The CSIC renounces the human trial of the most advanced public vaccine against COVID-19
One of the three COVID-19 vaccine prototype projects on which the Higher Council for Scientific Research (CSIC) was working has come to a standstill. The institution confirms that it has decided to withdraw the application to the Spanish Medicines Agency to carry out the clinical trial with humans and argues that there are difficulties in completing it in Spain, taking into account the "few people left unvaccinated" and the "irruption of the variant omicron”.
The Spanish Medicines Agency authorizes the Spanish Hipra vaccine to go to the last phase of the trial
This is the prototype that the team of Mariano Esteban and Juan García Arriaza (CNB-CSIC) was developing. It was the most advanced because it had already been tested in animal models and had been waiting since the summer for the authorization of the AEMPS to start testing with humans. However, the Spanish Medicines Agency requested clarifications from the promoters on some specific aspects of the trial. The Minister of Health, Carolina Darias, framed the temporary suspension as something usual, "quite routine" and said that they were waiting for the clarifications to occur.
Then there were rumors that the suspension was due to lung injuries of a monkey, but the CSIC and Mariano Esteban himself denied that this had occurred. “No macaque has died from the vaccine, that news is false. This is a process: first you administer the vaccine, then the virus to check if the vaccine has an effect, then a euthanasia process and finally the tissues are analyzed. All this information is sent to the Spanish Medicines Agency and they assess the data that has been presented. Until we have this information we cannot define the causes”, the scientist explained to elDiario.es.
The following news, seven months later, is that the CSIC and Biofabri -a Galician company in charge of manufacturing the batches of vaccines for human trials- have withdrawn from the process by having changed the conditions for carrying out the trial: the largest part of the population is already vaccinated, they wield. However, the promoters assure that research continues "to adapt the vaccine model to new variants." "It has been decided to continue with the investigation of the vaccine candidate, which is yielding new results that will be published shortly," responds a CSIC spokesman.
At the beginning of the year, the Minister of Science explained that "science is like that". "Research does not always achieve the results one would like," Diana Morant explained at an informative breakfast organized by Europa Press. And a parliamentary response in Congress this week, already advanced before a question from Vox that the promoters had taken a step back, according to Medical Writing.
Other ongoing projects
Until now, three vaccine projects against COVID-19 had been developed at the CSIC, of which Esteban's was the most advanced and during the tests with mice it achieved 100% efficacy. She was on the verge of starting the clinical phase in humans and, if she did, she would have been the first of the four Spanish women to make the pharmacological leap and become a real option.
Luis Enjuanes, from the National Center for Biotechnology of the CSIC, together with the virologist Isabel Sola, heads the research on the first intranasal vaccine and assured last week that it could be available in 2023. In a conference offered on Saturday, he advanced that they have already carried out the initial tests and demonstrated that this vaccine also induces immunity in the respiratory mucosa, the route of entry of the virus. The basis of this prototype is the development of a synthetic virion that has had its virulence genes removed by genetic engineering.
On the other hand, there is the vaccine project of Vicente Larraga, from the Margarita Salas Biological Research Center (CIB-CSIC), which consists of placing a gene of a SARS-CoV-2 antigen in a synthetic DNA vehicle (a plasmid). that can be introduced into the patient's body and induce protection against infection. This project is in preclinical phases in animal models, reports the CSIC.
Meanwhile, Hipra, the Spanish private initiative vaccine, is advancing much faster. It is in the final phase of the clinical trial (III) although a few days ago the AEMPS authorized a second phase IIb clinical trial, the previous one, which will serve to compare the response against omicron generated by people with two doses of AstraZeneca who receive a booster of this Spanish vaccine against one from Pfizer. The extension has been requested at the request of the European Medicines Agency (EMA), confirms a spokeswoman for the Catalan company Hipra.