Cuba Seeks WHO Backing for its Covid-19 Vaccines

An elderly woman receives the third dose of the Cuban Abdala vaccine against the SARS-CoV-2 virus, developed by the Cuban Carlos J. Finlay Institute, based in Havana. The government has set out on stepping up vaccine production so that 92.6% of the population aged over 2 years old will have been vaccinated by the end of November. Photo: Jorge Luis Baños/IPS

By Luis Brizuela  (IPS-Cuba)

HAVANA TIMES – Cuba will soon begin the prequalification process before the World Health Organization for its COVID-19 vaccines Abdala, Soberana 02 and Soberana Plus. Once it has the WHO’s backing, doors will open for Cuba to distribute its vaccines worldwide.

While very few details have been revealed about this exchange, WHO certification entails a rigorous assessment of phase II and III clinical trial results of the vaccines, as well as additional information about safety, efficiency, quality, and its risk management plan.

It will also include independent experts and WHO teams revising documentation, as well as in situ inspections of lab production.

Directors of the biotech sector have said that they have been sharing information with Cuban representatives at the Pan American Health Organization and World Health Organization (PAHO/WHO) ever since the first stages of vaccine development, and they have always been given updates about results.

“Strengths of the Cuban vaccines include the fact that they have been developed by highly prestigious institutions and with over 30 years of experience,” the Cuban representative at PAHO/WHO, Jose Moya, told IPS.

The biotech industry on this Caribbean island has been making breakthroughs since the ‘80s, and produces eight out of the 11 vaccines on the national immunization schedule, as well as medicines and high value supplies that satisfy some of the universal and free public health system’s needs.

Some noteworthy examples include the vaccines against Meningitis B and C and Heberbiovac HB, against Hepatitis B, the latter gaining WHO prequalification and was then used in the Americas, Moya pointed out.

“Cuba’s Center for State Control of Medicines and Medical Devices (CECMED) is a Level 4 National Regulatory Authority and is a point of reference for PAHO within the region,” the director highlighted when talking about the island’s credentials in the biotech industry.

Cuba is the first country in Latin America and the Caribbean to have its own vaccines against the SARS-CoV-2 virus, which causes COVID-19.

With results from the three phases of clinical trials and in view of national legislation, CECMED guaranteed that Abdala, Soberana 02 and Soberana Plus comply with standards to be considered vaccines and approved their emergency use in this country with 11.2 million inhabitants.

Vials of Soberana 01, Soberana 02 and Soberana Plus vaccines, produced by Cuba’s biotech industry. Acquiring WHO’s prequalification will open up doors for Cuba to mass distribute their vaccines worldwide, and they could even be included in the international COVAX program, which is led by the United Nations. Photo: Jorge Luis Baños/IPS

However, prequalification and including Cuban vaccines on the list of WHO’s emergency use vaccines is a condition for mass supply via the COVAX program, which is under the umbrella of the United Nations and seeks to ensure swift and fair access to vaccines to every country.

It also allows national regulatory agencies to speed up approval for importing them and administrating them to their own population.

Without the WHO’s backing, Cuba can still distribute its vaccines, but only via bilateral agreements.

On August 31st, the New Molecules Committee at the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) in Mexico issued a positive technical opinion about Abdala, considered a first step for its potential authorization for emergency use in this country of 130 million inhabitants.

Earlier, on June 19th, Iran’s Pasteur Institue authorized the emergency use of Soberana 02, which is commercialized there under the name “Pasteur”, in accordance with an agreement signed in Havana on January 8th, for technological transfer and complementarity in research.

The Headquarters of BioCubaFarma’s Biotech and Pharmaceutical Industries, in the Cuban capital. Cuban authorities say that the biotech industry has the conditions it needs to produce 100 million doses of local vaccines, this year. Photo: Jorge Luis Baños/IPS

Speeding up vaccination

The Cuban government has set out on stepping up vaccine production so that 92.6% of the population aged over 2 years old will have been vaccinated by the end of November, including people with allergies and those who have already suffered COVID-19.

Based on these indicators, the government is planning a gradual return of some 2 million students to classrooms, and a gradual opening up its borders in mid-November.

The pandemic has severely hit the strategic economic sector of tourism, which in combination with a stricter US embargo, and other factors, has led to an almost 11% decline in the gross domestic product (GDP), in 2020.

Advancing with vaccination coincides with the circulation of the highly contagious Delta variant, which according to experts, is responsible to a great extent for the spike in infections and higher COVID-19 death counts on the island.

Ever since April, Cuba has been navigating its worst period with the pandemic, with things getting a lot worse in July and August which pushed hospital services and isolation centers to their limit, as well as oxygen supplies in many of the country’s 15 provinces.

This country has a toll of 6,056 deaths and 720,739 COVID-19 infections, according to official statistics released on Thursday September 9th.

Read more from Cuba here on Havana Times.

2 thoughts on “Cuba Seeks WHO Backing for its Covid-19 Vaccines

  • First case of Covid 19 11th March 2020
    Reported deaths March 2020 – July 15, 2021 (16 months) 1,726
    Reported deaths 15 July 2021 – September 9, 2021 (2 months) 4,330 bringing total deaths to 6,056
    Clearly since July, there has been a massive increase in levels of infection.
    The gamble of opening up, is entirely dependent upon the success or failure of the Cuban vaccines, as Cuba chose not to join COVAX. The success or failure of opening up to tourism in November is entirely dependent upon the Cuban vaccines – which require three doses. What will be the level of infections carried by Russian tourists?
    I wish success, but the risk level is high.

  • I am skeptical that Cuba will continue with the rigorous WHO approval process. Cuban vaccines, in particular, and Cuban pharmaceuticals, in general, are less strenuously tested prior to public use. There are are simply fewer Cuban scientists and fewer study participants to provide adequate independent analyses. To the extent that these 3 Cuban vaccines are submitted for approval, it will be a first time that the world’s leading scientists will put the Cuban products through the rigors that others have to face on a regular basis. Again, I doubt that Cuba will pass the test.

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