A NEW Covid vaccine 100% 'made in Spain' could become a viable alternative to those currently on the market or about to be released, and is due to start the clinical trial stage very shortly after having been found to provide total immunity in mice.
Dr Mariano Esteban jointly leads the team developing three Covid-19 vaccines, one of which is expected to be signed off for clinical trials to start in the next two or three months (photo: CSIC)
Virologist Dr Mariano Esteban of the National Biotechnology Centre at Spain's National Research Council (CSIC) is heading up a team developing three different vaccines against the SARS-CoV-2 virus, and says the one which is most advanced will be tested on humans this spring.
Along with Dr Juan García Arriaza, joint head researcher, Dr Esteban (pictured) says the CSIC-Biofabri jab will initially be trialled on 112 volunteers to see what effects the doses have on humans.
Phase 2 will expand to 500 volunteers to monitor its safety and immunity effect, then Phase 3, the final step, will involve between 20,000 and 30,000 healthy people, aimed at making sure the vaccine is, in fact, effective.
So far, the CSIC team believes the drug will offer longer-lasting immunity than those currently being administered – potentially for several years – and would be suitable for combining with other versions now in use, meaning it would be suitable as a booster.
“Right now we're just finishing off trials on animals, on hamsters and macaque monkeys, so we can send a file with the results of these to the Spanish Medications and Healthcare Products Agency [AEMPS] and the European Medicines Agency [EMA]; if we've managed to meet all the requisites, we'll get approval to move onto the clinical trials,” says Dr Esteban.
“In the meantime, the Spanish firm Biofabri is already manufacturing batches to use on human volunteers.”
Once all trials are complete and the vaccine is signed off for production, it is likely to be used nationally either as a booster or among those who have not yet been immunised, and also in other countries worldwide which may need it, including, and especially, in developing nations.
Dr Esteban says 'considerable funding' will be needed for its production, however; to achieve this, the CSIC is attempting to drum up corporate support as well as State finance.
“Let's bear in mind that some countries have poured millions into mass production of vaccines – and from the clinical trials stage onwards, costs increase astronomically,” he explains.
“Spain cannot always rely on everyone else. We can't always leave it up to other countries to solve things. We need a corporate fabric capable of producing the vaccine, so we've already begun seeking agreements through the CSIC itself, the ministry of science and innovation and Spanish companies.
“We then need to maintain this logistic so we can act quickly whenever we need to; that's where the CSIC plays a major part, because in addition to our fundamental knowledge, we help provide the transition from research to the production sector.”
Data gathered so far show that the CSIC-Biofabri jab protects the recipient from becoming ill with the virus, prevents its becoming fatal, and blocks the replication of the virus within the person's system.
It is also very 'stable', says Dr Esteban, and can be stored and administered 'anywhere'.
“Also, we're seeing that it provides a wide level of immunity, and, we believe, a longer lasting level of immunity,” he explains.
As for how it differs from the Pfizer-BioNTech, the Moderna and the 'Oxford vaccine', or AstraZeneca versions, Dr Esteban says the CSIC-Biofabri immunisation uses 'a much more complex RNA structure'.
Until AEMPS and the EMA authorise the start of clinical trials, an appeal for volunteers has not yet been made, although previous trials, for Janssen, took place in eight different hospitals in Spain and sought people of all ages without any of the type of health conditions that could cause a Covid contagion to become much more serious or potentially fatal.
In all cases, volunteers are very closely monitored once they receive their trial dose, having gone through a stringent selection process.
Finding volunteers for the trials needed on the over-65s was harder for this reason: Not because of fewer people in that age group coming forward – in fact, hospitals involved said their phones were 'ringing off the hook' – but because it was difficult to recruit enough volunteers over 65 who did not have pre-existing health conditions.