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.
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.
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.