Health

How does Vietnam’s Covid-19 vaccine look like – VnExpress


Of the three Covid-19 vaccines Vietnam is working on, Covivac has postponed the trial, ARCT-154 has not yet reported the third phase of the mid-term and Nanocovax continues to supplement the application for a license.

These are the three brightest “made in Vietnam” Covid vaccine candidates, all of whom have completed the second phase of research and conducted the next steps. However, over the past time, for many reasons, the progress of research on these vaccines has faced many difficulties, even had to be stopped.

Deputy Health Minister Tran Van Thuan in a meeting in mid-March proposed redirecting domestic vaccine research according to the goal of using for booster doses, on the basis of consulting experiences from other countries. Information from the Ministry of Health on March 17 said that the Drug Administration of Vietnam developed the criteria for licensing Vietnam’s Covid-19 vaccine in the direction of a repeat dose, completed before March 30.

This redirection of the Ministry of Health is said to “resolving difficulties” in the research process of internal vaccines. With Nanocovax, the Ministry of Health requires the research team and the manufacturer to provide reports on the protective effect, reduce severe cases and deaths as soon as possible, take responsibility for research data, and add booster noses to testers. experience. For the ARCT-154 vaccine, the trial recipient and the sponsor rushed to finalize the third phase midterm results report.

The hardships of the domestic Covid-19 vaccine

Vietnam has been researching and testing a Covid-19 vaccine since mid-2020. At that time, four units participated in the race, including Vabiotech Company, Polyvac Center, Ivac Institute (researching Covivac) and Nanogen Company (researching Nanocovax vaccine). . In August 2021, Vingroup received the technology transfer of ARCT-154 vaccine and tested it in the country. At that time, domestic research, technology transfer, and vaccine production played a very important role and was a major policy of the Party and State.

However, these units did not achieve the goals of the research roadmap set out. As of early 2022, no vaccine has been approved.

Volunteers injecting and testing the Nanocovax vaccine at Ben Luc District Medical Center, Long An. Photo: Quynh Tran

Nanocovax is the vaccine candidate with the fastest research speed. In June 2021, phase three clinical trials will begin on 14,000 people in Hanoi, Hung Yen, Long An, and Tien Giang. Six months later, the team found that the vaccine’s effectiveness remained at 52 percent after 180 days of injection at a dose of 25 mcg. Nanogen intends to bring the vaccine to market in 2021, with the goal of producing 10 million doses a month, increasing to 30 million doses a month by early 2022. In August 2021, Nanogen proposed to the Ministry of Health to issue an emergency license for the vaccine. Nanocovax. December, National Council on Ethics in Biomedical Research has twice approved the Nanocovax vaccine midterm clinical trial report, agreeing to use this data in its emergency authorization application.

An expert on pharmaceutical clinical trials (who did not want to be named) said that Nanocovax’s data is not scientifically convincing enough and weaker than data on vaccines from China, Russia, the US and Germany. .. The immunological data of this vaccine also needs to be evaluated by independent experts. This is believed to be the main reason why the Ministry of Health constantly requires Nanogen to supplement Nanocovax research records.

The Covivac vaccine has entered a phase two clinical trial. The research team’s mid-term report of the second phase of clinical study said that the vaccine produced neutralizing antibodies higher than the vaccine of AstraZeneca, was promising, met the requirements for safety and immunogenicity. Ivac plans to bring Covivac to market by the end of 2021 or early 2022, which can provide 6 million doses of vaccine a year. But Covivac has now stopped in the second phase of the study, postponing the third phase. A representative of the Covivac research team said that it was not possible to find enough volunteers who have not been vaccinated against Covid-19 to participate in the third phase of the study.

VinBioCare Company (belonging to Vingroup) is expected to complete the application for the ARCT-154 vaccine and send it to the Ministry of Health for an emergency license in December 2021, and ship the first batch of vaccines in early 2022. Vabiotech has stopped at preclinical research on vaccines.

Explained causes of research bottlenecks For domestic vaccines, experts say that progress is now slow compared to the epidemic situation and vaccine coverage in the country, making the emergency licensing of domestic vaccines no longer meaningful. Nearly 100% of people over 18 years old received two injections, many new strains of the virus appeared compared to the time the vaccine was studied.

In a report on the Covid-19 situation on March 25, the Ministry of Health said that the whole country had injected over 202 million doses of the Covid-19 vaccine. Therefore, if the domestic vaccine is completed, researched, developed and licensed, it is unlikely to be used in two basic injections. “The domestic vaccine manufacturers only have a chance in the booster shots, but it is very necessary for the Ministry of Health to guide and conduct clinical trials of the boosters,” the report stated.

A representative of the Covivac research team also said that they are considering a vaccine research plan in the direction of booster injection, but the mechanism for emergency licensing for the vaccine is not clear. Therefore, they decided to postpone the third phase clinical study of the vaccine.

Thus, the current race to research a Covid-19 vaccine is only left with ARCT-154 and Nanocovax. The ARCT-154 research team continues the third phase of the clinical trial, completing the report at the request of the Ministry of Health. A representative of the Nanocovax research team said that it is supplementing the dossier at the request of the Ministry of Health, still trying to get the vaccine to be licensed urgently, although this is no longer of much commercial significance.

In another move, Vabiotech Company received technology transfer of Sputnik V vaccine from Russia and began production from September 24, 2021, with a scale of 5 million doses a month. This is a vaccine that is not researched and developed by Vietnam but is produced domestically.

Chile

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