Sputnik V COVID-19 vaccine liscenced for emegerncy use in Vietnam

Vietnam on March 23 gives emergency use authorization (EUA) for Russia’s Sputnik V vaccine, making it the second greenlighted COVID-19 vaccine in the country.

Jasmine Le

lehang1997hanu@gmail.com March 24, 2021 | 07:25

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Vials of Sputnik V vaccine (Photo: ABC)

As reported by Vietnamnet, Deputy Minister of Health Truong Quoc Cuong granted conditional approval for Sputnik V for urgent COVID-19 containment demands Tuesday afternoon.

The proposal was earlier made by the Center for Research and Production of Vaccines and Biologicals (Polyvac). Polyvac is in charge of coordinating with Generium JSC – Sputnik V’s manufacturer – to promptly respond to the Vietnam Ministry of Health (MOH)’s request, giving data, proactively updating information related to Sputnik V throughout the procedures in Vietnam.

The Drug Administration of Vietnam will issue the license to import Sputnik V once the importer's dossier is finished. Vaccine import management and quality control will be done in line with MOH’s protocols.

MOH also tasks the Department of Science, Technology and Training to conduct clinical assessments on the safety and immunogenicity of the vaccine.

Meanwhile, the National Institute of Vaccines and Medical Biologicals will be responsible for testing the vaccine ahead of vaccination.

MOH greenlighted Sputnik V based on its safety, quality and effectiveness data provided by Polyvac as of February 25.

To date, Vietnam has authorized two imported COVID-19 vaccines for emergency use. Earlier in January, UK’s AstraZeneca was licensed and is currently the sole vaccine used in the country’s vaccination campaign which kicked off on March 8.

A box of Sputnik V (Photo: Sputnik)

Sputnik V is the first COVID-19 vaccine to be approved around the world. The Russian Health Ministry rolled out the nationwide vaccination with Sputnik V on November 18, 2020 when the vaccine was still under stage 3 of clinical human trial. The vaccine has since been approved for use in over 50 countries.

Clinical trial results published on The Lancet journal shows Sputnik V is up to 91.6% effective. 98 percent of volunteers generate antibodies against nCoV after the second dose, which is 21 days apart the first one.

Last December, Belarus became the first nation in the world to approve Russia’s Sputnik V. In Europe, where the vaccination campaigns have fallen behind due to vaccine shortage, medical authorities are starting to license Sputnik V. The European Medicines Agency (EMA) on March 4 spoke highly of the vaccine. In southeast Asia, Sputnik V has been authorized in Laos and Myanmar.

Russian Security Council Secretary Nikolai Patrushev on March 16 has handed over a batch of Sputnik V vaccine to Vietnam on President Vladimir Putin’s decision.

As reported by VNE, Patrushev made the donation during his two-day visit to Hanoi for Russia-Vietnam security consultations on March 16-17.

The Sputnik V doses, which must be refrigerated at minus 18 degrees Celcius, have been transferred to a cold storage facility at the National Institute of Hygiene and Epidemiology for preservation, according to Dang Viet Hung, head of the International Cooperation Department under the Health Ministry.

One official from the Health Ministry who wants to stay anonymous said the batch contains 1,000 doses.

Last year, Deputy Health Minister Tran Van Thuan said Vietnam ordered to buy Sputnik V Covid-19 vaccine from Russia but he didn't reveal the specific figure, as reported by VNE.

The mass vaccination in Vietnam began on March 8, and so far nearly 16,000 medical staff and other frontline workers in 12 localities have received their first shot of the AstraZeneca vaccine developed by the British-Swedish company in collaboration with Oxford University.

Some of them suffered from anaphylaxis but returned to stable health soon after.

Sputnik V is expected to work by preparing the body to defend itself against infection with the SARS-CoV-2 virus. This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause COVID-19.

Sputnik V is made up of two different viruses belonging to the adenovirus family, Ad26 and Ad5. These adenoviruses have been modified to contain the gene for making the SARS-CoV-2 spike protein; they cannot reproduce in the body and do not cause disease. The two adenoviruses are given separately: Ad26 is used in the first dose and Ad5 is used in the second to boost the vaccine’s effect.

Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defenses − antibodies and T cells − against this protein.

If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the spike protein on the virus and be prepared to attack it: antibodies and T cells can work together to kill the virus, prevent its entry into the body’s cells and destroy infected cells, thus helping to protect against COVID-19, according to EMA.

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Jasmine Le