HUTTO, Texas (KXAN) Former Hutto city manager Odis Jones has sued the City of Hutto, two city councilmembers and the current city manager for racial discrimination, alleging they have worked to destroy his reputation, career, and livelihood, according to a lawsuit filed Thursday in federal district court.
City of Hutto, Council Member (Mike) Snyder, and Council Member (Tanner) Rose have taken unjust and racially driven actions to deny Mr. Jones his federally protected civil rights; to defame and disparage Mr. Jones; to tortiously interfere with his efforts to provide for his family; to breach the Employment Agreement and Separation Agreement that the City of Hutto negotiated, drafted, and lawfully entered into with Mr. Jones; and to intentionally inflict emotional distress upon Mr. Jones, the lawsuit states.
Now that the Food and Drug Administration has authorized emergency use of the first COVID-19 vaccine in the United States, health care workers will be among the first to get the vaccine.
Dr. CassandraPierre, an infectious disease physician at Boston Medical Center who serves as the acting hospital epidemiologist, joined WBUR's Sharon Brody to discuss when doses of the vaccine will arrive at Boston Medical Center, how the hospital plans to distribute the vaccine, and how health care workers are feeling about receiving the new vaccine.
On when Boston Medical Center will receive the vaccine and how many doses will be delivered:
Dr. Cassandra Pierre:So we are anticipating very eagerly anticipating that we will receive doses as soon as December the 14th or 15th. We're not entirely sure when we will receive it, but early in ... this week, and we are anticipating that we will receive sufficient doses for potentially up to maybe 2,000 or a little less of our health care personnel.
We have probably about, active on-site personnel, maybe 7,000 to 8,000 people, so it would only be a fraction of what we have in the hospital. But it will cover a great deal of the people who are frontline-facing, especially those who are actively caring for COVID-positive patients.
On vaccine availability for health care workers at Boston Medical Center who care directly for coronavirus-positive patients:
We do not anticipate that [frontline-facing health care workers will be unable to get the vaccine]. What we're actually anticipating is that not everyone will be able to get their dose their vaccine within the first week or two weeks. It might be a month. It might be two months to get everyone actively vaccinated. It really depends on how much we get up front. But we do anticipate that we will be able to sufficiently cover everyone who is frontline-facing, who is caring for patients especially those who are caring for COVID-positive patients. I should say, we really want to get everyone who is caring for patients, period, covered in the next few months.
... But more than that, this is really about health care personnel, not just people who are providers or nurses. This is also very much about our support staff, certified nursing assistants, medical assistance, but also our environmental service workers, our food service workers. All of us have some risk of ... getting COVID, whether it's in the hospital or in the community setting. And it's incredibly important and equitable to ensure that all of our health carepersonnel not just those who are actually caring for patients are covered as well.
On concerns about the vaccine side effects and whether they might temporarily incapacitate some health care workers:
This is actually one of our biggest concerns. We know that having looked at the data the vaccine is safe. But up to maybe, even up to 50% of people combined inthe Moderna and the Pfizer trials, have experienced these side effects, which are common among people who get vaccines in general.
[These side effects include] pain at the injection site of the vaccine, headaches, fatigue, maybe even up to fever. So it is concerning that these might potentially destabilize our workforce, not because of the severity of the symptoms by any means. We haven't seen any severe, adverse events yet. Of course, we're concerned about the severe allergy that has been reported in the UK. But other than that, we're not as concerned... The concern, obviously, is the overlap in between the symptoms, the adverse events that you could be seeing as a normal course of having received a vaccine, and symptoms for COVID. So that's the fever, the body aches, the fatigue. And so we have set up a system where ... we're... educating our staff, that if you develop a fever, if you develop maybe severe symptoms, we do want you to take some time off and we want you to get tested for COVID. So clearly that could quickly destabilize the workforce.
So in order to avoid that, hopefully, we are planning on staggering the doses. So not everyone in the same work group gets vaccinated at that certain time: that would be a recipe for disaster. [We're] trying to get people to get vaccinated right before they go off service or before the weekends so that people have time to recover and get over those side effects before they have to come back to work.
On hospital workers expressing some reluctance or anxiety about the vaccine:
You know, we did hear that in the weeks leading up to the results being released. And that is another issue and concern. You know, I think that the decision to vaccinate health care workers first is really essential for three reasons. I mean, obviously, we want to make sure that we maintain our health care worker force, that we preserve their safety and their health, that they don't become infected with COVID during this critical period when we need them to take care of our patients. We also want to make sure that our patients are aware this is a safe place to come. The majority of health care workers have been vaccinated. You are safe to come into the space. But the third important reason, that kind of gets to what you're talking about, is we want our health care workers to serve as both indirect and direct spokespeople for the safety and efficacy of this vaccine, to show Americans, "Yes, we believe in this so much that we ourselves are getting vaccinated to show you that it is safe and we believe in this." And part of that is making sure that we can promote vaccine confidence among our own health care workers.
So to mitigate any lingering concerns, we have had town halls where we've had both our CEO and then our chief medical officer talk about the safety, talk about the fact that they are going to be lining up themselves to get this vaccine. We have many leaders talking about this, but we're also going to be spotlighting vaccine trial participants. We have been a vaccine trial site for the Pfizer vaccine. And we are going to nurses, we're going to environmental service workers, food service workers, transport, to talk to people who have been vaccinated themselves as part of this trial.
Also just to talk to people who are interested and willing to get this. We're having town halls even among our sections. I'm going to be speaking to our clinic this coming week just to answer questions. This won't be in the vein of compelling people to get vaccinated by any means, but just letting them know what the data has been.
And just as a sidebar, we know that many of the people in the hospital, like myself, are Black or belong to Black and brown communities, belong to communities that have been marginalized. And so we reflect our patient population.
We want to make sure that we also can speak to the lived experience of [being] a part of a group that has been experimented on, who has been marginalized, that has been disenfranchised for medical care, but [who want] to ... ensure our safety our own individual safety and the safety of our communities and speak with knowledge, and speak with confidence to the fact that this is something that is going to safeguard our communities this year and for years to come.
On the most fair and helpful way to distribute the COVID-19 vaccine:
Yeah, I think this is something we've been struggling with. I think one of the things that we have been hoping to use to our advantage is this concept of a vulnerability index that the CDC has conceived and utilized to identify where the COVID-19 hot spots will be. So that social or community vulnerability index really refers to a set of factors that might leave a community vulnerable to COVID or really any other health disparities.
What is the density of housing in one area, are people living in multigenerational households? What are the percentage of people that work in the essential fields that mean that they cannot quarantine safely at home? What are the language barriers? What is the percentage of people who live below the poverty line?
We know the factors that put people at risk, not just for COVID, but for other kinds of chronic diseases and health disparities. How can we use that index to more effectively target those areas or those individuals who are going to really benefit the most? How can we maximize the benefit of this COVID vaccine by targeting it to people who are going to be most at risk for infection, hospitalization and death? So we're using that index. We're going to try to retrofit it into our model when it comes to distributing the vaccine through our community and looking not just at age, not just at medical co-morbidities although we're certainly looking at those but also the social and community vulnerability indexes to really target who needs that vaccine. And the expectation is that that formula will also target a very significant percentage of the Black and brown population that receive their care at our hospital.
Dr. Anthony Fauci, the nation's top infectious disease expert and a constant presence on TV during the coronavirus pandemic, was asked a blunt question during a forum hosted last week by the National Urban League: "Can you talk about the input of African American scientists in the vaccine process?"
Fauci did not hesitate when giving his answer.
"The very vaccine that's one of the two that has absolutely exquisite levels -- 94 to 95% efficacy against clinical disease and almost 100% efficacy against serious disease that are shown to be clearly safe -- that vaccine was actually developed in my institute's vaccine research center by a team of scientists led by Dr. Barney Graham and his close colleague, Dr. Kizzmekia Corbett, or Kizzy Corbett," Fauci told the forum. "Kizzy is an African American scientist who is right at the forefront of the development of the vaccine."
President Trump visits the biological lab, March 3, 2020, at the National Institutes of Health, with Dr. Anthony Fauci, 2nd-left, and Dr. Kizzmekia Corbett, right.
Corbett is an expert on the front lines of the global race for a SARS-CoV-2 vaccine, and someone who will go down in history as one of the key players in developing the science that could end the pandemic.
She is one of the National Institutes of Health's leading scientists behind the government's search for a vaccine. Corbett is part of a team at NIH that worked with Moderna, the pharmaceutical company that developed one of the two mRNA vaccines that has shown to be more than 90% effective.
Moderna's vaccine is expected to receive emergency use authorization from the U.S. Food and Drug Administration this month.
The other mRNA vaccine, developed by Pfizer, won emergency use authorization from the FDA on Friday.
As of now, the coronavirus has killed nearly 300,000 people and infected more than 15 million people in the U.S.
Even before Corbett took on one of the most challenging tasks of her professional career, she was a force to be reckoned with. As a student,she was selected to participate in Project SEED, a program for gifted minority students that allowed her to study chemistry in labs at the University of North Carolina at Chapel Hill and eventually landed a full ride to the University of Maryland Baltimore County, according to The Washington Post.
Corbett spent her summers at laboratories and earned a summer internship at the NIH, the very place where she would be instrumental in developing a vaccine for the coronavirus.
After graduating, Corbett enrolled in a doctorate program at UNC-Chapel Hill, where she worked as a research assistant studying virus infections and eventually received a PhD in microbiology and immunology, according to her LinkedIn page.
Her work with such pathogens began when she joined the NIH's Vaccine Research Center as a postdoctoral fellow in 2014.
She told ABC News that she could have never anticipated what she has since been able to accomplish on Fauci's team.
Dr. Kizzmekia Corbett, is a senior research fellow working with the Vaccine Research Center strategists in NIAIDs Viral Pathogenesis Laboratory and has become a central figure in covid vaccine science.
"The reason that I started to work in coronavirus was not to ever develop a vaccine, but really to have such a strong understanding in vaccine immune responses that we could potentially develop one," she said.
This year, Corbett said, she has had to put her last six years of training to work.
In early January, "with the knowledge that there was a respiratory outbreak in the Wuhan district of China, [Dr. Barney Graham] started sending emails essentially telling me and the team to buckle up," Corbett said.
Early in the pandemic, when Fauci predicted the world might see an effective vaccine in about a year, Corbett said she knew it was possible.
"It was certainly doable if all the things and all the pieces of the puzzle came together," she said.
Corbett first made headlines on March 3 as part of a team of scientists who spoke with President Donald Trump at the NIH. At the time, the global impact of the COVID-19 crisis had yet to be felt in America.
Vaccine Research Center director Dr. Barney Graham and Dr. Kizzmekia Corbett, discuss research on the coronavirus vaccine with several legislators from Maryland.
Corbett said that her participation during that event with the president marked an important step forward for young scientists and people of color.
"I felt like it was necessary to be seen and to not be a hidden figure so to speak," Corbett said. "I felt that it was important to do that because the level of visibility that it would have to younger scientists and also to people of color who have often worked behind the scenes and essentially [who have] done the dirty work for these large efforts toward a vaccine."
"This person who looks like you has been working on this for several years and I also wanted it to be visible because I wanted people to understand that I stood by the work that I'd done for so long as well," she added.
Fauci said Corbett's role as one of the scientists behind the vaccines should be a sign of hope for Black Americans who are hesitant to trust the vaccine.
Throughout the coronavirus pandemic, Black communities have been infected and killed at a disproportionate rate across the country, according to the CDC. But according to a November Axios/Ipsos poll, only 55% of Black Americans said they would take a vaccine if it was proven safe and effected by officials.
"So, the first thing you might want to say to my African American brothers and sisters is that the vaccine that you're going to be taking was developed by an African American woman," Fauci said. "And that is just a fact."
New Jersey reported another 4,170 new coronavirus cases and 24 additional deaths, as the first batches of the coronavirus vaccine were shipped from the manufacturing facility Sunday.
The seven-day average for daily positive tests declined Sunday to 4,809, down 2% from a week ago but up 59% from a month ago as the second wave of the virus has swept across the state.
That average has hovered around 5,000 for the past week the highest it has been during the nine-month outbreak though tests during the initial wave of cases were scarce and likely undercounted the extent of the infections.
The death toll for the first 13 days of December 688 confirmed fatalities is already higher than the entire month of November (615) and the combined totals for October (231), September (178) and August (238).
Hospitalizations rose slightly, with 3,591 coronavirus patients as of Friday night, more than double the hospitalizations at the beginning of November.
Those numbers come as the state is preparing for the first dose of the coronavirus vaccine to be administered in New Jersey on this week. Shipments of the vaccine began on Sunday following an emergency approval by federal regulators late Friday.
The first dose of the vaccine will be administered in New Jersey on Tuesday at University Hospital in Newark, Gov. Phil Murphy said on Sunday. The first 76,000 doses are earmarked for healthcare workers and staff and residents of long term care facilities.
Murphy tempered the positive news about the vaccine with caution about the possible severity of the outbreak in coming weeks.
For all the good news, the light at the end of the tunnel and the vaccine exemplifies that as much as anything the next number of weeks are going to be hell, I fear, Murphy said in an interview on ABC Sunday morning, asking for residents to continue to take precautions.
The states rate of transmission stayed steady on Sunday, remaining at 1.15. Any number over 1 indicates the outbreak is expanding. The rate of transmission had increased for six consecutive days before stagnating on Sunday.
The positivity rate for Tuesday, the most recent day available, was 10.8% based on 44,609 tests results. The rate has been above 10% for all but one day since Nov. 25. It was 9.92% on Monday.
The death toll from outbreak reached 17,732 including 15,864 confirmed and 1,868 probable fatalities. New Jersey has had 396,496 total positive cases out of 6.5 million tests administered, though those totals do not include recently-deployed rapid tests.
CORONAVIRUS RESOURCES: Live map tracker | Newsletter | Homepage
As cases and hospitalizations have been on the rise, Murphy continues to say hes keeping all options open for new restrictions to slow the outbreak.
But he reaffirmed on Friday that New Jersey is staying with what we got on indoor dining with 25% capacity limits and a requirement for indoor service to end at 10 p.m. each day. Murphy also gave counties and municipalities the ability to order bars and restaurants to close as early as 8 p.m. daily.
Murphy has said hes watching hospital capacity closely when deciding whether to impose more orders to try and stop the spread. The governor said a month ago he was looking at three potential restrictions in particular indoor dining, elective surgeries at hospital and indoor sports.
The governor has since ordered the suspension of all indoor organized sports at the youth, high school and adult recreational levels. That started on Dec. 5 and lasts until at least Jan. 2. Hes since said he hopes indoor sports will be able to resume next month, but he left the door open to extending the temporary ban.
Murphy on Wednesday revealed two pairs of moderate-case and worst-case scenarios for the second wave. The moderate forecasts call for New Jersey to hit between 6,300 and 9,100 daily cases and between 5,700 and 7,100 patients hospitalized over the next two months.
HOSPITALIZATIONS
The number of people hospitalized as of Saturday night was higher than on Friday, again reaching the highest level since May 14 when 3,706 people were being treated.
There were 3,591 patients with confirmed or suspected COVID-19 cases across New Jerseys 71 hospitals as of Saturday (48 more than the previous day).
Of those hospitalized Friday, 691 were in critical or intensive care (one more than the previous night), including 448 on ventilators (10 more).
There were 467 coronavirus patients discharged from hospitals Friday, according to the states coronavirus dashboard.
SCHOOL CASES
New Jersey officials have reported 18 new in-school outbreaks and 103 new positive cases among students, teachers and school staff in one of the worst weeks since the state started tracking how many people were being infected with COVID-19 at school.
The names of the schools were not released to protect the privacy of the children and school staff members who tested positive, state officials said.
Although hundreds of school districts have announced coronavirus cases and dozens of New Jersey schools have temporarily switched to all remote classes since the start of the school year, state health officials have said only 88 schools have had confirmed COVID-19 outbreaks.
There have now been 388 total cases of in-school transmission in those 88 schools since the start of the school year.
Those numbers do not include students or staff believed to have been infected outside school, or cases that cant be confirmed as in-school outbreaks.
Though the numbers keep rising every week, Murphy has said the school outbreak statistics remain below what state officials were expecting when schools reopened for in-person classes. The extensive rules for schools, which include social distancing guidelines for classrooms and strict mask requirements, have made schools among the safest places in the state, he said.
But for the second week in a row, every region in New Jersey is orange on the states COVID-19 map, indicating high virus activity across the state.
The color coding on the map is being closely watched by many school districts because if any area moves to red, indicating very high coronavirus activity, all schools in that region will be required to close classrooms and switch to all-remote learning, according to state health guidelines.
AGE BREAKDOWN
Broken down by age, those 30 to 49 years old make up the largest percentage of New Jersey residents who have caught the virus (31.6%), followed by those 50-64 (24%), 18-29 (19%), 65-79 (11.3%), 80 and older (6.1%), 5-17 (6.5%), and 0-4 (1.3%).
On average, the virus has been more deadly for older residents, especially those with pre-existing conditions. Nearly half the states COVID-19 deaths have been among residents 80 and older (47.69%), followed by those 65-79 (31.78%), 50-64 (15.84%), 30-49 (4.31%), 18-29 (0.37%), 5-17 (0%) and 0-4 (0.02%).
At least 7,373 of the states COVID-19 deaths have been among residents and staff members at nursing homes and other long-term care facilities. That number has been rising again at a steeper rate in recent weeks.
GLOBAL NUMBERS
As of Friday, there have been 71.8 million positive COVID-19 tests across the world, according to a running tally by Johns Hopkins University. More than 1.6 million people have died from coronavirus-related complications.
The U.S. has reported the most cases with 16 million and the most deaths at more than 297,000.
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Katie Kausch may be reached at kkausch@njadvancemedia.com. Tell us your coronavirus story or send a tip here.
Health care workers will be among the first to receive a COVID-19 vaccine when they become available. But the vaccines have not been tested on pregnant women, raising questions about whether pregnant and lactating health care workers should get the shots. Justin Tallis/Pool/Getty Images hide caption
Health care workers will be among the first to receive a COVID-19 vaccine when they become available. But the vaccines have not been tested on pregnant women, raising questions about whether pregnant and lactating health care workers should get the shots.
The Food and Drug Administration is likely soon to authorize distribution of the Pfizer-BioNTech COVID-19 vaccine. But the vaccine trials have so far excluded pregnant people.
Among those first in line to get the vaccine, this is a significant exclusion. Three-quarters of health care workers are women, including more than 85% of nurses. The Centers for Disease Control and Prevention estimates 330,000 health care personnel could be pregnant or recently postpartum at the time of vaccine implementation.
Studies have found that pregnant people are at an increased risk of severe COVID-19. As NPR's Richard Harris reported, vaccine researchers don't expect that the shots will put mothers or newborns at risk but unfortunately, pregnancy-specific data do not yet exist. Studies involving pregnant people are not expected to begin enrollment until the first quarter of 2021.
Why aren't pregnant women part of vaccine trials?
Denise Jamieson is chair of the Department of Gynecology and Obstetrics at Emory University School of Medicine, and is part of the American College of Obstetricians and Gynecologists' working group on COVID-19.
She says pregnant women are systematically excluded from most clinical trials in the U.S. because it makes running the trials simpler: "There are actually very few medications, for example, that are approved in pregnancy because it's easier, basically. It's easier to exclude pregnant women because when you include pregnant women, you have to be concerned about both the woman's health as well as the development of the fetus and baby."
Pregnant women have been given vaccines for decades, she says, with few issues. "We don't generally give live viral vaccines in pregnancy because there's theoretical risk that the live virus could be passed and it infects the fetus," Jamieson says. "But with the exception of smallpox vaccines, there really have been very few problems with vaccines."
The Pfizer and Moderna vaccines both rely on brand-new messenger RNA technology but Jamieson doesn't see any scientific cause for concern there. With these vaccines, she says, the mRNA basically goes into the muscle cells, provides information to the cells about how to manufacture the spike protein of the SARS-CoV-2 virus, and then the mRNA is rapidly degraded.
"So I can't think of any potential reason or theoretical reason to be concerned about mRNA vaccines in pregnancy, with the one exception of when you give a vaccine and you mount an immune response, you can get a fever. And fever is something that we try and avoid in pregnancy," she says. "So it may be important that if women get a fever, that they treat [it] with acetaminophen, which is what we recommend for fevers in pregnancy."
"Knowing what I know about the [mRNA vaccine's] mechanism of action, I would anticipate that this vaccine should be very safe in pregnancy," Jamieson says.
Ruth Faden, founder of Johns Hopkins University's bioethics institute, says it's not an ideal situation rolling out a vaccine that hasn't been tested on pregnant people. "We're in a situation right now where we have to go forward with the information that we absolutely do not have. It's understandable that we don't have data from pregnant women yet, but it would be nicer if we did," she told NPR's Weekend Edition.
The American College of Obstetricians and Gynecologists, or ACOG, has urged the CDC's Advisory Committee on Immunization Practices not to exclude pregnant and lactating people from the high-priority populations for COVID-19 vaccine allocation. The group notes that pregnant people are at high risk from the coronavirus for multiple reasons: "In addition to being an identified at-risk group by themselves, upwards of half of pregnant women also fall into another priority category, including frontline workers and those with underlying conditions."
In Britain, regulators have advised against offering the Pfizer-BioNTech vaccine to pregnant people or those who are breastfeeding. They also warn that "women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose."
Jamieson says that Canada's approach is better than the United Kingdom's. "The Pfizer instructions in Canada specify that pregnant women should talk to their health care provider," she says. "It's listed under one of the things that 'if you have this condition, discuss with your health care provider,' but they do not list it as a contraindication, and pregnant women are being vaccinated with the Pfizer vaccine in Canada."
What about breastfeeding?
In the U.S., the Society for Maternal-Fetal Medicine has stated that "there is no biological plausibility for the exclusion of lactating women from these trials."
"For some reason that does not make any sense to me, lactating and pregnant women are always lumped into one group," Jamieson says. "They're actually two very different groups, and there's even less theoretical reason to be concerned about lactating women. We give live viral vaccines measles, mumps and rubella vaccine routinely to lactating women. And that's a live viral vaccine."
Dr. Laura Riley, chair of the Department of Obstetrics and Gynecology at Weill Cornell Medicine and chair of ACOG's immunization committee, agrees.
"The thought that this mRNA vaccine is going to get into breast milk really? We want to stop people from dying, and get the vaccine. I would hate to see a woman who is breastfeeding stop so that they could get the vaccine," Riley says.
Considerations for getting the vaccine while pregnant
Jamieson is hopeful, based on the public comments of the FDA, that the agency will do what ACOG has advocated: If a pregnant woman would otherwise be offered the opportunity to be vaccinated, she should talk to her health care provider and potentially be vaccinated.
The FDA could decide that pregnant people should not take the vaccine. But more likely, Faden says, it will be up to them and their doctors to decide what's best.
So assuming they get the option, how should pregnant people decide whether to get vaccinated for the coronavirus?
Faden recommends they assess their individual risk: their risk of becoming infected in the first place, and the risk of becoming seriously ill if infected with the virus.
"A disproportionate amount of burden of disease in pregnancy seems to be hitting women who are low-income, women who are from communities of color, women who are otherwise disadvantaged," she says. "There's nothing about pregnancy that is protective."
In consultation with a health care provider, Jamieson says, the pregnant person can then put that risk assessment together with what's known about mRNA vaccines, what's known about other vaccines during pregnancy and decide what makes sense.
Riley says she is getting flooded with calls from pregnant health care workers, asking what they should do: "I work in an ICU, I work in a COVID unit should I get the vaccine?" they ask her.
"It's easy to say it's hand-wringing, but they're the front-line workers whether they're a nurse, or a doc, or sitting at the front desk," Riley says. "I worry about the ladies at the grocery store every single day. At least if you're in a hospital, you've got PPE. But if you work in a grocery store, and you're riding the train to work a lot of those people are pregnant or thinking of getting pregnant."
In the absence of vaccine trial data on pregnant people, the call on whether to get vaccinated will likely come down to that conversation between the pregnant person and the health care provider.
"People who are pregnant have a lot to worry about, and we don't need to add to people's stress," Faden says. "Unfortunately, this is a stressful circumstance. Take a deep breath, and if you're given the choice, it may make good sense to have this vaccine. It may not."
Not all local health systems know when their doses may arrive.
CLEVELAND Under Governor Mike DeWines orders, ten hospitals in Ohio will receive the COVID-19 vaccine this week.
Closest to home, they include Cleveland Clinic, MetroHealth (which expects to start giving people the shots on Tuesday), and Aultman Hospital in Stark County.
The Cleveland VA Medical Center will be getting it, too. Others, including University Hospitals, which played a big role in the Pfizer trials, will soon follow, though many of the specifics are not yet clear.
We still dont know exactly when we will receive our first dose and we dont know how much we will get, said Dr. Robyn Strosaker, Chief Operating officer of the systems Cleveland campus.
When they do get the drug, Dr. Strosaker said the priority will go first to caregivers, based on risk.
Sometimes it isnt a COVID unit, but sometimes it is in a unit like the emergency department or labor and delivery or front entrance screeners who are exposed to lots and lots of people, Dr. Strosaker said.
Pfizer says shipments will leave Sunday from a manufacturing plant in Michigan and go directly to FedEx and UPS distribution centers.
The Clinic confirms their first shipment will include less than 1,000 doses, but go up over time, as the Chief Operation Officer for Operation Warp Speed calls this a monumental week.
We expect 145 sites across all the states to receive the vaccine on Monday. Another 425 sites on Tuesday. And the final 66 sites on Wednesday, General Gus Perna said. I have 100% confidence that we will get the vaccine to the American people and it will be safe.
All of it comes as the crisis deepens in the United States.
The nation has topped 16 million cases and will likely pass 300,000 confirmed deaths this weekend.
In a pre-taped message on Twitter, President Trump said the vaccine is A Medical Miracle and a reminder of Americas Unlimited Potential.
This is one of the greatest scientific accomplishments in history. It will save millions of lives and soon end the pandemic once and for all, said President Trump.
At the same time the nations biggest drug store chains, such as CVS and Walgreens, hope to begin vaccinations within nursing homes by Christmas.
Walgreens has set Dec. 21 as its target date.
Well be able to administer that vaccine so that they are protected, said Rina Shah, Walgreens. When the vaccine is available, we are confident that wed be able to support vaccinations to ensure that our patients are protected.
A recent survey reveals 60% of Americans say they will get vaccinated, up from 51% in September. It may be the light at the end of what has been a very long and dark tunnel.
CLEVELAND (WJW) - The first round of COVID-19 vaccinations is expected to arrive in Cleveland on Tuesday.
Today, vaccines left a Pfizer manufacturing facility in Michigan, heading out to the United Parcel Service and FedEx hubs. They'll then go out to the 636 locations nationwide, including Metrohealth Medical Centers and the Cleveland Clinic in Ohio.
Updated: 8:30 p.m.
Minnesotas death toll from the COVID-19 pandemic climbed past 4,400 on Sunday, with state health officials reporting more than 80 deaths on four of the past five days.
That includes the 85 additional COVID-19 deaths reported Sunday, as the daily average over the past week climbed to nearly 66, a record high.
The grim death toll continues as the number of new cases and hospital admissions each day continues to trend downward. The average test positivity rate over the past week also dropped, to below 9 percent the first time thats happened since October.
Here are Minnesotas current COVID-19 statistics:
4,444 deaths (85 new)
378,823 positive cases (3,439 newly reported); 341,530 off isolation (about 90 percent)
4.89 million tests, 2.76 million people tested (about 48 percent of the population)
8.9 percent seven-day positive test rate (officials find 5 percent or more concerning)
The average number of new cases reported each day over the past week is about 4,014 the lowest that number has been since the first week of November. It peaked at more than 7,100 in late November.
The average number of new COVID-related hospital admissions each day over the past week dropped below 190 on Sunday the first time thats happened in a month.
Minnesota officials continue to anticipate a wave of COVID-19 cases and hospitalizations originating from Thanksgiving holiday celebrations.
It hasnt happened yet, though. Because of that, health leaders are somewhat hopeful that many families heeded public pleas to not gather in big groups for Thanksgiving, and so the worst-case scenarios of a post-holiday surge might not materialize.
Gov. Tim Walz echoed that hope on Friday, noting the slowing case counts as well as a recent decline in positive test rates, a key metric in judging the spread of the disease.
Health Commissioner Jan Malcolm urged caution, though, saying it was still too soon to judge whether a Thanksgiving surge was coming. While the states caseloads have eased, we are still at a very vulnerable place, she told reporters.
Walz must still decide soon whether to extend the states current monthlong ban on in-person bar and restaurant service, which is set to run through Dec. 18.
While a decision had been expected Monday, a Walz spokesperson said Friday that the governor has now pushed it back until Wednesday because he wants the most up-to-date data before deciding.
The newest numbers put Minnesotas total of confirmed or probable cases at more than 378,000 to date. In about 90 percent of those cases, people have recovered to the point where they no longer need to be isolated.
The deaths reported Saturday raised Minnesotas count to 4,359. Among those whove died, about two-thirds had been living in long-term care or assisted living facilities; most had underlying health problems.
COVID-19 is now killing Minnesotans at a rate far higher than any recent flu season. Roughly one-third of all recent deaths in Minnesota are tied to COVID-19.
In the past few years, respiratory illnesses have been a major contributing factor in about 5 to 10 percent of all deaths in Minnesota, depending on the time of year.
They accounted for around 20 percent of deaths during the states May COVID-19 wave.
Now its even higher: nearly 40 percent of all deaths in Minnesota in recent weeks have been attributed to a respiratory illness such as COVID-19, influenza or pneumonia.
People in their 20s still make up the age bracket with the states largest number of confirmed cases more than 72,000 since the pandemic began, including nearly 39,000 among people ages 20 to 24.
The number of high school-age children confirmed with the disease has also grown, with more than 26,000 total cases among children ages 15 to 19 since the pandemic began.
Although less likely to feel the worst effects of the disease and end up hospitalized, experts worry youth and young adults will spread it to grandparents and other vulnerable populations.
Its especially concerning because people can have the coronavirus and spread COVID-19 when they dont have symptoms.
Central and western Minnesota drove much of the increase in new cases over the past five weeks, while Hennepin and Ramsey counties showed some of the slowest case growth in the state.
After a spike in confirmed cases through much of November, all regions of the state have seen new case numbers plateau or start to fall.
Hot spots continues to pop up in rural counties relative to their population.
In Minnesota and across the country, COVID-19 has hit communities of color disproportionately hard in both cases and deaths. Thats been especially true for Minnesotans of Hispanic descent for much of the pandemic.
Distrust of the government, together with deeply rooted health and economic disparities, have hampered efforts to boost testing among communities of color, officials say, especially among unauthorized immigrants who fear their personal information may be used to deport them.
Similar trends have been seen among Minnesotas Indigenous residents. Counts among Indigenous people jumped in October relative to population.
Officials continue to plead with Minnesotans to wear masks in public gathering spaces, socially distance, stay home if they dont feel well and otherwise stay vigilant against the spread of COVID-19.
State health officials on Thursday noted that several of the newly reported deaths included people in their 20s, 40s and 50s, emphasizing the disease isnt simply focused on the very old.
This is not just a problem for the elderly, for our fellow Minnesotans who have medical conditions. It is a problem for all of us, state epidemiologist Dr. Ruth Lynfield told reporters.
Until we have safe and effective vaccines, we really need to do everything we can to stop transmission between fellow Minnesotans, she added. We know this is hard. It is taking a big toll on so many areas of our lives. But we have to hang in there and we have to do the best we can.
The Minnesota Department of Public Safety on Sunday suspended the liquor license of an East Grand Forks, Minn., bar that had been operating in violation of state COVID-19 restrictions.
The Boardwalk Bar and Grill reopened to in-person service last week. Owner Jane Moss said her business would go under if she could not serve patrons in person.
The 60-day liquor license suspension announced Sunday is set to expire in February; another violation could result in a five-year license revocation.
The action follows a temporary restraining order issued Friday by a Polk County District Court judge, ordering the bar to close to in-person service.
Minnesotas monthlong shutdown of in-person bar and restaurant service, along with youth sports and other activities, is set to expire at 11:59 p.m. Friday. Gov. Tim Walz has not yet said whether he'll extend the restrictions.
Representatives of a group called the Reopen Minnesota Coalition told KARE-TV on Friday that dozens of businesses plan to defy the governor's order in the coming week.
MPR News staff
What's in Santa's bag? Masks, plexiglass and Zoom: With surging COVID-19 cases nationwide and new restrictions in place throughout Minnesota to help curb the spread of the disease, Santas lap is off limits this year. That has spurred creativity in Santa's workshops.
Burnout is the new normal for hospital workers: As the weeks go by with hospitals beds full and staff in short supply, doctors and nurses are under incredible pressure. One Minnesota doctor says shes worried itll lead to an exodus of providers after the pandemic ends.
Data in these graphs are based on the Minnesota Department of Health's cumulative totals released at 11 a.m. daily. You can find more detailed statistics on COVID-19 at theHealth Department website.
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For Immediate Release: December 11, 2020
Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
The FDAs 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, M.D. Todays action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agencys career scientists to ensure this vaccine met FDAs rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. 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.
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccines use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 viruss mRNA that instructs cells in the body to make the viruss distinctive spike protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
While not an FDA approval, todays emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States, said Peter Marks, M.D., Ph.D., Director of the FDAs Center for Biologics Evaluation and Research. With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccines known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDAs expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDAs review process also included public and independent review from members of the agencys Vaccines and Related Biological Products Advisory Committee. Todays achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.
FDA Evaluation of Available Safety Data
Pfizer BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart. The available safety data to support the EUA include 37,586 of the participants enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants. These participants, 18,801 of whom received the vaccine and 18,785 of whom received saline placebo, were followed for a median of two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.
It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the EUA include an analysis of 36,523 participants in the ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants, who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. Among these participants, 18,198 received the vaccine and 18,325 received placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. Of these 170 COVID-19 cases, one in the vaccine group and three in the placebo group were classified as severe. 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 EUA Process
On the basis of the determination by the Secretary of the Department of Health and Human Services on February 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and then issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.
The issuance of an EUA is different than an FDA approval (licensure) of a vaccine. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.
The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.
The company has submitted a pharmacovigilance plan to FDA to monitor the safety of Pfizer-BioNTech COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Pfizer-BioNTech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.
The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).
The EUA for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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A scientist works at the mAbxience biosimilar monoclonal antibody laboratory plant in Argentina. Juan Mabromata/AFP via Getty Images hide caption
A scientist works at the mAbxience biosimilar monoclonal antibody laboratory plant in Argentina.
The Food and Drug Administration has issued emergency use authorizations for two monoclonal antibody treatments for COVID-19 one produced by Eli Lilly and another by Regeneron. But emergency use authorization doesn't assure the drugs are effective.
In this episode of Short Wave, NPR's daily science podcast, science correspondent Richard Harris explains how the new treatments work and whether they could really make a difference for patients with COVID-19.
Listen to more episodes of Short Wave on Apple Podcasts or Spotify.
