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Center for Biologics Evaluation and Research

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COVID-19: FDA Approves Updated Booster Shots Targeting New Variants COVID-19: FDA Approves Updated Booster Shots Targeting New Variants
Covid-19: FDA Approves Updated Booster Shots Targeting New Variants Health officials are one step closer to rolling out updated COVID-19 vaccines just in time for a rise in cases heading into the fall and winter months. The US Food and Drug Administration (FDA) approved new vaccines on Monday, Sept. 11, that are meant to better target currently circulating COVID-19 variants and provide better protection against hospitalization and death, the agency announced. Monday’s move affects vaccines manufactured by Moderna and Pfizer. The updated mRNA vaccines are each approved for people ages 12 and older and are authorized under emergency use for children ages 6 mo…

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by Michael Mashburn
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COVID-19: Vaccine Targeting Omicron Variant Authorized For Young Children By FDA COVID-19: Vaccine Targeting Omicron Variant Authorized For Young Children By FDA
Covid-19: Vaccine Targeting Omicron Variant Authorized For Young Children By FDA The Food and Drug Administration has authorized the use of updated COVID-19 booster shots targeting the Omicron variant for younger children. The FDA announced the amended emergency use authorization of the bivalent Moderna and Pfizer booster vaccines on Wednesday, Oct. 12. Today, FDA amended the EUA of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. https://t.co/C2Sx5Nkk0R pic.twitter.com/xsPfO2Mek3 — U.S. FDA (@US_FDA) October 12, 2022 The Moderna bivalent booster is autho…

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by Nicole Valinote
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COVID-19: FDA Clears Moderna, Pfizer Boosters For All US Adults COVID-19: FDA Clears Moderna, Pfizer Boosters For All US Adults
Covid-19: FDA Clears Moderna, Pfizer Boosters For All US Adults Federal health officials have given the green light for all Americans to get COVID-19 booster shots for all adults. The Food and Drug Administration (FDA) authorized Moderna and Pfizer COVID-19 booster shots for all adults in the US 18 and older, paving the way for expanding the eligibility of boosters in advance of the holiday season. Previously, the FDA had only authorized booster shots for Americans 65 and older, and those who were at a high risk of contracting COVID-19 due to pre-existing conditions of their job. “Authorizing the use of a single booster dose of either the Moderna or Pf…

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by Zak Failla
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COVID-19: FDA Approves Changes To Moderna Vaccine COVID-19: FDA Approves Changes To Moderna Vaccine
Covid-19: FDA Approves Changes To Moderna Vaccine The Food and Drug Administration has approved changes to the Moderna COVID-19 vaccine. On Thursday, April 1, the FDA announced that it has ruled that Moderna can put 50 percent more vaccine dosages in each vial, moving from 10 doses each to 15, which will allow for a more expeditious rollout of the vaccine. The FDA is also allowing 11 doses to be extracted out of the current 10 dose vials. Additionally, the FDA authorized the Moderna vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. …

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by Zak Failla