Picovacc proved effective in the first challenge study on monkeys. “Our study shows that after injecting the inactivated vaccine […] non-human primates, especially the rhesus monkey, to form Sars-CoV-2 neutralizing antibodies. In fact, the results showed that our vaccine candidate provided safe and complete protection of rhesus monkeys against Sars CoV-2 strains, ”said Weidong Yin, CEO of Sinovac.
Work on developing a vaccine began in January in collaboration with other academic research institutes in China. In April Sinovac received approval to conduct the Phase I / II studies. The phase I study includes 144 healthy adults aged 18 to 59 years. People have been testing since mid-April. This means that the vaccine will now be used for the first time on a small number of healthy volunteers under controlled conditions. The preliminary data on tolerability, pharmacokinetics and pharmacodynamics obtained in this way are to be expanded as soon as possible by carrying out the phase II study. “As we begin our Phase I studies, we will also accelerate the progress of our research to support the global fight against Covid-19,” said Yin.
Effective on monkeys
The first results of the animal study in monkeys are positive: the injection of the vaccine resulted in the animals forming sufficient antibodies so that they were immune to Covid-19 by the administration of pathogen fragments. With active vaccination, either weakened pathogens (live attenuated vaccine) or components that are no longer capable of replication are injected. As a result, the body’s immune system is stimulated to produce antibodies. The researchers injected the vaccine into rhesus monkeys. Three weeks later, the monkeys were exposed to the novel corona virus. The viral load was checked another seven days later. The monkeys who received the largest dose of the vaccine did not have the virus in their lungs – the vaccine was found to be effective. The animals that did not get Picovacc all developed severe pneumonia, according to the researchers.
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The vaccine is currently in the Phase II trial. The first findings on tolerance, pharmacokinetics and pharmacodynamics are already available. In the second phase, the drug to be tested is administered to a limited number of patients who are thought to have an effect. And this is exactly where, according to Chinese researchers, a problem could arise: there are fewer and fewer known coronavirus patients in China, so researchers fear they will no longer find enough volunteers. “The same situation brought the development of Sars vaccines to a standstill in 2003,” said Sinovac. Phase II studies are usually further divided: Phase IIa studies are clinical pilot studies that primarily evaluate drug safety. Phase IIb studies examine the efficacy and dosage range, as well as the safety of the drug.
Phase I study also in Germany
Marburg virologists have also developed a possible vaccine candidate that is now to be tested on humans: “We are now in the phase that we have everything financially and logistically together to start clinical phase I,” said Professor Dr. Stephan Becker, the director of the Virology Institute at the University of Marburg. Becker believes it is important that researchers and companies all over the world take part in the search: “We need a relatively large number of vaccine approaches and candidates in order to then fish out those who are the best.” Because after the first clinical tests would take place usually also many vaccine candidates are dropped. A global search is also important because a manufacturer alone does not have enough manufacturing capacity for the required quantities.
Vaccination in pharmacies
Who and where will receive an approved vaccine remains open for the time being. Optimally, experts expect a vaccine at the beginning of next year. Abda President Friedemann Schmidt is convinced that as soon as a vaccine against Covid-19 is available, pharmacies will be one of the first addresses. According to Schmidt, public pharmacies want to participate in a solution to implement large-scale immunization. This has already been discussed with Federal Minister of Health Jens Spahn (CDU). Actually, there should already be model projects for flu vaccinations in the pharmacy. But these were unfortunately “somewhat stalled by the pandemic,” says Schmidt. But soon there will be the first agreements on this, he announced. “We will then learn from this that pharmacies can do that, I’m sure of that.” And then pharmacies would be one of the top addresses for a Covid 19 vaccination.
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