Partners Pfizer, BioNTech Seek Emergency Vaccine Authorization From FDA

Pharmaceutical company Pfizer and its German partner, BioNTech, said Friday they have filed for emergency authorization from the U.S. Food and Drug Administration (FDA) to use their COVID-19 vaccine, saying they are poised to begin distribution within hours after authorization. The application comes after the companies said testing shows the vaccine has an effectiveness rate of 95 percent, with no serious safety concerns observed to date. In a news release, the companies say in addition to their submission to the FDA, they are seeking authorization from authorities in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world. FILE – A worker passes a line of freezers holding coronavirus disease vaccine candidate BNT162b2 at a Pfizer facility in Puurs, Belgium, in an undated photograph.With the COVID-19 pandemic surging around the world, the regulators will be under pressure to make a quick decision on the vaccine. In an interview, former U.S. FDA chief scientist Jesse Goodman explained the standard for emergency use authorization only requires that a product “may be effective.” He said the agency performs an assessment on whether the available data determines if the potential benefits outweigh the potential risks. During a White House briefing Thursday, the leading U.S. infectious disease expert, Dr. Anthony Fauci, said he understands that people might be concerned about the speed with which these vaccines have been developed, but he expressed confidence that the vaccines will be safe. “The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” he said. “It was a reflection of the extraordinary scientific advances in these types of vaccines, which allowed us to do things in months that actually took years before.” Fauci cautioned that just because a vaccine appears to be on the way, people should not stop taking precautions. “If you’re fighting a battle and the cavalry is on the way, you don’t stop shooting. You keep going until the cavalry gets here. And then you might even want to continue fighting,” he said. Another U.S. company, Moderna, says it is not far behind with its COVID-19 vaccine. They report their vaccine is testing as strong as Pfizer’s, and they also plan to seek emergency authorization within weeks. 
 
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