What are the characteristics that distinguish Cuban vaccines against COVID-19?

How is the international recognition, and the evaluation by WHO, of Cuban vaccines against COVID-19 going?

Clinical studies showed the Cuban vaccines against COVID-19 have over 90% efficacy.

By Liz Conde Sánchez | internet@granma.cu

More than a year after the beginning of the massive anti-COVID-19 vaccination in our country, Cuban vaccines against the pandemic continue to prove to be safe, effective and capable of controlling the epidemic, even against the new highly contagious variants of the virus appearing in the world.

The sustained control of the incidence of the disease on the Island is a reliable proof of this.  Another one is the growing international recognition obtained by Cuban vaccines, regardless of the progress of the recognition process by the World Health Organization (WHO).

In an interview, with Dr. Eduardo Martínez Díaz, president of the BioCubaFarma business group, he listed the characteristics that make Cuban vaccines stand out, the evidence that proves their effectiveness, the international recognition they have obtained, and the evaluation process by the WHO.

- What are the characteristics that distinguish Cuban vaccines against COVID-19?

- Cuban vaccines against COVID-19 have several characteristics that make them stand out among others that have been developed.

"First, they have proven to be very safe.  After dozens of millions of doses applied, in Cuba and in other countries, it has been observed that adverse events are mild and with a very low frequency, even in pediatric population from two to 18 years old, which is a unique experience in the world to date.

"These are not casual results; the very nature of the technological platforms used and the design of the vaccines justify them.

"Secondly, these vaccines have high thermo-stability.  Unlike others that require special conditions for storage, at freezing temperatures, ours can be stored between 2 and 8 degrees Celsius.

"They have even been shown to maintain their quality characteristics at temperatures above 30 Celsius degrees for at least a week, making them attractive for use in poor countries where there are difficulties in maintaining the immunogen's cold chain.

"Thirdly, Cuban vaccines have proven to be very effective.

"In the clinical studies carried out, they have proven to have an efficacy of over 90 %.  However, the most important evidence of their effectiveness was the decrease in the transmission of the disease in Cuba, starting October 2021, when the population have been immunized in 60% using Abdala and Soberana vaccines."

- How effective have Cuban vaccines proven to be against the Omicron variant?

- Cuban vaccines have proven to be effective against the Omicron variant, the most infectious variant of this disease known so far.

"Epidemiological evidence proves it. In Cuba, unlike most countries in the world, the peak of infections with the Omicron variant and its subvariants have been lower when compared to the previous ones, including the peak with Delta.

"Undoubtedly, the effectiveness of the vaccines created by our scientists against these new SARS-COV-2 strains and the vaccination strategy have a lot to do with this behavior on the island.

"We have found, in laboratory studies done in Cuba and in other nations, that the antibodies induced by Cuban vaccines neutralize the Omicron variant.  While some vaccines report a decrease of up to 20 times in their capacity to neutralize the Omicron variant of SARS-COV-2, compared to the original, Cuban vaccines only decrease this neutralization capacity by two times.

"This phenomenon we are observing has its explanation in the nature of the antigen we use and the very design of our vaccines.

"The Abdala and Soberana vaccines use the RBD antigen, that is, the spike (S) protein region, which binds to the virus receptor in the cell.

"The RBD antigen has been found to induce neutralizing antibodies against a conserved region of that protein among the different variants of the virus, possibly because of the importance of that region in the functionality of the virus; therefore, mutations in this area of the protein are not selected.

"However, when immunized with the complete spike (S) protein, this conserved region is not immunodominant, in other words, antibodies are preferentially induced against other areas of the protein, in which there is a high rate of mutations, and a process of selection of variants that escape recognition by neutralizing antibodies occurs.

"Most of the vaccines currently on the market use the spike (S) protein as antigen, which has generated the phenomenon of successive pandemic peaks resulting from the appearance of variants of the virus that escape the immunity generated by these vaccines.

"We defend the hypothesis that vaccines based on the RBD antigen may constitute a universal booster for the rest of the vaccines against COVID-19, amplifying a protective immunity against the different variants of the SARS-COV-2 virus, which have circulated or could appear in the future.

"Recently, several groups of scientists around the world have published papers supporting this hypothesis."

- How is the international recognition of Cuban vaccines advancing?

- All these results have been published in recognized scientific journals, which means, they have been reviewed by international experts, in a peer review process.

"To date, more than 20 scientific articles have been published in high-impact journals and other reports are being prepared.

"Cuban vaccines have also been evaluated by regulatory authorities in several countries, which have finally granted the Emergency Use Authorization.

"Eight countries have given this authorization so far and others are evaluating them.

"Not so long ago, a group of experts and scientists from prestigious institutions in the United States, the Caribbean and Africa visited our country and had access to all the information available on the results obtained, held meetings with specialists, doctors, scientists and technologists, both in health institutions and in biotechnological facilities, recognizing the work done and the quality of Cuban vaccines, and issued a public report".

- How is the process of evaluation and recognition of Cuban vaccines by the WHO going?

-The WHO recognition process started this year, and several steps have been taken in line with the established procedures.

"Information from the Abdala vaccine dossier has been sent and is being exchanged with those authorities.

"However, one of the components of the evaluation process is behind schedule.

-The delay is due to the visit of WHO experts to the plants where the vaccines are manufactured.

"We had prepared this visit to take place at the end of the year at the production facilities of the CIGB-Mariel biotechnology complex, where the production of the Abdala vaccine is being transferred.

"Although the production line, in which the formulation, filling and packaging operations of that complex are already active and producing, the line in which the recombinant products are manufactured has delays in its start-up.

"This delay is given because it has not been possible to make the payments to the company in charge of the start-up of the equipment and systems of that production line.

"We have been trying for nine months to make the payments, which have not been possible due to the refusal of several banks to make the transfer operation.

"Notwithstanding these difficulties, we’ve made progress and we hope that the WHO evaluation process will be completed in 2023."

Translated by ESTI

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Covid is forever

COVID: THE FEARFUL SYMMETRIES

By Professor Gilbert Morris

IMAGINE: a new brutal variant that exceeds the protection of vaccines…

The Samurai is the finest master of self-discipline the world has ever known; more Stoic than the Stoics of ancient lore, more vicious than the Cossacks of Russia or the Gurkhas of Sri Lanka (the most fearsome worries of modern times).

One core element of Samurai culture is he must contemplate his death dozens of times in a day: he must cultivate commerce and comfort with the varieties of death’s multitudinous propensities.

As a strategist, one’s brief is to show clients the varieties of means, methods, incidences, architectures and emerging possibilities of the death of their enterprises; whether they be companies or countries.

There is a childish notion in modern culture by which disease of the mind, the Samurai imperative is avoided. People say things like: “couldn’t you put a positive spin on that”? As if strategy is their favourite ice cream or pizza, upon which they can heap their desired delights!

Others plead, “let’s look at the bright side”, as if one is the marketing and promotions department.

The strategist is a scavenger of risk: his job is to induce discomfort based on the most realistic analysis, not by prediction or even forecast, but by immediate extrapolation from the factual circumstances.

Where the lazy analyst says “well, thing A could likely impact thing B. The competent strategist demonstrates A and B are extremes of a single continuum.

Or where the fawning ‘yes man’ says: ‘things go in phases, there are always ups and downs’, the master strategist shows the phase-guide lacks structural depth or systemic coordinates.

Where the fool treats “success” as organic. The strategist framed it as a “success window”, that is already closing at the moment of its most obvious prowess (Ask Nokia or IBM).

The role of the strategist is to game the situation, enterprise or national prospects in such a manner, at such a scale and with such dimensional scope as to force the client out of complacency into innovation…before the risk metastasises or is realised; to drive the client into the Samurai imperative.

Let’s take the current pandemic: In 2020, I gave four 90 minute lectures on the history, logistics and economic consequences of pandemics from the 4th Century AD to the present. In interviews leading up to the lectures I extrapologised the following:

1. Covid is forever

2. Covid will change the world more in 3 years than the last 300

3. Countries will optimise to save lives but will cost more lives by the measure they impose

4. Democracy under the pandemic will transition to a power vertical with the public’s safety as an excuse

5. Variants will outrun vaccines

6. Vaccine visas will emerge

7. You have to check into countries the way you check into hotels

8. Health records will become the new identity

9. No country will arrive at “herd immunity”, because of the lack of global coordination

10. A variant will emerge and generate so much fear that citizens and governments would turn on each other

I am satisfied that all of these have proven true…yet, it does not have to be this way: the strategy for which I argued was/is:

1. Universal free testing, with 48 billion free tests in an 8 week period

2. Upload tests to a database to gain pattern and flow of the virus

3. Deploy Blue tooth contact tracing and digital diagnostic surveys to overlay the Fibonacci patterns as the emerge

4. Make decisions from data/extrapolations and not events, because humans react arithmetically but pandemics have exponential velocities.

5. Hold global summit to streamline boarder entry protocols

6. Embark $4.5 trillion for global stimulus (using SDRs) rather than raising interest rates

Across the world, only 8 nations gain a measure of these protocols.

Now, today, during this holiday season, in more than 9 European nations, citizens will suffer lockdowns again because of the result of poor, reactionary Covid management by their governments.

In the US, governors of more than 7 states are openly defying basic public health management measures for purely political reasons.

In much of the rest of the world, useless national dashboards, fascistic attacks on unvaccinated persons, desperate copycatting and inflexible, convoluted procedures rule the day: the result will be VARIANTS!

I seem to see (to quote the ancient Seer) that this is all metastasising toward an eschatological global health crisis orders of magnitude beyond what we’ve witnessed or suffered so far. This level of global leadership vacuum and incompetence cannot continue without consequences.

IMAGINE: a new brutal variant that exceeds the protection of vaccines…countries would slam their doors shut, the global economy would collapse, within countries, their oligarchical structures would undermine public trust, billions of children would go uneducated, those with non-Covid medical complaints would die in equal numbers to Covid sufferers. That is to say…our social worlds are poised to retreat by fear, ignorance and hysterical speculation into the worlds imagined in Zombie apocalypses.

Terrifying?

This is what a Samurai would imagine, given what we are witnessing…then he would act to prevent it.

The problem is…it’s happening now!

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