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FDA Authorizes Pfizer's COVID-19 Vaccine For Emergency Use

The FDA Authorizes Pfizer's COVID-19 Vaccine For Emergency Use; New York Nurse Receives Vaccine

Sandra Lindsay(L), a nurse at Long Island Jewish Medical Center, is inoculated with the Covid-19 vaccine by Dr. Michelle Chester, at Long Island Jewish Medical Center, on December 14, 2020 in the Queens borough of New York. - The rollout of the Pfizer and BioNTech vaccine, the first to be approved by the Food and Drug Administration, ushers in the biggest vaccination effort in US history. More than 299,000 Americans have been killed by the virus, including over 35,000 residents of New York state. (Photo by Mark Lennihan / POOL / AFP) (Photo by MARK LENNIHAN/POOL/AFP via Getty Images)

On Dec. 11, the Food and Drug Administration (FDA) announced that the Pfizer-BioNTech COVID-19 vaccine has been granted emergency approval for use in the United States. The US becomes the sixth country to clear the vaccine, joining Britain, Bahrain, Canada, Saudi Arabia, and Mexico, according to The New York Times.

"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 Stephen M. Hahn, MD, said, according to a press release from the FDA. "Today's action follows 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."

Nurse Sandra Lindsay Receives First COVID-19 Vaccine in NY

On Dec. 14, critical care nurse Sandra Lindsay was one of the first people in the US to receive the COVID-19 vaccine in an event that was televised and live-streamed just after 9 a.m. ET. She was administered the vaccine at Long Island Jewish Medical Center in Queens, NY. "I feel hopeful today," she said after getting the injection. "I feel like healing is coming. I hope this marks the beginning to the end of a very painful time in our history."

Original post, Nov. 20: Days after announcing a 95 percent effectiveness rate for their COVID-19 vaccine, Pfizer and BioNTech are asking FDA regulators to approve the vaccine for emergency use in the US. If approved, the companies said shots could be available on a limited basis to high-risk individuals as early as mid- to late December.

Pfizer and BioNTech are asking for emergency approval on the grounds that the vaccine has proven both safe to use and highly effective in clinical trials. The trials included 38,000 participants globally, covering a range of ages, races, and ethnicities, and to date, the companies have not found "any serious safety concerns related to the vaccine."

"Our work to deliver a safe and effective vaccine has never been more urgent as we continue to see an alarming rise in the number of cases of COVID-19 globally," said Pfizer Chairman and CEO Albert Bourla, PhD, in the company's press release. "Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential." Pfizer is also seeking approval across the globe in countries including Australia, Canada, Japan, and in Europe and the UK.

While they await approval, the companies are moving forward with manufacturing and distribution plans, enormous undertakings requiring collaboration with regulatory agencies across the world. The mRNA-based vaccine will require two shots taken three weeks apart and, in just one hurdle that must be overcome, has to be stored at minus 70 degrees Celsius, or minus 94 degrees Fahrenheit.

Even as the Pfizer vaccine moves toward approval, officials have warned that it won't be an immediate fix. The CEO of Moderna, which also announced promising results from its clinical trials, said this week that the vaccine shouldn't be seen as a "silver bullet . . . we need surveillance to be stronger. We need public health measures."

Anthony Fauci, MD, director of the National Institute of Allergies and Infectious Diseases, has estimated that both vaccines will be available to high-risk people by December and to the general public by spring 2021. In the meantime, staying safe, wearing a mask, and taking necessary precautions remains crucial as cases continue to rise around the country.

POPSUGAR aims to give you the most accurate and up-to-date information about the coronavirus, but details and recommendations about this pandemic may have changed since publication. For the latest information on COVID-19, please check out resources from the WHO, CDC, and local public health departments.

Additional reporting by Christina Stiehl

Image Source: Getty / Mark Lennihan
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