Pfizer formally asked U.S. regulators Friday to allow emergency use of its COVID-19 vaccine
|Pfizer Biotech is seeking approval for the use of their vaccine in public in the USA|
Pfizer formally asked U.S. regulators Friday to allow emergency use of its COVID-19 vaccine, what it does is start the clock ticking process that could bring some shots early next month and finally be able to end the epidemic – but long after, severe winters.
Pfizer Inc. Its German partner Bionatech has announced that its vaccine has been tested in a large, ongoing study 95% effective in preventing mild to severe COVID-19 diseases.
The agency said the vaccine, which has a record of safety plus a good protective record, should be eligible for approval for emergency use, which could be approved by the Food and Drug Administration before the final tests are completed. In addition to submitting to the FDA, they have already launched “rolling” applications in Europe and the United States, and will soon begin the process of submitting similar information.
The coronavirus is growing in the United States and around the world, putting pressure on regulators to make quick decisions.
Ahead of Pfizer’s announcement, Dr. Anthony Fawcett, the top infectious disease specialist in the United States, said, “Assistance is being provided.” Friday’s filing puts the shots ready, according to the FDA and its independent advisers, but launches a series of events as a matter of debate. If that happens, another government group will decide how initially limited supplies are anxiously awaiting Americans.
How many vaccines are available and when will it be introduced? However, plans are afoot to make primary supplies scarce and rationed. Worldwide, Pfizer estimates that it will deliver 50 million doses by the end of the year. According to data presented at the National Academy of Medicine this week, about 25 million may be available for use in December, 30 million in January and 35 million in February and March for the United States. Recipients must take two doses at three-week intervals. The United States has contracts to buy millions of Pfizer-Bioentech doses, as well as candidates other than Pan-Out, who have promised that the shots will be delivered free of charge.
Competitor Moderna Inc. Its Covid-19 vaccine is not far behind. From its preliminary data it can be inferred that the shots are as powerful as Pfizer and the company also expects emergency approval within a few weeks.