Interim results of the safety and immune-efficacy of 1 versus 2 doses of COVID-19 vaccine BNT162b2 for cancer patients in the context of the UK vaccine priority guidelines
Adam G. Laing,
Duncan R. McKenzie,
Irene del Molino del Barrio,
Clara Domingo Vila,
Thomas S. Hayday,
Isaac Francos Quijorna,
Maria Conde Poole,
Michael H Malim,
Francesca Di Rosa,
Adrian Adrian C. Hayday,
Posted 17 Mar 2021
medRxiv DOI: 10.1101/2021.03.17.21253131
Posted 17 Mar 2021
Background: The efficacy and safety profile of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have not been definitively established in immunocompromised patient populations. Patients with a known cancer diagnosis were hitherto excluded from trials of the vaccines currently in clinical use. Methods: This study presents data on the safety and immune efficacy of the BNT162b.2 (Pfizer-BioNTech) vaccine in 54 healthy controls and 151 mostly elderly patients with solid and haematological malignancies, respectively, and compares results for patients who were boosted with BNT162b.2 at 3 weeks versus those who were not. Immune efficacy was measured as antibody seroconversion, T cell responses, and neutralisation of SARS-CoV-2 Wuhan strain and of a variant of concern (VOC) (B1.1.7). We also collected safety data for the BNT162b2 vaccine up to 5 weeks following first dose. Findings: The vaccine was largely well tolerated. However, in contrast to its very high performance in healthy controls (>90% efficacious), immune efficacy of a single inoculum in solid cancer patients was strikingly low (below 40%) and very low in haematological cancer patients (below 15%). Of note, efficacy in solid cancer patients was greatly and rapidly increased by boosting at 21-days (95% within 2 weeks of boost). Too few haematological cancer patients were boosted for clear conclusions to be drawn. Conclusions: Delayed boosting potentially leaves most solid and haematological cancer patients wholly or partially unprotected, with implications for their own health; their environment and the evolution of VOC strains. Prompt boosting of solid cancer patients quickly overcomes the poor efficacy of the primary inoculum in solid cancer patients.
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