FDA Grants Emergency Authorization to First COVID-19 Vaccine

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.

"[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.”