Pfizer and BionNtech request authorization to distribute their vaccine in the EU

In a joint statement the two companies expressed their hope that the vaccine could be used in Europe before the end of the year.

| 12/01/2020 | ionicons-v5-c09: 05 | . |

Berlin.- The American company Pfizer and his german partner BioNtech have requested before health authorities European authorities the authorization for the use in the European Union of the vaccine against covid-19 that they have developed jointly.

« For us as a company settled in the heart of Europe This is an important milestone, we will continue to strive to distribute the vaccine worldwide after a possible authorization, « said the president of BioNtech, Ugur Sahin.

In a joint statement, the two companies expressed their hope that the vaccine could begin to be used in Europe before the end of the year.

« In the event that the EMA (European Medicines Agency) concludes that the benefits of the coronavirus vaccine are greater than the possible risks, the agency will recommend a conditional release to the market, » the companies estimate in their statement. about the decision they expect.

A week ago Pfizer Y BioNtech had requested an emergency authorization for their vaccine before the health authorities from the US, where the competent body (the Food and Drug Administration, FDA, in English) will meet on December 10 to decide on the application.

The EMA has already started a special procedure to speed up the authorization; In the process to obtain this route, vaccine manufacturers can, before submitting the full application, advance data on the efficacy of the vaccine and its safety in relation to its side effects.

If these data are sufficient, a conditional authorization can be granted.

The distribution and application of the vaccine will imply a logistical challenge since it has to be kept at a temperature of minus 70 degrees Celsius and in order to guarantee them Pfizer Y BionTech they have developed a transportation system with their own refrigerators.

The vaccine Pfizer Y BioNtech, in the third phase of clinical studies, showed an effectiveness of 95 percent and has to be applied in two doses to offer protection against the coronavirus.

Before knowing the announcement of the companies, the German Minister for Research, Anja Karliczek, indicated that « vaccines from different laboratories will be needed » and warned that the authorization process is not only about evaluating their effectiveness, but also that it will not present adverse side effects, that it will be safe and accessible for everyone.