Nano Covax vaccine. (Photo: VNA) Hanoi (VNA) - The National Ethics Committee in Biomedical Research underthe Ministry of Health on September 19 issued a press statement on itsconclusions of a meeting one day earlier during which it looked into the mid-term phase 3 trial’sresults of homegrown COVID-19 vaccine Nano Covax.
Thedata available for review is from the developers – Nanogen PharmaceuticalBiotechnology JSC in Ho Chi Minh City with the support in administration andmedical monitoring from the Military Medical University in Hanoi – up untilSeptember 2 this year, as the final phase of clinical trials is ongoing for therecombinant DNA vaccine.
Regardingthe vaccine safety, Nano Covax is deemed to be safe in the short termbased on reports of phase 3 trials (during the monitoring of the volunteers’health seven days after administration of the first dose for 11,430 volunteers,seven days after the administration of second doses for 5,785 volunteers).
Regardingimmunogenicity, Nano Covax is deemed to be able to elicit immune responses,based on ongoing phase 3 results – anti-SARS-CoV-2 IgG test results on 924samples 42 days after first jab; results of neutralising antibodies tests on761 samples 42 days after first jab; plaque-reduction neutralisation test 42days after the first jab on 107 samples with the first detected strain ofcoronavirus, 41 samples with Delta variant, 39 samples with Alpha variant.
Thecouncil’s statement stressed that to date they haven’t had the data to“directly" evaluate the protective efficacy, or the ability of a vaccineto prevent infection or symptomatic infections (based on of the number ofpeople infected with COVID-19 after getting the shots), and said more study isneeded for assessment of this "most important criteria to determine thevaccine's quality."
Thecurrently available estimation of Nano Covax’s protective efficacy extrapolatedfrom its immunogenicity, or the level of antibodies in the vaccinated, however,has “enough scientific grounds” for the council to send the vaccine documentsto the Advisory Council for the Registration of Circulation of Drugs andMedicinal Ingredients for reviews.
Regardingthe proposal to grant Nano Covax conditional approval for emergency use,the ethics committee said they reached ‘consensus’ in the use of mid-termphase 3 trials for the drugs advisory body to deliberate.
Butit asked the vaccine candidate’s developers to supplement their reports as perthe conclusions of the meeting and continue with the trials of the vaccinebased on the approved outline to complete trials in March 2022, and give timelyupdates to the relevant committees and health authorities.
Expertsfrom the Advisory Council for the Registration of Circulation of Drugs andMedicinal Ingredients, who will take up the case and make decisions on whetherto give the emergency approval for the vaccine to be used in Vietnam, were alsopresent at the meeting, the press statement reads.
Currently,13,000 volunteers in phase 3 trials of Nano Covax – which started on Julyand is set to wrap up by 2022 February – have been given the second shotsof the vaccine with dosage set at 25mcg.
Underthe latest guidelines from the health ministry, domestically developed COVID-19vaccines could be authorised for emergency use if they prove to be safe andeffective in mid-term phase 3 findings, with further monitoring required evenafter obtaining such approval./.
Thedata available for review is from the developers – Nanogen PharmaceuticalBiotechnology JSC in Ho Chi Minh City with the support in administration andmedical monitoring from the Military Medical University in Hanoi – up untilSeptember 2 this year, as the final phase of clinical trials is ongoing for therecombinant DNA vaccine.
Regardingthe vaccine safety, Nano Covax is deemed to be safe in the short termbased on reports of phase 3 trials (during the monitoring of the volunteers’health seven days after administration of the first dose for 11,430 volunteers,seven days after the administration of second doses for 5,785 volunteers).
Regardingimmunogenicity, Nano Covax is deemed to be able to elicit immune responses,based on ongoing phase 3 results – anti-SARS-CoV-2 IgG test results on 924samples 42 days after first jab; results of neutralising antibodies tests on761 samples 42 days after first jab; plaque-reduction neutralisation test 42days after the first jab on 107 samples with the first detected strain ofcoronavirus, 41 samples with Delta variant, 39 samples with Alpha variant.
Thecouncil’s statement stressed that to date they haven’t had the data to“directly" evaluate the protective efficacy, or the ability of a vaccineto prevent infection or symptomatic infections (based on of the number ofpeople infected with COVID-19 after getting the shots), and said more study isneeded for assessment of this "most important criteria to determine thevaccine's quality."
Thecurrently available estimation of Nano Covax’s protective efficacy extrapolatedfrom its immunogenicity, or the level of antibodies in the vaccinated, however,has “enough scientific grounds” for the council to send the vaccine documentsto the Advisory Council for the Registration of Circulation of Drugs andMedicinal Ingredients for reviews.
Regardingthe proposal to grant Nano Covax conditional approval for emergency use,the ethics committee said they reached ‘consensus’ in the use of mid-termphase 3 trials for the drugs advisory body to deliberate.
Butit asked the vaccine candidate’s developers to supplement their reports as perthe conclusions of the meeting and continue with the trials of the vaccinebased on the approved outline to complete trials in March 2022, and give timelyupdates to the relevant committees and health authorities.
Expertsfrom the Advisory Council for the Registration of Circulation of Drugs andMedicinal Ingredients, who will take up the case and make decisions on whetherto give the emergency approval for the vaccine to be used in Vietnam, were alsopresent at the meeting, the press statement reads.
Currently,13,000 volunteers in phase 3 trials of Nano Covax – which started on Julyand is set to wrap up by 2022 February – have been given the second shotsof the vaccine with dosage set at 25mcg.
Underthe latest guidelines from the health ministry, domestically developed COVID-19vaccines could be authorised for emergency use if they prove to be safe andeffective in mid-term phase 3 findings, with further monitoring required evenafter obtaining such approval./.
VNA
