Important Citizen Petition to FDA, signed by prominent academics calls for immediate update of COV19 vac’s labels. No proof re efficacy against infection & transmission, serious AEs like CA, impact on fertility & holding back data re impact on pregnancy. https://t.co/N9S4aJBhNg pic.twitter.com/CkZ9FtQOrr
— Retsef Levi (@RetsefL) February 3, 2023
To request that the Commissioner of Food and Drugs (the “Commissioner”) require that the sponsors of Comirnaty, Spikevax, Pfizer-BioNTech COVID-19 Vaccine, and Moderna COVID-19 Vaccine (collectively, “Pfizer and Moderna COVID-19 vaccines”) amend current product labeling.
Incomplete, inaccurate, or misleading labeling of any medical product can negatively impact the health and safety of Americans, with global ramifications considering the international importance of FDA decisions. For these reasons, and due to the compelling need to ensure the safety and efficacy of any COVID-19 vaccine licensed by the FDA and to allow Petitioner the opportunity to seek emergency judicial relief should the instant Petition be denied, it is respectfully requested that FDA act on the instant Petition by April 30, 2023.
I. ACTIONS REQUESTED
Petitioner requests that the FDA amend current labelingi of Pfizer and Moderna COVID-19 vaccines (for all authorized or approved indications and populations) in the following ways:
1. Add language clarifying that phase III trials were not designed to determine and failed to provide substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death.
2. Add language clarifying that the immunobridging surrogate endpoint used in multiple authorized indications has not been validated to predict clinical efficacy.
3. Add safety and efficacy results data from manufacturer randomized trials of current bivalent boosters that reported results after EUA was granted.
4. Add a clear statement that FDA authorized a new Pfizer vaccine formulation containing Tris buffer without requiring clinical studies to evaluate efficacy, safety or bioequivalence to the formulation containing phosphate buffer.
5. 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.
6. Add a clear statement that Pfizer vaccine efficacy wanes after 2 months following dose 2 according to the Pfizer phase III randomized trial.
7. The following adverse event types should be added to the Adverse Reactions section of labeling:
a. multisystem inflammatory syndrome (MIS) in children;
b. pulmonary embolism;
c. sudden cardiac death;
d. neuropathic and autonomic disorders.
8. The following reproductive health and lactation related adverse event types should be added to the Adverse Reactions section of labeling:
a. decreased sperm concentration;
b. heavy menstrual bleeding;
c. detection of vaccine mRNA in breastmilk.
9. Add frequency data for clinical and subclinical myocarditis.
10. Labeling should present trial results on serious adverse events in tables with statistics, as is done for non-serious adverse events.
Petitioner also requests the FDA create a Medication Guide and communicate these labeling changes via a Dear Health Care Provider (DHCP) letter.
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