- BBC News World
Venezuela this week became the second country in America -after Cuba- to start using a vaccine that has not yet been approved
The government of Caracas received from Havana and began to administer in areas of the capital the first shipment of Abdala, a vaccine candidate developed by the island that still does not have emergency authorization from any regulatory medical entity.
The arrival of the first batches (it has been officially said that they will be received around 12 million doses) took place a few days after authorities of the Cuban pharmaceutical industry presented the results of the third phase of study of two of its most advanced vaccines.
As they assured, one of them, Soberana 02, would have an efficacy of 62%, with two doses, while Abdala -the one that arrived in Venezuela-, with three, would be more than 92%, which would make it one of the most effective of those developed so far against the coronavirus.
These effectiveness results, however, have not been validated. by any regulatory agency, have not been published in a scientific journal endorsed by peers or received the approval of any international or regional health organization.
This led to the decision of the Venezuelan government to use a vaccine to which not even Cuba has given an emergency authorization, generated controversy.
The Academy of Medicine of Venezuela, the non-governmental Doctors Unidos por Venezuela and the Association of Researchers of the Venezuelan Institute of Scientific Research (AsoInIVIC) expressed “worry” before what they considered “products of doubtful scientific credibility”.
The Venezuelan opposition has also pointed out that the closures of centers where other vaccines were administered that had arrived in Venezuela after Abdala’s arrival.
“What happened to the vaccines of the Covax system? Now Venezuelans are totally defenseless and without the possibility of choice before the imposition of the biological product Abdala without WHO approval. We demand approved vaccines for all,” the Communication Center wrote on Twitter Nacional, the account of the “presidency” of the opposition leader Juan Guaidó.
The Venezuelan government, for its part, considered that the reception of the Cuban doses was a “historic moment“and announced that Abdala would join the other doses used in its vaccination schedule against the coronavirus.
“With the main objective of protecting the health of the Venezuelan people in the midst of the covid-19 pandemic, the first doses of the Abdala vaccine, developed by Cuba, arrived in the country,” the Venezuelan Foreign Ministry said on Twitter.
What is known about Abdala
Cuba has extensive experience in the development of vaccines and for more than three decades it has created a large part of the immunizations it uses for its population.
At the beginning of the pandemic, the Cuban government decided not to participate in the Covax mechanism, which seeks to bring approved vaccines to the poorest nations, but instead opted for develop your own dosages.
To date, the Cuban medical authorities claim to be developing five vaccines against the coronavirus, of which Soberana 02 and Abdala, as they have said, are the most advanced.
The only information available from Abdala is that provided by Cuba.
So far, no scientific journal has published any study on this vaccine candidate.
Immunization was developed by scientists from the Center for Genetic Engineering and Biotechnology (CIGB) and takes its name from a poem written in his youth by the Cuban writer and national hero, José Martí.
Cuba has said that for both Soberana 02 and Abdala, they have used a technology known as “subunit vaccine” in which virus-derived proteins “conjugated” to other carrier proteins are used to trigger an immune response.
In the first case, they bind the virus antigen to a tetanus toxoid and aluminum hydroxide and in the second they use a culture in yeast cells.
Cuban health authorities recommend for Abdala an immunization scheme for three doses (the highest number of doses among existing vaccines), administered within 14 days.
As they have said, with this candidate the greatest protection after 42 days (In most internationally approved vaccines it is two weeks).
Cuba completed the third stage of study of this candidate at the end of April, although it had already begun to administer it to “risk groups” of its population without even completing the clinical trials or knowing effectiveness data.
Last week, the CIGB announced on Twitter that its vaccine had “an efficacy of 92.28%, in its three-dose scheme“.
“That victory is only comparable to the size of our sacrifices. And it is a clarion call from the poor of the earth, a warning of the power that resistance, unity, consecration and love for the country give so beautifully described by Marti’s verses. in Abdala, “Cuban President Miguel Díaz Canel wrote on Twitter.
In their report, the Cuban authorities did not offer data on Abdala’s effectiveness against the variants of the coronavirus, although they affirmed that there was a “high probability” that it would work against those that “were mostly circulating.”
The data they made public just showron efficacy against symptomatic disease.
The information on the effectiveness against severe and asymptomatic forms of Covid-19 is still unknown, a data that international pharmaceutical companies have generally published along with the effectiveness against symptomatic disease.
Last week, official media on the island reported that the CIGB had sent the documentation to the drug regulator in Cuba to opt for an emergency authorization, which it has not yet been granted.
The fact that Cuba began to mass vaccinate without even knowing the effectiveness results raised questions among the population, who even asked themselves on social networks why their leaders did not show themselves in public receiving the vaccine candidates to set an example and convey confidence.
The island’s health authorities said it was due to the island’s “epidemiological situation” as the dose had been shown to be safe.
The arrival of the vaccine in Venezuela generated a similar controversial situation: although by then Cuba had already assured that its vaccine was effective, no independent regulatory or scientific entity had endorsed these data.
As the Pan American Health Organization previously explained to BBC Mundo, the decision of which vaccine to use, how and when is one “sovereign decision” of each country.
“PAHO does not participate in these actions and only recommends using vaccines when the three phases of clinical trials have been completed and the vaccines are approved by a regulatory agency or included by WHO in its list for emergency use,” said a statement sent. last May to BBC Mundo.
According to the text, PAHO / WHO enters the process when the producer submits their vaccine to WHO for evaluation and inclusion in the emergency use list.
“And for this you have to have passed the three phases, be published in a scientific journal, and if it is also approved by a regulatory agency, that makes the process faster, “he added.
The fact that it has begun to be used in Venezuela without complying with all these requirements led to numerous questions from independent medical organizations.
“The credibility of any vaccine, and its acceptability by the community, is largely based on the publication of the results in prestigious scientific journals,” the National Academy of Medicine of Venezuela said in a statement.
In that sense, he questioned that the main source of information on the two Cuban products it has been the Granma newspaper, official organ of the Communist Party, and official Cuban media.
The AsoInIVIC also criticized the lack of valid scientific information on Abdala and questioned that they had reached Venezuela even before the island’s own drug governing body approves it.
“We consider that the biological Abdala is still a vaccine candidate, therefore its administration should be carried out under the clinical trial modality in our country, with the informed consent of the volunteers,” he indicated.
What the Venezuelan government says
The Venezuelan government has defended Abdala’s effectiveness and considered his arrival in Venezuela a “triumph.”
“This extraordinary vaccine, which has one of the best efficacy in the world, will be incorporated into the immunization process of Venezuela and it will be the people who enjoy it,” said Vice President Delcy Rodríguez.
It also considered that Cuba, with its vaccine candidates, was “giving ethical, moral, scientific and technological lessons“.
“Here is the triumph of Cuba, and it is a very significant day to be able to share in our homeland the arrival of the Abdala vaccine, presented just two days ago to humanity with an efficiency of more than 92%,” he added.
Although Cuba and Venezuela are the first countries in the Americas to begin to inoculate their population with vaccine candidates, they are not the only ones in the world they have.
Last July, China approved its vaccine, then in the third phase of clinical trials, for use among its military forces and a few days later, Russia authorized Sputnik V when it was still in phase II.
The government of India, last January, also gave emergency authorization to two national vaccines that had not completed the third phase of clinical studies.
Venezuela, with some 28 million inhabitants, has received from February to the end of June about 3.5 million Russian and Chinese vaccines, according to official figures, which is why the vaccination plan has been slow.
The government assures that it managed 5 million vaccines through Covax, which have not arrived, as they have said, because there are four “blocked” payments.
“The rich countries have sabotaged this solidarity mechanism to distribute vaccines in the world (…) They intend to use vaccines as a political instrument, of blackmail, of extortion, such as the blockade against Venezuela,” said Rodríguez.
Official data indicate that coronavirus cases in the country exceed 269,000 and 3,000 deaths, although medical unions and opponents consider that the figures are higher.
Now you can receive notifications from BBC Mundo. Download our app and activate them so you don’t miss our best content.
Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.