En Español | The U.S. Food and Drug Administration (FDA) on Dec. 11 granted an emergency use authorization (EUA) to Pfizer and BioNTech's coronavirus vaccine, making it the first that will be available to the American public to help combat a virus that has so far infected more than 15.7 million in the U.S. this year.
The vaccine's authorization coincides with some of the country's deadliest days since the start of the pandemic — more than 3,400 people in the U.S. succumbed to COVID-19 on Dec. 9; 2,760 lost their lives to it a day later. So far, 95 percent of COVID-19 deaths in the U.S. have occurred in people 50 and older, data from the Centers for Disease Control and Prevention (CDC) shows.
“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, M.D., said in a statement. "The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide," he added.
Pfizer’s vaccine has been scrutinized and endorsed by a panel of independent external experts, known as the Vaccines and Related Biological Products Advisory Committee, who on Dec. 10 voted in favor of an EUA for Americans 16 and older, concluding that the benefits of the vaccine outweigh the risks. An FDA analysis showed that Pfizer’s two-dose vaccine far exceeds the agency’s previously established EUA standards: It was about 95 percent effective at preventing illness caused by the coronavirus in clinical trial participants, regardless of age, race or health risks known to complicate COVID-19, and no major safety concerns were uncovered.
Trial participants did experience side effects after vaccination including injection site pain, fever, chills, headaches, muscle aches and joint pain. However, these symptoms were temporary and are in line with side effects that accompany other common vaccines, experts say. British health officials, who began vaccination efforts this week with Pfizer's medicine, have documented two cases of anaphylaxis in vaccine recipients. Its government is now advising people in the U.K. who have had a serious allergic reaction to medicines, vaccines or food to hold off on getting the vaccine until more is understood.
In addition to the U.S. and Britain, Canada has authorized Pfizer's vaccine, as well.
Vaccine distribution begins
Distribution of the vaccine to states is underway and vaccination can begin immediately now that a CDC committee has formally recommended the vaccine.
This same group, known as the Advisory Committee on Immunization Practices (ACIP), previously issued guidance that since initial supplies will be limited, health care workers and residents and staff of nursing homes and assisted living centers should receive the first available doses. Forty percent of COVID-19 deaths in the U.S. have been linked to long-term care facilities, a Kaiser Family Foundation analysis shows.
"Hopefully we will start impacting people's lives very quickly after the onset of the campaigns to immunize,” Moncef Slaoui, the top scientist for Operation Warp Speed, told reporters Wednesday. The public-private partnership formed by the U.S. government is tasked with facilitating the development and distribution of coronavirus vaccines.
The U.S. plans to distribute 2.9 million doses of Pfizer's vaccine in its first shipments, followed by another 2.9 million when the first people vaccinated are due for their second shot, Gen. Gustave Perna, who oversees logistics for Operation Warp Speed, explained in a recent press briefing. Supplies needed for vaccination, including syringes, needles, alcohol wipes and diluting agent, have already been sent to state governments.
The federal government expects to have enough vaccine to inoculate 20 million Americans by the end of the year, with priority populations determined by ACIP to be first in line. (Essential workers, individuals with underlying health conditions and adults 65 and older are expected to follow health care workers and long-term care residents and staff.)
Officials predict it will take several more months to vaccinate everyone who wants a vaccine, even as production ramps up and more vaccine candidates clear FDA authorization. A vaccine from Moderna and the National Institutes of Health is also with the FDA for EUA consideration, and two other promising vaccine candidates are in phase 3 clinical trials in the U.S.
Emergency authorization vs. full FDA approval
It's important to note that an EUA — which can be used during public health emergencies like the current pandemic — is not the same as official FDA approval. That said, federal officials expect any vaccines receiving emergency authorization to obtain full FDA licensure once more safety data is collected. Long-term data will also answer other key questions that are still unknown, including how long the vaccine provides protection against COVID-19 and whether it's effective at blocking transmission.
"When vaccines are available, Americans should talk with their health providers to decide what is best for them,” said Nancy A. LeaMond, AARP's executive vice president and chief advocacy and engagement officer. “It is also critical to remember that even with a vaccine, prevention measures such as wearing masks and practicing physical distancing remain essential to slowing the spread and negative impact of the coronavirus."
Even with millions of Americans expected to be vaccinated in the coming months, health experts say preventive efforts put in place to slow the spread of the coronavirus — face masks, social distancing and frequent handwashing — cannot be abandoned any time soon.
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"[We can't] lose track of the tools that are sitting in front of us,” said Michael Mina, M.D., assistant professor of epidemiology at Harvard's T.H. Chan School of Public Health. “And now more than ever, we need them. We are at the peak of transmissibility of this virus,” and likely will be for a few more months, he added, referring to the record-breaking surge in new cases, hospitalizations and deaths.
"I know people are tired of all the restrictions and requirements, but I'm afraid, if anything, we really need to double down right now,” NIH Director Francis Collins told AARP at a recent tele-town hall event. “The vaccines really do represent a light at the end of the tunnel, but the tunnel still [has] a ways to go.”