Pfizer’s coronavirus vaccine candidate stood poised to become the first to earn U.S. Food and Drug Administration authorization, possibly as soon as today.
The 17-member independent Vaccines and Related Biological Products Advisory Committee is meeting now to review and discuss data from Pfizer and German startup BioNTech on their vaccine, then vote on whether the FDA should authorize it.
The companies are requesting an “emergency use authorization,†shy of a full approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed. But corners, FDA says, have not been cut.
The U.S. reported more than 3,000 COVID-19 deaths for the first time Wednesday, a single-day toll worse than 9/11. The Johns Hopkins University data dashboard reported 3,124 deaths, breaking a record of 2,885 set just last week. New infections are also booming, and across the nation hospitals are running out of beds, prompting stay-at-home orders in some places and mask mandates in 38 states.
Other news you need to know today:
- A CDC scientist told a House committee that she was ordered to destroy an email regarding attempts by political appointees to interfere with the publication of weekly CDC reports.Â
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The European Union agency responsible for approving vaccines said it has been the subject of a cyberattack. The European Medicines Agency said it “swiftly launched an investigation” but provided no details.
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The number of people applying for unemployment aid jumped last week to 853,000, the most since September. Before the coronavirus paralyzed the economy in March, weekly jobless claims typically numbered only about 225,000.
📈 Today’s numbers: The U.S. has reported more than 15.3 million cases and 289,000 deaths, according to Johns Hopkins University data. The global totals: 69 million cases and 1.57 million deaths.
📰 What we’re reading: It may not have started here, but the novel coronavirus became a US tragedy. In the earliest days of a historic pandemic, the virus had unfettered access into and throughout the United States.
This file will be updated throughout the day. For updates in your inbox, subscribe to The Daily Briefing newsletter.
Ellen DeGeneres tests positive but ‘feels fine’
Ellen DeGeneres has tested positive for the coronavirus but is “feeling fine right now,” she announced Thursday. Production on “The Ellen DeGeneres Show” has been paused until January, a Telepictures spokesperson confirmed to USA TODAY. The television host, 62, said in a tweet that “anyone who has been in close contact with me has been notified, and I am following all proper CDC guidelines.” In October, “The Ellen DeGeneres Show” became one of the first TV productions to return to inviting a limited number of in-studio audience members. On Oct. 28, 40 fans attended the “Ellen” taping in person in a studio generally holds about 300.
“I’ll see you all again after the holidays,” DeGeneres said. “Please stay healthy and safe.”
– Hannah Yasharoff
HHS: US to produce 180M N95 masks monthly starting in January
U.S. production of N95 masks will reach 180 million per month in January, up from 20 million a year ago, federal officials said Thursday. About 150 million of the U.S.-made masks are being produced now, senior Health and Human Services officials said in a press call.
“Anyone can find a disgruntled nurse on the street to talk about someone not getting an N95 mask. We can’t account for that,” said Paul Mango, Deputy Chief of Staff for Policy at HHS. “We are in a significantly better position than we’ve ever been, and a dramatically better position than we were in in January 2020.”
Before the pandemic, the nation’s Strategic National Stockpile, which harbors emergency medical supplies, contained less than 13 million N95 masks, said Brigadier General David Sanford, director of the Supply Chain Task Force. It now contains “15 times that number of masks,” between the stockpile and FEMA counterparts, Sanford said.
– Grace Hauck
CDC scientist ordered to destroy email evidence, House probe finds
The chairman of a House subcommittee is demanding more information after a Centers for Disease Control and Prevention scientist told the committee this week that she was ordered to destroy an email regarding attempts by political appointees to interfere with the publication of weekly CDC reports.
Panel Chairman Rep. James Clyburn revealed the information in a letter sent to CDC Director Robert Redfield and HHS Secretary Alex Azar on Thursday seeking to interview Redfield about the allegation.
Dr. Charlotte Kent, chief of the Scientific Publications Branch and editor-in-chief of the Morbidity and Mortality Weekly Report at the CDC, told the committee she was instructed to delete an Aug. 8 email sent by HHS senior adviser Dr. Paul Alexander, and that she understood the direction came from Redfield, according to the letter.
In the email, Alexander demanded that the CDC insert new language in a previously published scientific report on coronavirus risks to children or “pull it down and stop all reports immediately,” according to the letter. HHS and the CDC did not immediately respond to requests for comment.
– Grace Hauck
First vaccine could win approval today
The safety and effectiveness of the nation’s first COVID-19 vaccine is taking center stage today as a critical committee vets and votes on whether to allow its general use by the American public. The 17-member independent Vaccines and Related Biological Products Advisory Committee is meeting to discuss data from Pfizer and German startup BioNTech on their vaccine, BNT162b2. The daylong, live-streamed meeting is expected to end with a vote recommending the FDA authorize the Pfizer vaccine, which could come within hours or days.
“If there are no untoward scenarios that come up, authorization could be relatively soon,” said Norman Baylor, former director of FDA’s Office of Vaccines Research and Review.
– Elizabeth Weise and Karen Weintraub
Viral hoaxes greet first vaccinations – and it could be just the beginning
Hours after Margaret Keenan, a 90-year-old grandmother from the United Kingdom, became the first person to get the COVID-19 vaccine, anti-vaxxers heated up social media with claims that Keenan didn’t exist, that she was dead or that she was part of a Bill Gates scheme to implant microchips.
Researchers warn this is just the beginning of viral hoaxes on social media that will feed off the unknowns of the virus and the vaccines to undercut public trust in the coming wave of immunizations.
“I am deeply concerned,” said Emerson Brooking, resident fellow at the Atlantic Council’s Digital Forensic Research Lab. “The same information campaign which initially downplayed the severity of COVID-19, downplayed the number of cases, then downplayed the number of deaths is now shifting to focus on the vaccine.â€
Vaccines: Don’t forget that second dose
People who get one of the new COVID-19 vaccines will be expected to get their second shot 21 or 28 days after the first one, depending on the manufacturer. But what happens if someone misses that deadline by a day, a week or even longer?
Moncef Slaoui, co-leader of Operation Warp Speed, the federal government’s vaccine development effort, says that from a scientific perspective, such precision is not that important and the immune system generally responds better when there’s a wider gap between vaccinations. But during a pandemic, when the risk of infection is high, he noted that people are better off getting the second shot – and being fully protected – according to the authorized schedule.
“If there is significant transmission of disease, as is the case here, we should absolutely get the second dose exactly as has been studied,” he said.
– Karen Weintraub
As states prioritize the vaccine line, college students present a quandary
States are prioritizing frontline health workers and other vulnerable populations as the first to be immunized, but remaining unclear is the place in line for college students. The overwhelming majority of young adults are not among the nation’s most vulnerable. But students fueled some of the nation’s top outbreaks this fall, and they’re expected to return to campuses early in 2021.Â
Will they — can they — be required to get the vaccine once it’s readily available? And why are college students different than schoolchildren? It’s complicated, education experts across the country say — and we’re a long way from answers. Read more here.
– Lindsay Schnell
First in line: For some health care workers, thanks but no thanks
Millions of health care workers are slated to receive the first batch of potentially lifesaving COVID-19 vaccines by the end of this month. But not all of them want to be first in line. Only one-third of a panel of 13,000 nurses said they would voluntarily take a vaccine, another third said they wouldn’t and the rest said they were unsure, according to a late October survey by the American Nurses Association.
“I actually even hate getting a flu shot, but I’ve had to get one every year since I became a nurse,” said Nina Siegrist, a registered nurse with Hospice of the Piedmont in Charlottesville, Virginia. “If my medical director says, ‘Listen, all hospice clinicians are going to get vaccinated,’ then I’ll get vaccinated. But I definitely want to read the details on the clinical trials first.â€
– Christine Vestal, Stateline
America’s worst day: 1 died every 28 seconds
The U.S. reported a record 3,124 deaths Wednesday, meaning about 130 people died of the virus every hour or one died every 28 seconds. That’s far worse than any day of the spring or summer surges. And another dark record was broken – most deaths over a seven-day period. The 15,927 deaths equals 95 per hour, or one death every 38 seconds, breaking a record set in April.
At the current pace, the U.S. death toll from the entire pandemic could reach 300,000 in just a few days.
The U.S. also reported 227,828 new coronavirus cases Wednesday, the second-worst day on record. And the number of infections in a week set a record of almost 1.5 million, 145 new cases per minute.
Wednesday also saw a record in current hospitalizations, with 106,688. Hospitalizations never reached 60,000 at the peak of the spring or summer virus surges.
– Mike Stucka
Vaccine may be ready, but are Americans?
A new poll finds only about half of Americans are ready to roll up their sleeves when their turn comes. The survey from The Associated Press-NORC Center for Public Affairs Research shows about a quarter of U.S. adults aren’t sure if they want to get vaccinated against the coronavirus. Many on the fence have safety concerns and want to watch how the initial rollout fares. And roughly another quarter of Americans say they won’t get it.
Experts estimate at least 70% of the U.S. population needs to be vaccinated to achieve herd immunity, or the point at which enough people are protected that the virus can be held in check.
“Trepidation is a good word,” said Kevin Buck, a 53-year-old former Marine from Eureka, California. “I have a little bit of trepidation towards it.â€
Sacramento falls into California’s stay-at-home order
The greater Sacramento region will be placed under California’s most restrictive coronavirus rules this week because capacity in hospital intensive care units has fallen below 15%. The 13-county region encompassing the state capital has an ICU capacity of 14.3% and will face a regional stay-at-home order at 11:59 p.m. Thursday, according to the state Department of Public Health website.
Under the restrictions, restaurants must stop outdoor dining, personal care businesses such as barbers must close and the number of people allowed inside stores is reduced. Residents are asked to stay home except for essential activities.
The Southern California and San Joaquin Valley regions are already in the strictest category, and several counties in the San Francisco Bay Area chose to implement their own voluntary orders independent of the state.
Texas official who protested COVID-19 regulations tests positive
A Texas state official who has been critical of measures ordered by Gov. Greg Abbott in efforts to slow the coronavirus pandemic said he has tested positive for the virus. Texas Agriculture Commissioner Sid Miller was among an estimated 200 people who rallied outside Abbott’s home in October to protest his pandemic orders, including a continued statewide mask mandate and lockdowns. In a statement Wednesday, the 65-year-old Miller said he has been quarantining at his ranch.
In his words: “Not feeling my best, but I’ve survived rodeo injuries, broken bones, hip, double knee and shoulder surgery, west nile virus and cancer, and I’m going to beat this too.â€
Wyoming doctor resigns after claiming COVID was biological weapon
A Wyoming Department of Health doctor who told audiences at an event last month that COVID-19 was created by Russia and China to spread communism has resigned from the state agency.
Dr. Igor Shepherd, who shared a debunked conspiracy theory about the forthcoming COVID-19 vaccine at a Nov. 10 event in Loveland, Colorado, has since resigned, a department spokesperson confirmed via email to the Casper Star-Tribune on Wednesday
COVID-19 resources from USA TODAYÂ
Contributing: The Associated Press
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