Category: Covid-19

For Immediate Release: December 18, 2020

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Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day, said FDA Commissioner Stephen M. Hahn, M.D. Through the FDAs open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agencys career staff.

The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential riskssupporting the companys request for the vaccines use in people 18 years of age and older. 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 Moderna 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. After 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.

Guided by science and data, the agencys career staff determined that the vaccines known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDAs expectations described in our June and October guidance documents have been met, said Peter Marks, M.D., Ph.D., Director of the FDAs Center for Biologics Evaluation and Research. Todays authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained. This achievement is yet another testament to the dedication of FDAs career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19.

FDA Evaluation of Available Safety Data

Moderna COVID-19 Vaccine is administered as a series of two doses, one month apart. The available safety data to support the EUA include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S. These participants, 15,185 of whom received the vaccine and 15,166 of whom received saline placebo, were followed for a median of more than 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, swollen lymph nodes in the same arm as the injection, nausea and vomiting, 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 ModernaTX, Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Moderna 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 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine. Among these participants, 14,134 received the vaccine and 14,073 received placebo. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. At the time of the analysis of these 196 COVID-19 cases, none in the vaccine group and 30 in the placebo group were classified as severe. After the analysis of these 196 cases was completed, one severe case in the vaccine group was identified and is awaiting confirmation. At this time, data are not available to determine 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 Feb. 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 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 that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits. If the product meets the effectiveness standard and 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 Moderna COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

ModernaTX, Inc. has submitted a pharmacovigilance plan to the FDA to monitor the safety of Moderna 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 Moderna 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 Moderna COVID-19 Vaccine was issued to ModernaTX, Inc. The authorization 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. The EUA for Moderna COVID-19 Vaccine 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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FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA.gov

ITHACA, N.Y.Four staff members and one assisted living resident have tested positive for COVID-19 at Bridges Cornell Heights, an assisted living facility on Wyckoff Avenue in Ithaca.

The positive tests have been reported over the last 10 days, and visits were suspended for two weeks on Dec. 14 after post-Thanksgiving holiday testing showed two of the positive tests among staff members. According to Bridges ownership, the resident who tested positive has very mild symptoms, while most of the staff members are doing well also (with one exception, who is "struggling with symptoms" at home but has not been hospitalized).

The facility has been posting updates to its website, particularly after the number of cases among its residents and staff rose recently. Obviously, tensions are high surrounding nursing home COVID cases in Tompkins County as the outbreak continues at Oak Hill Manor nursing home that has claimed the lives of 11 residents there. Thus far, though, no resident has died as a result of the current spate of cases at Bridges.

"We know that the road ahead will not be easy, and a vaccine, no matter how promising and thrilling it is to imagine, will not bring us back to 'normal' any time soon," the facility wrote in its latest update. "However, it will provide one more layer of protection against COVID-19 for the people we love who are at increased risk for severe illness. This is a hope filled and exciting moment as we wait for the call to set up the vaccine clinic the minutes cannot move quickly enough for us."

Bridges owner Elizabeth Classen Ambrose lamented that the facility had seen the jump in positive tests after months of avoiding the coronavirus pandemic penetrating campus.

"We've had really good luck for this entire marathon," Classen Ambrose said. "And right as soon as we're about to cross this finish line and get to the vaccine, we get tagged."

There was one person in a separate rental property who passed away after having tested positive for COVID-19 more than a month ago, Classen Ambrose clarified, though that resident was in very poor health prior to contracting the virus.

Classen Ambrose said that, thanks to Cayuga Health System CEO Dr. Martin Stallone, the resident who tested positive is receiving therapeutic monoclonal antibody infusions, which they qualify for because of their age and relatively mild symptoms. Other residents have been treated with this same method at CMC, she said, and each has had beneficial results.The aforementioned resident who died while renting was on hospice care and thus ineligible to receive the antibody infusions, according to Classen Ambrose.

Vaccinations will likely start at Bridges Cornell Heights soon, as Classen Ambrose said they have been approved to be a COVID-19 vaccination site.

More here:

Several positive COVID-19 tests found at Bridges Cornell Heights nursing home - The Ithaca Voice

Harrisburg, PA - The Pennsylvania Department of Health today confirmed as of 12:00 a.m., December 23, that there were 9,605 additional positive cases of COVID-19, bringing the statewide total to 581,156.

There are 6,151 individuals hospitalized with COVID-19, double the peak in the spring. Of that number, 1,236 patients are in the intensive care unit with COVID-19. Most of the patients hospitalized are ages 65 or older, and most of the deaths have occurred in patients 65 or older. More data is availablehere.

The trend in the 14-day moving average of number of hospitalized patients per day has increased by nearly 5,600 since the end of September.

Statewide percent positivity for the week of December 11 December 17 stood at 15.8%.

The most accurate daily data is available on the website, with archived data also available.

As of 11:59 p.m. Tuesday, December 22, there were 230 new deaths reported for a total of 14,442 deaths attributed to COVID-19. County-specific information and a statewide map are available on the COVID-19 Data Dashboard.

Mask-wearing is required in all businesses and whenever leaving home. Consistent mask-wearing is critical to preventing the spread of COVID-19.

There are 44,800 individualswho have a positive viral antigen test and are considered probable casesand 640 individualswho have a positive serology test and either COVID-19 symptoms or a high-risk exposure.

There are 3,181,266 individuals who have tested negative to date.

In nursing and personal care homes, there are 49,042 resident cases of COVID-19, and 8,942 cases among employees, for a total of 57,984 at 1,435 distinct facilities in all 67 counties. Out of our total deaths, 8,138 have occurred in residents from nursing or personal care facilities. A county breakdown can be found here.

Approximately 18,143 of our total cases are among health care workers.

COVID-19 Vaccine Distribution

Pennsylvania hospitals began receiving shipments of the Pfizer-BioNTech COVID-19 vaccine the week of Dec. 14 and Moderna COVID-19 vaccine the week of Dec. 21.

Through Dec. 22:

Through Dec. 23:

A spreadsheet of facilities that have received vaccine can be found here.

Statewide the Wolf Administration has since noon, Dec. 22:

The Wolf Administration stresses the role Pennsylvanians play in helping to reduce the spread of COVID-19:

Updated Coronavirus Links: Press Releases, State Lab Photos, Graphics

All Pennsylvania residents are encouraged to sign up for AlertPA, a text notification system for health, weather, and other important alerts like COVID-19 updates from commonwealth agencies. Residents can sign up online at http://www.ready.pa.gov/BeInformed/Signup-For-Alerts.

MEDIA CONTACT: April Hutcheson - RA-DHpressoffice@pa.gov

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Originally posted here:

Department of Health Provides Update on COVID-19: 6,151 Patients Hospitalized and 1,236 Patients in the Intensive Care Unit - Pennsylvania Pressroom

The vaccines were prepared for shipments at the McKesson distribution center in Olive Branch, Miss. Wochit

The federal government is close to delivering 20 million doses of COVID-19 vaccine during the month of December, as promised, but states are taking longer than expected to get those doses into people's arms, officials admitted Wednesday.

About 15.5 million doses will be delivered by the end of the year, with the remaining 5 million arriving between Jan. 4-6, said Gen. Gus Perna, who co-leads Operation Warp Speed, the federal effort to develop and distribute COVID-19 vaccines, treatments and tests.

But only about 1 millionof the 9 million doses distributed so far have been reported administered,his co-leadMoncef Slaoui confirmed during a news conference.

Thedeath rate from COVID-19 in the U.S.reached an all-timehigh in the week ending Tuesday, and an American is dying of the virus every 32 seconds.

Reporting of the shots can take 3-4days, Slaoui said, sothe vaccination figures are probably better than theyappearbut there's still a substantial lag.

Where's the COVID-19 vaccine? Who's been vaccinated?Here's how we'll know.

"Exactly how fast the ramp-up ofimmunizations shots in arms is happeningisslower than we thought it would be," Slaoui said.

He offeredfederal help to states to accelerate that process. "It's important that the states are able to increase the cadence of immunization, but it's also important that they do it at a pace wherethey are in control, that no mistakes are made and no accidents are happening," he said. "That's super important."

The lag is likely caused by a variety of factors, including the logistical challenge of starting a new program, the difficulties of administering these vaccines, and the fact that many hospitals are nearly overwhelmed with COVID-19 patients right now.

"I don't think the rollout went as well as many of us would have hoped, saidDr. Daniel Griffin, an infectious disease specialist atProHEALTH Care in New York.

Nurse Debbie Mahoney administers a COVID-19 vaccine to nurse Alexa Zarlengo at Ascension Saint Thomas Hospital West in Nashville, Tenn., on Dec. 17.(Photo: Andrew Nelles, The Tennessean)

At first, the shots were not where the workers needed them to be, he said. The first weekthe Pfizer-BioNTech vaccine was available, he was offered a shotat 7:30 a.m. at a hospital 45 minutes fromwhere he works. Weekends were not an option.

This week, thearrival of the second vaccine, made by Moderna, has made a difference, he said. Griffin, who treated30 COVID-19 patients on Wednesday,was able to get his firstof the two-dose vaccine the same day.

Griffin said he imagined the vaccinations would be like the flu shot, where someone would walk over to him while he was seeing patients, he'd roll up his sleeve and get the shot. But with these vaccines, the person vaccinated has to wait around for 15 minutes tomake sure they're not having a bad reaction.

Your vaccine questions, answered: I had COVID, should I still get vaccinated? What are the side effects? What are its 'ingredients?'

He hopes things will go more smoothly with the next round of vaccinations, which will be distributed in the community, rather than at hospitals where the first priority has to be taking care of the sick.

The story is much the same at other hospitals.

"I suspect the efficiency of everybodys system will go up over time but Im not surprised that the injections arent quite keeping up with the supply,"said Dr. Robert Wachter, chair of the department of medicine at the University of California, San Francisco.

UCSF is vaccinating about 650-700 peopleper day, he said. So far,4,000 workers have been given shotsout of 11,000 doses received.

"You need enough people trained to do the shots, and a variety of other people to keep track of the flow," he said. Before getting vaccinated, people have to sign consent forms, which takes a few minutes, and then there's the 15-minute waiting period.

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Potential side effects from the vaccines also meanhospitalshave avoided vaccinating a whole departmenton the same day,to ensure workersdon't all get sidelinedat the same time, he said.

It's a logistical challenge to deliver the vaccine, agrees Dr. Otto Yang, a professor of infectious diseases at the David Geffen School of Medicine at UCLA.

"There needs to be staffing to give the vaccine, pharmacies set up to store the vaccine and distribute it to the clinic, as well as scheduling to have people come in and get the vaccine," he said.

Although the pace of vaccination may seem slow, it's actually astonishingly fast, considering that the first vaccine was only authorized for emergency use by the Food and Drug Administration 11 days ago, Yang said.

"If you do the math, since FDA approval, assuming an 8-hour work day, including weekends, that's 11,363 doses given per hour in this country," he said. "It's hard to imagine it going any quicker than that."

Hospital workers have been extremely eager to get vaccinated, saidDr. Paul Biddinger, medical director ofEmergency Preparedness, Mass General Brigham, a Boston-based hospital system.

Our spots are filling as quickly as we receive the vaccine and interest remains very high," he said.

Deliver a safe, effective COVID-19 vaccine in less than a year?Meet Moncef Slaoui.

Also Wednesday,Slaoui said studies will begin soon looking at whether the Moderna vaccine could be stretched by giving people lower doses. Right now, people are given 100 micrograms in each of two doses, he said, but early indications suggest that the 50-microgram dose might be equally effective.

Although a single dose of the vaccine appears to be very effective, he warned people against getting just one shot. A second dose usually trains the immune system to fight off a disease for longer, so the protection from one shot is not likely to last as long, he said.

Experts say side effects from the COVID-19 vaccine range from soreness to fatigue.(Photo: Getty)

Johnson & Johnson is testing a vaccine that could be given in just one dose. Their large trial is now fully enrolled and the first hints of its effectiveness should be available within a few weeks, Slaoui said. If that vaccine proves safe and effective, it is likely to win FDA authorization in February, adding 100 milliondoses to the U.S. supply.

A candidate vaccine developed by AstraZeneca in collaboration with Oxford University is also nearing full enrollment of its crucial American trial, he said, with authorization likely in late February or early March, if it proves safe and effective.

More US supply?FDA says Pfizer-BioNTech COVID-19 vaccine vials may hold extra 'obtainable' doses

Moderna and Pfizer-BioNTech have each promised to deliver 100 million doses in the first quarter of 2021 and another 100 million each in the second quarter.

If all those doses come through, the adult population will be more than covered by next summer, Slaoui said, noting that most of the 80-million Americans younger than 18 may have to wait until later in the summer, because trials on teenagers need to be completed before vaccine makers will extend their studies into younger children. The Pfizer-BioNTech vaccine is authorized for use in 16-17-year-olds.

Slaoui and Perna ended their talks Wednesday by thanking all the people who have been involved in developing, manufacturing and delivering the vaccines, as well as those who volunteered for the clinical trials.

"Thank you, thank you, thank you to the men and women who are on the front lines in our hospitals, emergency rooms, ICU'sthe doctors, thenurses, thepeople who support them 24/7, the people really on the front lines," Perna said. "Our hats are off to everything they do."

Contributing: Mike Stucka, USA TODAY

ContactKaren Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Operation Warp Speed is living up to its name, but COVID-19 immunizations are going 'slower' than expected, officials say - USA TODAY

Need to stay updated on coronavirus news in Texas? Our evening roundup will help you stay on top of the day's latest updates. Sign up here.

In one of the Texas facilities hardest hit by the COVID-19 virus, Texas medical workers lined up to receive the Pfizer COVID-19 vaccine on Saturday. While a long road lies ahead and officials stress that people need to continue wearing masks and social distancing some who received the vaccine were optimistic that this could be the beginning of the end for the pandemic.

Disclosure: DHR Health has been a financial supporter of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.

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Watch Texas front-line workers get the COVID-19 vaccine - The Texas Tribune

Corrie Detweiler, a professor of molecular, cellular and developmental biology, eyes some samples in the lab. (Photo: CU Boulder)

As scientists around the globe wage war against a novel, deadly virus, one CU Boulderlab is working on new weapons to battle a different microbial threat: a rising tide of antibiotic-resistant bacteria which, if left unchecked, could kill an estimated 10 million people annually by 2050.

The COVID-19 situation is definitely putting us at risk for increasing resistance to antibiotics, so its more important now than ever that we come up with alternative treatments, said Corrie Detweiler, a professor of molecular, cellular and developmental biology who has spent her career seeking those alternatives.

In a paper published Dec. 18in the journal PLOS Pathogens, Detweiler and her research team unveil their latest discoverya chemical compound that works with a hosts innate immune response to push past cellular barriers that help bacteria resist antibiotics.

Along with their other recently published discoveries, the authors say, the finding could lead to a new arsenal for fighting what could be the next big public health threat.

If we dont solve the problem of finding new antibiotics or somehow making old antibiotics work again, we are going to see sharply increasing deaths from bacterial infections we thought we had beaten decades ago, said Detweiler. This study offers a totally new approach and could point the way toward new drugs that work better and have fewer side effects.

In the United States alone, 35,000 people die annually from bacterial infections that could not be treated because theyve grown resistant to existing drugs. Countless others suffer life-threatening bouts with once-easily treatable illnesses like strep throat, urinary tract infections and pneumonia. By 2050, the authors note, there could be more deaths from antibiotic resistance than from cancer.

As our existing antibiotics adapt and work less, we risk essentially going back to a period 100 years ago, when even a minor infection could mean death, said Detweiler.

The pandemic has shone even more light on the problem, she notes, as many patients die not from the virus itself but from hard-to-treat secondary bacterial infections.

Meanwhile, she and other scholars worry that heightened use of antibiotics to prevent or treat those secondary infections, while at times necessary, may be exacerbating resistance.

Fragile healthcare systems in many parts of the world may not withstand the COVID-19 pandemic if also faced with a substantial increase in antimicrobial resistance, wrote the authors of an editorial in the British Medical Journal in November.

Most antibiotics in use today were developed in the 1950s, and pharmaceutical companies have since scaled back on research in the field in favor of more profitable ventures.

To feed the pipeline, Detweilers lab developed a technique called SAFIRE for screening for new small molecules, which work differently than older drugs.

Of 14,400 candidates screened from a library of existing chemicals, SAFIRE identified 70 that hold promise.

The new paper centers around JD1, which appears to be particularly effective at infiltrating what are known as Gram-negative bacteria.

With a tough exterior membrane that prevents antibiotics from accessing the cell, and another interior membrane providing a buffer, these bacteria (including Salmonella and E. coli) are inherently difficult to treat.

But unlike other drugs, JD1 takes advantage of the hosts initial immune assault on that outer bacterial membrane, then slips inside and goes after the inner membrane too.

Professor Corrie Detweiler in her lab at CU Boulder

This is the first study to show that you can target a Gram-negative bacterias inner membrane by exploiting the innate immune response of the host, Detweiler said.

In laboratory and rodent experiments, JD1 reduced the survival and spread of Gram-negative bacteria called Salmonella enterica by 95%.

But while it damaged the bacterial cell membranes, it couldnt penetrate the fine layer of cholesterol that lined its mammalian hosts cell membranes.

Bacteria are vulnerable to JD1 in a way that our cells are not, said Detweiler, noting that for this reason, side-effects would likely be minimal.

Further studies are underway to explore JD1 and other compounds like it.

Meanwhile, Detweiler has formed a spin-off company to help commercialize other compounds that work by inhibiting pumps, called efflux pumps, that bacteria use to pump out antibiotics.

The reality is, evolution is way smarter than all of the scientists put together and these bacteria will continue to evolve to resist what we throw at them, she said. We cannot rest on our laurels. We have to keep feeding the pipeline.

See the article here:

With COVID-19 exacerbating the threat of superbugs, researchers ID new weapon - CU Boulder Today

This is part one in a three-part series. Click here to read part two.

Aired 12/21/20 on KPBS News

Listen to this story by Claire Trageser.

Community outbreaks of COVID-19 have touched every corner of San Diego County and all types of establishments over the past nine months, but they are most prevalent in big box stores, restaurants and group living situations like nursing homes and jails, according to county outbreak records obtained exclusively by KPBS.

If youve gone out at all since the pandemic first struck, you quite likely walked into a place where an outbreak occurred, according to the KPBS analysis of 1,006 outbreak records dating from March through the end of November. For example:

At least 208 outbreaks have occurred in restaurants, with popular chains like Olive Garden, Cheesecake Factory, Dennys and The Broken Yolk Cafe having multiple outbreaks each.

At least 205 outbreaks have occurred in businesses with services that run the gamut from car repair to pet care to banking and shipping.

At least 125 outbreaks have occurred in large retailers and grocery stores like Walmart, Costco, Target, Home Depot and Trader Joes.

Editors note: This interactive map and searchable database contains records obtained by KPBS of COVID-19 community outbreaks in San Diego County. When viewing these records it is important to keep in mind that just because you visited a place that had an outbreak doesnt necessarily mean you were exposed to the virus. And it doesn't mean you can catch COVID-19 by going there now. By the countys definition, an outbreak occurs when three or more people with COVID-19, who aren't close contacts, were known to be in a specific location during the same 14-day period. It's possible none of them caught the virus at the outbreak location. And being the site of an outbreak doesn't necessarily mean the businesses had unsafe practices.COVID-19 is a virus that spreads easily without fear or favor. KPBS is releasing the outbreak locations because transparency and public health information is vital for our community.

However, just because you visited a place that had an outbreak doesnt necessarily mean you were exposed to the virus and doesn't mean you can catch COVID-19 by going there now.

An outbreak means three or more people with COVID-19, who aren't close contacts, were in that place over the same 14-day period. So, those people may have never crossed pathsthey could have even been there on different days. And it's possible none of them caught the virus at the outbreak location. Being the site of an outbreak doesn't necessarily mean the businesses had unsafe practices.

The records reviewed by KPBS include all outbreak locations during the first nine months of the pandemic, but only specific case counts for the month of November. The November records show that most of the outbreaks are smallfewer than 10 casesand they dont reveal whether employees or patrons were infected.

But the overall records do show you're far more likely to be exposed to an outbreak based on your living circumstances and/or your behavior. For example:

At least 252 outbreaks occurred in nursing homes, jails, rehab facilities and shelters.

At least 136 outbreaks occurred in five lower income ZIP codes in East and South County, where many essential workers live.

At least 30 outbreaks have occurred at religious organizations since March. In November, outbreaks at houses of worship had a combined case count of at least 187, almost half of those coming from Awaken Church.

At least 86 outbreaks happened in the Pacific Beach and Gaslamp ZIP codes, two of the countys biggest party spots.

Seven casinos in the county have had outbreaks with a combined case count of more than 638.

This is the first time the public has seen this much outbreak data with this level of specificity for San Diego County. Since the onset of the pandemic, county officials have kept outbreak locations secret, instead only listing outbreaks by category such as "bar/restaurant" or "business."

The records obtained by KPBS represent a snapshot in time of an ever-changing dataset. Cases continue to increase at existing outbreak locations and new outbreaks pop up regularly, especially as the San Diego region is in the midst of a huge surge of COVID-19 cases.

County officials refused to comment for this story. But Greg Cox, the chairman of the county Board of Supervisors, sent a letter last week to KPBS General Manager Tom Karlo, urging him stop the publication of this story.

Editors note: This interactive map and searchable database contains records obtained by KPBS of COVID-19 community outbreaks in San Diego County. When viewing these records it is important to keep in mind that just because you visited a place that had an outbreak doesnt necessarily mean you were exposed to the virus. And it doesn't mean you can catch COVID-19 by going there now. By the countys definition, an outbreak occurs when three or more people with COVID-19, who aren't close contacts, were known to be in a specific location during the same 14-day period. It's possible none of them caught the virus at the outbreak location. And being the site of an outbreak doesn't necessarily mean the businesses had unsafe practices.COVID-19 is a virus that spreads easily without fear or favor. KPBS is releasing the outbreak locations because transparency and public health information is vital for our community.

In the past officials have said it is not important for the public to know detailed information about community outbreaks because they only account for about 4% of all COVID-19 cases in the county. The KPBS analysis of November outbreaks shows they accounted for about 8% of all cases during the month. Officials also argue that businesses and other organizations would not report outbreaks to the county if they were made public.

News organizations and other public interest groups have opposed the county, arguing that public health and the public interest is best served when people have the public health records of outbreak locations at their disposal.

In August, Voice of San Diego, KPBS and The San Diego Union-Tribune sued the county under the California Public Records Act for all of its outbreak location records. The news organizations have pointed out that other jurisdictions, including Los Angeles County and the state of Oregon, make their outbreak information public.

During an October hearing in the case, county lawyer John Cooley said the countys contact tracing program "would break down" if more detailed outbreak information were made public.

"Without voluntary disclosures, the county can't do the necessary contact tracing," Cooley said. "The county depends on voluntary disclosures to combat the pandemic here. There's no way for the county to find out if a mom and pop shop on El Cajon Boulevard had an outbreak if they don't disclose it."

However, businesses and other organizations would be breaking the law if they failed to report their outbreaks to the county.

Last month, a Superior Court judge ruled in favor of the county. KPBS and the other news organizations are appealing that decision.

How are outbreaks found?

A description on the countys website details how outbreaks are identified. It starts with contact tracing. When someone tests positive for COVID-19, they get a call from a case investigator.

"We interview all cases about their activities during the two weeks prior to their illness onset," the county's website says. "They may mention places they worked, shopped, visited, went to church, attended a gathering, etc."

If three people mention the same location within a 14 day period, it's labeled as an outbreak.

But Rebecca Fielding-Miller, an epidemiologist at UC San Diego, said given the current case surge, it would be extremely difficult for contact tracers to do all the detailed interviews required to accurately pinpoint the risk someone has of catching the virus in a specific location.

"If its nine staff members all working in the kitchen together and you have nine people test positive within a 14 day window, my initial assumption would be that those are connected," she said. "But if nine people report they happened to be in a Walmart in Chula Vista within a 14-day window because they were grocery shopping, youd have to narrow it down to a specific window, say they were all there between 2 and 5 pm on a Wednesday. And you cant do that when you have 2,000 cases a day."

Press play to see the number of outbreaks in San Diego County change from the start of the pandemic to the end of November.

Historically its made sense to trace outbreaks for sexually transmitted diseases, and for very rare diseases like measles, Fielding-Miller said. But with COVID-19, which is both highly contagious and widespread, tracing outbreaks isnt necessarily practical.

"It's like the wildfire analogy, where it can tell you where there are flare ups, which is useful when everything is not on fire," she said. "But when everything is on fire, its not as useful."

Fielding-Miller also said considering the context in the numbers obtained by KPBS is important. A higher number of outbreaks at retail chains is likely partly because they have multiple locations and more people work there and visit them.

"You wouldn't say Otay Mesa Detention Center has only had one outbreak and Dennys has had five, therefore Otay Mesa is safer," she said.

But there are also trends in the data that make sense with what else we know about COVID-19. There are multiple large outbreaks at retail centers like Walmart and Costco, and none at Whole Foods. That doesn't necessarily mean Whole Foods is saferit could be because lower-income people, who by virtue of their living situations are more vulnerable to COVID-19, are more likely to shop at the bigger retail chains, Fielding-Miller said.

She added that it's likely the outbreaks at restaurants and grocery stores are occurring between employees, because they spend more time in close proximity, but it's impossible to know because the county does not keep separate records for employees and customers.

Workers at risk

The records obtained by KPBS show how the pandemic has evolved throughout the year in San Diego County. During the spring, nursing homes and senior care facilities accounted for more than half the countys outbreaks. By November, even though case counts remain high in these facilities, they represented only 12% of new outbreaks for the month.

Meanwhile, 20% of the November outbreaks were in retail and grocery stores and 19% were in restaurants and bars. This means that an increasingly large number of workers are in establishments that have experienced outbreaks. Many say they are not being adequately protected.

Last month, workers at an AT&T call center in Sorrento Valley planned a walkout because they said 11 people had tested positive for COVID-19 and they didn't feel safe working there. But the employees said the county didnt inform them of the cases. Instead, Chris Roberts, the president of the local Communication Workers of America union, said they collect and notify union members of cases.

"If we weren't diligent in discovering the outbreak, no one would have known," Roberts said.

He said if the county publicly posted information about outbreaks at businesses, it would better protect workers. The county records obtained by KPBS do show an outbreak at that location, but with three cases, not 11.

"Family members want to know," Roberts said. "People want to be able to make decisions about whether to go to work, so people can make informed decisions."

In response to questions from KPBS, an AT&T spokesman said in an emailed statement that many employees work from home, but "some teams must report to an office due to the nature of the work that they perform." Those employees receive rapid testing and follow safety protocols, he said.

Workers at Costco are "very afraid" of contracting the virus, said Jaime Vasquez, the secretary-treasurer of the Teamsters Local 542, which represents some of the region's Costco employees. The records obtained by KPBS show 132 cases tied to 16 different outbreaks since the beginning of March.

When the pandemic first hit, Costco "did a fabulous job, they limited entrance to 600 people including staff," he said. Vasquez said the stores are allowing half capacity, which can still feel packed, "especially with Christmas shopping." Vasquez argues Costco is a retail store, which he said means it should be limited to 20% of its max capacity.

Costco did not respond to a request for comment. Other big retailers, such as Walmart, Target and Home Depot, sent statements to KPBS saying they prioritized safety and have taken extra measures during the pandemic.

A spokeswoman for Target acknowledged having multiple cases among employees at some of its stores. The records obtained by KPBS show 95 cases tied to 10 outbreaks at Target stores in San Diego County.

"Were paying these team members while theyre on leave and our thoughts are with them during this challenging time," the spokeswoman said in a statement. "After learning about positive cases, we also work quickly to deep clean and sanitize the store, which is the recommendation of public health experts and is in addition to the frequent disinfecting and cleaning we do at stores throughout each day. We notify the entire store team and provide them with the appropriate CDC guidance."

At Walmart, as well as at other big box retailers, store policy is to do temperature checks and health screenings on employees, have plexiglass barriers at checkout and limit store capacities to 20%.

"During this challenging time were working to balance health and safety concerns while still meeting the needs and expectations of our customers and associates," a Walmart spokeswoman said in a statement.

Devon Hannagan, who works as a supervisor at Vons on Balboa Avenue, said he would like more information on outbreaks at businesses. "Every man and woman who works for a company should be able to evaluate their own risk and come up with an idea of what's too much," he said.

San Diego County's health order says when an employee tests positive for COVID-19, the employer must notify "any employees, and contractors (who regularly work at the workplace), who may have been exposed."

Next month, the state will begin posting some data about employees who've been exposed, but without naming specific locations.

Unequal treatment

Certain businesses, including gyms and salons, have faced some of the most severe restrictions from the stay-at-home order while having relatively few outbreaks. Gyms had 14 outbreaks total since March, and salons and barber shops only had 10, according to the records obtained by KPBS.

Bryan Welch, general manager at Point Loma Sports Club, said he wishes the county could close businesses based on business practices and safety, not categories.

"I wish I could wave a magic wand to say each business gets evaluated on its merits, but then you would have to have 10,000 people working for the county going out to each business," he said.

The number of outbreaks at restaurants surged to 46 in July after dining was reopened, including indoors. But then the number fell to 18 for August after dining was restricted to outdoors. The number of restaurant outbreaks gradually increased through the fall, and rose to 60 in November, according to the numbers KPBS obtained.

Last week, a San Diego Superior Court Judge ruled that businesses "with restaurant service" could remain open. County officials at first said they would "suspend enforcement activities against restaurants and live entertainment establishments," prompting many restaurants to reopen, including for indoor dining. By Friday, an appeals court judge stayed the ruling, meaning restaurants had to close again, at least temporarily.

In addition, some businesses have refused to close or modify their operations to match county orders and have been served with cease and desist orders. Some businesses with more than one outbreak also have received cease and desist or closure letters, including El Prez and King and Queen Cantina.

San Diego County has argued in the past that revealing case numbers at businesses might let people decipher who has had COVID-19 at that business, which could be a privacy issue. But El Cajon City Manager Graham Mitchell called that argument "a cop out."

"I had it, there's no stigma around it, we dont shy away from telling people we had the flu or chickenpox," he said.

He said he thinks the county has pointed out categories with outbreaks to defend its decisions about what to close.

"That data point serves them because they have to defend the closure of bars and restaurants," he said. "But they cant play it both ways, cant use the numbers and then not reveal them."

KPBS obtained County Health Department records on the virus that have been withheld from the public, finally revealing where COVID-19 outbreaks have happened in San Diego County. Plus: Top county health officials detail vaccine rollout progress and future plans plus the ongoing legal battle impacting local restaurants and more local news you need.

Aired: December 21, 2020 | Transcript

If youve gone out at all since the pandemic first struck, you quite likely walked into a place where an outbreak occurred, according to the KPBS analysis of 1,006 outbreak records dating from March through the end of November.

Aired: December 21, 2020 | Transcript

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Here's Where COVID-19 Outbreaks Have Happened In San Diego County - KPBS

A new $900 billion coronavirus stimulus deal has finally been struck but U.S. stocks are falling.

Fears over a new strain of the coronavirus that causes COVID-19, discovered in the U.K., have spooked investors at the beginning of Christmas week. The U.K.s health minister Matt Hancock warned that the new strain, said to be highly infectious, was out of control as the government scrapped a planned relaxation of the rules over the holiday period. Prime Minister Boris Johnson said the strain could be 70% more transmittable.

A number of European countries, including France, Italy and the Netherlands have suspended all travel to and from the U.K. Italy has also detected a patient with the new strain.

The developments have brought a return to uncertainty, hitting global stocks early on Monday. Despite the COVID-19 aid deal, the Dow Jones Industrial Average DJIA, +0.12% fell 0.9% in early trading, before recovering to trade 0.3% down, while the pan-European Stoxx 600 SXXP, -2.33% was 2.3% lower.

In our call of the day, Markets.com analyst Neil Wilson described the market move as near-term volatility and said corrections of this nature are to be expected on the road to full vaccine deployment.

This is the kind of near-term volatility we can expect until the full force of vaccines is felt. There has been a lot of hope already priced in with the vaccine-inspired November rally so we cannot expect a straight line higher for stocks, he said in a note on Monday.

He added that the rotation trade was unwinding, at least in the U.K., due to tighter measures and travel restrictions, with oil companies BP BP, -4.90% and Royal Dutch Shell RDSB, -5.67% and British Airways owner IAG IAG, -7.96% among the notable fallers, and online grocer Ocado OCDO, +5.57% and food-delivery company Just Eat Takeaway JET, +1.88% among the few European stocks rising.

With the full impact of the vaccine some months away, Wilson warned investors to be prepared for a rough ride. The cavalry may be coming but the homesteaders need to batten down the hatches and face another onslaught before they arrive, he said.

After closing 0.4%, or 124.32 points, lower on Friday, the Dow Jones Industrial Average DJIA, +0.12% was 0.2% lower into afternoon trading after recovering from steeper losses. The S&P 500 SPX, -0.39% fell 0.8% and the Nasdaq Composite COMP, -0.10% slipped 0.7%. The discovery of a new strain of coronavirus in the U.K. was to blame for the negativity, with European stocks hit hardest. The German DAX DAX, -2.82% fell 2.8% and the French CAC PX1, -2.43% dropped 2.4%.

The pound GBPUSD, -0.43% tumbled 1.3% as a result of countries banning travel to the U.K. amid the new virus strain and a lack of progress in the Brexit trade deal talks. Sterlings weakness mitigated losses for the internationally-exposed FTSE 100 UKX, -1.73%, which declined 1.7% lower. Oil prices CL00, -0.46% BRN00, -0.29% fell sharply on concerns the new strain will hit demand.

Our chart of the day from Fundstrat shows that the percentage of the U.S. with falling cases is at 38% the highest level since early October, which its analysts said may suggest the third wave has peaked. But they added that the situation in California was pretty serious.

Biotech Moderna MRNA, -1.38% began distributing its COVID-19 vaccine on Sunday, the second vaccine to be authorized in the U.S.

The European Union authorized its first vaccine against COVID-19 on Monday, joining the U.K. and the U.S. in approving the Pfizer PFE, -0.80% and BioNTech BNTX, +2.13% jab.

A suggestive tweet by Tesla Chief Executive Elon Musk has led to a discussion about a potential $1-trillion favor for Tesla shareholders.

Tesla TSLA, -6.49% stock debuted as an S&P 500 index component with a thud, as it opened 4.1% lower, before extending losses.

Anglo-Dutch oil major Royal Dutch Shell RDSB, -5.67% said it expects to book charges of between $3.5 billion and $4.5 billion in the fourth quarter due to write-downs, asset restructuring and onerous contracts. The stock fell 3.7% in early trading.

Pharmaceutical company GlaxoSmithKline GSK, -1.18% said on Monday that the European Union has granted market authorization for ViiV Healthcares long-acting HIV treatment Vocabria.

New York Governor Andrew Cuomo called it reprehensible and grossly negligent to allow U.K. travelers to fly into JFK Airport without being tested despite a contagious new mutations of coronavirus shutting down London.

Couple holds 10,000 guest drive-thru wedding.

A giant computer-generated version of singer Rita Ora will arrest anyone trying to leave London, a viral Twitter TWTR, -2.20% joke warns.

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A new COVID-19 strain is sending stocks tumbling, but here's why investors shouldn't panic, says this analyst - MarketWatch

President-elect Joe Biden receives a COVID-19 vaccination Monday at the ChristianaCare Hospital in Newark, Del. Alex Edelman/AFP via Getty Images hide caption

President-elect Joe Biden receives a COVID-19 vaccination Monday at the ChristianaCare Hospital in Newark, Del.

Updated at 3:48 p.m. ET

President-elect Joe Biden publicly received his first dose of the Pfizer-BioNTech COVID-19 vaccine on Monday as the death toll from the disease nears 320,000 in the United States.

Rolling up his sleeve at Christiana Hospital in Newark, Del., Biden told nurse practitioner Tabe Mase, "I'm ready!" and thanked her for her work with COVID-19 patients. "We owe you big, we really do," Biden said.

Biden said his wife, Jill, also received her first vaccine shot Monday.

"I'm doing this to demonstrate that people should be prepared when it's available, to take the vaccine. There's nothing to worry about," the president-elect said of his first vaccine dose. He said he was "looking forward" to getting the second dose.

"This is just the beginning. It's one thing to get the vaccine out, and now [vaccine-maker] Moderna is going to be on the road as well, but it's going to take time," he added, imploring Americans to continue following health guidelines, including wearing masks, keeping social distance and avoiding unnecessary travel.

The president-elect, who said the Trump administration "deserves credit" for getting the development and distribution of vaccines off the ground, has set a goal of distributing 100 million vaccine shots in the first 100 days of his administration.

In receiving the vaccine on Monday, the Bidens join a growing list of political leaders who are sharing videos or photos of themselves getting inoculated in an effort to boost public trust in the efficacy and safety of the vaccines that have been authorized for emergency use. The federal government has allotted vaccine doses to officials according to continuity of government protocols.

Vice President Pence, second lady Karen Pence and Surgeon General Jerome Adams were administered their initial vaccination shots during an on-camera event on Friday.

"Vaccines are how we beat this virus," Senate Majority Leader Mitch McConnell, R-Ky., tweeted on Friday after receiving his first shot.

House Speaker Nancy Pelosi, D-Calif., also shared photos of her vaccination, reminding the public to continue to follow social distancing guidelines and to wear masks as the vaccine is being distributed over the next several months.

Biden is 78, an age that puts him at higher risk of severe symptoms, should he contract the virus.

A Centers for Disease Control and Prevention panel on Sunday recommended that people over 75 be among the group prioritized next for a vaccine following health care workers and residents and workers at long-term care facilities.

Rep. Cedric Richmond of Louisiana, who will lead Biden's Office of Public Engagement, tested positive for the coronavirus last week. He did not have close contact with the president-elect before the positive test, an aide said.

According to a December NPR/PBS NewsHour/Marist survey, 61% of Americans said they will take a vaccine when they are able to, up from 49% in September.

Among those most reluctant to get the vaccine are supporters of President Trump, people who live in rural areas and people without college degrees.

The White House has not said when Trump or first lady Melania Trump, both of whom were infected with the virus earlier this year, would receive the vaccine.

Vice President-elect Kamala Harris is expected to begin her course of vaccination next week.

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'There's Nothing To Worry About,' Biden Says As He Receives COVID-19 Vaccine - NPR

BLOOMINGTON, Ind. -- While the world is focused on the promise of the COVID-19 vaccines now being released, researchers continue to look for new and innovative ways to fight the pandemic. Indiana University is part of a consortium -- including AstraZeneca, the Wistar Institute, Inovio and the University of Pennsylvania -- that just received a $37.6 million grant to develop and study DNA-encoded monoclonal antibodies as an additional way to fight SARS-CoV-2, the virus that causes COVID-19.

The grant, awarded from the Defense Advanced Research Projects Agency and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, will enable IU and its consortium partners to take its DNA-encoded monoclonal antibodies from the design stage into human phase II clinical trials in the next two years. The technology works by providing the genetic information the body needs to produce its own antibodies against a bacteria or virus, such as SARS-CoV-2.

IU's role in this research study -- under the leadership of Jesper Pallesen, assistant professor of molecular and cellular biochemistry in the College of Arts and Sciences at IU Bloomington -- will be focused on the structural analysis of the DNA-encoded monoclonal antibodies, known as DMAbs, from the design phase all the way through to human clinical trials.

"My lab specializes in structure-guided vaccine and therapeutics design," Pallesen said. "As part of the consortium, we'll be evaluating how and where our DMAbs bind to the surface proteins of SARS-CoV-2."

To do this, Pallesen and his team will use cryo-electron microscopy, which enables them to see, atom by atom, how proteins and viruses are built. He will use this technology to view all samples of the DMAbs produced by the consortium starting as early as January.

As well as simply being another weapon in the fight against COVID-19, DNA-encoded monoclonal antibodies technology holds many advantages. It's highly specific to the virus it's protecting against, it's quick to manufacture with a low cost of production, and it does not need special cold storage. In addition, DMAbs can introduce antibodies independently of the patient's own immune response.

"Our technology does not rely on the continual development of a patient's own immune response to react to SARS-CoV-2 but rather independently creates a recipe for an optimal response," Pallesen said. "I am really excited to help advance DNA-based therapeutics and vaccines against SARS-CoV-2 and beyond. The distribution advantages of DNA technologies are indisputable, and we have the potential to bring therapeutics and vaccines to people much faster and -- perhaps most importantly -- to parts of the world that are currently very challenging to service."

IU's world-class researchers have driven innovation and creative initiatives that matter for 200 years. From curing testicular cancer to collaborating with NASA to search for life on Mars, IU has earned its reputation as a world-class research institution. Supported by $854 million last year from our partners, IU researchers are building collaborations and uncovering new solutions that improve lives in Indiana and around the globe.

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$37.6M grant awarded to develop innovative COVID-19 treatment - IU Newsroom