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Covid-19: Single vaccine dose is 33% effective against variant from India, data show

BMJ 2021; 373 doi: (Published 25 May 2021) Cite this as: BMJ 2021;373:n1346

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Mambisa, one of the five nasal COVID-19 vaccine candidates in the world.

Dear Editor

Mambisa vaccine candidate, developed at the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba, is one of the five nasal administration that have reached the stage of clinical studies in the world.
The formulation is also the only one of its kind based on the platform of recombinantly produced antigens. Said technology has the main advantages of safety (with slight adverse effects recorded) and the possibility of giving multiple doses in order to reinforce the immune response over time.

Another benefit is its potential to induce this type of action in the nasopharyngeal mucosa, something particularly convenient, since it is a vaccine candidate against a disease whose entry point is through the respiratory tract. In 2015, the CIGB registered HeberNasvac, the first nasal administration therapeutic vaccine obtained in the world against a chronic infectious disease (chronic hepatitis B).

For the development of Mambisa, one of the proteins that are part of the referred product was used: the nucleocepsid or protein that makes up the nucleus of the virus, which has the ability to stimulate the immune response. Currently, this vaccine candidate has completed the phase 2 clinical study carried out at the National Toxicology Center (Cenatox). At this stage, the drug demonstrated a good level of safety and preliminary results revealed an effective immunological action.

Likewise, in studies carried out with people who suffered from the disease during the first peak of the epidemic in Cuba, Mambisa proved to be a good candidate for strengthening the immune system with the administration of a single dose.

Taking into account the simplicity of its use and high safety, this immunogen could serve as a reinforcement of immunization schedules with other vaccines that, due to their nature or the adverse reactions they cause, cannot be used in multiple applications.

Coordination with the Hermanos Ameijeiras Hospital and the health area of the municipality of Centro Habana, in this capital, are already underway for a phase II / III clinical study in people previously infected with the virus.

Those selected people will receive a single dose of the vaccine candidate Mambisa, with the purpose of evaluating the safety and capacity of that single administration to enhance immunity.

Kind Regards

Competing interests: No competing interests

03 June 2021
Maria Eugenia Bravo Rodriguez
Dr Milena Lopez Hernandez, MSc. Ihosvany Castellanos Santos, Dr Amabel Torres Salas, Lic Ana Cecilia Hernandez Rendon, Dr Madelaine Veronica Fernandez Garcia
Francisco Javier Zerquera 15. Trinidad. Cuba.