MIAMI — Cuba will start testing its own COVID-19 vaccine candidate next week, according to the official Cuban registry of clinical trials.
The vaccine, Soberana 01, was produced by the state-run Finlay Institute of Vaccines and will be tested during a phase I and II trial involving 676 adults between 19 and 80 years old. The results will not be published until February 2021.
A phase I clinical trial evaluates a drug’s side effects and toxicity. If the results are good, the process can continue to a phase II trial to determine if the medication works.
It’s unclear if a late-stage, phase III trial, usually involving thousands of people to test a vaccine’s effectiveness and safety in a larger population, will follow. According to the data published on the register, the Cuban study will assess both safety and the resulting immune response.
The study will be a “randomized controlled, double-blind trial,” meaning doctors and participants will not know who will be injected with the vaccine candidate. Recipients will be selected randomly. Those in the control group will get another vaccine produced in Cuba against meningitis.
Details about the vaccine candidate to be tested are scarce, but its description indicates it’s an RBD candidate, a vaccine that uses a receptor-binding domain, a type of protein located on the virus “spike” to induce neutralizing antibodies. The technology has been previously used in SARS vaccines.
In May, Cuban leader Miguel Díaz-Canel said the country needed to produce a local vaccine to ensure the nation’s “sovereignty.”
“Finding an efficient vaccine to fight COVID-19 is a top priority for our science and innovation system,” Cuba’s top epidemiologist, Francisco Durán, said in a press conference on Tuesday.
Cuba’s biotechnology industry produces vaccines and medications used locally. A few, like a drug to prevent ulcers caused by diabetes, are also exported. At the beginning of the coronavirus pandemic, the government was aggressively promoting an interferon medication to combat COVID-19, but studies about its efficacy have produced mixed results.
Cuban bio labs also manufacture unproven homeopathic compounds that health authorities use as a preventive therapy to fight the coronavirus.
Last week, Cuban state media reported that Kiril Dmítriev, the head of the investment fund that financed Sputnik V, the first Russian-registered vaccine, said that Cuba could begin producing it in November. Vladimir Putin’s announcement of a Russian vaccine has sparked criticism as the country approved it without conducting more extensive tests to prove its efficacy and safety.
The news about the Cuban vaccine comes in the middle of an outbreak in Havana, which has forced the government to roll back the reopening and order a city lockdown. Regular flights are still suspended.
On Wednesday, health authorities reported 74 new coronavirus infections, all in Havana and nearby Artemisa and Pinar del Rio provinces. In total, the government has confirmed 3.408 coronavirus cases and 88 deaths.
©2020 Miami Herald