Phase 2 clinical trial

Production and manufacturing facility

This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.

Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80 per cent.

The vaccine was well tolerated and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization.”

Production and manufacturing facility

AstraZeneca will continue to analyse the data and prepare for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks. In parallel, the primary analysis will be submitted for publication in a peer-reviewed journal.

Amongst participants in the interim analysis, approximately 79 per cent were white/Caucasian, 8 per cent black/African American, 4 per cent Native American, and 4 per cent Asian, and 22 per cent of participants were Hispanic.

Approximately 20 per cent of participants were 65 years and over, and approximately 60 per cent had co-morbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity, or cardiac disease.

This AstraZeneca-led US Phase III trial included two doses administered at a 4-week interval. Previous trials have shown that an extended interval of up to 12 weeks demonstrated greater efficacy, which was also supported by immunogenicity data. This evidence suggests administration of the second dose with an interval longer than four weeks could further increase efficacy and accelerate the number of people who can receive their first dose.

The vaccine can be stored, transported, and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and administered without the need for preparation within existing healthcare settings.

AstraZeneca continues to engage with governments, multilateral organisations, and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.

Nitin Kapoor, chairman and general director of AstraZeneca Vietnam, said: “This great news once again confirms the high efficacy and good toleration of our vaccine, including for Asian people which made up 4 per cent of this large clinical trial participant pool. We appreciate the Vietnamese government and the Ministry of Health’s trust in our vaccine and science-led decision to carry out the Plan on Immunization against COVID-19 using AstraZeneca COVID-19 vaccine, now has provided protection against the virus for more than 34,000 frontline health workers and counting.”

This is the first phase of the Vietnam-made vaccine clinical trial program.

Vietnam started Covid-19 vaccine human trial on 60 volunteers who were injected with Nanocovax, the first made-in-Vietnam Covid-19 vaccine approved for human trials, on December 17.

This is the first phase of the Vietnam-made vaccine clinical trial program, said Nguyen Ngo Quang, deputy head of the Administration of Science, Technology and Training under the Ministry of Health.

Mr. Quang confirmed around 200 people had signed up within a week to be vaccinated with Nanocovax, a Covid-19 vaccine developed by Nanogen Pharmaceutical Biotechnology JSC.

Vietnam Military Medical Academy, as part of first phase trials, has been overseeing administration of the Covid-19 vaccine.

Nanogen’s two vaccine products include injectable and spray form.

The academy has been racing against time to screen eligible volunteers for the first human trial stage. Selected candidates are between 18 and 50 years of age.

They will receive two intramuscular shots of the vaccine, with an interval of 28 days between them. The volunteers will have their health monitored for 56 days to assess the efficiency of the vaccine and continue to be under observation for sixth months following administration.

Dr. Ngo Quang also said that all the volunteers have been covered by health insurance. The second and third trial phases will be conducted in March 2021 and August 2021 on 3,000-4,000 people or even 10,000.

According to Professor Do Quyet, director of the Vietnam Military Medical Academy, his institution and Nanogen have prepared very well for the clinical trial stages. In particular, the volunteers’ safety will be the top priority.

He noted that the strength of Vietnam-made Covid-19 vaccines would be normal refrigerator temperature (2-8 degrees Celsius) storage, while vaccines of some foreign manufacturers must be stored in minus 75 degrees Celsius, which will result of a lot of transport inconvenience.

Do Minh Si, Nanogen’s director for research and development, said all risks and variables have been assessed, with medical staff from 103 Military Hospital and the Vietnam National Institute of Burns on standby.

Nanogen has signed contracts with an insurance company to cover the unexpected cases as well as allocated a funding of up to VND20 billion (US$863,290) to pay for any accident not covered by insurance, Mr. Si stressed.

Nanocovax is expected to be priced at VND120,000 (US$5.17) per dose, the Nanogen’s director said, adding that the vaccine would be reasonably priced and affordable to all Vietnamese, and hopefully included in health insurance policy. The vaccine is scheduled to enter mass production in May 2021.

Vietnam currently has four Covid-19 vaccines under development, by Nanogen, the Institute of Vaccines and Medical Biologicals (IVAC), the Vaccine and Biological Production Company No. 1 (Vabiotech) and the Center for Research and Production of Vaccines and Biologicals (Polyvac).

The Covid-19 vaccine developed by IVAC is expected to enter human trials in March next year if approved by authorities. Vabiotech said it would seek approval for human trials in early 2021.

Vietnam has recorded 1,405 Covid-19 cases so far, 115 still active, most of whom are imported cases. Thirty-five have succumbed to the disease, many being elderly patients with underlying conditions like diabetes or kidney failure. No community transmission has been recorded in two weeks.

Clinical room for volunteers.

Sample-taking table for volunteers.

Clinical table for volunteers.

Room for 72-hour supervision after volunteers are taken samples.

The first volunteer was vaccinated with Nanocovax on December 17.

A volunteer gets her 2nd shot of Nano Covax vaccine in the second trial phase (Photo: VNA)

Hanoi (VNA) – The Military Medical University under the Ministry of National Defence on March 25 began giving the second shots of the Nano Covax COVID-19 vaccine in the second trial phase to 26 volunteers who receive the first jabs between February 26 and March 10.

Nano Covax developed by the Nanogen Pharmaceutical Biotechnology Company is Vietnam’s first candidate vaccine to reach the human trial stage.

According to Associate Prof. Dr. Chu Van Men, Director of the Military Medical University’s Centre for Clinical Trials and Bioequivalence, after receiving the first shots, volunteers exhibited symptoms such as pain at the injection point, a light fever, muscle aches, joint pain, and fatigue, but did not require medical intervention .

The health of the 560 volunteers remains stable, he said, adding that Nano Covax is safe and the volunteers are ready for their second shots.

The second trial is being organised simultaneously at the Military Medical University and the Pasteur Institute in Ho Chi Minh City, with volunteers including those with mild background ailments such as hypertension, diabetes, and cardiovascular issues.

As planned, the Military Medical University will submit the preliminary test results to the Ministry of Health and the National Council for Ethics in Biomedical Research in May for review and evaluation, before conducting the third phase of trials.

Previously, at a meeting of standing members of the National Steering Committee for COVID-19 Prevention and Control, a representative from the Ministry of Health said that the third phase of trials will take place from May to September, with the vaccine then registered for circulation in September, three months earlier than scheduled.

Vietnam expects to have its locally-produced vaccine available by the end of the third quarter./.