The FDA Has Officially Authorized and Administered the First Coronavirus Vaccine—Here’s How That Affects You
The first doses were administered this morning, but we still need to mask up until shots are available to the masses.
After almost a year of unparalleled uncertainty and crisis—and a pandemic-related death toll of nearly 300,000 Americans—there’s finally a beam of light at the end of the long, COVID-19 tunnel. On Friday, December 11, the U.S. and Drug Administration (FDA) issued emergency use authorization to the Pfizer and BioNTech vaccine for the prevention of the coronavirus disease in people ages 16 and older.
The FDA confirmed the Pfizer-BioNTech vaccine—reported to be safe and 95 percent effective in preventing disease in a massive clinical trial, and already approved in several countries, including Canada and Britain—has met the required criteria for emergency use authorization issuance. No time was wasted getting the very first shipment of doses out to hospitals and medical centers nationwide over the weekend through Pfizer’s distribution network. Pfizer has said it hopes to deliver up to 100 million doses this year and another 1.3 billion doses next year.
“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,” said FDA Commissioner Stephen M. Hahn, MD, in a written statement by the FDA on Friday. “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited time frame after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
Starting Monday morning, December 14, the very first clinically authorized shots were administered in the U.S. to health care workers and nursing home residents, including a critical care nurse in New York, an emergency room nurse in Iowa, and an emergency medicine physician in Ohio.
According to the FDA, the vaccine is given in two separate doses, administered three weeks apart. “At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person,” the statement notes, adding that ongoing research is underway to answer these unknowns. Based on clinical trials of the vaccine, the most commonly reported side effects are pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever, with reactions typically lasting up to several days.
With an initial vaccine supply underway, the natural question on everyone’s minds now is, how and when can I get one? There is currently a limited number of vaccine doses available, and priority for injections is, for now, being given to those with high exposure to the disease, such as high-risk healthcare workers and residents of long-term care facilities, as counseled by the CDC Advisory Committee on Immunization Practices.
While the welcome news and initial inoculation of this historic vaccine is certainly something to celebrate, it’s important to be patient: The majority of Americans who don’t fall into either of these high-risk, high-priority categories shouldn’t expect to be getting a shot at their local pharmacy quite yet. Big picture, the CDC reports that all adults should be able to get vaccinated later in 2021 as supplies increase and ordering and distribution processes are streamlined.
The nation’s top infectious disease expert Anthony Fauci, MD, laid out his expectations in an interview with MSNBC on Monday, predicting that healthy individuals with no underlying health conditions will likely be eligible for an injection sometime in the late spring or early summer of 2021. Dr. Fauci also stressed that the vaccine is in no way a replacement for the public safety measures we’ve been practicing since March. Even with ubiquitous availability of the vaccine on the horizon, socially distancing, mask-wearing, avoiding large groups and indoor gatherings, and frequent hand-washing remain as important as ever in keeping the spread of COVID-19 at bay.