Over 240 volunteers get jabs in phase 3 of human trials of home-grown Nano Covax vaccine

Over 240 volunteers get jabs in phase 3 of human trials of home-grown Nano Covax vaccine hinh anh 1A volunteer takes a screen test before receiving Nano Covax COVID-19 vaccine shot in the third phase of the human trials. (Photo: VNA)


Hanoi (VNA) –
The first 240 volunteers in the third phase of the of the home-grown
Nano Covax COVID-19 vaccine received shots at the Vietnam Military Medical
University in Hanoi on June 11.

Developed by the
, Nano Covax is Vietnam’s first
COVID-19 vaccine candidate and was approved by authorities for clinical trials last
December.

According to Associate
Professor Dr Chu Van Men, Director of the university’s Centre for Clinical
Trials and Bioequivalence, the third phase targets 13,000 people aged from
18-75, with an optimal dosage of 25mcg.

Apart from the
university, the third phase, also the final one, will be carried out in the
northern province of Hung Yen and the Mekong Delta provinces of Long An and
Tien Giang.

Following the
clinical trials in Phase 2, which lasted three months, all volunteers
experienced an increase in antibody levels against the coronavirus. This is a
positive sign that not only makes it possible for developers to safely speed up
Phase 3 but also raises hopes that a Made-in-Vietnam vaccine will soon become
available amid the growing complexity of the pandemic both locally and regionally.

As of June 11,
more than 6,500 volunteers had registered for this phase, which aims to further
test the safety and efficacy of the vaccine in humans before mass production
begins.

Associate
Professor Ho Anh Son, Deputy Director of the university’s Institute of
Biomedicine and Pharmacy, said a dossier will be submitted to the Government,
the Ministry of Health, and the National Council for Ethics in Biomedical
Research seeking emergency approval for conditional use in mid-September, or 42
days since the first 1,000 volunteers received their second shot.

Phase 2 trials began
on February 26 involving 560 volunteers divided into four groups, with three
administered doses of either 25mcg, 50mcg, or 75mcg and the fourth a placebo.

With this phase now
completed, volunteers will continue to undergo health monitoring for six months
since the first shot to evaluate the vaccine’s ability to build immunity
against the virus.

Many COVID-19
vaccines around the world are 90 percent effective and some just 60-70 percent,
Son said. With Nano Covax, all volunteers have produced immune responses
against COVID-19.

The study found an
increase in antibody levels in all volunteers, Son continued, and all were in
good health and no one needed drugs or emergency care. It was a very
encouraging result and the vaccine is safe for humans so far, he emphasised.

Another domestic
vaccine candidate, Covivac from the Institute of Vaccines and Biological
Medical (IVAC) in Nha Trang city, Khanh Hoa province, is preparing for Phase 1 trial
data to be reviewed by the Ministry of Health and could start Phase 2 around
late-June or early-July if results are deemed acceptable.

Another
locally-developed vaccine, from Vabiotech, is in pre-clinical trials
on animals, while yet another from Polyvac (the Centre for Research and
Production of Vaccines and Biologicals, under the Ministry of Health) is still
under laboratory research./.

VNA

Source: VietnamPlus

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