Achieving effective vaccines against Covid-19 is an ongoing task for scientists and having already four vaccines on clinical trials represents a bigger challenge. And Cuba has assumed this challenge.
Soberana 01 (Sovereign 01), Soberana 02 (Sovereign 02), Mambisa and Abdala complete the proposal of the Caribbean island to tackle the pandemic and to have had vaccinated the majority of the population by the end of 2021. But what stages each of the candidates are at? Who is included in the next study phases and what are the closest dates to go to the next steps?
The leaders of the vaccines: Finlay Institute with Soberana 01 (Sovereign 01) and Soberana 02 (Sovereign 02), and Center for Genetic Engineering and Biotechnology (CIGB) with Mambisa and Abdala, answered these questions, during an online presentation at the headquarters of the Pan american Health Organisation in Havana.
When referring to Soberana 01 (Sovereign 01), the director from Finlay, Vicente Vérez explained that this vaccine is a possible reinforcement, ideal for patients recovering from coronavirus SARS-Co V-2, the pathogen that causes Covid-19, and for those vaccinated with biotech products.
The first project presented by the Caribbean island in 2020 already showed being highly safe in its first phase of trials, with people who were convalescing from the pandemic having no adverse reactions to it.
Vérez noted that the neutralising capacity of the serum has multiplied 200 times in those recovering from Covid-19 who were vaccinated with Soberana 01 (Sovereign 01).
He stated that this experience shows the importance of strengthening the vaccines against Covid-19 and it was decided to use Soberana 01 (Sovereign 01) as a third dose in order to achieve this goal.
Furthermore, he stated that phase II/III of the clinical trials for Soberana 01 (Sovereign 01) was scheduled to start this month, with two and three dose schemes in order to prepare the population to deal with more complex scenarios of the pandemic.
Phase III designed a placebo and other cohort study, where non-immunised people will be given more doses of the vaccine in order to check the results.
In addition, Vérez said that phase III of clinical trials for Soberana 02 (Sovereign 02) is expected to start on 1 March.
There will be around 150,000 doses ready for that period and the use of a third dose with booster action in order to achieve inducing an immune response of viral neutralization is also being assessed.
He also stressed that the clinical trial with both vaccines (Soberana 01 and 02 (Sovereign 01 and 02)) in the paediatric population will begin at the end of February.
Patients between five and 18 years old will be included, the objective being to ensure safety at school stages.
Children between the ages of zero and five will not receive the vaccine as their immune systems are already exposed to other vaccines.
Similarly, people over the age of 80 will not be part of the trials, because, as the director of Finlay indicated, their immune systems are not as strong, nor do they produce as many antibodies.
With regards to Mambisa and Abdala, developed by CIGB, Dr. Marta Ayala, the center’s director, pointed out that if the second vaccine continues to have a favourable progress, the country could register with international authorities and begin immunisation from next August.
Phase II clinical trials for this product begin today with almost 680 volunteers and phase III is estimated to start around March 15.
Preliminary results for Abdala indicate positive safety and reactogenicity profiles, without severe adverse reactions. Moreover, it showed immunogenicity and ability to neutralise the virus.
Meanwhile, Mambisa, the only Cuban vaccine out of the four that is administered nasally, has also been tolerated very well and has proven safe for the people that received it during phase I of the clinical trial, noted Ayala. Both products closed the short cycle of trials, of zero, 14 and 28 days, and after the samples have been processed, these will transition over to another longer evaluation period, of zero, 28 and 56 days. (PL)