Another day, another story about a healthcare worker suffering a “severe allergic reaction” after receiving Pfizer’s COVID vaccine — this time, in New York. The report follows the news Children’s Health Defense (CHD) has been covering about similar severe reactions, first in the UK, then in Alaska and Illinois.
In light of these events, and because CHD previously warned the U.S. Food and Drug Administration (FDA) officials and Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases (NIAID), about the potential for the Pfizer and Moderna vaccines to cause anaphylactic reactions, we have some questions we’d like Fauci and the FDA to answer.
1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?
In January 2019, the U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research issued a document, “Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody (ADA) Detection: Guidance for Industry.”
The document, described as providing “recommendations to facilitate industry’s development and validation of essays for the assessment of the immunogenicity of therapeutic protein products during clinical trials,” clearly acknowledges the existence of anti-drug antibodies, such as polyethylene glycol (PEG), in humans. The document states:
- Immune responses to therapeutic protein products have the potential to affect product pharmacokinetics, pharmacodynamics, safety and efficacy.
- The clinical effects of immune responses in subjects are highly variable, ranging from no measurable effect to extremely harmful.
- Detection and analysis of ADA formation is a helpful tool in understanding potential immune responses.
- Information on immune responses observed during clinical trials, particularly the incidence of ADA induction or any implications of ADA responses affecting pharmacokinetics, pharmacodynamics, safet, or efficacy is crucial for any therapeutic protein product development program.
- Accordingly, such information, if applicable, should be included in the prescribing information as a subsection of the ADVERSE REACTIONS section entitled Immunogenicity.