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All over the world we are working hard on the development of a corona vaccine. Now the Mainz-based company Biontech has taken another decisive step. The European pharmaceutical regulator started the approval process.
European pharmaceutical regulator EMA has started the approval process for the corona vaccine from Biontech and Pfizer. The authority confirmed in Amsterdam that the active ingredient BNT162b2 will be tested in the so-called continuous review process. Biontech and the pharmaceutical company Pfizer, which supports the development, had previously announced the testing procedure.
In this process, clinical trial data is continuously submitted and evaluated. The EMA’s decision to begin the process is based on encouraging preliminary data from preclinical and early clinical trials in adults, the agency said. “The ongoing review process will continue until a sufficient basis is established to support a formal request for approval,” the EMA said.
Preliminary admission with possible conditions
It could also be the case with EU approvals that a mid-term evaluation would provide good data on the efficacy and safety of a vaccine and based on this a so-called Conditional Marketing Authorization, an approval with conditions, could take place “before the clinical one or two years The phase III examination is fully completed, “explained Klaus Cichutek, president of the Paul Ehrlich Institute (PEI) responsible for vaccines and biomedicine.
British-Swedish vaccine is already being tested
Since the beginning of the month, the EMA has been reviewing clinical trial data for a candidate vaccine that the British-Swedish pharmaceutical company AstraZeneca is developing together with the University of Oxford. The active ingredient, known as AZD1222, is based on the weakened version of a chimpanzee cold virus.
After one participant in the phase III study fell ill, clinical trials with the active ingredient were discontinued worldwide. In Great Britain they started again after a week, later also in Brazil, South Africa, India and Japan. In the US, a decision on resumption of clinical trials was pending in early October.
A dozen Phase III vaccine trials around the world
According to the World Health Organization (WHO), phase III studies are currently underway in about a dozen vaccine candidates. According to the PEI, four of the so-called RNA vaccines and two vector vaccines are in different phases of clinical trials in Germany.
Russia had already started the first vaccinations against the corona in the population when the decisive phase III study for the preparation “Sputnik V” had not even begun. That is inconceivable in the EU, “because we need phase III data on the efficacy and safety of the vaccine,” said PEI chief Cichutek. “These tests are absolutely necessary to be able to make a risk-benefit assessment based on sufficient scientific data.”
In China, tens of thousands were vaccinated without completing an exam
In China, too, certain population groups, such as military and hospital personnel, are already exposed to vaccine candidates for whom examination in such clinical studies has not been completed in any way. According to estimates, tens of thousands have already been vaccinated in the country.
Lamination process to save time.
The responsibility for the approval of new vaccines and medicines in Europe is based on the EU level. The EMA decides this for all member states at the same time. According to Biontech, a continuous submission process is a special model in which the EMA continuously analyzes the test series data to save time.
Typically, all study results are first collected and then submitted as part of a complete marketing authorization application. On the contrary, in the case of a continuous process, the authority previously verifies the partial data, which the companies involved make available to it. Once the EMA believes that sufficient information is available, the company can officially request approval of its candidate.
