|A volunteer gets a Nano Covax dose during the third trial of the vaccine. — VNA/VNS Photo
HÀ NỘI — The National Ethics Committee in Biomedical Research has said more data about the efficacy of the homegrown COVID-19 vaccine Nano Covax is needed.
The Ministry of Health on Monday announced the conclusion of the committee meeting on December 16 to look into updated reports on mid-term phase 3 trial results of the vaccine.
The data available for review was until November 30, 2011. The report was submitted to the committee on December 9.
Nano Covax meets the requirements regarding vaccine safety and immunogenicity, according to the committee’s conclusion.
However, regarding the efficacy or the ability of a vaccine to prevent infection or symptomatic infections (based on the number of people infected with COVID-19 after getting the shots), the committee said more data was still needed to evaluate it fully.
The committee approved the Việt Nam Military Medical University and the Pasteur Institute in HCM City, which are in charge of the trial, and Nanogen Pharmaceutical Biotechnology JSC in HCM City as the donor, to identify those who took part in the trial and were infected with COVID-19 as of December 13 to have more data for analysing and assessing the vaccine efficacy.
They were required to complete the report and submit it to the Committee before 3pm, December 22, for evaluation.
Under the latest guidelines from the health ministry, domestically developed COVID-19 vaccines could be authorised for emergency use if they prove to be safe and effective in mid-term phase 3 findings, with further monitoring required even after obtaining such approval. — VNS