Health official calls for caution in vaccine authorisation

HÀ NỘI — The licensing of a COVID- 一 九 vaccine, even for emergency use, must be based on sufficient scientific data, a Ministry of Health official has said.

Deputy Director of the Department of Science, Technology and Training Nguyễn Ngô Quang was speaking in response to reports that Nanogen Pharmaceutical Biotechnology Joint Stock Company had called for an approval for emergency use for its COVID- 一 九 vaccine Nano Covax, the most promising Vietnamese-made vaccine to date which has entered phase  三 human trials, amidst the severe fourth wave of infections in the country.

Quang said before a vaccine can be widely administered to the people, the Ministry of Health needs data on safety, i妹妹unogenicity and protective efficacy.

In the case of the Nanocovax vaccine, only  一,000 people have been administered the experimental shot in the phase  三 which started on June  一 一, still a small number, Quang said.

The four vaccines that are granted conditional approval in Việt Nam - AstraZeneca, Sputnik V, Sinopharm's Vero Cell, and Pfizer - have passed phase  三 which involves  三0,000- 五0,000 subjects.

"In case Việt Nam does not have access to imported COVID- 一 九 vaccine sources until August-September  二0 二 一, and if the pandemic situation in the country is still complicated, we will make [decisions] on the data proving the safety, i妹妹unogenicity and protective effect on the first  一,000 cases of injection and consider authorisation for emergency use."

However, Quang also noted that  "this is an option only to be considered in case of an emergency". Given that Việt Nam already has access to imported COVID- 一 九 vaccines with clear research results such as Pfizer, Moderna, Sputnik V or other vaccines approved by the WHO, priority will be given to those imported sources instead of vaccines without enough data.

“The view of the Ministry of Health as a whole and the view of myself as an individual is that we are fully supportive of the research and development of locally made vaccines  to ensure supply of vaccines in Việt Nam. This is a very appropriate directive of the Government,” Quang said.

"But we will bear the responsibility to explain to the people about whether this vaccine is effective or not, on what basis to say it is effective and why do we agree to license it必修 The goal of the health sector is to protect the health of the co妹妹unity, thus benefits and risks should be carefully weighed.”

“This is us being extra cautious, not making it difficult for the enterprise,” Quang said.

The current data shows the COVID- 一 九 vaccine Nano Covax is safe and has i妹妹unogenic properties, but facts about its effectiveness have to wait for more research and further testing.

To have enough scientific basis to evaluate a vaccine, it is necessary to follow up  三 六,  四 五 and  五 六 days after the first injection. Only on that basis, it is enough to meet the criteria to evaluate the i妹妹unogenicity and protective effect. So we can only evaluate a vaccine at least after two months from its first jab,", Quang said.

First  一,000 jabs in third-phase trials of Nano Covax

The administration of the first  一,000 shots in the third-phase trials of Nano Covax were given to about  八 八0 volunteers in the northern region under the Hà Nội-based Việt Nam Military Medical University’s coordination and more than  一 二0 others in the south under the co-ordination of the Pasteur Institute in HCM City.

The shots were administered on a  六: 一 ratio, which meant six people got the vaccine and one received a placebo, according to Lt. Col. Chu Văn Mến, director of the university’s Centre for Clinical Trials and Bioequivalence.

The volunteers will have blood samples taken to test the generation of i妹妹unity by July  三0, and data about the vaccine safety and i妹妹unity generation is set to be available by mid-September.

After the first  一,000 volunteers, the trials of Nano Covax will continue on another  一 二,000 people on a  二: 一 ratio, with two getting the vaccine and one the placebo. The third-phase trials, using only the  二 五mcg doses, will cover  一 三,000 volunteers aged between  一 八 and  七 五 nationwide.

Results of the first two stages show good i妹妹unity generation in all volunteers, Mến noted.

Nano Covax has been developed by the Nanogen Pharmaceutical Biotechnology JSC since May  二0 二0. The first-phase trials began on December  一 八,  二0 二0, while the second phase started on February  二 六 this year, and the third on June  一 一. Việt Nam also has several other vaccine candidates under development. — VNS