FDA authorizes 1st COVID-19 vaccine in United States

The Food and Drug Administration authorized the United States' first COVID-19 vaccine for people age 16 and over late Friday, a historic moment in a pandemic that has killed over 290,000 in this nation and nearly 1.6 million people worldwide. 

"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 emergency use authorization was expected to trigger the first shipment of 2.9 million doses to 636 sites across the country within 24 hours, primarily to hospitals where front-line health care workers are expected to receive them. Nursing homes and other long-term care facilities are also considered a top priority. 

Pfizer, which produced the vaccine alongside German company BioNTech, has said it will ship the doses from its Michigan warehouse directly to those sites, pre-selected by governors and local health officials. 

"Today, we can begin to turn millions of Americans hopes into reality," Pfizer CEO Albert Bourla said. "That's because we have received the great news that the FDA has authorized the emergency use of our COVID-19 vaccine for people 16 or older." 

A second batch of 2.9 million doses was expected to follow close behind, with the U.S. government opting to keep 500,000 doses in reserve to address any shipping or distribution mishaps. 

The U.K. has already begun distributing the vaccine. Regulators in Mexico and Canada also endorsed the vaccine. 

It is the first vaccine that uses the genetic technology mRNA to be authorized in the United States. 

While the timing was not certain, the expectation was that vaccination shots would begin quickly, possibly on Monday. 

The authorization comes after federal advisers -- an independent group of infectious disease experts, doctors and scientists -- agreed the benefits of the Pfizer vaccine strongly outweighed any potential risks based on trial data. 

"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization," Denise M. Hinton, chief scientist at the FDA, wrote in approving the EUA. 

Data from clinical trials involving 44,000 volunteers this year estimated the vaccine to be 95