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    Poster

    Influence of Vaccine-Induced Anti-PEG Antibodies on In Vitro Measurement of Pegylated Drug Concentrations (P207)

    Monday, November 18, 2024
    5:00 PM – 6:30 PM CT
    The adoption of mRNA-based technology for vaccine creation has introduced new vaccine components, notably polyethylene glycol (PEG), to global populations. We investigated the presence of anti-PEG antibodies produced in response to mRNA-based vaccines in human serum and evaluated their impact on our ability to measure drug concentration in human serum as would be completed in the assessment of new and biosimilar pegylated drugs.
    We analyzed serum samples from individuals who received COVID-19 vaccines, as well as unvaccinated controls, for the presence of anti-PEG antibodies and their impact on the quantification of a pegylated drug product (pegfilgrastim). We detected increased anti-PEG antibody titers, persisting for extended periods, in individuals who received the mRNA-1273 vaccine compared to those who received the BNT162b2 and Ad26.COV2.S vaccines. Among recipients of the mRNA-1273 vaccine, anti-PEG antibody levels exhibited an approximate 15-fold increase post-vaccination compared to pre-vaccination levels in approximately 33% of individual donor samples. In some individuals, elevated anti-PEG antibody levels remained observable for six months. Serum from donors with elevated anti-PEG antibodies displayed reduced detection of the pegylated drug, pegfilgrastim, measuring up to a 50% reduction in multiple donor sera, using two distinct in vitro bioanalytical methods. This study underscores that anti-PEG antibodies generated by mRNA-based vaccines have the potential to impact bioanalytical assays during the development of pegylated pharmaceutical products.