The pandemic is over (POTUS)Uploaded 21-09-22https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccinesEmergency use authorizationsAugust 31, 2022https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-useToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine,and the Pfizer-BioNTech COVID-19 Vaccine,to authorize bivalent formulations,for use as a single booster doseOriginal strain + BA.4 and BA.5 lineagesFor each bivalent COVID-19 vaccine, the FDA based its decision on the totality of available evidence, including extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from omicron variant BA.1 lineagethat is similar to each of the vaccines being authorized,Biden administrationHas already placed an order for 170 million doseshttps://www.science.org/content/article/omicron-booster-shots-are-coming-lots-questionsData collected by the companiesHuman data, only available BA.1 boosterBA.1 trails did not look for protection against severe disease, (People trials are very expensive)For the BA.4/BA.5 boosters, the companies have submitted animal data. (not released publicly)Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose, (for EMA)Showed an increased antibody response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.Clinical trials for the BA.4/BA.5 vaccines will begin this monthAugust 19, 2022https://www.fda.gov/news-events/press-announcements/fda-roundup-august-19-2022Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, in individuals 12 through 17 years of age. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. July 13, 2022https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvantedToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, in individuals 18 years of age and older. June 17, 2022https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-childrenToday, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine,in children down to 6 months of age.December 22, 2021https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid Learn more about your ad choices. Visit megaphone.fm/adchoices
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