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Monday, September 07, 2020
The German company Biontech gets the green light for a clinical study of its corona vaccine in Germany. If successful, approval could already be requested in October. However, progress in the search for a vaccine has also been reported in other countries.
Around the world, pharmaceutical and biotech companies are working under great pressure on a corona vaccine. The pace is significantly faster than with other vaccine projects in the past. And there is progress: Mainz company Biontech and its partner, US pharmaceutical manufacturer Pfizer, can now test their candidate for a corona vaccine in Germany. In addition, Britain is hopeful that the Astrazeneca company will approve the vaccine. And trials of another vaccine are starting in Russia.
The clinical trial in Germany, approved by the Paul Ehrlich Institute (PEI), is part of the global approval study that Biontech and Pfizer began in July. This is a so-called second and third phase clinical study, as the companies announced: it will examine the safety and efficacy of its candidate vaccine in up to 30,000 test subjects. Study participants receive the vaccine or a placebo.
The clinical study is being conducted in about 120 study centers around the world. So far, according to the information, more than 25,000 test subjects have participated. “A large, controlled phase 3 study is an essential prerequisite to establish beyond doubt the safety and efficacy of a vaccine,” said Biontech co-founder Ugur Sahin. The aim of integrating study centers in Europe and now also in Germany is “to support local approval”.
If the clinical trials are successful, Biontech and Pfizer plan to apply for regulatory approval for their vaccine in October. If the corona vaccine is approved, up to 100 million doses of vaccine will be produced by the end of the year and more than 1.3 billion doses of vaccine by the end of 2021.
Will the Astrazeneca vaccine arrive in early 2021?
The UK is “more likely” to have a Covid-19 vaccine in the first few months of next year, according to Health Secretary Matt Hancock. Hancock told national news broadcaster LBC that production of the first order of 30 million doses of the coronavirus vaccine had already begun. The vaccine is being jointly developed by Astrazeneca and the University of Oxford.
“We have already signed a 30 million can contract with Astrazeneca. In fact, they start manufacturing these cans before approval, so if approval is granted, and it’s still not sure, but it looks good” in case that approval is granted, then we are ready to go to market, “said Hancock LBC.
The vaccine has not yet been approved for use and is still in advanced stage clinical trials in the UK, Brazil and South Africa. According to Hancock, the vaccine could already be available this year in the best scenario, but it will most likely be early 2021.
Russia plans to finish the first study on a possible second coronavirus vaccine by the end of September. This is reported by the RIA news agency, citing the health authorities. The Vector Institute is investigating this drug. With Sputnik-V, Russia became the first country to approve a vaccine in August, but without a large-scale study beforehand.
