Photo: pl
Besides Soberana Plus, another Cuban immunizer, Soberana 02, reached the old continent.
Soberana 02, designed at the Caribbean Island’s Finlay Vaccine Institute (IFV), like Soberana Plus; received the green light for partial production in Italy since April thanks to an agreement between the said company and the company ADIENNE Pharma & Biotech and the Agency for Economic and Cultural Exchanges with Cuba (AICEC) -both Italian-.
The memorandum signed during the BioHabana 2022 Congress will allow the island’s immunogen to be formulated, bottled and packaged in the European country.
On that occasion, the Director General of the IFV, Vicente Vérez, indicated that the agreement was finalized as he was thinking of a possible date for the launch of this vaccine in Europe or even North America. “This requires alliances to share the science,” he stressed.
Vérez also explained that in a second phase they want to evaluate whether they could be fully manufactured in this Italian company Soberana 02 and other IFV vaccines.
With Italy, the threads that bind the armored personnel carrier’s anti-COVID-19 products are stronger. In November 2021, about 30 people between the ages of 19 and 59 traveled from that country to Cuba to volunteer for the Soberana Plus Turin clinical trial.
The aim of the study was to evaluate the immunogen in convalescents from COVID-19 and subjects with no history of disease but immunized with other vaccines.
As a background for this joint analysis, since July last year, sera from Cuban volunteers vaccinated with Soberana Plus have been evaluated at the “Amadeo di Savoia” hospital in the city of Turin.
The results demonstrated the ability of Soberana Plus to induce neutralizing antibodies against the alpha, beta and delta variants of the SARS-CoV-2 coronavirus, which causes the disease.
As the world’s first company specifically designed to re-stimulate immunity previously induced by other anti-COVID-19 vaccines or by natural infections, Soberana Plus has also been used in Cuba as a booster dose in the anti-COVID-19 vaccination regimen, which was developed by the IFV of two doses of its other product Soberana 02.
The combination of the two showed 92.4 percent efficacy against symptomatic disease in clinical trials, according to the report on the final results of the phase III study of Soberana 02.
This was the schedule used for anti-COVID-19 vaccination in children aged 2 to 18 in the country, the first campaign worldwide to reach more than 1.7 million infants.
The Cuban authorities described the vaccination in pediatric age as a “complete success”; Well, about 70,000 cases have been avoided, and no child has died from COVID-19 in Cuba since 2021.
The “sovereigns” are not only known in Europe. Soberana 02 came to Iran in early 2021, when it was still a vaccine candidate, with the aim of complementing Phase III of its clinical trials.
“As part of the collaboration with other countries in the development of vaccines against COVID-19, 100,000 doses of Soberana02 have been sent to the Iranian Pasteur Institute, which is used in clinical trials in that country,” announced the BioCubaFarma group of companies.
At the end of June of the same year, Soberana 02 received approval for emergency use in the Islamic Republic of Iran. The approval was granted to the Pasteur Institute of Iran (IPI), which will commercialize the vaccine on Iranian territory under a collaborative agreement signed with the Finlay Vaccine Institute.
In this way, the Persian country was the first in the world to produce Cuban anti-COVID-19 vaccines.
A center for the serial production of the PastoCorona vaccine injection was inaugurated in this country, which was the result of the transfer of the technology of the Cuban Soberana 02 vaccine to the Pasteur Institute.
On this side of the world, in Nicaragua and Venezuela; Both Sovereign 02 and Sovereign Plus are approved for emergency use.
Soberana 02 is among the vaccines approved by Venezuelan health authorities for use in children over the age of two, and a shipment of one million doses of Soberana Plus arrived in the Bolivarian country in early 2022.
Health officials said they will use this last drug to provide protection against re-infection by the Omicron variant.
For its part, the Nicaraguan regulator has indicated since October 2021 that Soberana 02 is offered as a safe-access therapeutic agent to reduce the transmissibility of Covid-19; particularly in the pediatric population aged two to 17 years.
Soberana 02 also reached the poor of children in the Sahrawi Arab Democratic Republic. In February, Cuba donated a batch of 458,000 doses of this vaccine for pediatric use to this country.
Abdala also protects outside of Cuba
Although the Sovereign lineage immunizers are already known in several nations; The same is happening with Abdala, a vaccine developed at the Cuban Center for Genetic Engineering and Biotechnology and the first in that country and in Latin America conceived against the SARS-Cov-2 virus.
Millions of doses of this immunizer have arrived in Vietnam, Mexico, Venezuela and Nicaragua. When used in a schedule of three doses every 14 days, it demonstrated 92.28 percent efficacy against symptomatic disease. Additionally, it showed 100 percent effectiveness in preventing serious systemic illness and death from COVID-19.
In September 2021, at the request of the Center for Research and Production of Vaccines and Medical Biologicals, the Vietnamese Ministry of Health approved the importation and use of the Abdala vaccine in this Indochinese nation.
That same month, the first batch of the Cuban vaccine arrived in that country, consisting of 900,000 doses purchased by Vietnam and another 150,000 donated by the Caribbean nation.
During the reception of this first shipment, Deputy Foreign Minister Dang Hoang Giang thanked Cuba for the doses, totaling 10 million, agreed with the largest of the Antilles, from which the technology to produce the vaccine in Cuba will also be transferred to Vietnam from that country.
In Nicaragua, Abdala has been licensed for emergency use since October 2021; while Venezuela signed a supply deal for 12 million units of the immunogen with the Caribbean island that same year.
At the end of 2021, the Federal Commission for Protection against Health Risks (Cofepris) of the Mexican government decided on the approval for Abdala’s emergency response.
As a national reference regulatory authority, qualified by the Pan American Health Organization; Cofepris decisions are recognized by several countries in the region, so the approved vaccines are likely to be used in other countries as well.
As a member of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use, all decisions of this authority are made on the basis of the technical and scientific knowledge presented.
In December of the same year, the Ministry of Health of St. Vincent and the Grenadines announced on its Facebook social media account that Abdala was available at vaccination centers in that country.
With this announcement, this nation became the first in the Caribbean Community (Caricom) to approve one of Cuba’s vaccines against Covid-19.
And the WHO certification?
Despite all the evidence presented above, many skeptics will say that Cuban vaccines are still not recognized by the World Health Organization (WHO); and they are not without reason; just clarify that; Although the problem is lasting longer than expected, any country can authorize the use of a vaccine, regardless of whether it is endorsed by this international organization or not.
However, this does not mean that Cuba will be stopped in this process.
This was recently confirmed by WHO Director-General Tedros Adhanom, who assured last May that the agency is following up the certification process for the anti-Covid-19 vaccines created and developed in Cuba.
Since March, the group of biotechnology and pharmaceutical industries of the Caribbean nation (BioCubaFarma) said on its Twitter account that the WHO has been informed of the finished document, which will be reviewed by experts and begin the process of international recognition of the Abdala vaccine .
The company noted on the same social network that the Center for Genetic Engineering and Biotechnology (CIGB) responsible for this immunizer started formal exchanges with the healthcare company this month.
In mid-February this year, the director of BioCubaFarma, Eduardo Martínez, explained that the company was working on the text, which consists of several chapters with results on clinical and preclinical research, pharmaceutical development, as well as anything related to productive facilities , one aspect , to which adjustments have been made.
Regarding the processes carried out with Abdala for this evaluation, Martínez pointed out that the decision was made to transfer the production site to the recently inaugurated Mariel plant, located in this industrial pole west of Havana.
Operating since November 2021, the CIGB-Mariel Technological Industrial Park is considered the most modern in Cuba and one of the most advanced in Latin America and the Caribbean, with quality control laboratories and warehouses for raw materials and finished products.
It also has facilities for obtaining the active ingredient of vaccines and complete immunogens in liquid, powder and spray formulations.
The aim is that the representatives of the WHO will also visit the production sites of this entity, where they will carry out the necessary inspection to later obtain the authorization and their inclusion in the list of products recognized by the United Nations Organization, stressed Martínez.
“Cuba always maintains exchanges with the WHO/PAHO representation on everything related to the prequalification of anti-Covid-19 vaccinees,” he said.
And the statement is no less true, since September last year the representative of the Pan American and World Health Organization (PAHO/WHO) on the Caribbean island, José Moya, reported to the AP agency about a virtual meeting between specialists from Havana , Geneva and Washington to exchange information , to coordinate documentation and to draw up schedules.
Cuba’s solidarity has not only wrapped the world in white coats; It also arrives in bulbs in several countries, which can save millions of lives. Vaccines developed on this island carry the dedication, effort and capacity of scientists with more than three decades of experience creating their own immunogens.
(taken from PL)