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X-WR-CALDESC:Events for Global Biodefense
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DTSTART;VALUE=DATE:20211014
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CREATED:20211004T005916Z
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UID:50034-1634169600-1634342399@globalbiodefense.com
SUMMARY:VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters
DESCRIPTION:On Oct. 14 and 15\, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster). \nOn Oct. 14\, the committee will discuss an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose\, in individuals 18 years of age and older. \nOn Oct. 15\, the VRBPAC will discuss amending the emergency use authorization of Johnson and Johnson’s Janssen COVID-19 Vaccine for the administration of a booster dose\, in individuals 18 years of age and older. \nAdditionally\, on Oct. 15\, the committee will hear a presentation from the National Institute of Health’s National Institute of Allergy and Infectious Diseases on the heterologous use of booster doses following the primary series of the three currently authorized or approved COVID-19 vaccines. \nDuring the meeting\, the committee will hear presentations from the companies on the data for their respective vaccines. The FDA will also present its own analyses of each of the manufacturers’ data. There will be an open public hearing each day during which the public will be given an opportunity to provide comments. \nThe FDA intends to make background materials for both VRBPAC meetings available to the public\, including the meeting agendas and committee rosters\, no later than two business days before each meeting. \nThe FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page.
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-janssen-and-moderna-covid-19-vaccine-boosters/
CATEGORIES:Government Hosted,Webinar-Webcast
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2021/10/fda-vrbpac-mix-match-booster-shots-janssen-moderna-boosters-covid-19.jpg
LOCATION:https://www.youtube.com/watch?v=BhlshZ7Lkr0
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DTSTART;TZID=America/New_York:20211020T100000
DTEND;TZID=America/New_York:20211021T170000
DTSTAMP:20210925T181613Z
CREATED:20210925T181613Z
LAST-MODIFIED:20210925T181613Z
UID:49859-1634724000-1634835600@globalbiodefense.com
SUMMARY:Advisory Committee on Immunization Practices (ACIP) Meeting
DESCRIPTION:The CDC Advisory Committee on Immunization Practices will convene 20-21 October 2021. ACIP typically holds three meetings each year at CDC in Atlanta\, Georgia to make vaccine recommendations. Due to the coronavirus disease 2019 (COVID-19) pandemic\, ACIP meetings have been held more frequently and have been virtual only (no in-person attendance). \nThe agenda will include discussions on adult immunization schedule\, child/adolescent immunization schedule\, Ebola vaccine\, hepatitis vaccines\, herpes zoster vaccines\, Orthopoxviruses vaccine\, influenza vaccines\, pneumococcal vaccine\, cholera vaccine and tickborne encephalitis vaccine. Recommendation votes on adult immunization schedule\, child/adolescent immunization schedule\, hepatitis vaccine\, herpes zoster vaccine\, Orthopoxviruses vaccine\, pneumococcal vaccine and Ebola vaccine are scheduled. No Vaccines for Children votes are scheduled. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda visit https://www.cdc.gov/​vaccines/​acip/​meetings/​meetings-info.html. \nPublic Participation\nInterested persons or organizations are invited to participate by submitting written views\, recommendations\, and data. Please note that comments received\, including attachments and other supporting materials\, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore\, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name\, contact information\, or other information that identifies you in the body of your comments\, that information will be on public display. CDC will review all submissions and may choose to redact\, or withhold\, submissions containing private or proprietary information such as Social Security numbers\, medical information\, inappropriate language\, or duplicate/near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket. \nWritten Public Comment: The docket will be opened to receive written comments on October 1\, 2021. Written comments must be received on or before October 21\, 2021. \nOral Public Comment: This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIP’s Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below. \nProcedure for Oral Public Comment: All persons interested in making an oral public comment at the October 20-21\, 2021 ACIP meeting must submit a request at http://www.cdc.gov/​vaccines/​acip/​meetings/​no later than 11:59 p.m.\, EDT\, October 18\, 2021\, according to the instructions provided. \nIf the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time\, CDC will conduct a lottery to determine the speakers for the scheduled public comment session. CDC staff will notify individuals regarding their request to speak by email by October 19\, 2021. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings\, each speaker will be limited to 3 minutes\, and each speaker may only speak once per meeting. \nThe Director\, Strategic Business Initiatives Unit\, Office of the Chief Operating Officer\, Centers for Disease Control and Prevention\, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities\, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. \nACIP consists of 15 experts who are voting members and are responsible for making vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members after an application and nomination process. Fourteen of these members have expertise in vaccinology\, immunology\, pediatrics\, internal medicine\, nursing\, family medicine\, virology\, public health\, infectious diseases\, or preventive medicine. One member is a consumer representative who provides perspectives on the social and community aspects of vaccination. \nAll of ACIP’s recommendations are posted online. Once they are reviewed and approved by the CDC Director and Department of Health and Human Services\, recommendations are published in the CDC’s MMWR. \nThe MMWR publication represents the official CDC recommendations for immunizations of the U.S. population.
URL:https://globalbiodefense.com/event/advisory-committee-on-immunization-practices-acip-meeting/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20211026
DTEND;VALUE=DATE:20211027
DTSTAMP:20211004T010523Z
CREATED:20211004T010523Z
LAST-MODIFIED:20211004T010523Z
UID:50037-1635206400-1635292799@globalbiodefense.com
SUMMARY:VRBPAC Meeting on Pfizer Data on Its COVID-19 Vaccine for Children 5-11
DESCRIPTION:The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request\, the FDA is scheduling an Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Oct. 26 to inform the agency’s decision-making. \nThe FDA intends to make background materials for both VRBPAC meetings available to the public\, including the meeting agendas and committee rosters\, no later than two business days before each meeting. \nThe FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page.
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-pfizer-data-on-its-covid-19-vaccine-for-children-5-11/
CATEGORIES:Government Hosted,Webinar-Webcast
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2021/10/fda-vrbpac-covid-vaccine-children-meeting-oct-2021.jpg
LOCATION:https://www.youtube.com/watch?v=laaL0_xKmmA
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