The National Committee for Ethics in Biomedical Research under the Ministry of Health (MoH) has agreed that the mid-term results from Nano Covax's phase 3 clinical trials will be submitted to the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients for considering the issuance of a registration certificate for the conditional circulation of the vaccine.
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Nano Covax vaccine likely to get a registration certificate for conditional circulation
In its statement issued on August 28, the National Committee for Ethics in Biomedical Research affirmed that the homegrown COVID-19 vaccine meets safety requirements.
The statement also mentioned the committee’s conclusion at its urgent meeting on August 22 to evaluate the mid-term result of Nano Covax's phase 3 clinical trials until August 18, stressing that the COVID-19 vaccine has immunogenicity on the tried cases.
The committee also requested additional results of the plaque reduction neutralization test (PRNT) of Coronavirus on Delta and Alpha variants to meet enough test results in accordance with the approved plan.
The committee proposed domestic vaccine developer Nanogen Pharmaceutical Biotechnology JSC and the research team to complete a report on updating and supplementing the clinical trial research results of Nano Covax and send it to the ethics committee and the advisory council for evaluation and approval.
“If Nano Covax vaccine is granted a registration certificate for circulation, it can only be used conditionally basing on the quantity and plan approved by the Ministry of Health," the statement said.
People administered with the vaccine must be closely monitored for safety similar to those joined the phase 3b clinical trials, it added.
The two agencies will specify conditions for continuing or stopping circulation when they collect enough data on the protective efficacy and safety of the vaccine, according to the statement.
According to the ethics committee, the MoH has created favorable conditions for domestic vaccine producers, including Nanogen, to research and develop COVID-19 vaccines.
Previously, the ethics committee convened to accept the result reports of clinical trials of the phases 3a, and assess the results of the phase 3b, of safety and immunogenicity of the vaccine developed by Nanogen.
Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced COVID-19 vaccine, followed by COVIVAC from the Institute of Vaccines and Biologic Medical and mRNA vaccine ARCT-154 (by Arcturus and VinBioCare) just starting phase 2 trials./.
VNA
