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New York / Mainz. A big step on the road to the long-awaited anti-corona active ingredient: Mainz-based company Biontech and American pharmaceutical giant Pfizer have applied for emergency approval for their corona vaccine from the American pharmaceutical authority FDA. Pfizer confirmed this on Twitter on Friday. The companies had previously announced that approval applications were being prepared for Europe and other regions.
“We can deliver within hours if we get a permit,” said a Biontech spokeswoman in Mainz. If the active ingredient is approved, particularly vulnerable people in the US could be vaccinated in mid to late December.
Biontech CEO and co-founder Ugur Sahin spoke of a “decisive step in making our candidate vaccines available to the world’s population as quickly as possible.” The goal is the rapid worldwide distribution of the vaccine. “As a German-based company in the heart of Europe”, close contact with the European Medicines Agency (EMA) is of particular importance to Biontech.
Biontech and Pfizer are the first Western manufacturers to publish promising study results and are paving the way for emergency FDA approval. According to the company, an extensive series of tests for the vaccine with the designation BNT162b2 showed effectiveness offering 95 percent protection against Covid-19 disease. The vaccine works equally well in all age groups and other demographic differences and shows virtually no serious side effects, the companies announced after their final analyzes.
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There is relentless research on a COVID-19 vaccine. The first candidate was in the admission phase in just one year.
The FDA must first review the application after it has been submitted. It was initially unclear how long that might take. However, the American experts were sure that there could be an audit result before the end of the year. An expedited approval process is applied to corona vaccines due to their particular urgency.
Biontech and Pfizer are already sending data to the European Medicines Agency (EMA) and other countries. In this way, manufacturers can transmit partial information on the quality, safety and efficacy of a preparation even before the formal application for approval. “We continually submit data in a continuous submission process,” the Biontech spokeswoman replied when asked about preparations for vaccine approval applications at the EMA and in Switzerland. The objective is to use this data to allow the approval of an application.
A first vaccine could be approved in Europe from the second half of December, the head of the EU Commission, Ursula von der Leyen, said on Thursday, referring to information from the EMA.
A plant in the city of Marburg in Hesse will play an important role in the production of the vaccine. The acquisition of this production plant from the Swiss pharmaceutical company Novartis was completed in October, according to Biontech.
After production, the doses of the vaccine must be distributed “evenly” according to the company. “One country will not get everything.” Germany and the EU have already signed a framework agreement for the purchase of 300 million doses of the vaccine from Biontech and Pfizer. Based on delivery forecasts, Biontech predicts that up to 50 million doses of vaccines will be shipped worldwide this year and up to 1.3 billion doses will be manufactured next year.
Biontech had already started developing the BNT162b2 vaccine in mid-January in the “Lightspeed” project. The phase 3 study, which is crucial for its approval, began in late July.
The preparation is a so-called mRNA vaccine, which is based on a new mechanism. It contains genetic information about the pathogen, from which the body produces a virus protein, in this case the surface protein with which the virus enters cells. The goal of vaccination is to stimulate the body to produce antibodies against this protein to intercept viruses before they enter cells and multiply.
An advantage of mRNA vaccines is that they can be produced much faster than conventional vaccines. However, the vaccine must be stored at minus 70 degrees. Pfizer has extensive experience in refrigerated storage and vaccine transportation and already has a corresponding global infrastructure, the companies said.
In addition to Biontech / Pfizer, several other pharmaceutical companies are currently working on advanced-stage corona vaccines, including Johnson & Johnson, Astrazeneca, and Sanofi-GSK. In Russia, China and recently in Bahrain, vaccines with restrictions have already been launched, and vaccinations have started there. However, little is known about how well these active ingredients actually protect and what side effects they may have.
Federal Minister of Health Jens Spahn (CDU) recently stated that he expected a speedy approval process. At the same time, he announced an extensive information campaign on corona vaccination. First of all, the elderly, people with previous illnesses, doctors and nurses, police officers, firefighters, teachers and educators should be vaccinated, in accordance with the recommendations of the German Ethics Council, the Academy of Sciences of Leopoldina and the Permanent Commission on Vaccination.
Mainz Mayor Michael Ebling (SPD) said on Friday that the world looked to Mainz with hope these days. In addition to the development of the vaccine in the Mainz laboratories of Biontech, the Mainz Schott special glass manufacturer produces the pharmaceutical vials for the transport of vaccines.
