Photo by Ivan Diaz
9 February 2021, Issue 1084
Cuba is scaling up its bio-pharma production facilities to manufacture millions of doses of its COVID-19 Soberana vaccines.
Speaking on the television and radio programme, Mesa Redonda, Eduardo Martínez, the President of the Business Group of BioCubaFarma, said that Cuba is currently working on having the capacity to produce 100m doses of its injectable vaccines to satisfy the needs of the country and other nations.
“Once we have the results, we will have doses of vaccines to begin a vaccination campaign and our country will be one of the first to be able to immunise its entire population”. Martínez however cautioned Cubans that until the studies are complete it was not possible to say that they are effective. “March and April will be decisive months for Cuban vaccines and we are confident that the results will be what we expect, and we will be able to enjoy the Soberanos”, he told the programmes viewers.
Martínez also noted that Cuba was intending developing the manufacturing capacity to guarantee the production of all four of Cuba’s candidate vaccines’ – Soberanas 01 and 02, Mambisa, which is administered intranasally, and Abdala, an intermuscular vaccine that has antibody values up to four times higher in those receiving it than before vaccination – and had begun research into emerging COVID variants.
Also speaking on the same programme, Vicente Vérez, the Director General of the Finlay Institute, which with BioCubaFarma has developed and is overseeing Cuba’s vaccine development programme, said that Cuba is already manufacturing 100,000 doses to support the clinical trials of its two leading Cuban candidate vaccines, Soberana 01 and Soberana 02, and expects in April to be producing 1m does for trial purposes. Vérez said that clinical trials of both will also begin for young people between five and 18 years of age at the end of February.
It is expected that Soberana 02, which has been reported to have produced more efficacious results than Soberana 01, will on 1 March begin Phase III clinical trials involving 42,600 volunteers. Vérez said that third stage trials of Soberana 02 will involve two doses plus one booster. This booster, he explained, will be from either candidate vaccine, and will induce a viral neutralisation immune response.
Vérez said that although Soberana 02 started its Phase I clinical trial later than Soberana 01, it has progressed faster. “Its Phase I trial showed that it is a very safe vaccine, which allowed us to move to Phase II”. In tests, he said, it had been found to result in a significant number of people creating higher levels of antibodies and that more than 70% of the people vaccinated in the Phase I trial showed a strong and specific cellular response generating memory.
Having two candidates at the same time, he said, made it possible to make the decision to apply the third dose to all the people who participated in the Phase I trial. Vérez said that the aspiration is to start the Phase III study in the month of March in various municipalities of Havana.
In his remarks, Vérez stressed that in commercialising the vaccine Cuba would adopt a strategy that combines humanity and its impact on world health. He said that foreign visitors who arrive in the country and want to be vaccinated with the Cuban vaccines will be able to do so.
Also appearing on Mesa Redonda on 4 February, Dr Eduardo Ojito, the Director General of the Centre for Molecular Immunology (CIM), said that the pharma enterprises AICA and BIOCEN already had the capacity to enable more than 100,000 vaccine vials to be filled daily in each plant.
CIM’s Director stressed that BioCubaFarma had to fight very hard to obtain the necessary raw materials, as many suppliers had demanded that nothing the company used has a component that came from the US market. “This has led us to seek internal solutions in the country to strengthen our position as producers”, Ojito explained.
“They are reasons enough to tell our people to be calm and have confidence. The technologies are available and ready for when the regulatory authority approves Phase III [of the Soberana vaccines] to begin mass production and distribution”, he said.
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