Military Medical Academy shares information on immunogenicity of Nanocovax vaccine (Vietnam vaccine approval process continues)

Major General, Associate Professor, Dr. Nguyen Viet Luong of the Military Medical Academy, Ministry of National Defence - the unit participating in the trial of home-grown COVID vaccine Nanocovax, has given more details addressing concerns about the vaccine’s immunogenicity in an interview with the Vietnam News Agency.

On August 29, after a meeting to consider the application for an emergency use licence for Nanocovax by Nanogen Biopharmaceuticals, the Advisory Council for Registration of Circulation of Drugs and Medicinal Ingredients acknowledged the results submitted and appraised by the Legal Subcommittee under the National Institute for Control of Vaccines and Biologicals, the Quality Subcommittee, and by the Pharmacology and Clinical Subcommittee. It also asked the company to urgently supplement and update a number of contents of the quality dossier: safety data on pharmacological and clinical records; immunogenicity in response to new virus strains; and size of samples for immunogenicity assessment according to the research plan; the relationship between vaccine immunogenicity and protective efficacy of at least 50 per cent according to World Health Organization guidelines.

(The article ended with)

"Luong said after reviewing the report on the results of the first two phases and phase 3a of the Nanocovax vaccine trial, the Ethics Council had made a conclusion and transferred the file to the Advisory Council to consider emergency licensing for the Nanocovax vaccine.

“The evaluations and comments of the National Ethics Council in Biomedical Research are correct, fair and objective. Currently, the company and research units have supplemented the required documents. It is hoped that the Nanocovax vaccine will be granted an emergency licence by the Advisory Council for Registration of Circulation of Drugs and Medicinal Ingredients in the first half of September 2021 so Viet Nam will have an ‘important weapon’ in the war against the pandemic, contributing to protecting people's health and soon returning life to a new normal," said Luong."

It sounds to me, like the approval provess can now continue?

Maybe?

Lots, and lots of Vietnamese, need vaccines.

Lots.

No one needs a vaccine for coronaviruses. Good thing too, because after decades of trying they still haven't succeeded in making one that works. But this illness is similar to flu, and we don't have to outsource our immune system from this day forward.

ransomnote: Spike proteins. Why is it alway spike proteins. We know by now how damaging they are and so they start referring to them as 'protein subunit' vaccines now..... :(

From Wikipedia

"Nanocovax is a Vietnamese COVID-19 vaccine candidate developed by Nanogen Pharmaceutical Biotechnology JSC.^[1]^[2]^[3]^[4] It is a subunit vaccine (SARS‑CoV‑2 recombinant spike protein with aluminum adjuvant).^[2]"

^{ransomnote: Ridiculously short and small participant co-horts. They aren't even trying to pretend to be careful - just shove that stuff in arms.}

Preclinical and phase I[edit]

On 7 December, the National Institute of Hygiene and Epidemiology (Vietnam) announced the Nanocovax test results on hamsters. The hamsters were vaccinated and then exposed to the novel coronavirus for 14 days. They were not infected and results from lung fluid tests also showed they were negative for the virus. Meanwhile, mice that were not vaccinated tested positive for the novel coronavirus and showed signs of fatigue.^[5] On 17 December 2020, Nanogen commenced human trials of Nanocovax vaccine.^[6]^[7]

The clinical trial Phase 1 (open-label, dose-escalation) recruited 60 healthy Vietnamese adult volunteers to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine intramuscularly in the participants. The first-stage trials of Nano Covax showed the vaccine was safe and vaccinated volunteers had antibodies against the Alpha variant.^[8]

Phase II[edit]

On 26 February 2021, the pharmaceutical company began second phase trials in two places, Hanoi and southern province of Long An.^[9] The clinical trial Phase 2 (randomization, double-blind, multicenter, placebo-controlled) enrolled 560 healthy volunteers to evaluate the safety, immunogenicity, and determined the optimal dose of the vaccine intramuscularly in participants. From 25 March to 6 April, volunteers receiving the first jabs in phase II between 26 February and 10 March were given the second shots of the Nanocovax vaccine.^[10] Some volunteers experienced side effects around the injection site, yet did not require medical intervention.^[11]

Results of the trial issued in April 2021 show the homegrown COVID-19 vaccine is safe.^[12] According to the trial results, people injected with 25mcg dose got the highest index with more than 90% at 14 days after the second shot and 42 days since the first doses. The research team is expected to submit a report to the Research Ethics Committee of the Ministry of Health and propose a plan for the third phase of human trials, possibly on 5 May.^[13]

Phase III[edit]

In April 2021, the representative of Nanogen JSC said that the third phase of the Nanocovax vaccine trial is expected to start in May and finish at the end of June, 3 months earlier than planned. The third phase of human trials is expected to involve 10,000-15,000 people in both Vietnam and Asian countries with severe outbreaks. Volunteers will be administered with 25mcg – the only dose for this stage. Each person will receive two jabs. They are set to get second shots 28 days after the first one.^[14]^[13]

In June 2021, Nanocovax entered phase III of clinical trials on 13,000 volunteers.^[15] The clinical trial Phase 3 (adaptive, multicenter, randomized, double-blind, placebo-controlled) enrolled volunteer subjects 18 years of age and older to evaluate the safety, immunogenicity, and efficacy of Nanocovax vaccine in participants.^[16]

looks good ! It’s helpful they compared it to Moderna, and confirms what we’ve seen in western vaccines regarding normal antibody reduction over time

“Regarding the decline in antibody levels after the peak, Lương explained normally the half-life of IgG is about 25 days, which means that for all vaccines after IgG antibody production is stimulated and peaks, the antibody levels will gradually decrease.

“That doesn’t mean the vaccine loses its ability to protect. Vaccination helps the body to form specific B cells. This cell will continue to produce antibodies when antigens or viruses enter. This also shows that it is necessary to re-inject the vaccine against COVID-19 after a certain period of time,” Lương.

It had been shown in research results published by Moderna regarding its emergency licensed vaccine, Lương said. With Moderna vaccine antibody concentration decreased 3.96 times on day 119 compared to day 43. By comparison, Nanocovax had a similar reduction of 3.7 times (16.25 U/ml on day 90 versus 60.47 U/ml on day 42).

Yet the antibody level on day 90 in the vaccinated group was still much higher than that in the group of recovered COVID-19 patients (16.25 U/ml versus 5.63 U/ml).

So they are using the FAKE PCR test, which assures fake results as it has in all the other 'vaccines'. Oh this phase III trial lasts a whole 42 days - when 12 years is usually required to determine safety and efficacy. This is the smallest phase III trial I've seen to date.
As usual, they exclude persons who had Covid, who are pregnant or have co-morbidities for the trials - but note the other vaccines are forced on pregnant women and those with co-morbidities. I read about the death of a 99 year old man in hospice who hadn't eaten for a week (Pfizer or MOderna, I forget). But that's not a cohort the 'trials' ever tested.

The info below is from Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19 - Full Text View - ClinicalTrials.gov

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	13000 participants

Official Title:	a Phase 3, Adaptive, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older.
Actual Study Start Date :	June 7, 2021
Estimated Primary Completion Date :	July 7, 2022
Estimated Study Completion Date :	August 7, 2022

Primary Outcome Measures :

Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
Per 1000 person-years of follow-up
Percentage of participants reporting Serious adverse events or medically attended adverse events [ Time Frame: From dose 1 through one year after the last dose ]
Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants [ Time Frame: days 0, 42, 180, 365 after vaccination ]
Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants [ Time Frame: days 0, 42 after vaccination ]

Secondary Outcome Measures :

Percentage of participants reporting solicited local and systemic reactions [ Time Frame: 7 days after each study vaccination ]
Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events [ Time Frame: 28 days after each study vaccination ]
Proportion of participants achieving ≥4-fold rise of Anti-S IgG at each time point in a subset of participants [ Time Frame: days 0,42, 180, 365 after vaccination ]
T-cell responses (intracellular cytokine staining) [ Time Frame: days 0, 42 after vaccination ]
Change from baseline in the cell-mediated immune response in a subset of participants
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} asymptomatic case of COVID-19 [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
Per 1000 person-years of follow-up
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} mild case of COVID-19 [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
Per 1000 person-years of follow-up
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} moderate to severe case of COVID-19 [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
Per 1000 person-years of follow-up
Number of participants who death due to covid-19 confirmed with (RT-PCR) positive [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
Per 1000 person-years of follow-up

Eligibility Criteria

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Be a male or female 18 years of age or older.
For females: Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through 6 months after completion of the vaccine series.
Willingness to provide a signed, printed, and dated informed consent form.
Able and willing to participate in all activities in the clinical trial.
Participants with HIV, HBV, HCV should have a health record, determined to be stable for 6 months prior to the screening.

Exclusion Criteria:

Participants with unstable pre-existing medical conditions over the three months before enrollment (condition that has worsened to require hospitalization or significant changes in therapy).
Planned administration/administration of a vaccine not foreseen by the study protocol from within 45 days before the first dose of study vaccine.
Previous vaccination with any Covid-19 vaccine.
History of COVID-19 disease.
History of allergic reactions or anaphylaxis to previous immunizations or allergies to any components of the vaccine.
Planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase through 6 months after the second immunization.
History of bleeding disorders/hemostasis or use of anticoagulants.
Currently having cancer or undergoing cancer treatment.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose (inhaled and topical steroids are allowed).
Women who are pregnant or breastfeeding.

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