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Trial Okayed in Germany for Covid-19 Vaccine

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, responsible for Covid-19 infections (NIH.gov)

23 Apr. 2020. Regulators in Germany cleared a clinical trial to begin testing a vaccine with synthetic RNA to prevent coronaviruses from causing Covid-19 infections. The early- and mid-stage trial is testing a vaccine developed by biotechnology company BioNTech SE in Mainz, Germany and drug maker Pfizer Inc. in New York.

As new cases, hospitalizations, and deaths from worldwide Covid-19 pandemic continue to mount, vaccines to prevent infections are needed to reliably control spread of the disease. BioNTech is spun off from Johannes-Gutenberg University in Mainz developing immunotherapies from synthetic forms of messenger RNA, a nucleic acid transcribed from DNA, and transmitted to cells for production of amino acids in proteins to carry out functions in the body.

Much of the company’s current pipeline is devoted to cancer treatments that go beyond messenger RNA immunotherapies to protein and small molecule drugs, and cell and gene therapies, including chimeric antigen receptor, or CAR T-cell treatments for cancer. BioNTech also has a diagnostic division and manufacturing facilities. A key part of BioNTech’s business strategy is partnerships with other biotechnology developers, pharmaceutical companies, and academic research labs. As reported in Science & Enterprise in August 2018, BioNTech and drug maker Pfizer are collaborating on a vaccine to prevent seasonal influenza using messenger RNA.

BioNTech’s Covid-19 vaccine, code-named BNT162, results from another collaboration with Pfizer. The Paul-Ehrlich-Institut, Germany’s regulatory body for clinical trials and vaccines, yesterday authorized the companies to begin their clinical trial of BNT162. In an indication of the trial’s urgency, the institute says BioNtech and Pfizer were able to provide preclinical evidence and complete the authorization procedure in only four days.

“The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved,” says BioNTech CEO and co-founder Ugur Sahin, in a statement.

The clinical trial is enrolling 200 healthy adults to test the vaccine’s safety and tolerability, as well as generate an immune response to SARS-Cov-2 viruses responsible for Covid-19 infections. While all participants are receiving BNT162 in lipid nanoscale particles — none are given a placebo — the study is testing four different formulations of the vaccine. The variations alter the type of messenger RNA in the vaccine, or target a different binding receptor on the viral protein. In addition, the trial is testing different dosage levels and effects of repeated immunizations of the vaccine. A second phase of the trial will test the vaccine in people considered at particularly high risk of Covid-19 infections.

“Now that the work in Germany can commence,” adds Pfizer chairman and CEO Albert Bourla, “we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future.”

BioNTech says it’s also collaborating with Fosun Pharma in Shanghai to develop BNT162 in China, including clinical trials of the vaccine.

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Disclosure: The author owns shares in Pfizer.

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