WHO Accepts the Documentation of the Cuban Abdala Vaccine

Waiting line to receive the Cuban Abdala vaccine in Havana. (EFE/Ernesto Mastrascusa)

14ymedio bigger14ymedio, Madrid, 4 April 2022 — The World Health Organization (WHO) has accepted the documentation sent by the Cuban Center for Genetic Engineering and Biotechnology on Abdala, which is another step on the road to approval. The institution updates monthly the status of the vaccines against covid-19 that have requested approval for their emergency use and in its most recent document, dated this Saturday, April 2, the change can be verified in the case of the three-dose Cuban vaccine.

Abdala appeared in the previous report, dated March 2, with the status “expression of interest under review,” which has now been changed to “accepted.” On the other hand, in the case of Soberana 01, 02 and Plus, from the Finlay Vaccination Institute, the dossier has not yet been sent and its status in the same section is “awaiting information on strategy and deadlines to deliver.”

The news had been communicated last Saturday by BioCubaFarma, which affirmed the beginning “in the month of March of the formal exchange with the World Health Organization to start the evaluation process of its anticovid-19 Abdala vaccine,” although there have been so many announcements and so many dates have been considered that the confirmation of the UN health organization was long in coming.

The state business group also added that “the Finlay Vaccine Institute and the CIGB are working to present, soon, to the Regulatory Authority for Medicines, Equipment and Medical Devices of the Republic of Cuba the data from the clinical studies of Soberana 01 and Mambisa,” although nothing was specified about the delay that Sovereign 02 has before the WHO.

Abdala was the first Cuban vaccine against covid-19 approved by the Cuban regulator in July 2021, although Soberana 02 seemed to be winning the race initially and its joint development with the Pasteur Institute in Iran seemed to give it more reliability because its studies were being compared in very different countries, according to some Cuban experts such as Dr. Renato Sánchez.

In January, Vicente Vérez, director of the Finlay Vaccine Institute, announced that Abdala had already taken the lead before the WHO and had presented his dossier, but that they would do so as soon as possible. The scientist attributed the delay to the center he himself directs since, he maintained, changes were made in the facilities that entailed modifications in the documentation.

“There are things that we have to complete, that we have to adjust,” he said, noting that the process to present the dossier to the WHO is “long, cumbersome, complex and expensive.”

In the WHO follow-up, only the expressions of interest of two vaccines appear as rejected: IMBCAMS, China, for being in too early in its state of development, and that of Medicago, Canada, which was ruled out due to the participation as a shareholder and investor of one of the world’s largest tobacco companies, Philip Morris.

If Abdala gets emergency use authorization from the WHO, it could become part of the Covax program, a fund made up of the Gavi Alliance for Vaccines, the Coalition for the Promotion of Innovations for Epidemic Preparedness (CEPI) and the World Health Organization through which rich countries provide, under advantageous conditions or even as a donation, vaccines for the most needy nations.

Cuba refused to be part of the Covax mechanism on the grounds that it was capable of developing its own serums (and then selling them), and the fund requires disbursements of money that are not affordable for the island, plus the vaccines arrive late and in a bad way. However, the refusal meant that vaccination in Cuba began much later and many doctors reproached the government for not buying time that would have saved at least the most exposed professionals.


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