Home Kinh doanh COVID-19 vaccine AstraZeneca conditionally authorised for emergency use in Vietnam

COVID-19 vaccine AstraZeneca conditionally authorised for emergency use in Vietnam

Following the recommendations of the Advisory Committee under the Ministry of Health on January 28 to approve AstraZeneca’s COVID-19 vaccine, the vaccine was granted conditional authorisation on February 1 to help address the urgent need for the prevention and control of COVID-19 in Vietnam.
covid 19 vaccine astrazeneca conditionally authorised for emergency use in vietnam
AstraZeneca and Vietnam Vaccine JSC (VNVC) are partnering up to distribute about 30 million doses of AstraZeneca’s COVID-19 vaccine to Vietnam

At the government meeting on January 29, Nguyen Thanh Long, Minister of Health, said this is the first COVID-19 vaccine licensed by the Ministry of Health (MoH) to be distributed in Vietnam.

AstraZeneca and Vietnam Vaccine JSC (VNVC) are partnering up to distribute about 30 million doses of the former’s COVID-19 vaccine in Vietnam, 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 Phase III of the programme conducted by the University of Oxford and published in The Lancet on last December 8. 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 can be stored, transported, and handled at normal refrigerated conditions (2-8 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.

Nitin Kapoor, chairman cum general director of AstraZeneca Vietnam, said, “We are grateful for the Vietnamese government and MoH’s decisive leadership in this fight against the pandemic. 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, said, “This is a historic partnership for VNVC and for Vietnam. Under this agreement, Vietnamese people will be able to access one of the world’s best quality and safest COVID-19 vaccines, on par with advanced countries. We appreciate the government and the MoH’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 the MoH, 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 ensure access to more people.

Across the world, AstraZeneca is partnering with the University of Oxford, governments, leading health organisations such as the World Health Organization, CEPI, the Vaccines Alliance (Gavi), 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.

COVID-19 Vaccine AstraZeneca was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

Vietnam’s recommendation was based on an analysis of 23,745 participants aged 18 years and older, accruing 232 symptomatic COVID-19 infections from the UK and Brazil Phase III trials conducted by Oxford University.

The safety data published so far is from over 20,000 participants enrolled across four clinical trials in the UK, Brazil, and South Africa. The publication in The Lancet confirmed that COVID-19 Vaccine AstraZeneca was well tolerated and that there were no serious safety events confirmed related to the vaccine. The participants were from diverse ethnic and geographic groups who were healthy or had stable underlying medical conditions.

In addition to the programme led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally. COVID-19 Vaccine AstraZeneca has already been granted a CMA or emergency use approval in 20 countries, spanning four continents including a number of Latin American countries, India, Morocco, and the UK.

 

By AstraZeneca

Nguồn: Vietnam Investment Review

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