Nicaragua issued EUA for Iran CoV- Barekat Vaccine partially based on unknown trials

Nicaragua issued EUA for an Iranian covid vaccine, partially based on the results of trials which there are no records of it.

Many pandemic stories are worth exploring further. In Iran, the story of vaccines is one of the most important. The Cov-Iran Barekat vaccine is at the center of this controversial story. 

This vaccine has produced by Shifa Pharmed, a subsidiary company under the umbrella of Barekat pharmaceutical company.

 Barekat pharmaceutical company is under The Execution of Imam Khomeini’sKhomeini’s Order (EIKO). EIKO is one of the wealthiest organizations in Iran, which operates under the supervision of the supreme leader’s office. 

After the supreme leader of Iran banned the import of mRNA vaccines from the U.S. U.K, and for some unknown reason from France (which hadn’t any vaccine at the time,) the story of the Barekat vaccine for Covid-19 or CoV-Iran Barekat became a more political story than before. 

This story has many layers, from the misinformation about the vaccine, conflict of interests, using the special economic privileges and putting roadblocks in the way of other companies, the high price tag for each dose of the vaccine and many others.

Despite all these controversies, the CoV-Iran Barekat received its emergency use authorization from the Iranian health ministry on June 15th, 2020. This process wasn’t without controversies either. There were political pressures to speed up the process and ignore the lack of documentation. These pressures forced Dr. Farid Nadjafi, the deputy minister of health for research and the head of the committee of ethics in medical research in Iran, to write a letter to the minister and warned him about the unregular process and pressures for issuing this Emergency Use Authorization (EUA) and laid down concerns for the procedure. This letter was sent just a few days before the announcement of giving the EUA for Barekat CoV Iran vaccine, and it has been mentioned in the EUA. 

 The day after issuing this letter of authorization, Mohammad Mokhber, head of the EIKO (who became the vice president of the Islamic Republic of Iran under president Raiessi,) wrote a letter to the supreme leader, Ali Khamenei and congratulated him for this ”achievement” and also promised to deliver more than 50 million doses of this vaccine by the September (which never became a reality.) 

There are some discrepancies in this series of events. According to the letter Mokhber sent to Khamenei, he mentioned that the EUA was issued on June 14th, 2021. The letter that the health ministry sent to the Shifa Pharmed (producer of CoV Iran Barekat) has the date of June 15th, but it emphasized that the EUA for this vaccine was issued in a meeting held on June 13th. 

There is another interesting issue with this letter. It emphasizes that this EUA is valid for six months and needs to be renewed. There is no public record of any re-authorizations of this vaccine, and if the EUA renewed it, nobody cared to announce it for some reason. 

The mystery of the EUA in Nicaragua

Even when the CoV-Iran Barekat was in the preclinical phase, there were many unsubstantiated claims by the Barekat institute and the EIKO about the considerable interest in the international community for buying this vaccine from Iran. One year after receiving EUA in Iran, CoV-Iran Barekat gets only two EUA. One from Venezuela and one from Nicaragua. 

The Barekat Company published copies of these two EUA for its shareholders in the Tehran Stocks Exchanges portal. (you can see these copies here.)

EUA for CoV-Iran Barekat in Venezuela
EUA for CoV-Iran Barekat in Nicaragua

The EUA issued by Nicaragua has the signature of the Director-General of the National Authority for Sanitary Regulation. 

In the second paragraph, this letter emphasized: 

“The emergency use certification is different from the sanitary registry in terms of a temporary and conditional authorization which allows the use of biological medicines that still do not have all the information required to obtain a sanitary registry, and it was issued through the presentation after the result of the preclinical investigations, Phase I, II and III carried out in Cuba plus the legal administrative documentation manufacturing methods and Good Manufacturing Practices certifications of Laboratory (s) that they intervene in the process of making the product.”

The mysterious point here is that among all the documents published by the Iranian health ministry, Barakat Foundation, and Iranian and Cuban media, there is no mention of any clinical trials for CoV-Iran Barekat in Cuba. Also, the Cuban Registry of Clinical Trials has no record of such trials.

There is no mention of any trails for CoV-Iran Barekat outside of Iran in the WHO’s COVID-19 vaccine tracker and landscape either.

I contacted the Nicaraguan health ministry and the Cuban registry of clinical trials for comments about this issue. I didn’t receive any answer from either of them. I couldn’t get any response to my questions from the Iranian health ministry or the Barekat foundation. 

I can only think of three options for this issue:

First, there were some clinical trials carried on in Cuba which completed all the phases and had outstanding and reliable results. Those results gave the Nicaraguan authorities enough confidence to issue the emergency use authorization for this vaccine. If this is the case, why is there no mention of such a trial inside Iran or Cuban resources? Especially when we remember that this vaccine and its reliability were the subjects of controversies inside Iran, it is hard to imagine that such a piece of significant evidence was simply overlooked.

The second option is that, for some reason, this letter is not authentic. This means maybe the Barakat foundation forged this letter.

In this case, why did they want to add this false claim inside the letter and publicly publish it that only raises eyebrows?

There is also a third option. Maybe during the meeting between Iranian and Nicaraguan authorities, there was a mention of phase one to phase three of a joint project between Cuba and Pasteur Institute of Iran, which has no tie or relationship with the Barekat foundation. Pasteur Institute of Iran is one of the partners with Cuba in researching the Cuban Soberana 02 vaccine, which in Iran is marketed as PastuCovac. These are two completely different projects, and why should there be any mention of these trials in the EUA letter for Cov-Iran Barekat? 

We don’t know which of these options or maybe any other is true. It seems that nobody cares to explain it. 

But these are essential questions. People must trust the health system if they want to rely on it. This trust is the most valuable asset of any health system during a crisis, such as a pandemic. 

This issue may result from a simple mistake or something more serious. But in this age of misinformation, we need to check every claim and ask about them; answering these questions should be part of the health system’s job.

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