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FDA Panel Recommends Pfizer Vaccine Approval

(Bloomberg) – The first COVID-19 vaccine expected to be deployed in the United States won the backing of a panel of government advisers who met Thursday to consider approving the injection for emergency use. Advisory panel of the US Food and Drug Administration (FDA) voted 17 to 4, with one abstention, that the benefits of the vaccine from Pfizer Inc. and BioNTech SE outweigh its risks in greater 16 years old. The FDA does not have to follow the recommendation, although it often agrees with its advisers. The vote on the authorization of the experimental vaccine, which could occur in a few days. The government is prepared with a safety monitoring system that will go into effect on the first day of the immunization campaign, says Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention. ” Vaccine safety and effective monitoring are a priority for the US government, ”he told the panel in an online meeting. The CDC is considering working with the National Academy of Sciences, Engineering and Medicine to assess the safety concerns that may arise when the vaccine is used in the general population, he said. Deaths from covid are growing A positive vote scheduled for Thursday would bring the vaccine closer. experimental to authorization. After obtaining clearance, the vaccines will be distributed across the U.S. in a massive venture that will put healthcare workers and residents of long-term care facilities at the front of the line. The US government expects 2.9 million doses to be available to states immediately. Pfizer rose 0.3% at 3:50 p.m. in New York. Germany-based BioNTech’s US warehouse receipts gained up to 5.8%. FDA advisers, a group of independent vaccine experts, confirmed that the vaccine was 95% effective and worked well regardless of age, Sex, race, ethnicity, or underlying conditions that cause people to be at high risk for severe COVID-19 symptoms. The vaccine is expected to be the first available in the United States, where some 290,000 people have died from the virus. Side effects were mild and developed most often in those 55 and younger, with no signs of serious safety concerns based on data from two months of testing. After the second injection, fatigue and headache were some of the most common reactions.Messenger RNA technology causes the body’s cells to produce proteins that induce an immune response that can be repeated if an actual infection occurs. Moderna Inc. also makes an experimental messenger RNA-based Covid-19 vaccine, and the FDA’s advisory committee will meet Dec. 17 to discuss whether the agency should grant it an emergency clearance. From Pfizer who showed no signs of COVID-19 infection during vaccination, there were eight cases of the virus within the group that received the injection and 162 in those that received a placebo, according to FDA staff. Pfizer enrolled nearly 44,000 people in the trial.If the FDA approves Pfizer’s vaccine, Gustave Perna, the general who is leading the vaccine’s rollout, said people would begin receiving injections within 96 hours, although the Secretary of Health and Human Services, Alex Azar, has said it could happen within 24 hours. Between the Pfizer and Moderna vaccines, 20 million people in the US are expected to have received an injection in the two-dose regimen by the end of the year. Vaccines from AstraZeneca Plc and its partner, the University of Oxford, as well as Johnson & Johnson, may be available next year Original Note: Pfizer Shot Gets FDA Panel Review as Clearance Decision Near (1) For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source. © 2020 Bloomberg LP

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