Safety Comparison of Two Enterovirus 71 (EV71) Inactivated Vaccines in Yiwu, China

Area of Science:

• Vaccinology
• Public Health
• Pediatrics

Background:

• Enterovirus 71 (EV71) poses a significant public health threat, particularly to young children.
• The development and post-marketing surveillance of effective EV71 vaccines are crucial for disease prevention.
• Understanding the safety of different EV71 vaccine formulations is essential for widespread adoption.

Purpose of the Study:

• To evaluate and compare the safety of two post-marketing enterovirus 71 (EV71) vaccines in a Chinese population.
• To identify any significant differences in adverse event profiles between the two vaccine groups.
• To assess the safety of EV71 vaccination across different age strata.

Main Methods:

• A randomized controlled study involving 14 vaccination clinics.
• Children received a two-dose vaccination schedule (0 and 28 days) with either the Sinovac or CAMS EV71 vaccine.
• Participants were monitored for adverse events at 30 minutes post-vaccination, and via phone or on-site follow-up at days 3 and 30.

Main Results:

• No severe EV71-associated adverse events were reported in either vaccine group.
• No significant difference in overall adverse events was observed between the Sinovac and CAMS vaccine groups (p=0.556).
• A higher proportion of adverse events was noted in the CAMS group compared to the Sinovac group among children aged 24-35 months (5.3% vs. 2.5%, p<0.001).

Conclusions:

• Both EV71 vaccines evaluated demonstrated satisfactory safety profiles.
• Adverse events following vaccination were generally normal and acceptable.
• While overall safety was comparable, specific age groups may exhibit slightly different adverse event proportions, warranting continued surveillance.