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Message: <blockquote data-quote="sam_sajith" data-source="post: 26791707" data-attributes="member: 206455"><h3>New flexibility</h3>Full approval gives doctors flexibility in using vaccinations, as long as the uses are considered reasonable. Such “off label use” is not permitted for products under emergency authorization.Given that increased flexibility, doctors may face pressure from patients who want to receive booster shots soon, before the FDA clears them. The Biden administration recently said the effectiveness of the Pfizer-BioNTech and Moderna vaccines at preventing mild and moderate covid-19, the illness caused by the coronavirus, appears to be waning. Officials said they plan to roll out booster shots beginning the week of Sept. 20, assuming the FDA clears the applications from the vaccine makers.“Many of us are worried that full approval means you don’t get more of the people who should get vaccinated but instead the worried well are going to get additional doses,” said a federal official who spoke on the condition of anonymity because he was not authorized to talk about the issue.Experts said it would be especially concerning if parents with children younger than 12 attempt to get their children vaccinated. Those inoculations have not yet been cleared, and scientists are still determining the correct doses.Legal ambiguities might discourage doctors from using the products in a way that is not recommended, said Penn’s Lynch. For one thing, she said, it isn’t clear whether doctors using the Pfizer vaccine off label would be shielded from legal liability if someone was injured by the shot.The Centers for Disease Control and Prevention’s vaccine advisory committee is expected to meet soon to recommend use of the vaccine. Since the Advisory Committee on Immunization Practices and the CDC have recommended Pfizer for use in people 16 and older under the emergency authorization, they are virtually certain to recommend it for the licensed product.The Pfizer-BioNTech approval is part of what is shaping up as a period of extraordinary activity on the vaccine front. Moderna, the second most widely used vaccine in the United States, filed for full approval June 1. Johnson & Johnson, maker of the third coronavirus vaccine authorized for emergency use in the United States, has said it plans to apply for approval later this year.Pfizer-BioNTech, which has submitted early-stage data to the FDA as part of its application for a booster, is expected to add late-stage information shortly to that application. Johnson & Johnson, which unlike the two-dose Pfizer-BioNTech and Moderna vaccines is a single-shot vaccine, is expected to announce data soon from a trial testing the effect of adding a second shot.Meanwhile, Moderna’s application for using its vaccine among 12- to 17-year-olds is pending at the FDA; Pfizer-BioNTech already has clearance for its vaccine to be used in adolescents. Those companies are conducting vaccine studies in children under 12, and Pfizer-BioNTech is aiming to file data for 5- to 11-year-olds with the FDA by the end of September. Moderna is expected to follow soon after.Officials recently recommended third shots of the Pfizer-BioNTech and Moderna shots for the immunocompromised. And the Biden administration’s <a href="https://www.washingtonpost.com/health/2021/08/18/covid-booster-faq/?itid=lk_inline_manual_61" target="_blank">booster</a> plan adds another element to an already crowded and complicated fall calendar.Way to go Hail Science ! </blockquote>

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