Why has the Ministry of Health not urgently approved the Nano Covax vaccine?

Why has the Ministry of Health not urgently approved the Nano Covax vaccine?  - Photo 1.

Nano Covax vaccine – Photo: Duyen PHAN

Answering at a press conference on clinical trials with Nano Covax vaccine, Deputy Minister of Health Tran Van Thuan said that inviting volunteers to participate in a voluntary spirit, for the cause of scientific research and development. vaccines of Vietnam with the desire to have vaccine autonomy.

“Currently the vaccine of Nanogen Company has not completed phase 3, but is in the middle of phase 3”, Mr. Thuan informed.

The Deputy Minister of Health said that on August 22, Nanogen Company combined with research institutes, Military Medical Academy, and Pasteur Institute in Ho Chi Minh City to submit documents after the completion of the phase 3a clinical trial. The Ethics Council, the Ministry of Health’s Licensing Advisory Council considers emergency licensing for the Nano Covax vaccine.

However, there are still some shortcomings that the License Advisory Council of the Ministry of Health recommends to solve.

“In terms of wishes, we hope to have a vaccine as soon as possible, but this is a special product that affects not only one person but the whole community and possibly many generations, so the policy of the Prime Minister, the Ministry of Health Economically, we must be quick but tight, safe and effective,” said Mr.

According to Mr. Thuan, based on the conclusions of the Licensing Advisory Council, there are still three contents that the company and research units need to supplement and update data: on the safety of all injected subjects, serious incidents and adverse events; on immunogenicity, supplementing and updating the assessment of immunogenicity on new strains on Delta and British strains in accordance with the published research protocol; on the protection, analyze and discuss the relationship between the immunogenicity of the vaccine and the protection, in order to achieve at least 50% of the WHO recommendations.

With the case of getting 2 doses of the experimental vaccine, Mr. Thuan said this is a matter for the Ministry of Health and the Government to discuss soon with relevant ministries and agencies, based on scientists’ opinions and internal opinions. … have suitable proposals in the near future.

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