Will Cuba Seek EUA From United States FDA? Not Required, But Politically Might Be Prudent Marketing Strategy To Reinforce What Cuba Can Do Under Sanctions

With questions about efficacy enveloping the Republic of Cuba's entries into the COVID-19 vaccine global marketplace, Republic of Cuba manufacturers should consider seeking EUA from the Biden Administration. One candidate to provide assistance who already has an OFAC license to conduct clinical trials for a cancer vaccine is Buffalo, New York-based Roswell Park Comprehensive Cancer Center. Or, the manufacturers could retain legal counsel to assist with the process.

U.S. Food & Drug Administration- Washington DC

About Emergency Use Authorizations (EUAs) LINK To FDA

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.

Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

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.

Prensa Latina News Agency- Havana, Republic of Cuba

Havana, June 22 (Prensa Latina) Varied foreign press media highlighted today the news that Cuba´s anticovid vaccine candidate Abdala, reached 92.28 percent of effectiveness in clinical studies, phase III.

Engineered by the Biotechnology and Genetic Engineering Center (BGEC), the drug showed these numbers in its three-dose program, fulfilling the requirements by World Health Organization (WHO) to become a vaccine. The good news of this drug´s effectiveness transcended borders this Monday and many have been the acknowledgements abroad.

Listín Journal newspaper, CDN and NDigital television chains, from Dominican Republic, published the information broadcast yesterday and highlighted the Cuban achievement, specifying that Abdala gets to be the second vaccine candidate from the Caribbean island to meet the requirements set by WHO.

The news was also shown in television chains like CNN in Spanish, Russia Today, Latin American subscription German television chain DW Español, North American newspaper The New Herald, and many more.

Abdala´s good news is added to the previous one reported by the Finlay Vaccine Institute (FVI) from the Caribbean island last Saturday that Soberana 02 had reached a 62 percent of effectiveness in the two-dose plan. Such variable remains to be checked in the three-dose plan formula, last from which is Soberana PLUS, by FVI as well.

After learning results from Abdala, president of the Republic Díaz-Canel highlighted the achievement on his twitter account. ¨I think of (José) Martí, who wrote that ¨it is not the acquired and casual intelligence that brings honor to men; but the way they use it and save it. There is but one way to live on, that is to serve¨.

And it is that Abdala carries the name of a poem from Cuba´s National Hero, and it carries its image in the Revolution Square in Havana in the graphic label. Cuban authorities have announced that in a couple of weeks, they hope to ask the Medical Devices and Drug Control State Center, the regulating authority, for the permission to use the emergency vaccines.

The New York Times

New York, New York

22 June 2021

Cuba reports a high success rate for its homegrown Abdala vaccine.

By Ed Augustin

Cuba began its Covid-19 mass vaccination campaign more than a month ago with homegrown, unproven vaccines, wagering that they would prove effective enough to blunt the rapid spread of the coronavirus on the cash-strapped Caribbean island. The gamble appears to be paying off.

The Cuban health authorities said on Monday that their country’s three-shot Abdala vaccine had proved about 92 percent effective against the coronavirus in late-stage clinical trials.

Throughout the pandemic, Cuba has declined to import foreign vaccines while striving to develop its own, the smallest country in the world to do so.

The announcement places Abdala among the most effective Covid vaccines in the world, according to data from clinical trials, on a par with Pfizer-BioNTech’s 95 percent rate, Moderna’s 94.1 percent, and Russia’s Sputnik V at 91.6 percent. On Saturday, Cuba’s state-run biotech corporation, BioCubaFarma, said that another of its vaccines, Sovereign 2, had 62 percent efficacy after two of its three required doses. Results for the full three doses are expected in the next few weeks.

The vaccine news was seen as a rare cause for celebration on an island that has been hammered both by the pandemic, which has devastated its tourism industry, and by Trump-era economic sanctions that have not been eased by the Biden administration.

Cuba is currently experiencing its worst coronavirus outbreak since the start of the pandemic. It reported 1,561 new cases on Monday, a record. In May the health authorities began a mass vaccination campaign in Havana before the completion of Phase 3 trials, which assess a vaccine’s effectiveness and safety. The emergency step was intended to help combat the Beta variant, first detected in South Africa, which was spreading rapidly in the Cuban capital. Close to one million Cubans — about 9 percent of the national population — have now received all three doses of either Abdala or Sovereign 2, according to official figures. Officials say they are seeing a slowing of the virus’s spread in Havana, where vaccinations have been concentrated so far.

Countries including Mexico, Argentina, Vietnam and Iran have expressed interest in Cuba’s coronavirus vaccines. The high announced rate of efficacy could reinforce hopes that biotechnology exports will help lift Cuba from the depths of its economic crisis.