Spikogen vaccine licensed for emergency use

October 8, 2021 - 17:22

TEHRAN – The Food and Drug Administration has issued an emergency permit for the Iranian-Australian Spikogen vaccine, IRNA reported on Thursday.

“Vaccines such as Pfizer have been shown to be less effective against new strains of the coronavirus, in some cases below 50 percent.

However, the effectiveness of the Spikogen vaccine has been higher than the permitted values in the World Health Organization guidelines,” Mohammad Reza Shanehsaz, head of the Food and Drug Administration, said.

“Currently, the predominant coronavirus in the country includes Delta, British, and Wuhan variants; the clinical study of the Spikogen is one of the few studies in the world to have been conducted entirely at the peak of the Delta variant.

At the third phase of the clinical study, the efficacy of the vaccine before the onset of symptomatic and mild cases of Covid-19 and in the prevalence of delta strain in the country is estimated at about 60 to 65 percent,” he noted.

The monthly production capacity of Spikogen is at least three million doses, according to the Sinogen pharmaceutical company.

The first phase of the study was performed on volunteer Australians and received the necessary approval, the second phase was administrated to 400 Iranians, which has had no serious side effects.

Vaccines against viruses can be divided into three main categories: live attenuated, inactivated/killed, and subunit vaccines. Recombinant protein subunit vaccines are composed of at least 1 type of viral antigen. These vaccines are significantly more secure than live attenuated and inactivated vaccines.

Mass vaccination against COVID-19 started on Iranian citizens with the Russian-made Sputnik V vaccine on February 9.

While Iran continues efforts to mass-produce local candidates, over 80 million doses of foreign vaccines have already been imported and others are expected soon.

Iran is also producing vaccines jointly with two countries of Cuba and Russia.


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