Ministry of Health approved the first COVID-19 vaccine to be distributed in Vietnam

Following the Ministry of Health Advisory Committee’s recommendation on January 28 to approve AstraZeneca’s COVID-19 vaccine, the vaccine on February 1 was officially been granted conditional authorisation for urgent needs in the prevention and control of the novel coronavirus in Vietnam, reported VOV.

At the Government meeting on January 29, Prof. Dr. Nguyen Thanh Long, Minister of Health, said this is the first COVID-19 vaccine licensed by the Ministry of Health to be distributed in Vietnam. AstraZeneca and Vietnam Vaccine JSC (VNVC) are partnering to deliver 30 million doses of AstraZeneca’s COVID-19 vaccine to Vietnam, starting from the first half of 2021. This approval and vaccine supply agreement mark another important milestone in Vietnam’s fight against the pandemic.

The approval decision was based on a rolling submission which included results of an interim analysis of the Phase III programme conducted by the University of Oxford and published in The Lancet on December 8, 2020.

Vietnam’s conditional authorisation is for the two-dose standard regimen of COVID-19 Vaccine AstraZeneca for people aged 18 years and older, which was shown in the clinical trials to be well tolerated and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.

The vaccine so far has been granted conditional marketing authorisation or emergency use approval in the EU, the UK and across markets spanning four continents. COVID-19 Vaccine AstraZeneca is stored, transported and handled at normal refrigerated conditions (two to eight degrees Celsius) for at least six months, meaning that it can be distributed and administered within existing healthcare settings.

In addition to the University of Oxford-led programme, AstraZeneca is conducting a large study in the US as part of a global programme.

In total, the University of Oxford and AstraZeneca expect to enrol more than 60,000 participants worldwide. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

“We are grateful for the Vietnamese Government and Ministry of Health’s decisive leadership in this fight against the pandemic, said Nitin Kapoor, Chairman cum General Director of AstraZeneca Vietnam. "Patient safety of the vaccine is of the utmost importance to AstraZeneca and it is great news that it meets the stringent requirements established by the Ministry."

"We are proud to partner with VNVC, with their extensive network and outstanding capabilities in Vietnam, to deliver our vaccine to millions of people across the country in the safest and fastest way possible. We will continue to provide broad and equitable access to our vaccine so that we can quickly combat the pandemic and accelerate economic recovery”.

Ngo Chi Dung, Chairman cum General Director of VNVC, shared the view that "We appreciate the Government and the Ministry of Health’s timely support and guidance to settle this agreement, so that the health and lives of Vietnamese people will soon be protected against the pandemic and the economy can soon recover”.

According to Dung, VNVC has fully prepared the best facilities and capacity to store large amounts of vaccines and inoculate millions of people. Nationwide, these include 50 vaccination centres; more than 50 GSP-compliant vaccine warehouses; distribution systems; 5,000 professional doctors, nurses, and staff; and a safe vaccination procedure.

Following the regulations and guidelines of the Vietnamese Government and Ministry of Health, VNVC will soon announce further details about this immunisation action plan. It is expected that the price of COVID-19 Vaccine AstraZeneca in Vietnam will be affordable to give opportunities to more people.

Around the world, AstraZeneca is partnering with the University of Oxford, governments, leading health organisations such as WHO, CEPI and Gavi (the Vaccines Alliance) and manufacturers to provide the vaccine to as many countries as possible.

In December 2020, AstraZeneca concluded an Advance Purchase Agreement with Gavi to supply 170 million doses of COVID-19 Vaccine AstraZeneca to the COVAX Facility, of which Vietnam is a participant, to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries./.

BTA