Second Iranian-made coronavirus vaccine receives clinical trial approval

January 18, 2021 - 18:29

TEHRAN – The second homegrown COVID-19 vaccine developed and proposed by the Razi Vaccine and Serum Research Institute has been approved to begin a clinical trial.

The clinical trial protocol has been approved by both the Food and Drug Administration and the National Committee for Ethics in Biomedical Research.

However, the protocol should be returned to the Food and Drug Administration to receive a license to begin clinical research, and then the clinical trial can begin.

The vaccine is protein-based, which employs recombinant versions of the spike protein and tutors the immune system against the virus by producing antibodies.

According to the proposed protocol, 13 volunteers will receive the vaccine through the first phase, and then 120 people enter the research in four different groups.

Normally, if the first phase is successful, the acceptable dose of the vaccine will be determined, and based on the results of phase one, the second phase will begin with 500 people.

In all stages, the National Committee for Ethics in Biomedical Research and the senior experts will supervise the project.

Mass vaccination by next 2 months

On Saturday, President Hassan Rouhani said the government is trying its best to start mass vaccination against the coronavirus by the next two months with the priority given to medical staff and high-risk individuals.

The COVAX vaccines will be provided to the country by the end of the current [Iranian calendar] year (March 20) or at the beginning of the next [Iranian calendar] year, Rouhani said at a meeting of the National Headquarters for Coronavirus Control.

Other vaccines have also been purchased which will be available soon, he noted, adding, a co-produced vaccine called “Pasteur” will also be mass-produced during the spring.

Referring to the homegrown vaccines, he announced that two domestic vaccines that have been licensed for the clinical trial will also be available by the next summer.

Homegrown vaccine

Production of COVID-19 vaccine was followed by 16 Iranian companies since the beginning of the outbreak, and so far 12 companies applied to produce the vaccine, of which eight are operating, one of the companies have entered the human trial phase, and two more companies will soon test the vaccines on human, Kianoush Jahanpour, head of the Information Center of the Ministry of Health, said on January 10.

COVIRAN BAREKAT, the first coronavirus vaccine made by Iranian researchers of the Headquarters for Executing the Order of the Imam, was unveiled and injected into three volunteers during a ceremony on December 29, 2020.

On January 11, the second dose of the vaccine was injected into the three volunteers.

So far, 14 people have received the first dose of the vaccine, and this number should reach 56 people in the clinical study phase.

After the results of the study are determined, the second stage begins with the injection in 500 people, and after 28 days, the third phase begins with mass production.

Hojjat Niki-Maleki head of the information center of Headquarters for Executing the Order of the Imam, said by the next six months, vaccine production will reach up to 12 million doses per month.

COVID-19 daily new cases and mortalities

In a press briefing on Monday, Health Ministry spokesperson Sima-Sadat Lari confirmed 5,806 new cases of COVID-19 infection, raising the total number of infections to 1,336,217. She added that 1,125,499 patients have so far recovered, but 4,348 remain in critical conditions of the disease.

During the past 24 hours, 83 patients have lost their lives, bringing the total number of deaths to 56,886, she added.

So far, 8,580,126 COVID-19 diagnostic tests have been performed in the country.

Lari noted that currently, 10 cities are in high-risk “red” zones, and 23 cities are in the orange zone and 163 in low-risk “yellow” zones.


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