Channel: Dr. John Campbell

Category: Education

Tags: human biologydiseasebiologymedical educationphysiologyhealthnursingmedicinehuman bodycampbellnclexpathophysiologynurse education

Description: For young healthy adults, MODERNA SUBMITS AMENDMENT TO THE EMERGENCY USE AUTHORIZATION FOR AN ADDITIONAL BOOSTER DOSE OF ITS COVID-19 VACCINE IN THE U.S. (Pfizer, 65 and older for 4th shot) twitter.com/moderna_tx/status/1504628697894113285 investors.modernatx.com/news/news-details/2022/Moderna-Submits-Amendment-to-the-Emergency-Use-Authorization-for-an-Additional-Booster-Dose-of-its-COVID-19-Vaccine-in-the-U.S/default.aspx request to the U.S. Food and Drug Administration, for an amendment to the emergency use authorization, to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273), in adults 18 years of age and older who, have received an initial booster of any of the authorized or approved COVID-19 vaccines. (A booster dose of the Modern, 50 µg authorized for emergency use in the U.S. under EUA for adults 18 years and older) Clinical trials are ongoing for Moderna's Omicron-specific booster (mRNA-1273.529), and a bivalent Omicron-specific booster (mRNA-1273.214). Questions Will the 4th shot increase antibodies? Is it an emergency for a healthy 18 year old to get a 4th dose of vaccine today? Can beneficial endpoints be demonstrated for the individual? What n would be needed to demonstrate these beneficial outcomes? Will the 4th shot reduce T cell immunity for internal viral proteins? If someone has had omicron infection, will a 4th dose increase beneficial outcomes further? Is it time to end emergency shortcuts and get back to RCTS? Will there be guarantees a 4th dose will not be mandated once emergency use authorization is granted? Full FDA Approval of a COVID-19 Vaccine: What You Should Know hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/full-fda-approval-of-a-covid-19-vaccine-what-you-should-know The approval system for vaccines uses scientific data and exacting standards, to ensure safe and effective vaccines Review processes include Clinical trials The FDA requires rigorous testing of vaccines through a series of clinical trials, to make sure they work and are safe before authorizing or approving them for the public. The laboratories that conduct the trials are independent from the vaccine companies and the government, process is not biased. Risks and benefits must demonstrate that the benefits of a vaccine are greater than its risks for those who will be vaccinated Continual monitoring the FDA may pause the administration of vaccine to do more studies, and ensure that the problem does not outweigh the vaccine’s benefit. Manufacturing guidelines test the vaccine doses in batches (lots), to ensure the quality and effectiveness of the vaccines remain consistent and reliable. UK 4th Jab telegraph.co.uk/news/2022/03/20/fourth-covid-jabs-rolled-five-million-vulnerable-people-starting/?li_source=LI&li_medium=liftigniter-onward-journey Fourth Covid jabs to be rolled out to about five million vulnerable people starting from next week The Joint Committee on Vaccinations and Immunisations (JCVI) gov.uk/government/news/jcvi-advises-a-spring-covid-19-vaccine-dose-for-the-most-vulnerable Another dose of Pfizer or Moderna, (six months after third dose) care home residents over-75s immunosuppressed people over 12 years