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Carol Taccetta, MD, Requests References from CBER Director to Support CDC’s “[Building] Evidence” That Experimental Bivalent COVID-19 Vaccines Are “Safe and Effective” During Pregnancy and “Not Associated with Fertility Problems”

July 18, 2023 • by Carol Taccetta, MD, FCAP

Introduction

 

Pfizer/BioNTech’s study, “To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older,” has a status of “completed” as of July 15, 2022. Results were just submitted to ClinicalTrials.gov on July 14, 2023, but are not yet posted. (https://clinicaltrials.gov/study/NCT04754594?tab=results)

 

On January 31, 2023, the Coalition Advocating for Adequately Labeled Medicine submitted a Citizen’s Petition to “Add a clear statement disclosing that a Pfizer phase III randomized trial in pregnant women (NCT04754594) was completed as of July 2022 but there have been no results reported.” On April 18, 2023, the FDA denied this request to amend the vaccine’s product labeling.(https://downloads.regulations.gov/FDA-2023-P-0360-0191/attachment_1.pdf)

 

 

The currently active or recruiting Pfizer and Moderna phase 2/3 studies below exclude pregnant and breastfeeding women.

 

In Moderna’s “Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters [includes the currently available bivalent mRNA-1273.222] for SARS-CoV-2 Variants”:

In BioNTech’s “AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BIVALENT BNT162b RNA-BASED VACCINE CANDIDATES [includes the currently available BNT162b2 Bivalent (WT/OMI BA.4/BA.5)] AS A BOOSTER DOSE IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALS”:

https://clinicaltrials.gov/study/NCT05472038

Dr. Carol Taccetta’s Letter to Dr. Peter Marks

July 8, 2023

Peter Marks, MD, PhD

Director, Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

10903 New Hampshire Avenue

WO71-7232

Silver Spring, MD 20993

Peter.Marks@fda.hhs.gov

Dear Dr. Marks,

I have a question, please: Are you able to provide references for the currently cited building “evidence” that the bivalent COVID-19 vaccines are “safe and effective” during pregnancy and “not associated with fertility problems”?

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html

• “The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the U.S.” (https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccines)
• “The FDA authorized the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.” (https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccines)
• Per a 2015 final rule, pregnancy categories A, B, C, D, and X have been removed from all drug product labeling. This information has been replaced by the “Risk Summary” section of the labeling. (https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-28241.pdf)
• Regarding pregnancy, the “Risk Summary” sections of the Moderna and Pfizer Fact Sheets, respectively, state:

(https://www.fda.gov/media/167208/download, https://www.fda.gov/media/167211/download)

• We know, per the respective Fact Sheets, that “data are not available” and “no data are available” regarding the use of the bivalent vaccine in pregnancy.
• Both the Moderna and Pfizer –BioNTech COVID-19 Vaccines (Bivalent (Original and Omicron BA.4/BA.5)), were first EUA-authorized on August 31, 2022. (https://www.fda.gov/media/144636/download, https://www.fda.gov/media/150386/download)
• But when I click on the hyperlink for “Evidence,” I’m taken to a webpage that only shows references from prior to the August 31, 2022 authorization date of the bivalent vaccines, i.e., the data is based solely on the older, now obsolete, monovalent vaccine: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html – anchor_1628692520287.

In light of this apparent disconnect, I would greatly appreciate your urgent response to my question at the top of this letter.

Sincerely,

Carol Taccetta, MD, FCAP

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 Food and Drug Administration (FDA).