Cuba’s Covid-19 vaccine approved by regulators in Havana
By Atahualpa Amerise
Havana, Jul 9 (EFE).- Cuba’s CECMED medical safety agency issued an emergency use authorization Friday for the Abdala vaccine against Covid-19, developed on the Communist-ruled island.
“We are going to continue working to obtain the definitive health registration, which we think could come before the end of the year,” Dr. Eduardo Martinez, head of state-owned pharmaceutical firm Biocubafarma, told a press conference in Havana.
The World Health Organization (WHO) has designated CECMED as a Regional Reference Authority for medicines in the Americas, meaning that the Cuban agency can certify drugs for use throughout the region.
But only the WHO can extend to Abdala the international certification already granted to the vaccines from Pfizer/BioNTech, Oxford/AstraZeneca, Moderna, Johnson & Johnson, Sinopharm and Sinovac.
The Center for Genetic Engineering and Biotechnology (CIGB) reported that in clinical trials, the three-dose Abdala vaccine achieved 92 percent efficacy among 48,000 test subjects ranging in age from 19 to 80.
Though Cuba has already been administering Abdala on a limited basis, CECMED approval will allow mass vaccination on the island and the export of the drug to other countries in Latin America.
Until now, the region has had to rely on vaccines developed in the United States, Europe, Russia and China.
“We are the process of increasing the levels of production, in the first place, to prioritize vaccination in our country, but in parallel we will be supplying some friendly countries,” Martinez said.
“There is interest from a group of countries of the region and the world,” he said, without naming any of them.
The Abdala protocol calls for three doses to be administered over the course of 28 days.
Cuba’s other promising vaccine candidate, Soberana 02, is expected to secure CECMED approval in the near future.
“In the case of Soberana 02 and Soberana Plus, the documentation will be presented to the regulatory authority in the coming days,” Martinez said.
Cuban health officials said Thursday that the combination of two doses of Soberana 02 and a single injection of Soberana Plus proved 91.2 percent effective in clinical trials.
Regulatory approval for Abdala comes as Cuba struggles to cope with its worst surge of Covid-19 infections since the start of the pandemic.
On Friday, the island marked its latest record for new cases in a single day with 6,422, bringing the total to 224,798, while fatalities increased by 28 to 1,459.
The situation is particularly acute in Matanzas province, east of Havana, where some hospitals are at risk of being overwhelmed. EFE