Pfizer requests a license for the Corona vaccine at the end of next month

The American company Pfizer announced that it will request a license for a vaccine against Corona at the end of next month, after positive results of the final trials.

According to Arabnet, the German-American alliance Biontech / Pfizer, which is among the most advanced laboratories in developing a vaccine against Covid-19, announced earlier that it submitted its tests to obtain The approval of the European Medicines Agency.

The review will undergo a rapid procedure known as continuous evaluation, in order to reduce the time required in the event that the vaccine appears to be on the market.

The German laboratory Biontech said in a statement that the decision of the European Medicines Regulatory Authority to start a continuous evaluation comes after encouraging initial results of preclinical trials and initial clinical trials in adults.

It is the second German-American alliance to submit trials of a COVID-19 vaccine to the European regulatory body after AstraZeneca and the University of Oxford.

Biontech and Pfizer began large-scale clinical trials at the end of July. In early July, they reported initial positive results after testing the experimental vaccine on 45 people.

Currently more than 37,000 people are participating in their experiences, mainly in the United States, Brazil, South Africa and Argentina. The statement said that more than 28,000 of them had recently received a second injection of the experimental vaccine.

The European Medicines Agency said in a separate statement that the continuous evaluation process would continue until sufficient information was available to support a formal request for approval.

The agency also stressed that the decision to initiate an urgent review does not mean that any conclusion can be drawn so far regarding the safety and effectiveness of the vaccine, as most of the elements of the trials are still expected to be presented.

The continuous evaluation mechanism is used in emergencies to allow regulators to review test data during development, without waiting for the laboratory to submit the complete and final file.

The World Health Organization has identified 35 candidate vaccines that have reached the stage of human clinical trials around the world. And among them, nine are already in the final stage, or preparing for it.