COVID-19 vaccines approved for use in Vietnam go through three clinical trial phases: ministry
All types of COVID-19 vaccine approved by Viet Nam for emergency use have gone through three stages of clinical trials, the Health Ministry has affirmed.
COVID-19 vaccine (Photo: VNA) |
As of June 23, Viet Nam has conditionally approved four vaccines against COVID-19, namely Comirnaty of Pfizer, A2D1222 of AstraZeneca, Sputnik-V of Gamalaya, and Vero-Cell of Sinopharm to serve urgent needs of pandemic prevention and control, the ministry said, adding that Moderna vaccine is also in the process of being approved.
Following international practice, all vaccines, before being put into emergency use in Viet Nam, must ensure three factors of safety, immunogenicity and most importantly, protection effectiveness.
All of the above-mentioned vaccines had to go through three phases of clinical trials, of which the third phase involved from 20,000 to 50,000 participants.
Specifically, the third phase of AstraZeneca's vaccine was carried out in 11 countries with 49,626 participants, Vero-Cell vaccine in six countries with over 45,000 participants, Sputnik-V in five countries with 21,977 participants, Pfizer's vaccine in six countries with 43,418 participants, and Moderna vaccine in four countries with 30,420 participants, according to the ministry.
In the context of COVID-19 breaking out worldwide, the urgent authorisation of a vaccine against the disease is necessary. However, this does not mean skipping the mandatory clinical trial stages, the ministry added.
Source: VNA