Prospects for a safe COVID-19 vaccine.

Area of Science:

• Immunology
• Vaccinology
• Infectious Diseases

Background:

• The COVID-19 pandemic necessitates rapid development of effective vaccines against SARS-CoV-2.
• Assessing vaccine safety, particularly the risk of immune enhancement of disease, is critical.

Purpose of the Study:

• To evaluate the potential risk of vaccine-associated enhanced disease (VAED) with COVID-19 vaccines.
• To review existing data on immune enhancement from viral infections and vaccines.
• To inform safety assessments for SARS-CoV-2 vaccine candidates.

Main Methods:

• Review of scientific literature on immune enhancement and viral diseases.
• Analysis of preclinical data and emerging information on COVID-19.
• Evaluation of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group research.

Main Results:

• Vaccine-associated enhanced disease is a rare phenomenon observed with some vaccines and viral infections.
• Preclinical models for SARS-CoV-2 may offer insights but do not fully predict human responses.
• No current data definitively prioritize COVID-19 vaccine candidates based on safety regarding immune enhancement.

Conclusions:

• Rigorous clinical trials are essential to detect potential enhanced disease in humans receiving COVID-19 vaccines.
• Post-licensure surveillance is a reliable strategy for identifying adverse events, including potential enhancement of COVID-19 severity.
• Current understanding does not allow for prioritizing vaccine candidates based on immune enhancement risk alone.