One of the Spanish vaccines that is being developed to reduce the effects of the Covid-19 virus could suffer an unexpected delay.
It is because the team led by researcher Mariano Esteban has not received authorisation from the Spanish Medicines Agency (AEMPS) to begin human trials of the Spanish vaccine, as confirmed by sources at the Higher Council for Scientific Research (CSIC).
The CSIC is awaiting the report from the AEMPS that will assess the latest lab trials to be carried out with the vaccine, but they do not know the precise reason for the delay. However, the public body has categorically denied that the stoppage of the process is due to the alleged death of a macaque that was subjected to tests as a 'guinea pig'.
This Phase 1 trial, which was planned with around a hundred volunteers, was due to be carried out at the Hospital de la Paz in Madrid, which had already started looking for people willing to take part.
“The reason why the planned start of the clinical trial has been postponed is that it is waiting to know the response of the Spanish Agency for Medicines and Health Products (AEMPS) to the request for its authorisation,” said the CSIC in a statement and it added, "it is totally false that the administration of the vaccine caused the death - by lung lesions - of one of the macaques used in preclinical trials."
According to those responsible for the research, in Phase 1 trials 112 volunteers were going to be recruited, before progressing to Phase 2 with 500 people and, finally between 20,000 and 30,000 volunteers would be evaluated in Phase 3 tests.
The project consists of using a highly attenuated virus of the smallpox family as a vaccine vehicle to introduce the SARS-CoV-2 spike protein, which is what allows the virus to enter the cells.