No proposal to license Nanocovax vaccine yet
The Advisory Council for Licensing of Drugs and Pharmaceutical Ingredients, Ministry of Health, met on August 29 and requested that businesses continue to supplement the dossier of Covid-19 Nanocovax vaccine.
The press release from the Advisory Council for granting registration certificates for drugs and pharmaceutical ingredients, Ministry of Health (referred to as the Advisory Council) on the evening of August 29 said as above.
Accordingly, the Advisory Council has thoroughly and repeatedly assessed the Nanocovax vaccine dossier, based on legal, quality, pharmacological, clinical records and conclusions of the National Council of Ethics in Biomedical Research (Ethics Council).
After the meeting, the Advisory Council noted the results achieved for the application for a registration certificate for the circulation of the Nanocovax vaccine. Advisory CouncilSuggest businesses continue to add:Quality profile; Clinical and pharmacological profile that provides safety information for all individuals who have received at least one dose of vaccine to date and explains the serious adverse events (SAEs).
The Nanocovax vaccine dossier also needs to supplement immunogenicity, update immunogenicity assessment data on new variants, for example Delta and Alpha strains; the immunogenicity assessment sample size needs to be carried out in accordance with the approved research protocol.
Regarding the immunogenicity of the vaccine, the company needs to coordinate with the research team to analyze and discuss the relationship between the immunogenicity of the vaccine, the minimum protective efficacy of 50% according to the guidelines of the World Health Organization (WHO) and medical literature data.
The Advisory Council requested Nanogen Company to urgently supplement and update the above contents. After that, the company must report to the Ethics Council and the Advisory Council to continue reviewing and evaluating the research results in order to grant emergency permission.
According to the procedure, after approving the dossier, the Advisory Council will propose that the Ministry of Health grant an emergency license for the vaccine. Thus, after today's meeting, the Advisory Council requested that the enterprise supplement the dossier, meaning that it has not yet proceeded to the step of proposing a license for Nanocovax.
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| Nanogen employees hold Nanocovax samples at a laboratory in District 9, Ho Chi Minh City. Photo: Quynh Tran. |
Nanocovax isCovid-19 vaccineResearched and developed by Nanogen Company, a two-dose regimen given 28 days apart. To speed up the progress of clinical trials of the vaccine amid the pandemic, the Ministry of Health has allowed the use of mid-term results of clinical trials for evaluation, then halting the trial.
The clinical trial of the Nanocovax vaccine consists of three phases. Phase 1 studies 60 volunteers aged 18 to 50, including three dose levels of 25 mcg; 50 mcg and 75 mcg, each dose level has 20 participants, lasting from December 2020 to July 2021, with the aim of evaluating the safety and exploring the immunogenicity of the vaccine on volunteers.
Phase 2 research on 560 volunteers aged 18 and over, including 4 groups: 80 people injected with placebo; 3 groups injected with vaccine with 3 dose levels of 25 mcg; 50 mcg and 75 mcg, each dose level 160 people). As soon as the mid-term evaluation results of phase 1 were available, the Ministry of Health approved the research outline for phase 2 clinical trials, the research period from February 2021 to February 2022, with the goal of evaluating the safety and immunogenicity of the vaccine to select the optimal dose to use in phase 3 clinical trials.
As soon as the results of the mid-term evaluation of phase 2 were available, the Ministry of Health approved the research protocol for phase 3 clinical trials, with the research period from June 2021 to February 2023, with the main goal of evaluating the safety and immunogenicity of the vaccine.
In this phase, the research team tested a dose of 25 mcg on 13,000 volunteers aged 18 and over, divided into phase 3a and phase 3b, with the aim of evaluating the safety, immunogenicity and protective efficacy of the Nanocovax candidate. Phase 3a has 1,000 people, the vaccine/placebo group ratio is 6:1. Phase 3b has 12,000 people, the vaccine/placebo group ratio is 2:1, the study period is from July 2021 to February 2023, with the main goal of evaluating the safety and protective efficacy of the vaccine.
Nanocovax is in phase 3b testing. Phase 3a is evaluating immunogenicity on day 42 after the first dose, expected to be completed by September 10.
On August 7, the Ethics Council held an emergency meeting to review the results of the Phase 1 trial and evaluate the mid-term results of the Phase 2 trial. On August 25, the Ethics Council continued to approve the mid-term report of Phase 3a, using the results of clinical trials up to the time of the mid-term evaluation of Phase 3a results, and sent it to the Standing Advisory Council for consideration of emergency authorization.
