covid-19-related death has occurred in the placebo group in the study.”
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Efficacy was consistent “by age, race, ethnicity, and gender.” The 196 Covid-19 cases included 33 over 65s and 42 minority volunteers. An ongoing review of the security data is underway and the company notes that it has not identified “new serious security issues.” From previous analyzes, the most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and injection site erythema or redness. Adverse reactions increased in frequency and severity after the second dose. Moderna also confirms that it will present data from the Cove study in a revised publication.
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The company, which today submits the application for its vaccine to the EMA and the FDA, recalls that it has already started the process of continuous review with the European Medicines Agency, Health Canada, SwissMedic, the Medicines and Products Regulatory Agency. Health Sciences of the United Kingdom (MHRA), the Ministry of Health in Israel and the Health Sciences Authority in Singapore and intends to apply for prequalification or Emergency Use List from the World Health Organization (WHO). In addition, Moderna specifies that the meeting of the Advisory Committee on Vaccines and Related Biologicals of the FDA to review the package of data on the safety and efficacy of mRna-1273 “will probably be scheduled for Thursday, December 17.”
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The company expects the U.S. Centers for Disease Control and Prevention (CDC) to make recommendations on which groups should be vaccinated as a priority, while shipping doses to vaccine distribution points will begin afterward. to obtain authorization for the vaccine. emergency use in the United States.
