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(CNN Spanish) – Pfizer and BioNTech said they will submit documentation to the U.S. Food and Drug Administration on Friday to obtain an emergency use authorization for their coronavirus vaccine.
This is the first coronavirus vaccine to seek regulatory approval in the United States. The companies said in a statement that their vaccine candidate, known as BNT162b2, will potentially be available for use in populations at high risk for coronavirus in the United States in mid to late December.
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Coronavirus vaccine: this is an emergency authorization
The submission to the FDA is based on the results of the phase 3 clinical trial of Pfizer’s vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers. The final analysis of the trial found that the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer and its German partner BioNTech announced this week. The presentation also includes safety data on about 100 children between the ages of 12 and 15.
About 42% of global participants and 30% of American participants in the Phase 3 study have diverse racial and ethnic backgrounds, the companies said in a press release, and 41% of global participants and 45% of Americans are between 56 and 85 years old.
“The submission to the US emergency use authorization represents a critical milestone in our journey to deliver a coronavirus vaccine to the world and we now have a more complete picture of the efficacy and safety profile of our vaccine, which gives us confidence in its potential, ”said Pfizer Chief Executive Albert Bourla in a statement.
Moderna, another pharmaceutical company, announced Monday that the first results of its clinical trials show that its vaccine is 94.5% effective. The company plans to apply for FDA clearance after it accumulates more safety data later this month.
The FDA has scheduled a meeting of its Advisory Committee on Vaccines and Related Biologicals, a group of outside experts, for Dec. 8, 9 and 10, a source familiar with the process told CNN this week. The agency could make a decision at the end of the meeting on December 10 on whether to issue an emergency use authorization, the source said.
FDA Emergency Use Authorization, or US, is not the same as full approval. An EUA allows products to be used in particular circumstances before all the necessary tests for approval are available. The agency must determine that the “known and potential benefits of the product outweigh its known and potential risks.”