Challenges in evaluating SARS-CoV-2 vaccines during the pandemic Abu-Raya, Bahaa; Gantt, Soren; Sadarangani, Manish
Key points: - Challenges to the evaluation of SARS-CoV-2 candidate vaccines prior to approval or licensure during the ongoing pandemic include rapidly changing levels of exposure to the virus and population immunity, social distancing practices, and the possibility of antibody-dependent enhancement of disease. - In order to measure vaccine efficacy accurately, researchers should account for these factors in sample size calculations and also carefully consider selection of trial endpoints. - SARS-CoV-2 vaccines must also be evaluated in populations known to be at increased risk for severe COVID-19, such as older adults, people of African descent, and people with multiple comorbidities. - Given the speed of SARS-CoV-2 vaccine development careful attention must be paid to post-licensure assessment of vaccines, including the risk of antibody dependent enhancement of disease, which must be actively monitored closely over multiple years after vaccination.
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