FDA Approves First COVID-19 Vaccine in United States

The Food and Drug Administration has approved Pfizer and BioNTech's coronavirus vaccine for [...]

By Daniel S. Levine

The Food and Drug Administration has approved Pfizer and BioNTech's coronavirus vaccine for emergency use. FDA Chief Scientist Denise Hinton sent a letter to the pharmaceutical companies letting them know the vaccine was cleared for use, a turning point in the pandemic. Since the first coronavirus case was recorded earlier this year, more than 15.8 million Americans have tested positive for the virus and over 294,800 Americans have died after contracting the virus, according to Johns Hopkins University data.

The emergency use authorization means Pfizer's vaccine was given special authorization to use during an emergency, although it is not a complete approval, notes CNN. Pfizer still needs to file another application to get the vaccine fully licensed from the FDA. "The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," FDA Commissioner Dr. Stephen Hahn said in a statement.

The decision came after an "open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization," Hahn continued. He called the "tireless work" to develop the vaccine quickly a "true testament to scientific innovation and public-private collaboration worldwide."

President Donald Trump also posted a video message on Twitter, calling it a "medical miracle." The president later added, "We've delivered a safe and effective vaccine in just 9 months. This is one of the greatest scientific accomplishments in history."

Although the emergency authorization was granted, it could take some time for the majority of Americans to receive the Pfizer vaccine. The CDC's immunization advisory committee still has to recommend it to the CDC, which has to accept the recommendation. The committee is scheduled to meet Saturday morning. Pfizer hopes to ship 50 million doses before the end of the year, which is enough for 5 million people, reports CNBC. It will is expected to be sent out to frontline workers and vulnerable people first, but states have the authority to distribute the vaccines how they wish. The vaccine has been authorized for people 16 and older.

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