The Spanish Agency for Medicine and Health Products (AEMPS) has authorized the first clinical trial in Spain of an experimental vaccine against the novel coronavirus. That’s according to Health Minister Salvador Illa, who made the announcement on Friday at a government press conference.
The testing will involve a vaccine from Janssen, a company that is owned by the US multinational Johnson & Johnson, with 190 healthy volunteers from Spain. There will be a further 400 participants of the trial in Germany and Belgium. The recruitment of volunteers – who will be aged between 18 and 55, and over 65 – will begin “immediately,” Illa stated, with three Spanish hospitals – La Paz and La Princesa in Madrid, and Marqués de Valdecilla in Santander – taking part.
The recruitment of volunteers – who will be aged between 18 and 55, and over 65 – will begin “immediately”
“There is a tremendous effort underway to find a vaccine as soon as possible,” Illa continued. “We have learned that [US firm] Moderna has signed a deal with a Spanish company to manufacture the vials for the vaccine in our country. We count on high capacity here.”
Illa also pointed out that a definitive contract was signed on Thursday between the company AstraZeneca and the European Union, the first that has been negotiated with a pharmaceutical firm for access to experimental vaccines against the coronavirus. Member states from the EU will be able to acquire a total of as many as 400 million doses of the experimental vaccine manufactured by AstraZeneca and created by Oxford University in the United Kingdom. The injections will be shared out according to the population of each country.
“If everything goes well and safety is guaranteed, we are hoping to have the first doses by the end of December,” said Illa on Friday. The experimental vaccine from Oxford University has shown promising results until now, but its safety and efficiency is yet to be demonstrated. The prototype is being tested on more than 20,000 volunteers in the United Kingdom, Brazil and South Africa.
The scientific community in Spain is already working on a dozen or so experimental vaccines against Covid-19, but none of the projects has yet reached the stage where clinical trials in humans can begin. The two most-advanced initiatives are being headed up by the virologist Mariano Esteban, from Madrid’s National Biotechnology Center, and by Felipe García, from the Clínic Hospital in Barcelona.
The experimental vaccine from Esteban is using a weakened version of the Vaccinia virus, which has been used since the 1970s for the eradication of smallpox, but in this case with genetically added information from the SARS-CoV-2 coronavirus.
The project, he complained in June, has been delayed due to the lack of macaque monkeys for testing in Spain, and due to the shortage of these animals in international laboratories, which are currently overwhelmed as a result of the rise in research during the ongoing pandemic.
The experimental vaccine being coordinated by Felipe García is based on genetic language, RNA, as is that of Moderna, which is already carrying out clinical trials with a group of 30,000 people. These injections introduce a genetic formula with instructions so that human cells produce determined proteins of the novel coronavirus. In theory, the human body can thus train its defenses without any risks. This theory will now have to be demonstrated via major trials with tens of thousands of people.
There is a tremendous effort underway to find a vaccine as soon as possibleHealth Minister Salvador Illa
Last Tuesday, Spanish Science Minister Pedro Duque took part in a meeting to “coordinate the next steps to begin clinical trials for Spanish vaccines” against Covid-19.
There are already 173 experimental vaccines against the coronavirus being developed across the globe, and 31 of them are being tested in humans, according to a register kept by the World Health Organization (WHO). The European Commission has announced conversations and preliminary deals with five developers of experimental vaccines: British company AstraZeneca, Curevac from Germany, the US firms Johnson & Johnson and Moderna, and the alliance formed by French company Sanofi and British pharmaceutical firm GSK.
English version by Simon Hunter.