Copyright

(c) 2021 Jon L Gelman, All Rights Reserved.

Pandemic Preparedness Experts

Pandemic Preparedness Experts
COVID Safe Workplaces

Monday, December 7, 2020

Trust Through Transparency

A significant concern of employees, employers, and insurance companies is whether or not the new COVID-19 vaccines are safe to take. Vaccine efficacy is going to have a significant impact on the decision-making process.

The risk-benefit analysis has far-reaching consequences. While shielding employees from the Sars-Cov-2 (coronavirus) virus is critical to preventing the disease, it also balances against the risks involved for adverse events. 

On December 10, 2020, the Center for Biologics Evaluation and Research's (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

Meeting Materials
FDA intends to make background material available to the public no later than two business days before the meeting. Suppose FDA is unable to post the background material on its website before the meeting. In that case, any background material will be made publicly available at the advisory committee meeting, and additional materials will be posted on the FDA's website after the meeting.

Materials for this meeting will be available on the Vaccines and Related Biological Products Advisory Committee meetings main page.

The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2020-N-1898. The docket will close on December 9, 2020. Submit either electronic or written comments on this public meeting by December 9, 2020. Please note that late and untimely filed comments will not be considered.  Electronic comments must be submitted on or before December 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 9, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked, or the delivery service acceptance receipt is on or before that date.

Comments received on or before December 4, 2020, will be provided to the committee. Comments received after December 4, 2020, and by December 9, 2020, will be taken into consideration by the FDA. If the meeting is canceled, FDA will continue to evaluate any relevant applications, submissions, or information and consider any comments submitted to the docket, as appropriate.

You may submit comments as follows:

Electronic Submissions
Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov.  Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").

Written/Paper Submissions
Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions):  Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."

Instructions: All submissions received must include Docket No. FDA-2020-N-1898 for "Vaccines and Related Biological Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments." Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

  • Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies in total. 
  • One copy will include the information you claim to be confidential with a heading or cover note that states, "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 
  • If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments, and you must identify the information as "confidential." 
  • Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about the FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

On December 10, 2020, oral presentations from the public will be scheduled between approximately 12:00 p.m. and 1:00 p.m. EST.


Webcast Information
CBER plans to provide a free of charge, a live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

Everyone is encouraged to attend the hearing and read the material. Trust through transparency is essential.  


The online web conference meeting will be available at the following: 
https://youtu.be/owveMJBTc2I
https://twitter.com/US_FDA (Supported in Chrome browser)
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d.


Related Articles


Survivors of COVID-19 appear to be at increased risk of psychiatric sequelae 11/28/20


CDC Likely to Allocate COVID-19 Vaccine to Essential Workers Ahead of Seniors 11/25/20


ACLU Files Lawsuit Against Meatpacking Plant for Treacherous COVID-19 Conditions 11/24/20


Strategies to Prevent COVID Clusters and Spreaders 11/13/20


The Biden Plan to Strengthen Safety in the Workplace Anticipated 11/17/20


NJ Tightens COVID-19 Pandemic Restrictions 11/10/20


Halting Workplace COVID-19 Transmission: An Urgent Proposal to Protect American Workers 11/8/20


NJ Announces COVID-19 Worker Protection Complaint Form 11/6/20


NJ Takes Action to Put Workers’ Health Ahead of Covid 10/29/20


Nursing Homes Unprepared for the Winter  Coronavirus Surge 10/28/20


Is the workers' compensation system ready for the 2019-nCoV [coronavirus] virus? Live Updates

….


Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thomson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thomson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  has been representing injured workers and their families who have suffered occupational accidents and illnesses.

Blog: Workers ' Compensation

Twitter: jongelman

LinkedIn: JonGelman

LinkedIn Group: Injured Workers Law & Advocacy Group

Author: "Workers' Compensation Law" West-Thomson-Reuters