Cuba, one step away from requesting WHO approval of its vaccines

RIO DE JANEIRO, BRAZIL – As soon as the national regulatory body approves them, Cuba will begin the process to certify its vaccine candidates against covid-19 Abdala and Soberana 02 to the World Health Organization (WHO), after they registered an efficacy of 92% and 62% in clinical trials, respectively.

“The exchange with WHO/PAHO has been constant during the whole process” and the dialogue, “permanent”, assured this Thursday the director of Science and Innovation of the state group Biocubafarma, Rolando Pérez, in a press conference to inform about the development of the two potential vaccines and the next steps after knowing their preliminary efficacy data.

The World Health Organization (WHO) establishes that for a vaccine candidate to be considered a vaccine against the coronavirus, it must demonstrate efficacy equal to or greater than 50%.

Soberana 02, from the Finlay Vaccine Institute (IFV), showed 62% efficacy with a two-dose schedule in a trial with 44,010 volunteers. At the same time, Abdala, from the Center for Genetic Engineering and Biotechnology (CIGB), was tested with a sample of 48,000 people in a three-dose schedule and reached 92.2% efficacy, according to data disclosed by these institutions.

FROM CANDIDATES TO VACCINES
The main executives of Biocubafarma, CIGB, and IFV indicated that the dossier to request the emergency use of Abdala has already been submitted to the Center for State Control of Medicines, Equipment, and Medical Devices (Cecmed). In contrast, that of Soberana 02 will be submitted in the next few days.

Once this authorization is obtained, which means the conversion of the vaccine candidates into vaccines, their massive administration will begin in Cuba, which maintains its goal of immunizing this year the entire population (11.2 million) and hopes to become the first country in the world to immunize its entire population with its own vaccines.

This step will also make them the first vaccines against coronavirus developed in Latin America.

Read also: Check out our extensive coverage on Cuba

Biocubafarma’s deputy director, Eulogio Pimentel, said that since the efficacy data were released between the end of last week and the beginning of this week, they have received communications from several countries interested in the Cuban formulas.

INTERNATIONAL INTEREST
Countries such as Venezuela, Argentina, Mexico, and Vietnam had already shown interest in the potential Cuban vaccines’ last months. In contrast, Iran -where Soberana 02 was also tested- has announced the imminent emergency use of that formula, renamed Pasteur.

On Thursday, a donation of 30,000 doses of Abdala also arrived in Venezuela, which wants to buy 12 million units.

However, the president of Biocubafarma, Eduardo Martínez, regretted that the island has encountered “serious logistical difficulties” in the leap to large-scale production since it cannot have all the necessary inputs and materials.

The scientists attributed these problems partly to the U.S. embargo and partly to the shortage of these products due to the high demand during the pandemic. For now, they maintain their objectives of producing “tens of millions” of doses, with which they hope to cover both domestic and export demand.

ALTERNATIVE FOR POOR COUNTRIES
Another advantage of the Cuban vaccine candidates is that their conservation requires 2 to 8 degrees Celsius, which, according to Martínez, makes them a good alternative for countries with few resources where it is difficult to maintain the cold chain.

The executive also pointed out the advantage that this type of vaccine allows the administration of booster doses “if it is necessary to reactivate”.

Both are subunit vaccines -traditionally very safe- based on the receptor-binding site (RBD) of the S protein of the virus. However, in Soberana 02, this element binds to the inactivated tetanus virus to boost the body’s immune response.

The two formulas are already being administered to tens of thousands of Cubans under health intervention studies and in parallel to clinical trials as a strategy to curb contagions on the island, which is going through the third and worst wave of the pandemic.

More than 2.2 million people have received at least one dose of Abdala or Sovereign 02.

To date, the Caribbean country has accumulated 174,789 positives and 1,209 deaths from covid-19, according to data from the Ministry of Public Health (Minsap).