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The corona vaccine candidate developed by Mainz-based company Biontech is entering the approval process. The European Medicines Agency Ema confirmed this Tuesday in Amsterdam that the active principle BNT162b2 would be examined in the so-called continuous review process that has now started. In this process, clinical trial data is continuously submitted and evaluated. Ema’s decision to begin the procedure is based on encouraging preliminary data from preclinical and early clinical trials in adults, according to the agency.
This makes Biontech the first German company and, with AstraZeneca, the second overall to be approved by Ema for this process. “The ongoing review process will continue until sufficient information is available to support a formal request for approval,” Ema said.
In April, Biontech was the first German company to receive approval for a phase I / II clinical study from the responsible Paul Ehrlich Institute. During this phase, the safety and tolerability of the candidate vaccine are evaluated. Preliminary data showed that the active ingredient was well tolerated and had mild to moderate side effects, report Biontech and the pharmaceutical company Pfizer, which supports vaccine development. The subjects would have produced antibodies and other desired immune reactions. The committee responsible for Ema has begun to examine these data.
The vaccine is currently being tested in a phase II / III clinical trial. In this phase, efficacy is further checked and the appropriate dose is determined. To date, 37,000 participants have been included in the study, 28,000 have already received the second dose of vaccine, according to the announcement. More than 120 study centers around the world are involved, including the US, Brazil, South Africa and Argentina.
Accelerated procedure
The ongoing review process is intended to speed up the approval of a vaccine. If the committee responsible for Ema has presented and evaluated sufficient data, Biontech can request market approval. Businesses typically only submit all the data collected with the approval request.
It could also happen with EU approvals that an interim evaluation already provides good data on the efficacy and safety of a vaccine and based on this a so-called Conditional Marketing Authorization – an approval with conditions – may take place before the clinical trial, which usually takes one to two years. Phase III has been fully completed, “explained Klaus Cichutek, president of the German Paul Ehrlich Institute (PEI) responsible for vaccines and biomedicine.
The candidate vaccine will be subject to Ema’s strict quality, safety and effectiveness standards, emphasize Biontech and Pfizer in their communication. “As we work to develop a potential vaccine at an unprecedented rate to end this pandemic, it is our duty to ensure that we do so with the highest ethical standards and in accordance with sound scientific principles,” he said. The head and co-founder of Biontech, Ugur Sahin.
In mid-September, Biontech announced that it planned to apply for approval in the EU and the US at the same time, probably in October or November. The company recently bought a Novartis plant in Marburg to make vaccines. At the network of Pfizer and Biontech production facilities, 1.3 billion doses of vaccines could be produced, probably even more, next year, according to the mid-September press conference.
The active ingredient developed by Biontech is a so-called RNA vaccine. It contains genetic information about the pathogen. In the body, a viral protein is produced from this, which the pathogen uses to penetrate cells. The goal of vaccination is to stimulate the body to produce antibodies against this protein. If antibodies are present, they intercept viruses before they penetrate cells and multiply. In addition, the active ingredient should activate other defensive weapons of the immune system.
