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URGENT: FDA Opens Comments for COVID-19 Jab for Babies and Toddlers Ahead of Vaccine Advisory Committee Meeting


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The Food and Drug Administration’s ‘Vaccines and Related Biological Products Advisory Committee’ will meet on June 14th and 15th to review the COVID-19 shot for children between the ages of six months and five years.

The agency has opened the site for comments.

Comments received on or before June 7th will be provided to the committee.

Comments received after June 7th and by June 13th will be taken into consideration by the FDA.

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At the time of writing, the site has 5,119 comments.

You can write a comment to the FDA HERE.

regulations.gov explained where to access the online web conference:

Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. The online web conference meeting will be available at the following separate links on the respective days of the meeting:

Day 1: https://youtu.be/GbNpaZeDPiA

Day 2: https://youtu.be/Ixm4UmldTGQ

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2022-N-0904. The docket will close on June 13, 2022. Submit either electronic or written comments on this public meeting by June 13, 2022. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 13, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. ET at the end of June 13, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Comments received on or before June 7, 2022, will be provided to the committee. Comments received after June 7, 2022, and by June 13, 2022, will be taken into consideration by 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 the Docket No. FDA-2022-N-0904 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.



 

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