La farmacéutica multinacional Johnson & Johnson ha detenido el desarrollo de su vacuna contra COVID-19 debido a una “enfermedad inexplicable” presentada por uno de los participantes, informó Stat, citando un comunicado de la compañía.
“Siguiendo nuestras pautas, la enfermedad del participante está siendo revisada y evaluada por la Junta de Monitoreo de Seguridad de Datos (DSMB, por sus siglas en inglés) independiente de Ensemble [el nombre que le han dado al estudio], así como por nuestros médicos internos clínicos y de seguridad”, indicó Johnson & Johnson en un comunicado.
La empresa, que realizaba el ensayo clínico fase 3 en 60.000 pacientes, no ha proporcionado más detalles sobre el percance del paciente.
“Debemos respetar la privacidad de este participante. También estamos aprendiendo más sobre la enfermedad de este participante y es importante tener todos los hechos antes de compartir información adicional”, agregó la firma.
Este no es el primer ensayo de una vacuna contra el coronavirus que se ha suspendido debido a efectos adversos. Anteriormente, la vacuna de AstraZeneca, realizada en conjunción con la Universidad de Oxford se detuvo debido a una complicación neurológica en un voluntario en el Reino Unido. El protocolo se encontraba también en fase 3.
El ensayo se reanudó en el Reino Unidos y en otros países; no obstante, permanece paralizado en Estados Unidos a la espera de la investigación de la Administración de Medicinas y Alimentos del país (FDA, por sus siglas en inglés).
Sputnik V genera hasta dos años de inmunidad, según sus desarrolladores. La vacuna consta de dos componentes: el primero se basa en el adenovirus humano tipo 26, y el segundo, en el adenovirus humano recombinante del tipo 5. El medicamento se administra dos veces, en un intervalo de 21 días.
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