It is the question that is currently on everyone’s mind: when will there be a safe and effective vaccine against Covid-19? Researchers around the world are working hard to find an effective serum – also in this country. The Federal Ministry of Education and Research (BMBF) is supporting three companies with a total of 750 million euros in vaccine development: In addition to Curevac and Biontech, the federal government also funds IDT biologics.
“With our funding, we enable the three companies to set up their projects more broadly and move forward faster,” said Federal Research Minister Anja Karliczek at a press conference on Thursday. They assume that in the middle of next year “large parts of the population can be vaccinated”. They even consider it possible that a vaccine will be found earlier. “If it could go faster, it would of course be great,” she said.
However, she also pointed out that there are still some questions unanswered: for example, how long the immunity lasts after a vaccination or how often one needs to be vaccinated before protection exists. In addition, safety has the absolute priority: “A vaccine can only be used if the proven benefit is significantly greater than the possible risks,” she said.
Admission process started for the candidate from Biontech
The vaccine made by the Mainz-based company Biontech, which it produces together with its US partner Pfizer, is the most advanced. The active ingredient belongs to the group of gene-based vaccines and is a so-called RNA vaccine. He is currently in global phase III with a total of 44,000 subjects – 37,000 have already been vaccinated.
“We’re nearing the end,” said Sierk Poetting from Biontech. Earlier studies have already shown that the drug only causes mild to moderate side effects and is therefore well tolerated by all age groups. The subjects would have developed antibodies and other desired immune responses.
The approval process at the European Medicines Agency (EMA) will already start this week with the otherwise rather unusual so-called “rolling review”. This makes Biontech the first German company and the second European, alongside AstraZeneca, to be approved for this process.
The data on efficacy and safety are not assessed after the clinical studies have been completed, as is normally the case, but in parallel with the ongoing studies. Poetting did not want to be carried away to say when the vaccine will be available. That depends on the authorities and the final data of the clinical study.
Biontech intends to use the funding from the BMBF in the amount of 375 million euros for the expansion of production capacities. It should be possible to manufacture 750 million vaccine doses annually. The company had announced the takeover of a plant for vaccine production in Marburg, which is now being converted for this purpose.
Curevac expects the active ingredient in the middle of next year
Curevac receives a grant of 252 million euros. The active ingredient from the Tübingen-based company is currently in phase I. In June, Curevac received approval for a clinical trial. The vaccine is now also being tested in a clinical phase IIa study in Peru and Panama.
Curevac expects to be able to start the combined II / III phase at the end of this year and then to have completed it in the middle of next year, so that regular approval can be applied for. The size of the annual production depends on the final dose of the vaccine. “But we assume that there will be several hundred million cans,” said Mariola Fotin-Mleczek, Chief Technology Officer at Curevac.
IDT Biologika vaccinates the first test subjects
IDT Boilogika is developing a so-called vector-based vaccine in cooperation with the German Center for Infection Research (DZIF). The vaccine technology was developed at the Ludwig Maximilians University in Munich. The DZIF and IDT Biologika are already developing a vaccine against the MERS coronavirus using the same technology.
The Paul Ehrlich Institute approved the first clinical tests last week. On Friday they want to start vaccinating the first test subjects, said Andreas Neubert from IDT Biologika. Approval should then be applied for at the end of 2021. The company received a grant of 114 million euros from the federal government.