Mainz / New York (dpa) – The Mainz company Biontech and US pharmaceutical giant Pfizer have applied for approval from the European Medicines Agency (Ema) for their corona vaccine in the EU.
The application for a conditional marketing authorization was submitted on Monday, Biontech and Pfizer announced on Tuesday. On Monday, the American company Moderna also submitted a corresponding application for its vaccine to Ema.
Ema must now check the applications. It was initially unclear how long this would take. If the authority recommends conditional approval, the vaccine could still be used in December, Biontech said. The final decision is taken by the European Commission, which usually follows Ema’s recommendation.
Biontech announced that it could start delivering the first vaccines immediately after approval. Biontech / Pfizer and Moderna have also applied for an emergency permit from the US FDA.
For the Biontech / Pfizer vaccine with the designation BNT162b2, extensive series of tests showed an effectiveness that, according to the company, provides 95 percent protection against Covid-19 disease. The vaccine worked equally well across age groups and other demographic differences and showed practically no serious side effects, the companies said after the final analysis. The vaccination protection for people over 65 years of age is over 94 percent.
These positive results relate to protection against Covid 19’s disease. It is not yet clear to what extent the vaccine also protects against infection and possible transmission of the virus.
The Biontech / Pfizer vaccine is relatively similar to the Moderna preparation in its mechanism of action and also in its effectiveness. Ema is already running a so-called rolling review process for both vaccines, intended to speed up the approval process. Manufacturers can already submit individual parts about the quality, safety and effectiveness of a preparation before the complete application for approval.
According to Biontech, the vaccine doses must be distributed “fairly”. The company had announced that “one country will not receive all”. Germany and the EU have already signed a framework agreement to purchase up to 300 million doses of the vaccine. Based on delivery forecasts, Biontech estimates that up to 50 million vaccine doses will be shipped worldwide this year and up to 1.3 billion doses produced next year. The vaccination is given in two doses.
“As a company based in the heart of Europe, today’s milestone is hugely important to us as we continue to strive to enable global distribution following the potential approval of BNT162b2,” said Biontech CEO and Co-Founder Ugur Sahin. “We want to continue to work with regulatory authorities around the world to enable the rapid worldwide distribution of our vaccine in the event of approval. We would like to contribute to the global effort to fight the virus so that we can get back to normal. “
According to the information, Biontech and Pfizer have also filed for approval with the UK regulatory agency MHRA. There are also pending proceedings in Australia, Canada and Japan, among others. Further applications worldwide are planned.
Last week, Ursula von der Leyen, head of the European Commission, announced that a framework contract has been signed with Moderna for up to 160 million doses of vaccine. Accordingly, 80 million cans will be delivered initially, with the option of an additional 80 million units. According to Moderna, the product could be delivered to the EU as early as December, subject to approval.
The Pfizer and Biontech preparation is, like that of Moderna, a so-called RNA vaccine. It contains genetic information about the pathogen, from which the body then produces a virus protein. The purpose of vaccination is to stimulate the immune system to make antibodies to intercept the viruses. There is no approved vaccine of this type yet.
Countries such as Russia, China and most recently Bahrain have already released restricted vaccines and are already vaccinating parts of the population. But how well these vaccinations actually protect and what side effects they can have is currently largely open.