Cuba a step away from requesting WHO approval of local vaccines
By Lorena Cantó
Havana, Jun 24 (EFE) .- Cuba will begin the process to certify its Covid-19 vaccines Abdala and Soberana 02 with the World Health Organization (WHO) as soon as they are approved by its national regulatory body, after finding them 92 percent and 62 percent effective in clinical trials, respectively.
“We have maintained exchanges with the WHO and PAHO (Pan American Health Organization) and we keep them informed of the progress of the results that we have obtained. The dialog is permanent. We, of course, have already communicated with the PAHO office,” said the director of science and innovation of the state group Biocubafarma, Rolando Pérez, in a press conference Thursday.
The WHO establishes that for a vaccine candidate to be considered, it must demonstrate an efficacy equal to or greater than 50 percent.
Soberana 02, from the Finlay Institute of Vaccines (FIV), showed 62 percent efficacy with a two-dose schedule in a trial with 44,010 volunteers, while 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 an efficacy of 92.2 percent, according to data released by these institutions.
The main directors of Biocubafarma, the CIGB and the IFV indicated that the dossier to request the emergency use of Abdala has already been presented to the Center for State Control of Medicines, Equipment and Medical Devices, while that of Soberana 02 will take place in the next few days.
Once this authorization is obtained, its mass rollout will begin in Cuba, which maintains its objective of immunizing the entire population of 11.2 million this year and hopes to become the first country in the world to immunize its entire population with its own vaccines.
That step will also make them the first coronavirus vaccines developed in Latin America.
Nations such as Venezuela, Argentina, Mexico and Vietnam had already shown interest in having potential Cuban vaccines in recent months, while Iran – where Sovereign 02 was also tested – has announced the imminent emergency use of that formula, which was renamed Pasteur.
On Thursday a donation of 30,000 doses of Abdala also arrived in Venezuela, a country that wants to buy 12 million units.
However, the president of Biocubafarma, Eduardo Martínez, regretted that in the leap from large-scale manufacturing the island has run into “serious logistical difficulties” due to not being able to have all the necessary supplies and materials.
The scientists attributed these problems in part to the United States embargo and in part to the shortage of these products due to high demand during the pandemic, although for now they maintain their goal of producing millions of doses with which they hope cover both domestic and export demand.
The two formulas are already being administered to Cubans under health intervention studies and in parallel with clinical trials as a strategy to curb infections on the island, which is in its the third and worst wave of the pandemic.
More than 2.2 million people have received at least one dose of Abdala or Soberana 02.
The Caribbean country has accumulated 174,789 cases and 1,209 deaths from Covid-19 to date, according to data from the Ministry of Public Health. EFE