The Phase 1 clinical trial enrolled 30 volunteers and centered on evaluating the vaccine’s safety and tolerability with no severe complications or hospitalizations reported among participants, according to lead investigator Mohammad Reza Salehi.

The vaccine has showcased the ability to trigger a noteworthy immune response, especially when compared to individuals who received traditional vaccines.

Of particular significance is the vaccine’s demonstrated flexibility to address emerging subvariants of the coronavirus. “Iranian mRNA vaccine holds the potential to be recalibrated in response to these evolving strains,” Salehi affirmed.

While decisions regarding subsequent phases of clinical trials are pending regulatory endorsement, Salehi highlighted the vaccine’s potential for redesign to effectively target new viral strains. This forward-looking approach reflects the vaccine’s dynamic foundation, showcasing Iran’s commitment to advancing immunization strategies.

Notably, the manufacturer of Iran’s mRNA vaccine has already expressed readiness to refine the vaccine based on emerging subvariants of the coronavirus.

Navigating the path forward for COVID-19 vaccination continues to be a topic of discussion within the global scientific community. Amid ongoing uncertainties, esteemed institutions such as the American Centers for Disease Control and Prevention and the World Health Organization advocate for potential annual vaccinations targeting high-risk individuals, he stated.

The adaptability of mRNA technology in vaccine development is becoming increasingly evident. “mRNA technology offers a novel approach with minimal side effects, and its adaptability is a distinct advantage,” Salehi noted.

The completion of Phase 1 clinical trials for Iran’s first mRNA coronavirus vaccine is a noteworthy achievement in the ongoing efforts to counter the pandemic. Beyond its application in COVID-19, this technology holds promise for revolutionary advancements in cancer prevention drugs and vaccines.

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The first vial of this vaccine was produced two years ago, and with the injection of the first vial of this vaccine, this plan has entered clinical trials, ISNA reported.

For the production of the vaccine, processes such as vaccine design, genetic engineering (DNA structures), mRNA production and purification, formulation, and quality control have been implemented.

Conducting pre-clinical studies on rats and monkeys, obtaining relevant approvals and licenses, and conducting human clinical studies in three phases are among the measures taken in the trial phase.

Currently, among the vaccine platforms, the four models of inactivated virus, recombinant, vaccines based on adenovirus vector, and mRNA are preferred over others.

The results of the preclinical studies showed that by injecting this type of vaccine, the amount of neutralizing antibodies is greater than in other types of vaccines.

The durability of the antibody is also quite significant. In this way, more effectiveness of this type of vaccine in preventing the infection of COVID-19 will be expected.

Iran is the sixth country in the world and the first country in West Asia to gain the ability to produce the Coronavirus vaccine.

The country has been able to reduce the COVID mortalities from 700 cases to less than 10, and this successful experience of the Islamic Republic was made known in the seventy-fifth session of the World Health Assembly, Health Minister Bahram Einollahi said in May 2022.

Considering those five coronavirus vaccines that have so far been produced domestically, Mohammad Reza Shanehsaz, the former head of the Food and Drug Administration, said in June 2021 that Iran is one of the few countries that has all vaccine production platforms.

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Currently, two or three centers are working on the development of their own vaccines, deputy health minister Younes Panahi said on Monday.

“But this does not mean that a new vaccine will come and we will replace the existing vaccines,” ISNA quoted Panahi as saying.

The Covid-19 virus has mutated in various forms in the world and one of the most serious and dangerous strains is the XBB strain, he added.

“In Iran, studies are currently being conducted on new mutations, but there is no new vaccine that is specific for it. So, we and other countries use the same existing vaccines.”

For instance, the U.S. has a high mortality rate even with mRNA vaccines, and France and Japan also have high mortality rates.

“But in our country, due to observing social distancing rules and wearing masks, we can overcome the new strains with the vaccines that we currently have in sufficient quantity,” he explained.

Panahi went on to say that there is no new vaccine specific to Omicron, neither in the world nor in Iran, but the world is intensively studying to update their vaccines for new mutations.

On January 1, deputy health minister Hossein Farshidi said three new strains of BQ1, XBB, and BA2, have been diagnosed recently in patients, warning that the new wave of Covid began.

Fast-developing Covid-19 variants are spreading over Europe, and severely infected France and Germany, he noted.

Emphasizing that the transmission power of XBB is five times higher than Delta, Farshidi insisted that borders should be monitored quickly and suspicious patients should be identified.

Within the next one to two months, the new wave of the pandemic will reach its peak, he further lamented, ISNA reported.

The rate of hospitalization of the new strains is the same as the Omicron, but the higher the number of patients, the higher the percentage of hospitalizations, he also said.

He further emphasized that people should be injected with booster doses.

Medical researchers announced the risk of an Omicron variant emerging in the world that is resistant to all existing therapeutic antibodies, and the findings indicate that new treatments must be identified to deal with this variant.

According to new research at a German institute, BQ1.1, is resistant to all approved antibody treatments.

Omicron escapes neutralizing antibodies and causes symptomatic disease even in vaccinated or convalescent individuals due to mutations in the spike protein. This is known as an immune escape and is dangerous for high-risk populations, including the elderly and people with weak immune systems.

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The new strain of Omicron known as BA2.75 has not yet been identified in Iran. At present, the most available variant of COVID in the country (more than 90%) is the BA5 strain, and in other parts of the world, the BA5 strain is the most widespread, he explained.

In comparison to other countries where Omicron was first detected, Iran will probably not experience such a wide wave of Omicron. In comparison to other countries where Omicron was first detected, such as South Africa, Iran will probably not experience such a wide wave of Omicron, but in general, we cannot make an absolute prediction because the virus has shown us that something unexpected can happen at any moment, he highlighted.

He went on to note that there is a possibility of the eighth or more waves of the corona, but everything depends on what variant of the virus will emerge, which is also affected by other factors. Therefore, it cannot be said that the seventh wave is the last one in Iran.

Unless something unexpected happens, we probably won’t have a dangerous mutation; But this issue is not certain at all. The only thing we are more certain of is that there will be fewer deaths; Because the immune system of people has been stimulated during this period and the cellular immune response can prevent the high intensity of the virus, he emphasized.

Masoud Younesian, an epidemiologist, also warned that the Omicron variant may rise for the third time in the country.

Hamidreza Jamaati, secretary of the National Scientific Committee of Coronavirus, said in July that if preventive measures such as wearing masks and injecting booster doses are adopted, we will not experience the rates of mortality that happened in March with Omicron or last summer with Delta.

“Various studies have shown that in the first trimester after two doses of the vaccine, there is a 70 percent and after six months, about 50 to 60 percent effectiveness against omicron and its subtypes, so our emphasis is on completing the vaccination.”

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Infections have been on the rise, with 7,851 new cases reported on Friday, up from 463 new cases on July 1. The hospitalization rate has been inching up as well, though still well below previous peaks.

Considering that infection with the BA5 variant is milder than other variants, it is expected that the seventh peak of the disease to occur by October with lesser mortality, Hamidreza Jamaati, secretary of the National Scientific Committee of Coronavirus, said.

If preventive measures such as wearing masks and injecting booster doses are adopted, we will not experience the rates of mortality that happened in March with Omicron or last summer with Delta, he added, ISNA reported on Friday.

At present, in Asia and Europe, the incidence of Covid and its mortality is steady and declining, while in some African and American countries, there is a growing trend of omicron variants such as BA4 and BA5, which have not spread in Iran, Jamaati said in May.

“Various studies have shown that in the first trimester after two doses of the vaccine, there is a 70 percent and after six months, about 50 to 60 percent effectiveness against omicron and its subtypes, so our emphasis is on completing the vaccination.”

If preventive measures such as wearing masks and injecting booster doses are adopted, we will not experience the rates of mortality that happened in March with Omicron or last summer with Delta.

However, Hamid Souri, an epidemiologist predicted in April that the seventh wave of COVID-19 may hit the country as health experts warn of a rebound due to the New Year (Noruz) holidays which started on March 21.

The seventh wave is likely to occur in mid-May, as it probably takes between two to six weeks to appear, he explained.

Regarding the formation of the seventh wave of the disease in the country, he said that “Wherever the density of contacts is higher, we are more likely to see an outbreak of the new strain, but the main foci of infection are important. At present, there seems to be a combination of omicron and Delta variants in the country.

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Considering the return of Hajj and Arbaeen pilgrims and the reopening of schools and universities, it is necessary to pay special attention to the continued use of masks and compliance with the health guidelines, especially in high-risk groups, and to strengthen border health care and the cooperation of relevant agencies in timely detection of the arrival of new strains, deputy health minister Kamal Heydari wrote in the letter, emphasizing the recommendation to receive a booster dose for all age groups, more than six months have passed since their last vaccination.

COVID-19 infections significantly increase

It has been about a week that the number of outpatient cases has significantly increased again, and it seems that a new wave is happening in the country, Payam Tabarsi, a member of the scientific committee of coronavirus control, has said.

The national scientific committee to deal with coronavirus has said that omicron BA4 and BA5 variants may soon dominate the country.It seems that outpatient cases increase will show its effect on death and hospitalization in two to three weeks. Currently, it is strongly recommended to follow health protocols and inject vaccines by those who have not been vaccinated yet. Because the vaccine really reduces the severity of the disease, he suggested.

Masoud Younesian, secretary of the epidemiology and research committee of the national scientific committee to deal with coronavirus, has said that omicron BA4 and BA5 variants may soon dominate the country.

According to the official statistics, about 20 to 25 percent of eligible people in the society did not inject the coronavirus vaccine at all, and between 30 to 35 percent only injected a dose of the vaccine, who is called the vulnerable population.

In the first week of the Iranian calendar month of Tir which began on June 25, COVID-19 hospitalizations and outpatients have tripled in the country.

Also, unfortunately, a total of 11 patients died last week. Based on this, the total number of deaths from this disease has reached 141,390 people.

So far, about 150 million doses of vaccine have been injected into the Iranian population and the coverage of vaccination in the total population is about 75 percent, he highlighted.

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At present, in Asia and Europe, the incidence of Covid and its mortality is steady and declining, while in some African and American countries, there is a growing trend of omicron variants such as BA4 and BA5, which have not spread in Iran.

Various studies have shown that in the first trimester after two doses of the vaccine, there is a 70 percent and after six months, about 50 to 60 percent effectiveness against omicron and its subtypes, so our emphasis is on completing the vaccination.

In addition to reducing infection, hospitalization, and death, the vaccine can be effective in reducing post-coronavirus complications, which may even occur up to one year after infection, he noted.

The country will not face a new wave of the pandemic over the next three months, while it is difficult to predict a new wave in the cold seasons of the year, he stated.

Iran has been able to reduce the Covid mortalities from 700 cases to less than 10, and this successful experience of the Islamic Republic was made known in the seventy-fifth session of the World Health Assembly, Health Minister Bahram Einollahi said on May 27.

So far, about 150 million doses of vaccine have been injected into the Iranian population and the coverage of vaccination in the total population is about 75 percent, he highlighted.

Following the decision of the National Headquarters for Coronavirus Control and President Ebrahim Raisi, all universities affiliated with the ministries of science and health, and schools, started education in person on April 3 as the new cases of the disease have notably reduced.

However, Hamid Souri, an epidemiologist had predicted in April that the seventh wave of COVID-19 may hit the country as health experts warn of a rebound due to the New Year (Noruz) holidays which started on March 21.

The seventh wave is likely to occur in mid-May, as it probably takes between two to six weeks to appear, he explained.

Regarding the formation of the seventh wave of the disease in the country, he said that “Wherever the density of contacts is higher, we are more likely to see an outbreak of the new strain, but the main foci of infection are important. At present, there seems to be a combination of omicron and Delta variants in the country.

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President Raisi expressed his satisfaction with the report on the reduction of new cases during the sixth wave of the COVID-19 pandemic at a meeting of the National Task Force Against Coronavirus before noon on Saturday and said, “Of course, this should not lead to the weakening of observing health protocols”.

The President called on all people, guilds and employees to continue to strictly and completely observe health protocols, and especially to refrain from holding and attending gatherings, and added, “The related agencies should seriously and effectively follow the implementation of health protocols”.

He went on to point out some high-risk areas for coronavirus outbreak and said, “One of the most dangerous areas for coronavirus outbreak is public transportation, and therefore the relevant authorities are pursuing the strict implementation of protocols, including in airlines, and observing the 60-percent capacity in flights”.

Referring to the report presented at the meeting on the effectiveness of fines for non-compliance with health protocols, he stated, “These fines need to be reviewed in order to increase their deterrent effects and improve attention to the guidelines”.

In another part of his speech, the President pointed out the importance of research on the effects and social and psychological effects of corona, saying, “The study of corona effects is very important for people in personal and social dimensions and supports our better performance and decisions in the future”.

Referring to the report on traditional medicine presented at the meeting, Raisi called for wise mind-set regarding this issue in scientific and academic circles as examples of conflict of opinion and open-mindedness and called on medical universities and the Ministry of Health to provide space for specialists.

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According to the latest data released by the World Health Organization (WHO) on Thursday, the cumulative number of global COVID-19 cases had exceeded 360.5 million, with the death toll surpassing 5.62 million and any second the number is on the rise in the world.

Specifically, there had been 360,578,392 confirmed cases of COVID-19, including 5,620,865 deaths, as of 16:37 Central European Time (CET) on Thursday, according to the WHO.

A total of 9,679,721,754 vaccine doses had been administered as of Jan. 25, according to the WHO.

The cumulative confirmed COVID-19 cases in the United States exceeded 73.39 million as of Thursday, with the death toll surpassing 878,000, according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.

Specifically, the country’s case count rose to 73,397,025 and the death toll reached 878,325 as of 19:21 Eastern Standard Time (EST) Thursday.

A total of 533,570,351 doses of COVID-19 vaccines have been administered in the country, according to the CSSE tally.

On Tuesday, the World Health Organization also said the pandemic will not end as the omicron variant subsides in some countries, warning the high levels of infection around the world will likely lead to new variants as the virus mutates.

“We’re hearing a lot of people suggest that omicron is the last variant, that it’s over after this. And that is not the case because this virus is circulating at a very intense level around the world,” Maria Van Kerkhove, the WHO’s Covid-19 technical lead, said during a coronavirus update in Geneva.

New infections have increased by 20% globally over the past week with nearly 19 million total reported cases, according to the WHO. But Van Kerkhove noted that new infections that go unreported would make the real number much higher.

Dr. Bruce Aylward, a senior WHO official, warned high levels of transmission give the virus more opportunity to replicate and mutate, raising the risk that a new variant will emerge.

“We don’t fully understand the consequences of letting this thing run,” Aylward said. “Most of what we’ve seen so far in areas of uncontrolled transmission has been we paid a price for the variants that emerge and new uncertainties we have to manage as we go forward.”

Van Kerkhove said now is not the time to relax public health measures, such as curtailing mask wearing and physical distancing. She called on governments to strengthen those measures to bring the virus under better control and head off future waves of infection as new variants emerge.

The World Bank has also warned that global growth will “decelerate markedly” this year, but the Omicron variant of Covid-19 that is spreading rapidly worldwide could make the situation worse and exacerbate labor has shortages and supply chain snarls.

This deadly virus for almost three years has shattered the global economy and affected the lives of global, and there is still controversy over the origin and main cause of this global calamity.

The developed countries despite their claims and producing vaccines have been unable to curb this disease and the death toll in those countries has returned to the upward trend and sometimes is bigger than the under developing states.

The Islamic Republic of Iran has been one of the successful countries in controlling this disease comparing to the boastful developed countries but it needs a sincere and collective cooperation by the whole people in the country to surmount this nasty virus which has disrupted many social and economic activities.

Iran despite sanctions has done great in minimizing the death toll of this disease but any indifference and easy-going attitude by the people may help the resurface of this deadly virus as many epidemiologists in the country have warned.

As President Seyed Ebrahim Raisi and other health ministry officials have asked the people, observing the COVID-19 related health protocols and vaccinations can bring peace and health to the public and especially to the medical staff who are really exhausted of almost three years of efforts to treat the COVID-infect patients but each time one negligence causes the re-emergence of the disease which costs dear for the country either in terms of medical or human life cost.

It is time for the nation to work together to overcome this disease which is only possible through observing health protocols and vaccinations otherwise this cycle of concerns will continue in the country and will paralyze lives and economy in the country like what we have so far seen even in the developed countries.

So far according to the official statistics more than 132,000 Iranians have lost their lives because of this disease as the figure of infected people is rising again, and we should not let it rise because it will have negative impact on any realm of activities in the country. Negligence and indifference regarding the protocols will once again pull the detonator of devastating “virus bomb” in the country and the number of casualties would rise.

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Given that the country’s need is met in terms of vaccination, the Ministry of Health approved to export 20 percent of domestically produced vaccines, Kamal Heydari, the deputy health minister, said.

“We intend to use domestic products in the reminder dose and measures have been taken in this regard,” he stated, adding, homegrown vaccines have good immunogenicity and efficacy to be booster doses.

Health Minister Bahram Einollahi has announced on Sunday that from now on no coronavirus vaccines will be imported to the country, emphasizing that the priority is given to domestic products.

Homegrown vaccines

According to the Food and Drug Administration, 14 vaccines are being domestically developed in the country which are in different study phases.

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.

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.

Fakhra vaccine, the third domestically-developed COVID-19 vaccine, was unveiled and started the clinical trial on March 16.

Lately, the Food and Drug Administration issued an emergency use license for two other domestic vaccines of Razi Cov Pars and Fakhra.

The Iranian-Australian Spikogen vaccine and Pastu Covac, developed jointly by the Pasteur Institute of Iran and Cuba’s Finlay Vaccine Institute, are other homegrown vaccines, which have received the emergency use license.

Iran is one of the few countries that has all vaccine production platforms, Mohammad Reza Shanehsaz, former head of the Iranian Food and Drug Administration, said in June.

Meanwhile, World Health Organization (WHO) representative to Iran Jaffar Hussain said in September that the Organization was collecting the necessary information for the registration and certification of Iranian-made coronavirus vaccines.

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