Vaccines can only be approved based on sufficient scientific data: official
The emergency use authorisation for a COVID-19 vaccine is necessary but it must be based on sufficient scientific data, a health official said on June 22.
A medical worker gives a shot of Nano Covax to a volunteer in the third-phase trials at the Hanoi-based Vietnam Military Medical University (Photo: VNA)
Hanoi (VNA) – Theemergency use authorisation for a COVID-19 vaccine is necessary but it must bebased on sufficient scientific data, a health official said on June 22.
Nguyen Ngo Quang, DeputyDirector of the Health Ministry’s Department for Science, Technology andTraining, made the remark in response to the NanogenPharmaceutical Biotechnology JSC’s proposal for validating its NanoCovax, a COVID-19 vaccine candidate, for emergency use.
Quang noted that beforeapproving a vaccine for mass use, it is a principle that the Ministry of Health(MoH) must ensure the safety, the generation of immunity, and the protectiveeffect of that vaccine.
The emergency useauthorisation for a vaccine depends on many factors, and the MoH needsscientific data to make a decision, Quang emphasised.
He stressed the MoH’sabsolute support for the development of domestic vaccines, adding that thehealth sector’s ultimate goal is to protect people’s health, so benefits andrisks must be thoroughly considered.
Nano Covax is currently inthe third phase of trials, with 1,000 volunteers already getting the shots.
Results recorded so farshowed that this vaccine candidate is safe and has generated the immuneresponse in volunteers, but its protective effect is still under research.
To have sufficient scientificbasis to assess the immunity generation and protective effect, volunteers needto be monitored for 36 days, 45 days, and 56 days since the first jabs,according to the official./.
Two COVID-19 vaccines Nano Covax and Covivac, which were studied and developed in Vietnam, have proved to be safe and effective in the first and second clinical trials.
The World Health Organisation (WHO) has recently announced that Vietnam’s National Regulatory Authority (NRA) for vaccines reached Maturity Level 3, the second highest in the WHO classification of national regulatory system.
The clinical trials of Vietnamese COVID-19 vaccine candidate Nano Covax are set to enter Phase 3 this month with the optimal dosage of 25mcg, aiming to further test the safety and efficacy of the vaccine in humans before mass production begins.
The Standing Board of the National Steering Committee for COVID-19 Prevention and Control has agreed to create the best possible conditions for the trial of homegrown vaccines.
The administration of the first 1,000 shots in the third-phase trials of Nano Covax, a home-grown COVID-19 vaccine candidate, has completed, the Hanoi-based Vietnam Military Medical University said.
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Under the agreement, VNVC and Sanofi will gradually implement technology transfers to enable domestic production of several key Sanofi vaccines that are widely used in Vietnam. In addition, Sanofi will support VNVC in training human resources and quality management in vaccine research and manufacturing.
According to the World Health Organisation, more than 25,000 COVID-19 cases have been recorded globally over the past month. Notably, from January 1 to May 10, Thailand reported nearly 54,000 infections and 16 deaths. The rise in cases in Thailand has been linked to the spread of XBB.1.16 subvariant.
Recently, HCM City has experienced a noticeable increase in COVID-19 cases, with 26 reported in just one week, compared to an average of only 1-2 cases weekly earlier this year.