Viet Nam approves India’s COVID-19 vaccine for emergency use

The Ministry of Health on Wednesday approved India's Covaxin vaccine for emergency use, the ninth to have been endorsed in the Southeast Asian country.

The ministry said in July that it was seeking to secure 15 million doses of the COVID-19 vaccine Covaxin.

To date, Viet Nam has approved nine COVID-19 vaccines for emergency use including AstraZeneca, Sputnik V, Janssen, Spikevax, Comirnaty, Vero Cell, Hayat-Vax, Abdala, and Covaxin.

In October, the World Health Organization (WHO) issued an emergency use listing (EUL) for Covaxin developed by Bharat Biotech, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.

Covaxin was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally.

Covaxin was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).

The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multi-dose vials of 5, 10 and 20 doses.

The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. Covaxin was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.