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FDA designs fast-track approval for updated vaccines

(Bloomberg) – Drug makers will not have to conduct massive trials for the development of new vaccines or booster to combat new variants of the coronavirus, said the U.S. Food and Drug Administration (FDA, for its acronym in English). On Monday, in a published document, the agency said immunizations that protect against the variants could be licensed under so-called immunogenicity studies, where researchers vaccinate people and then run laboratory tests to measure the strength of their immune response. These tests, similar to those performed for annual flu vaccines, are much simpler than the initial standard efficacy studies used for vaccine approval, which involve thousands of volunteers and take months of work. Covid-19 cases have declined across the United States in recent weeks, health officials are concerned that the rapidly spreading variants could trigger higher infection rates even amid the mass vaccination campaign. The variants are already affecting the accuracy of some tests and the potency of treatments against the virus, the agency said. “By issuing these guidelines, we want the American public to know that we are using all the tools we have to combat this pandemic, including rotation as the virus adapts, “FDA Acting Commissioner Janet Woodcock said in a statement. The best way to combat the emergence of genetic mutations that make the virus more transmittable and contagious is to protect people from don’t get infected, public health officials said. The vaccination campaign accelerated after a slow launch, with 63.1 million doses administered through Monday, according to the Bloomberg Vaccine Tracker. Modified Products The agency is encouraging drug companies to test its modified products on people who were immunized. previously, which could come in the form of a booster shot, and in your first shot for those who haven’t been vaccinated. Manufacturers must demonstrate that the levels of neutralizing antibodies produced by a modified vaccine against new strains are at least as strong as those produced after vaccination against the initial strains.It is important to note that, because these studies are based on results from In laboratory tests in people, the suggestion means that drug companies would not have to conduct lengthy trials that directly measure how much a new vaccine reduces cases of disease compared to a placebo vaccine. Which would further simplify the process, drug manufacturers could conduct the trials in a single age group, such as adults aged 18 to 55, and extrapolate the findings to other ranges for which a vaccine has been licensed, the agency noted. FDA Vaccine strains have evolved rapidly and particularly the variants that have emerged in South Africa and Brazil have mutations that can reduce the effectiveness of existing vaccines. That has prompted companies like Moderna Inc. and Pfizer Inc .. to begin exploring plans to develop modified or booster vaccines. Original Note: FDA Outlines Fast Path for Shots Against New Virus Variants (1) For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source. © 2021 Bloomberg LP

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