FDA on Friday issued an emergency use authorization (EUA) for Pfizer's and BioNTech's coronavirus vaccine, and Monday morning, Long Island Jewish Medical Center in New York administered the first authorized doses of the vaccine in America.
CDC approves recommendation for vaccine's use among people 16 and older
The vaccine's distribution comes after the Advisory Committee on Immunization Practices (ACIP), which is a panel of outside experts that advises CDC on vaccines, on Saturday unanimously voted to recommend the use of Pfizer's and BioNTech's two-dose coronavirus vaccine among people ages 16 and older.
However, despite the unanimous vote, some ACIP members raised concerns about whether the vaccine should be administered among people with a history of severe allergic reactions to other medicines.
FDA's EUA for the vaccine warns against the vaccine's use among people who previously had severe reactions to one of the inoculation's ingredients, but the agency decided not to warn against the vaccine's use among people who have experienced a severe allergic reaction to any vaccine or injectable drug, STAT News reports. According to STAT News, severe allergic reactions to vaccines are not common, and severe allergic reactions stemming from any allergen were rarely reported during Pfizer's and BioNTech's clinical trials on their coronavirus vaccine. Overall, data released by FDA showed 0.63% of trial participants who received the vaccine experienced serious adverse reactions, compared with 0.51% of people who received a placebo, STAT News reports.
Peter Marks, director of FDA's Center for Biologics Evaluation and Research, on Saturday said FDA will continue to monitor the prevalence of severe allergic reactions in response to the vaccine and may ultimately revise its warnings in the future. But for now, Marks said FDA feels comfortable warning only against the vaccine's use among people with a history of severe allergic reactions to one of the vaccine's ingredients, rather than all Americans with a history of severe allergic reactions to any allergen.
"It turns out about 1.6% of the population has had a severe allergic reaction of some sort or another to a food or some environmental aspect and we would really not like to have that many people not be able to receive the vaccine, so we looked very closely at the databases, and we feel comfortable that we're telling people that unless they've had a severe allergic reaction to the vaccine, or one of its components, they can receive it," Marks said. He added, "We may have to modify things as we move forward, but for right now we're comfortable with this."
ACIP recommended that providers monitor patients with allergies for up to 30 minutes after their vaccination.
ACIP members also expressed concerns about administering the vaccine to children ages 16 and 17, as clinicals trials on the vaccine have not yet included large numbers of 16- and 17-year-olds. However, the committee members ultimately determined the known benefits of administering the vaccine to children those ages outweigh the known risks, and they voted to recommend the vaccine's use among children ages 16 and 17.
"Although (the study population) wasn't quite as large as you might have seen in other groups, there was enough there to make us comfortable that the known and potential benefits outweigh the known and potential risks" among 16- and 17-year-olds, Marks said on Saturday. He added, "Since some of those 16- and 17-year-olds, at least that I know of, are out there as check-out people or are interacting with communities, it may be wise that we are able to vaccinate them."
ACIP on Saturday also finalized its recommendations on which Americans should get the first available doses of the newly authorized vaccine. The committee recommended that:
- Health care workers and long-term care facility residents and staff be the first to receive the vaccine; and
- The second phase of vaccine distribution prioritize essential workers; people with underlying health conditions that place them at high risk of developing severe cases of Covid-19, the disease caused by the novel coronavirus; and people older than 65.
On Sunday, CDC Director Robert Redfield signed off on ACIP's recommendations, and the agency is expected to soon issue guidance on the vaccine's distribution and use.
Federal government, health systems begin distributing vaccine
On Saturday, officials involved with Operation Warp Speed, the federal government's initiative overseeing coronavirus vaccine development, said the federal government plans to complete its first shipment of Pfizer's and BioNTech's newly authorized coronavirus vaccine to states by Wednesday.
Gustave Perna, Operation Warp Speed's COO, said the initial shipment of the two-dose vaccine regimen will be delivered to a total of 636 distribution sites nationwide. According to the Associated Press, the distribution sites primarily are hospitals and other facilities capable of storing the vaccine at its required ultra-cold temperatures.
Perna said the first vaccine doses will begin to arrive at 145 sites by Monday, then reach 435 additional sites on Tuesday, and arrive at the final 66 sites on Wednesday. Officials said each of the distribution sites have already received kits containing supplies needed to administer the vaccine, including needles and syringes.
And on Monday morning, providers administered the first shots of the authorized vaccine at Long Island Jewish Medical Center, the New York Times reports. On Monday afternoon, George Washington University Hospital is scheduled to begin administering some of the first doses of the authorized vaccine, as well, during what HHS is calling a national "kickoff event," according to the Times.
Federal officials said they plan to begin sending out their second shipment of vaccine doses, which will include the second doses of the vaccine for those who receive their first doses from the initial shipment, to states and jurisdictions in about 21 days. Perna said, "The reason why we're holding on to the second dose, as well as some reserve, is that we don't have absolute confidence in the cadence. Not because Pfizer or [other manufacturers] aren't diligent in their process, but it is such a delicate process. We are being very diligent."
Perna also said the federal government put 500,000 of its initial batch of 6.4 million doses of the vaccine on reserve, to serve as backups in case any issues occur during the distribution process and shipped doses cannot not be used.
Overall, HHS Secretary Alex Azar during an interview on CBS News' "Face the Nation" on Sunday said he believes all nursing home residents could receive their first doses of the newly authorized vaccine by Dec. 25. And Moncef Slaoui, the scientific head of Operation Warp Speed, separately on Sunday said the federal government believes it will distribute about 40 million doses of coronavirus vaccines by the end of this year, which is enough to vaccinate about 20 million people.
Vaccine distribution begins as America's coronavirus epidemic surges to new heights
The vaccine's authorization and distribution come as U.S. officials on Friday reported more than 236,000 new cases of the novel coronavirus, setting a record for the highest number of new cases of the virus reported in the country in a single day, the Times reports. According to data compiled by the Times, U.S. officials as of Monday morning had reported a total of about 16.3 million cases of the virus since America's epidemic began—up from about 15.6 million cases reported as of Friday morning.
According to the Times, the United States' average daily number of newly reported coronavirus cases over the past week was 210,112—which is up by 30% when compared with the average from two weeks ago.
As of Monday morning, data from the Times showed that the rates of newly reported coronavirus cases were "staying high" in Puerto Rico; the U.S. Virgin Islands; Washington, D.C.; and 41 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and West Virginia.
Meanwhile, the Times' data showed that, as of Monday morning, the daily average number of newly reported cases over the past seven days was "going down" in eight states that had been seeing comparatively higher rates of coronavirus transmission. Those states are Iowa, Michigan, Minnesota, Nebraska, North Dakota, South Dakota, Wisconsin, and Wyoming.
Hawaii has had comparatively low case rates, but it was seeing those rates "going up" as of Monday morning, according to the Times. In Guam, meanwhile, rates of newly reported coronavirus cases were "staying low" as of Monday morning, the Times' data showed.
Meanwhile, U.S. hospitalizations for Covid-19 grew to a new high for the 16th consecutive day on Sunday, according to data from The Atlantic's COVID Tracking Project. The data showed that 109,331 Americans with Covid-19 were hospitalized for treatment on Sunday, including 21,231 who were receiving care in an ICU and 7,529 who were on a ventilator. Over the past five weeks, the number of hospitalizations for Covid-19 in the United States has doubled, the Wall Street Journal reports.
As of Monday morning, U.S. officials also had reported a total of about 299,328 U.S. deaths linked to the virus since the country's epidemic began, up from about 292,747 deaths reported as of Friday morning.
Over the past four weeks, the United States has reported more than 50,000 new deaths linked to the novel coronavirus, the Times reports (Wang, Inside Health Policy, 12/12 [subscription required]; Ross, STAT News, 12/12; Budryk , The Hill, 12/13; Lienhard, Inside Health Policy, 12/12 [subscription required]; Perrone et al., Associated Press, 12/11; Thomas, New York Times, 12/9; Quinn, "Face the Nation," CBS News, 12/13; Budryk , The Hill, 12/13; Fisher et al., Washington Post, 12/12; Wright et al., New York Times, 12/11; Wall Street Journal, 12/13; Healy et al., New York Times, 12/14; New York Times, 12/14; "The COVID Tracking Project," The Atlantic, accessed 12/14).