New COVID-19 vaccine shows promising efficacy and safety in phase 3 trial

In a significant development in the fight against COVID-19, a phase 3 clinical trial in Iran has demonstrated that the BIV1-CovIran vaccine, administered in two 5 µg doses with a 28-day interval, demonstrated efficacy of 50.2% against symptomatic COVID-19, 70.5% against severe disease, and 83.1% against critical cases, with good tolerability.

The trial revealed that a two-dose regimen of the BIV1-CovIran vaccine showed an overall efficacy of 50.2% against symptomatic COVID-19, 70.5% against severe disease, and an impressive 83.1% against critical cases. Notably, no deaths were reported among the vaccine recipients, whereas there were two deaths in the placebo group. These results offer hope for curbing the spread and impact of COVID-19 in Iran and beyond.

Safety was a paramount concern, and the vaccine demonstrated a favorable safety profile. Adverse reactions, primarily mild or moderate, were reported in a majority of cases and were mostly self-limiting. There were no serious adverse events linked to the vaccine.

Additionally, the trial investigated the prevalence of SARS-CoV-2 variants and found that 89.1% of cases were positive for the delta variant, underscoring the importance of vaccines in combating emerging variants.

Reference: BMJ 2023;382:e070464