The US pharmaceutical giant Pfizer expected to apply for a license for the emergency use of its COVID-19 vaccine, which it is developing in partnership with German Biontech, in late November, about two weeks after the US presidential elections scheduled for the third of the same month.
The company hoped to proceed with the launch of the vaccine after the availability of safety data in the third week of November, which immediately led to a 2% increase in its shares in the US financial markets.
Pfizer Chairman and CEO Albert Burla said in an open letter, “To be clear, if we assume that the data is positive, Pfizer will soon apply for a license for emergency use in the United States after achieving the (verification) phase of safety in the third week of November.” / November, “and added that Pfizer wants to provide greater clarity about the timetables for developing the vaccine, which is subjecting about 38,000 people around the world to its clinical trials.
To date, no organization around the world, outside of Russia and China, has been granted regulatory approval for the vaccine, making Pfizer a leader in the race.
The British “Financial Times” newspaper reported that Burla said in a memo addressed to his company employees that “intense political rhetoric” about vaccine development and timing “undermines public confidence.”
In the message sent Friday, Burla said that the company will be able to know whether the vaccine is effective by the end of October, but he warned that this data “may be prepared slightly earlier or later than the specified time depending on changes in infection rates.” Among the participants in the experiment.
Burla pledged to publish a full analysis of the results of clinical trials on the vaccine, whether positive or negative, “as soon as possible.”
Pfizer must provide safety data for at least half of the participants in clinical trials, indicating the course of interaction with the vaccine for a period of two months after the final dose, until it obtains an emergency license from the US Food and Drug Administration,
The vaccine that Pfizer is currently working on with Biontec adopts the new mRNA technology and is given two separate injections.
The two companies said they will be able to produce 100 million doses this year, and at least 1.3 billion next year.