Candidate Vaccine Manufacturing Contamination Adverse Events Signatures

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Abstract
Serious adverse events (SAEs) develop following coronavirus disease 2019 (COVID-19) immunization in some vaccine recipients. Adverse events (AEs) after immunization are represented by a combination of background AEs and possibly vaccine-associated AEs. When vaccine-associated events occur, they are related to one or more vaccine components, adjuvants, excipients, potentially manufacturing contaminants, or a combination of these constituents. In a retrospective study of Vaccine Adverse Event Reporting System (VAERS) menstrual AEs following immunization, statistically significant differences were observed for multiple manufacturing lots of the COVID-19 Pfizer-BioNTech and the COVID-19 Moderna vaccines. Manufacturing contaminants are likely causative candidates consistent with the observed data for menstrual AEs. Other manufacturing contaminants associated AEs may be detectable by contrasting the normalized frequency rates between predicted higher contamination lots or vaccines compared to lower contamination lots or vaccines. This retrospective study identified candidate pattern signatures for the most frequently reported AEs to VAERS for identified COVID-19 vaccine lots associated with these menstrual AEs and differences in AE frequencies between three human papillomavirus (HPV) vaccines. Six candidate pattern signatures were identified: hemorrhage (female), gynecologic including hemorrhage pattern, myopericarditis (male-biased), HPV vaccine-associated, neuropathy, and fetus patterns. The hemorrhage pattern was identified in six vaccines, including four influenza vaccines. The gynecologic pattern was identified in seven vaccines, including three COVID-19 and three HPV vaccines. And the myopericarditis pattern was identified in 14 vaccines, including five COVID-19 vaccines with two bivalent COVID-19 vaccines, and three smallpox vaccines. The four MCHPV AEs are elevated primarily in HPV vaccines. One or more of the five MCneuropathy AEs were elevated in 11 vaccines. One or more of the MCfetus AEs were elevated in 11 vaccines. For the identified safety signals for vaccines with more SAE and AE reports in VAERS, the observed differences in normalized frequencies of SAEs and AEs between lots for the same vaccine and comparisons between related vaccines are consistent with predicted differences in manufacturing contamination levels.

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