FDA Response To Doctor Raises New Questions

FDA Response To Doctor Raises New Questions

Due to my experience in the regulated industry of biotech/pharmaceuticals for over 25 years, I’ve felt obliged to point out apparent discrepancies between regulations and practice to the FDA over the past year and a half. Below is one of those letters to Dr. Peter Marks (CBER, FDA) questioning the absence of blood brain barrier and other clinical pharmacology data in the product labeling of covid-19 vaccines. In response (also below), the FDA’s Health Communications Specialist responded from the Office of Communication, Outreach and Development (which falls under CBER, which falls under Office of the Commissioner) with the following disclaimer at the bottom of the email: “This informal communication represents my best judgment at this time. It does not constitute an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent the formal position of FDA or otherwise obligate the agency to the views expressed.” ¹ 21 CFR 10.85 relates to requesting an advisory opinion from the Commissioner. ²

DailyClout published her first letter here.

1 https://www.fda.gov/about-fda/fda-organization-charts/fda-overview-organization-chart

2 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-10/subpart-B/section-10.85

Now Dr Taccetta has had a response from the FDA

Dear Dr. Taccetta:

Thank you for your recent letter to Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research regarding the use of lipid particles in the mRNA COVID vaccines. We appreciate your continued interest in this important topic and thank you for sharing your concerns with us.

As you may know, lipid particles enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARSCoV-2 S antigen.  Product developers must provide FDA data that includes a description of the manufacturing process, including analytical procedures, demonstrating that the product meets prescribed standards of identity, quality, safety, purity, and potency. This information ensures product quality and consistency. These procedures have been adequately qualified.

Following vaccination, after an immune response is triggered, the body breaks down the components of the vaccine and eliminates them in approximately 36 hours after vaccination.

FDA continues to maintain a strong focus on monitoring the safety of the COVID-19 vaccines – both approved, and available under Emergency Use Authorization (EUA). As part of this effort, the manufacturers submitted pharmacovigilance plans to FDA to monitor the safety of their vaccines.  The manufacturers also regularly provide safety updates to FDA on their safety monitoring results and any other relevant findings from their ongoing studies and international experience. The pharmacovigilance plan for each vaccine includes plans to continue and complete the large-scale clinical trials of safety and efficacy that were initiated prior to authorization, as well as other activities aimed at monitoring the safety of the vaccines, including both domestic and foreign active surveillance studies, pregnancy registries, and in-depth assessment of possible safety signals. Further information about COVID-19 vaccine safety surveillance can be found here.

Information on selected adverse events after COVID-19 vaccines are available here.  FDA and the Centers for Disease Control and Prevention (CDC) will continue to closely monitor reports of all adverse events and update the public as more information becomes available.

FDA and CDC have confidence that these vaccines are safe and effective in preventing COVID-19. The risk of serious health problems is much lower from the vaccine than the risk of being unvaccinated and being infected with the virus that causes COVID-19.

Thank you again for your interest in this topic, as well as the opportunity to provide this information to you.

Sincerely,

Jill Burkoff

Health Communications Specialist

Center for Biologics Evaluation and Research

Office of Communication, Outreach and Development

U.S. Food and Drug Administration

OCOD@fda.hhs.gov

This informal communication represents my best judgment at this time. It does not constitute an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent the formal position of FDA or otherwise obligate the agency to the views expressed.

In reply, Dr. Taccetta asks important questions:

Dear Dr. Marks and Ms. Burkoff,

Thank you for your response. May I ask two questions?

1)    As addressed in my prior letter, will the FDA be adding data regarding the presence of ‘vaccine’ components (such as mRNA/LNP) in the circulation and multiple organs to the Clinical Pharmacology section of the covid-19 mRNA ‘vaccines,’ per 21 CFR 201.80?

2)    Please provide the reference/data for your statement: “Following vaccination, after an immune response is triggered, the body breaks down the components of the vaccine and eliminates them in approximately 36 hours after vaccination.”

Below are references for human studies which demonstrate the presence of ‘vaccine’ components post-injection in lymph node germinal centers as long as eight weeks.¹

Sincerely,

Carol Taccetta, MD, FCAP

1 https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9

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Dr Taccetta is a U.S. licensed physician, board-certified in pathology, with a career in drug development spanning 25 years. Key agency interactions include Carol’s co- drafting of a chapter in the 1989 U.S. Surgeon General’s Report (CDC), as well as serving as Sponsor’s Responsible Medical Officer for a successful New Drug Application (NDA) to the FDA.

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