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Safety and efficacy of booster doses of BNT162b2 vaccine in immunocompromised patients with a cancer diagnosis

Balazs Halmos

Balazs Halmos

MD

Albert Einstein College of Medicine

Project Term: August 1, 2021 - July 31, 2022

It is now well-established that COVID-19 in patients with cancer carries a higher morbidity and mortality, especially in patients with hematologic malignancies (Kuderer et al, Lee et al). Effective vaccines have been developed and authorized by the FDA to combat this pandemic (Pfizer NEJM, Moderna NEJM, J&J NEJM). However, emerging data suggests that despite these vaccines inducing high levels of immunity in the general population, patients with hematologic malignancies have lower rates of seroconversion for the SARS-CoV-2 Spike antibody (Thakkar et al Cancer cell, Dimpy Shah cancer cell, Sheeba Irshad cancer cell). Evidence has also suggested that specific therapies, such as anti-CD20 antibodies, BTK-inhibitors and stem cell transplantation have an association with lower rates of seroconversion (Thakkar et al Cancer cell, Thakkar et al Nature cancer, Herishanu at al blood 2021). Novel immunization strategies such as booster dosing are urgently needed to protect this high-risk patient population. We propose a study to administer a third dose of the BNT162b2 mRNA vaccine to patients with cancer who have a negative SARS-CoV-2 Spike IgG at least 14 days after 2 doses of the BNT162b2 vaccine

Lay Abstract

Vaccinations against Covid-19 are highly effective preventing significant Covid-19 disease in the general population. Data including from our group suggests that similarly these vaccines can be very effective amongst patients with a cancer diagnosis with the exception of key subsets of patients, such as patients with blood cancers, in particular ones who had received highly immune suppressive prior therapies. Even in the general population it appears that with time immunity might slowly wane calling for consideration of additional “booster” doses- now authorized by the FDA. The current proposal aiming to recruit 250 patients addresses whether such a booster shot could achieve better immunity as measured by multiple tests assessing the levels of anti-Covid antibodies and immune cell activity and monitored over time in these key patient subsets as well as in the overall cancer population. This research should provide key information on the utility of further active immunization strategies as well as the need for ongoing protective measures for vulnerable patients with different cancer types, most specifically hematological malignancies.

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LLS Funded Initiative
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