Health Minister Akmaral Alnazarova has stated that Kazakhstan no longer considers the international registration of the domestic QazVac vaccine with the World Health Organization (WHO) to be expedient. The organisation put forward additional requirements for the procedure in 2023–2024; however, according to the minister, the issue has now lost its relevance.
WHY KAZAKHSTAN ABANDONED REGISTRATION
The minister explained that, despite Kazakhstan achieving the third level of maturity of its medicines regulatory system, this does not mean automatic approval of individual products by the WHO.
In April 2026, the organisation assigned Kazakhstan maturity level 3 (ML3) for its national regulatory system for medicines and imported vaccines. According to the WHO's assessment, this status confirms the existence of a functioning system that enables the national regulator to independently assess the quality, safety and efficacy of medical products.
HOW THE VACCINE WAS CREATED
The history of the product's development began in March 2020, when Kazakh specialists isolated the SARS-CoV-2 coronavirus from clinical samples taken from infected patients. In May 2020, scientists at the Research Institute for Biological Safety Problems developed the QazCovid-in vaccine, which later received the trade name QazVac.
In September 2020, the first phase of clinical trials began with the participation of 44 volunteers. In December, the Ministry of Health authorised the third phase of trials with the participation of 3,000 volunteers.
In January 2021, the vaccine received temporary state registration in Kazakhstan for a period of nine months. In February 2021, the registration certificate was renewed, extending its validity to 18 months.
On 22 April 2021, the first batch of QazVac was shipped. 50,000 doses were sent to the regions, and mass vaccination of Kazakhstanis began on 26 April.
CONTEXT
The ministry is now focused on developing laboratory infrastructure. Kazakhstan plans to build a laboratory complex to achieve the fourth, highest level of WHO maturity. Construction is intended to begin in 2027. The complex is to provide expert assessment of vaccines produced domestically and those arriving from abroad.
In addition, in September 2026, a modern virology laboratory opened in Turkestan, created with the support of the Pandemic Fund. The facility is intended for conducting diagnostic research and strengthening epidemiological surveillance.
