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BioWorld - Thursday, July 7, 2022

WHO

Home » Topics » Regulatory » WHO
  • Fda vaccine illustration
    July 1, 2022
    By Mari Serebrov

    US guidance on next-gen boosters a new era in COVID-19

    The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
  • Novavax covid 19 vaccine vial
    June 29, 2022
    By Mari Serebrov

    Novavax vaccine shows its chops

    Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead being played by the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE. But the data presented at the June 28 Vaccines and Related Biologic Products Advisory Committee meeting suggest the Novavax adjuvanted protein vaccine may have the chops to take on a larger role in taming the pandemic.
  • June 20, 2022
    By Mari Serebrov

    CDC: No ‘may’ about it when it comes to COVID-19 pediatric vaccines

    Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers.
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Authors

  • Nuala Moran
  • Michael Fitzhugh
  • Mark McCarty
  • Anette Breindl
  • Mari Serebrov
  • Annette Boyle
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