Latin America has played a significant role in Covid vaccine development, first as a clinical trial site and more recently as a developer of its own vaccines. Argentina, Cuba, Brazil and Mexico are all currently running clinical trials of domestically developed vaccine candidates.
Partly due to a weak regulatory environment for clinical trials, concerns about transparency have been widespread.
Below are two examples.
Cuban vaccines: rollout and export before approval
This year, Cuba has spearheaded the development of two vaccines: Abdala and Soberana 02.
The country has a relevant infrastructure and a strong track record of producing medical products.
The Centre of Genetic Engineering and Biotechnology in Cuba claimed that three doses of Abdala, within 28 days, showed an efficacy rate of 92.2% in the clinical trials. Similarly, the Finlay Institute of Vaccines asserted a 91.2% efficacy rate if the two doses of Soberana 02 are combined with a booster dose, called Soberana Plus.
Cuba’s medicines regulator approved Abdala in July 2021, and Soberana 02 and Soberana Plus in August 2021.
But the government had started vaccinating its health workforce with Soberana 02 far earlier, in March this year – when clinical trials were still ongoing – and had begun exporting the Abdala vaccine to other countries as far back as in June.
Despite official claims of high efficacy rates for Soberana 02 and Abdala, the results of neither vaccine’s clinical trials have been published in a scientific journal. Neither vaccine has been approved for use by the WHO.
To date, Cuba has exported Abdala and Soberana 02 vaccines to Venezuela and Nicaragua, and reached production and distribution agreements with Iran and Vietnam. Venezuelan and Cuban children aged 2 to 11 are currently being vaccinated with Soberana 02.
In Venezuela, several medical organisations expressed their concern about the use of Cuban vaccines. Opposition politicians have claimed that the government closed several vaccination centres where vaccines delivered through the global COVAX facility were being administered, and instead focused on providing Cuban vaccines.
Peruvian trials: politicians jump the queue
Early this year, Peru witnessed one of the worst Covid scandals in the region. Ex-president Martin Vizcarra was among 467 people who jumped the queue and got vaccinated with doses administered during ongoing clinical trials of the Sinopharm vaccine.
At least a quarter of queue jumpers were government officials. High-level members of the Catholic church and prominent businessmen and their family members were implicated too.
The episode had significant impact on legitimate participants in these clinical trials.
When the scandal came to light, the government confiscated all remaining Sinopharm doses as part of the investigation, leaving many volunteers stranded.
Not all sites provided certified letters to their volunteers, leaving them unable to sign up for the national vaccination campaign. Many volunteers criticised the absence of adequate follow-up and protection by the universities and health centres conducting these trials, in apparent breach of trial protocols.
Also, there was not enough transparency about who had received the vaccine and who had received a placebo.
This led many participants to miss their opportunity to get fully vaccinated, and had life-threatening consequences for some. For example, Juan Quiñones, a volunteer who got infected with Covid-19, informed the university leading the critical trial in about his condition but was never told whether he was in the vaccine or placebo group. After his death, his family filed a complaint with the Prosecutor’s Office.
Clinical trial transparency is now a global problem
Efforts to develop new drugs and vaccines are now global, as is their production and exportation.
As of 12 November, the WHO had approved eight vaccines for use, including China’s Sinopharm and Sinovac. The WHO has identified an additional 132 vaccines that are currently in clinical development and 194 more in pre-clinical development.
Lack of clinical trial transparency is a significant problem in Latin America and beyond. It puts people’s health at risk, contributes to public distrust and vaccine hesitancy, and undermines efforts to manage the pandemic.
This guest blog was written by Daniela Cepeda Cuadrado, U4 Adviser. She previously worked for Transparency International Global Health, where she wrote a report on the impact of Covid corruption at the point of health care service delivery worldwide. She can be reached on Twitter. TranspariMED did not independently fact check any of the claims made in this blog.