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The Food and Drug Administration of Iran has issued an emergency permit for the Spicogen corona vaccine

سازمان غذا و داروی ایران مجوز مصرف اضطراری واکسن کرونای اسپایکوژن را صادر کرد

The Food and Drug Administration of the Ministry of Health has issued an emergency permit for the sporadic corona vaccine, a joint production of Iran and Australia.

Haleh Hamedifar, CEO of Sinagen, while announcing the issuance of an emergency license for the Spicogen corona vaccine, said that the non-issuance of this license in recent days and weeks had sparked marginal controversy.

Spicogen vaccine is a joint product of Sinagen Iran and Australian vaccine. The first phase of its clinical studies has been conducted in Australia and the second and third phases in Iran. A summary of the results of phase two clinical trials of the spicogen vaccine states that the vaccine induced an immune response in 87% of study participants.

Spicogen vaccine is the first corona vaccine made by the private sector in Iran, which succeeds in obtaining an emergency use license from the Food and Drug Administration. Other licensed or under-licensed Crona vaccines are manufactured in Iran, or in government, government, and military institutions, or are under licensed production.

The CEO of Sinagen Pharmaceutical Company told the media that the results of the mid-phase studies of the third phase of the clinical study have been submitted to the Ministry of Health.

In an interview with Fars News Agency, Payam Tabarsi, the director of the Spicogen vaccine study project, stated that the ability to produce spicogen vaccine is three million doses per month.

The following is a summary of the results of clinical trials of phase two spicogen vaccines:

  • Spicogen induced an immune response in 87% of study participants.
  • Spicogen is safe.
  • Tolerance is acceptable.
  • The incidence of adverse events has been consistent with clinical trials of other vaccines.
  • No serious side effects were reported.

This vaccine is a type of subunit vaccine. The advantage of this type of vaccine is the use of recombinant protein and the absence of live or killed virus itself. Spicogen will be the brand name of this product in Iran and this product has been registered by the Australian vaccine company under the name of COVAX-19.

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