TEHRAN (Iran News) – “Razi Cov Pars” vaccine entered on Sunday the third phase of the human trial, being administrated to 40,000 people, IRIB reported.
Developed by the Razi Vaccine and Serum Research Institute, Razi Cov Pars is the second Iranian-made vaccine that started the clinical trial on February 27.
The vaccine is protein-based, which employs recombinant versions of the spike protein and tutors the immune system against the virus by producing antibodies.
It is developed in 3 doses. The first two doses are injectable and the third dose is intranasal. The second dose of the vaccine will be injected into the volunteers 21 days later and the third dose will be inhaled 51 days later.
The first phase of the studies was performed on 133 people, the second phase also started on May 28 by being injected into 500 people.
At the end of the second phase, Cov Pars proved 80 percent of the immunogenicity.
Razi Institute (affiliated to the Ministry of Agriculture) is capable of producing 20 million doses of vaccine by the end of 2021, Agriculture Minister Javad Sadatinejad said.
Ali Es’haqi, head of the Razi Institute, explained that in the third phase, two programs are envisaged.
In the first plan, the vaccine is compared with a consumer vaccine in the country, which inoculates more than 40,000 volunteers. While, through the second plan, the vaccine will be evaluated as the first and second phases with adjuvant or placebo vaccine, and if approved, the third phase will proceed with about 28,000 volunteers.
The Food and Drug Administration issues an emergency use permit with 35 percent of the positive results from the third phase, he emphasized.
If an emergency consumption permit is issued in September, we will provide between 20 and 30 million doses of vaccine to the Ministry of Health, Es’haqi stated.
Made by researchers at the Headquarters for Executing the Order of the Imam, COVIRAN BAREKAT was unveiled on December 29, 2020, and received the license for public use on June 14.
It proved effective against Indian strain, according to Hojjat Niki-Maleki, head of the information center of Headquarters for Executing the Order of the Imam.
Eleven countries from Asia and South America, and a European country have asked for importing COVIRAN vaccine, Hassan Jalili, the vaccine’s production manager, has said in June.
According to the Food and Drug Administration, 14 vaccines are being domestically developed in the country which are in different study phases.
Pastu Covac coronavirus vaccine, developed by Cuba’s Finlay Vaccine Institute and Pasteur Institute of Iran, is another homegrown vaccine, which has received the emergency use license, after COVIRAN.