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FDA:
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New: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine
- On July 13, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
- The Novavax COVID-19 Vaccine is administered as a two-dose primary series, three weeks apart.
- The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual.
- Overall, the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 cases in the placebo group.
- No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with 9 cases of moderate COVID-19 and 4 cases of severe COVID-19 reported in placebo recipients.
- In the subset of participants 65 years of age and older, the vaccine was 78.6% effective.
- The clinical trial was conducted prior to the emergence of delta and omicron variants.
CDC:
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New: CDC Recommends Novavax’s COVID-19 Vaccine for Adults On July 19, 2022, the Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that Novavax’s COVID-19 vaccine be used as another primary series option for adults aged 18 years and older. Novavax’s COVID-19 vaccine, which will be available in the coming weeks, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology for adults. Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers.
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Updated: As of July 18, 2022, CDC’s COVID-19 Program for Cruise Ships is no longer in effect and this page will no longer be updated. New guidance for cruise ships to mitigate and manage COVID-19 transmission will be available in the coming days. For more information, please see the cruise travel Frequently Asked Questions (FAQs).
VDH:
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- The recently approved Novavax vaccine will be available to order in VaXMaX beginning Thursday, August 4. Doses requested during this initial ordering window will be delivered on August 12 or August 15.
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For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.
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Upcoming Events
- CDC COCA Call: Recommendations for the Novavax COVID-19 Primary Series in Adults Ages 18 Years and Older
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CDC Office of Minority Health and Health Equity will host a webinar Protecting Our Children and Youth from COVID-19: Information for Parents, Caregivers, and Community Partners to provide accurate, timely, and trusted information about how to protect all children from COVID-19. Speakers include pediatric vaccine experts from HHS, CDC, and community partners leading vaccine efforts for children and youth.
- Date: Friday, July 29, 2022
- Time: 1:30–3:00 PM ET
- Webinar Link
- Passcode: COVID@19
- Dial In: US: +1 669 254 5252
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VDH External Web Updates
- Effective Tuesday, July 19, 2022, the COVID-19 Variant dashboard will be updated on a weekly basis (Mondays). It will feature more accurate and timely genomic sequencing data, but will no longer feature demographic or geographic information. What exactly is changing?
- VDH will no longer report demographic and location information.
- VDH will move to reporting variant percentages on a weekly basis.
- Variant infection percentages will now be shown together with case counts
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