Stop for the Spanish vaccine candidate promoted by the National Center for Biotechnology (CSIC). The team led by virologist Mariano Esteban has not received authorization from the Spanish Medicines Agency (AEMPS) to begin its clinical trials in people. This phase 1 trial, for which it was going to have around a hundred volunteers, was to be carried out at the Hospital de la Paz in Madrid, which had already started looking for them. Both the CSIC and La Paz confirm that the paralysis of the process has been reported, but not the reasons. At the moment, the hospital assures that it did not even have volunteers as such, but that it was still doing a pre-selection of potential candidates.
The news of the suspension, advanced by The Spanish, is a jug of cold water for the aspirations of the Spanish vaccine, after the Ministry of Science announced in January that this most advanced candidate had shown “100% efficacy” in her first tests on animals, after a trial with 22 mice genetically modified to be susceptible to the coronavirus. Esteban and Juan García Arriaza’s experimental vaccine is based on an attenuated version of the Vaccinia virus, which was used in the eradication of smallpox and has now been modified with genetic information to deal with the coronavirus. The results in mouse tests showed that it would take two doses to have an effect.
The work for this Spanish vaccine had run into a problem due to the lack of monkeys with which to test the vaccines, so the CSIC laboratory agreed with the Center for Biomedical Research in Primates, in Rijswijk (the Netherlands), a trial with 12 macaques. After this phase with monkeys, the AEMPS had to authorize the first phase with humans: the green light has not arrived and it has not yet informed the CSIC of the reason for the stoppage. “We are waiting for the report to be passed on to us,” says a CSIC spokesperson. Although health problems have been reported in one of the macaques, the virologist Esteban flatly denies it: “The news of the death of a macaque by the vaccine is false.”
As they advanced six months ago, the plan of these Spanish researchers was to carry out a first trial with 112 people to study the safety and the immune response generated. If successful, a large trial with more than 20,000 volunteers would later begin before the end of 2021, according to those initial plans. The vaccine is being developed with Biofabric, a company specialized in veterinary vaccines based in O Porriño (Pontevedra). Esteban’s 76-year-old laboratory has had a budget of about 700,000 euros and 11 specialists to develop his drug, compared to the hundreds of millions that other laboratories such as Oxford have.
[Noticia de última hora. Habrá actualización en breve]