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Business Not as Usual Covid-19 Vaccination in Persons with Substance Use Disorders - nejm.org
World Health Organization experts have warned that even though the coronavirus pandemic has been very severe, it is not necessarily the big one, and that the world will have to learn to live with Covid-19.
The destiny of the virus is to become endemic, even as vaccines begin to be rolled out in the US and UK, says Professor David Heymann, the chair of the WHOs strategic and technical advisory group for infectious hazards.
The world has hoped for herd immunity, that somehow transmission would be decreased if enough persons were immune, he told the WHOs final media briefing for 2020.
But Heymann, who is also an epidemiologist with the London School of Hygiene and Tropical Medicine, said the concept of herd immunity was misunderstood.
It appears the destiny of SARS-CoV-2 [Covid-19] is to become endemic, as have four other human coronaviruses, and that it will continue to mutate as it reproduces in human cells, especially in areas of more intense admission.
Fortunately, we have tools to save lives, and these in combination with good public health will permit us to learn to live with Covid-19.
The head of the WHO emergencies program, Dr Mike Ryan, said: The likely scenario is the virus will become another endemic virus that will remain somewhat of a threat, but a very low-level threat in the context of an effective global vaccination program.
It remains to be seen how well the vaccines are taken up, how close we get to a coverage level that might allow us the opportunity to go for elimination, he said. The existence of a vaccine, even at high efficacy, is no guarantee of eliminating or eradicating an infectious disease. That is a very high bar for us to be able to get over.
That was why the first goal of the vaccine was to save lives and protect the vulnerable, Ryan said. And then we will deal with the moonshot of potentially being able to eliminate or eradicate this virus.
Ryan warned that the next pandemic may be more severe. This pandemic has been very severe it has affected every corner of this planet. But this is not necessarily the big one, he said.
This is a wake-up call. We are learning, now, how to do things better: science, logistics, training and governance, how to communicate better. But the planet is fragile.
We live in an increasingly complex global society. These threats will continue. If there is one thing we need to take from this pandemic, with all of the tragedy and loss, is we need to get our act together. We need to honour those weve lost by getting better at what we do every day.
WHO chief scientist Dr Soumya Swaminathan told the briefing that being vaccinated against the virus did not mean public health measures such as social distancing would be able to be stopped in future.
The first role of the vaccine would be to prevent symptomatic disease, severe disease and deaths, she said. But whether the vaccines would also reduce the number of infections or prevent people from passing on the virus remains to be seen.
I dont believe we have the evidence on any of the vaccines to be confident that its going to prevent people from actually getting the infection and therefore being able to pass it on, Swaminathan said. So I think we need to assume that people who have been vaccinated also need to take the same precautions.
The WHO director general, Tedros Adhanom Ghebreyesus, said the end of the year was a time to reflect on the toll the pandemic had taken, but also the progress made. He said the year ahead would see new setbacks and new challenges.
For example, new variants of Covid-19, and helping people who are tired of the pandemic continue to combat it, he said.
New ground has been broken, not least with the extraordinary cooperation between the private and public sector in this pandemic. And in recent weeks, safe and effective vaccine rollout has started in a number countries, which is an incredible scientific achievement.
This is fantastic, but WHO will not rest until those in need everywhere have access to the new vaccines and are protected.
On 30 December 2020 this article was amended to correct the name of the head of the WHO emergencies program.
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WHO warns Covid-19 pandemic is 'not necessarily the big one' - The Guardian
Updated 1:30 p.m.
Minnesotas COVID-19 data continues to offer a mix of hope and uncertainty. New daily case counts fell below 1,000 for the first time since early October, but that came on very low testing, making it difficult to draw any conclusions about the pandemics path.
The death toll, meanwhile, continues to climb.
The state on Tuesday reported 988 newly confirmed or probable cases. The count of known, active cases in Minnesota fell below 13,000 for the first time since late October, part of an overall slowdown in caseloads since their late November, early December peak.
Hospitalization trends have also improved significantly the past two weeks. As of Monday, 966 people were in the hospital with COVID-19 in Minnesota, with 214 needing intensive care.
Overall, thought, the statistics are still distorted by reporting delays from the long holiday weekend, making it hard to say how Minnesotas COVID-19 outbreak is changing.
State health officials have warned that the improving picture could change dramatically if people dont stay vigilant. They continue to implore people to wear masks in indoor gathering spaces, socially distance and take other measures to help stem the spread of COVID-19.
The cases reported Tuesday put Minnesota at 411,110 in the pandemic. Of those, about 96 percent have recovered to the point they no longer need to be isolated.
The 36 newly reported deaths raised Minnesotas toll to 5,196. Among those whove died, about 64 percent had been living in long-term care or assisted living facilities; most had underlying health problems.
People in their 20s still make up the age bracket with the states largest number of confirmed cases more than 78,000 since the pandemic began, including nearly 42,000 among people ages 20 to 24.
The number of high school-age youth confirmed with the disease has also grown, with nearly 32,000 total cases among those 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 two months, while Hennepin and Ramsey counties showed some of the slowest case growth in the state.
Cases continue to fall statewide, with most regions dipping down to levels before the states COVID-19 surge that hit in November and early December.
Hot spots continue 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.
Even as new case counts ease from their peak a few weeks ago, the data shows people of color continue to be hit hardest.
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.
Nearly two weeks into Minnesota's vaccine distribution program, about 38,000 people have received their first shots.
Many hospitals started vaccinating their front-line workers the week of Dec. 21, with a few starting days before that. Long-term care providers started vaccinating residents this week, with nearly 600 given so far.
The state has so far received nearly 80,000 doses of the Pfizer vaccine and nearly 95,000 of the Moderna vaccine. That vaccine is mostly being used to inoculate people living and working in skilled nursing facilities.
The state is on track to get 250,000 doses by the end of the year.
After initially saying it would update numbers weekly, the Minnesota Department of Health said Tuesday it will be updating vaccination counts daily.
Minnesota student athletes must wear masks at all practices and games even during high-exertion sports such as hockey and basketball, state officials said Monday.
There are exceptions for swimmers while they're in the water, as well as wrestlers, and certain gymnastics and cheerleading routines.
The regulations came as part of the new COVID-19 guidance for youth winter sports. In November, Gov. Tim Walz ordered a pause on prep sports as part of a larger effort to minimize public gatherings to stop the diseases spread.
Under the new guidance, teams can conditionally begin games and scrimmages with other teams starting Jan. 14. Practices, which can start next Monday, may not include more than 25 people.
Matt Sepic | MPR News
A new federal pandemic relief package signed by President Donald Trump on Sunday will help thousands of unemployed Minnesotans.
Steve Grove, Minnesotas commissioner of employment and economic development, said more than 300,000 Minnesotans are receiving unemployment. He said more than 100,000 Minnesotans risked falling out of the system without the legislation.
The state has distributed more than $9 billion in federal unemployment benefits this year amid the pandemic, Grove said. Thats a record
Grove said a state emergency program will cover a one-week gap in extra pandemic benefits for many unemployed Minnesotans before the the new federal aid begins flowing.
Dan Gunderson | MPR News
COVID vaccinations ramp up in Minn. long-term care: Staff and residents in nursing homes and other long-term care facilities across the state began getting their first doses of the COVID-19 vaccine Monday, a hopeful sign in an industry hard-hit by the virus.
Trump reluctantly signs COVID aid, sparks fresh fight in GOP: Dropping his objections, President Donald Trump has signed a $2 trillion-plus COVID-19 and annual federal spending package into law. But Congress returns Monday to confront the White House on remaining priorities in a rare end-of-session showdown.
In the ICU and at George Floyd Square, one nurse fights two pandemics: Nurse Jeanette Rupert is hard to keep up with. When she's not treating COVID-19 patients in the ICU, she's dispensing medical care at George Floyd Square, just blocks from where she was born and raised. In the turbulence of 2020, Rupert says she's deepened her appreciation and commitment to her friends, family and community.
Emergency relief fund created for MN backstage professionals: The new Theater Emergency Relief Fund aims to help individuals who work in theater or dance production or design by offering grants of $1,200.
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.
You make MPR News possible. Individual donations are behind the clarity in coverage from our reporters across the state, stories that connect us, and conversations that provide perspectives. Help ensure MPR remains a resource that brings Minnesotans together.
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Latest on COVID-19 in MN: 36 deaths; new daily cases fall below 1K - Minnesota Public Radio News
Heres what you need to know:Health care workers treating a Covid-19 patient at Providence St. Mary Medical Center in Apple Valley, Calif., this month.Credit...Ariana Drehsler for The New York Times
Dozens of research papers published over the past few months have found that people whose bodies were teeming with the coronavirus more often became seriously ill and were more likely to die, compared with those who carried much less virus and were more likely to emerge relatively unscathed. Now that information could help hospitals.
The results suggest that knowing the so-called viral load the amount of virus in the body could help doctors distinguish those who may need an oxygen check just once a day, for example, from those who need to be monitored more closely, said Dr. Daniel Griffin, an infectious disease physician at Columbia University in New York.
Tracking viral loads can actually help us stratify risk, Dr. Griffin said. The idea is not new: Managing viral load has long formed the basis of care for people with H.I.V., for example, and for tamping down transmission of that virus.
Little effort has been made to track viral loads in Covid-19 patients. This month, however, the Food and Drug Administration said clinical labs might report not just whether a person is infected with the coronavirus, but also an estimate of how much virus is in their body.
This is not a change in policy. Labs could have reported this information all along, according to two senior F.D.A. officials who spoke on condition of anonymity because they were not authorized to speak publicly about the matter.
Still, the news came as a welcome surprise to some experts, who have for months pushed labs to record this information.
This is a very important move by the F.D.A., said Dr. Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health. I think its a step in the right direction to making the most use of one of the only pieces of data we have for many positive individuals.
Nearly half of England is under the nations strictest lockdown measures, and people have been ordered to stay at home, but the coronavirus is still spreading at an alarming rate. Hospitals are treating more patients than at any time during the pandemic, and there is a growing debate about allowing tens of thousands of students to return to classrooms after the holiday break.
The nations scientists have said that a more contagious variant of the virus is driving the rise in cases and, having already imposed severe restrictions on more than 48 million people, it remains unclear what other tools the government has at its disposal to get the outbreak under control.
There were 53,135 new lab-confirmed cases reported on Tuesday, the highest figure yet on a single day. The National Health Service said there were now over 20,000 people in the hospital there, more than at the peak of the pandemic in April.
With the government scheduled to meet to evaluate the current restrictions on Wednesday, Prime Minister Boris Johnson is under pressure to impose another national lockdown and shift students especially older ones in colleges and secondary schools, who may be more easily infected by the new virus variant to remote learning.
The government said that it would rely on mass testing to keep the virus from spreading in schools, with military help. Some 1,500 soldiers are being dedicated to providing schools with the guidance, materials and funding they need to offer rapid testing to their staff and students from the start of term, according to the education secretary, Gavin Williamson.
But two teachers unions have said that staff has not been given adequate time to set up mass testing and the countrys board of scientific advisers, known as SAGE, has recommended against allowing classrooms to reopen, according to British media reports.
Even as the countrys health workers find themselves under growing pressure to treat the influx of patients, they are also being asked to speed up the largest mass vaccination program in the nations history.
Around 200,000 people are getting their first shot of the Pfizer-BioNTech vaccine every week. Ursula von der Leyen, the European Commissions president, wrote on Twitter on Tuesday that the European Union would take an additional 100 million doses of that vaccine, bringing the total to 300 million doses.
With the approval of a vaccine from AstraZeneca and the University of Oxford expected in coming days, the number of doses available will expand drastically. The AstraZeneca vaccine, which comes without the stringent temperature requirements of Pfizers, should also be easier to distribute.
There is no evidence that the vaccines are any less effective against the variant of the virus spreading in Britain, and they remain the best chance for the country to break the spread of the current wave of infections.
transcript
transcript
Lets do it. All righty. Ready? Yeah, Im ready. That was easy. [laughing] Thank you. I have now been vaccinated as Joe likes to say, theres a big difference between the vaccine and vaccinations. I want to encourage everyone to get the vaccine. It is relatively painless. It happens really quickly. It is safe. Literally, this is about saving lives. Its literally about saving lives. I trust the scientists, and it is the scientists who created and approved this vaccine. So I urge everyone, when it is your turn, get vaccinated. Its about saving your life, the life of your family members and the life of your community.
Vice President-elect Kamala Harris received the first dose of the coronavirus vaccine on Tuesday and urged the public to get vaccinated as well, declaring, Literally this is about saving lives.
Ms. Harris received the Moderna vaccine at United Medical Center, a public hospital in Southeast Washington, where she rolled up her sleeve and received the shot in her left arm.
That was easy, she said when it was over. Thank you. I barely felt it.
Ms. Harris appeared on live television to receive her shot, just as President-elect Joseph R. Biden Jr. did last week when he received the Pfizer-BioNTech vaccine at a hospital in Delaware. Ms. Harriss husband, Douglas Emhoff, was also vaccinated on Tuesday.
After getting the vaccine, Ms. Harris urged Americans to get vaccinated as well, saying: It is relatively painless. It happens really quickly. It is safe.
I trust the scientists, and it is the scientists who created and approved this vaccine, she added. So I urge everyone, when it is your turn, get vaccinated. Its about saving your life, the life of your family members and the life of your community.
MOSCOW After months of questions over the true scale of the coronavirus pandemic in Russia and the efficacy of a Russian-developed vaccine, the state statistical agency in Moscow has added to the uncertainty with new figures indicating that the death toll from Covid-19 is more than three times as high as officially reported.
From the start of the pandemic early this year, the health crisis has been enveloped and, critics say, distorted by political calculations as President Vladimir V. Putin and Kremlin-controlled media outlets have repeatedly boasted of Russian successes in combating the virus and keeping the fatality rate relatively low.
Russia has reported more than three million cases of infection, making it the worlds fourth-hardest-hit country, and 55,827 deaths, which ranks it No. 8 worldwide for the highest number of deaths from the virus. A demographer at a government agency who questioned the official fatality figures, dismissing them as far too low, was fired over the summer.
New data issued on Monday by Rosstat, the state statistics agency, however, indicated that the demographer was right and that the real number of fatalities was far higher than previously reported. The agency reported that the number of deaths from January to November was 229,732 higher than over the same period last year, an increase that a senior official blamed largely on the coronavirus.
Tatiana Golikova, a deputy prime minister leading Russias efforts to combat the pandemic, told a government briefing on Monday that more than 81 percent of the increased number of deaths in 2020 was due to Covid, which would mean that the virus had killed more than 186,000 Russians so far this year.
This is still far fewer than the more than 334,000 deaths caused by Covid-19 in the United States but means that Russia has suffered more fatalities as a result of the pandemic than elsewhere in Europe like Italy, France and Britain, whose poor record has been regularly cited by Russian state media as proof of Russias relative triumph.
President-elect Joseph R. Biden Jr. on Tuesday criticized the speed of vaccine distribution under the Trump administration and promised to step up the pace when he takes office, while offering a sobering warning about the continuing toll of the pandemic.
As I long feared and warned, the effort to distribute and administer the vaccine is not progressing as it should, Mr. Biden said in Wilmington, Del., adding that at the current pace, Its going to take years, not months, to vaccinate the American people.
Mr. Biden promised a much more aggressive effort under his administration.
This is going to be the greatest operational challenge weve ever faced as a nation, Mr. Biden said, but were going to get it done.
The president-elect will take office in just over three weeks amid a crisis that has already killed more than 335,000 people in the United States. He has vowed to get at least 100 million vaccine shots into the arms of Americans in his first 100 days in office.
The administration of vaccines has gotten off to a slower start than federal officials had hoped. As recently as earlier this month, federal officials had said their goal was for 20 million people to get their first shots by the end of the year. As of Monday morning, 11.4 million doses of the Pfizer and Moderna vaccines had been distributed across the country, but just 2.1 million people in the United States had received their first dose, according to a dashboard maintained by the Centers for Disease Control and Prevention that most likely reflects a reporting lag of several days.
Earlier Tuesday, Vice President-elect Kamala Harris received her first dose of the coronavirus vaccine. She got her shot on live television, just as Mr. Biden did last week. Ms. Harriss husband, Douglas Emhoff, was also vaccinated on Tuesday.
Margaret Keenan, the first patient in Britain to receive the coronavirus vaccine on Dec. 8, received her second injection on Tuesday, making her the first publicly known person to be fully vaccinated against the virus outside a clinical trial.
Ms. Keenan made headlines this month when she became the first person in the world to receive a clinically authorized, fully tested coronavirus vaccine, wearing a Christmas penguin T-shirt and saying she felt privileged to be vaccinated. At the time, she said, If I can have it at 90, then you can have it, too!
The second injection given to Ms. Keenan, now 91, provided some good news in Britain as the country reported 53,135 new lab-confirmed cases on Tuesday, its highest daily number since the start of the pandemic.
Although nearly half of England is under lockdown, the virus is spreading at an alarming rate, and hospitals are treating more patients than at any time during the health crisis.
Over 600,000 people have received the first dose of the coronavirus vaccine in Britain, but scientists at the London School of Hygiene and Tropical Medicine said that two million people needed to be vaccinated every week to avoid hospitals being overwhelmed like they were during the first wave.
Since the beginning of the pandemic, over 71,000 people in Britain have died from the coronavirus, the second highest death toll in Europe after Italy.
The New Yorker did something on Monday that had few precedents in the magazines 95-year history: It published an issue devoted to a single feature article. The topic was, of course, the coronavirus.
The Plague Year, by Lawrence Wright, examines how the United States permitted the virus to become the yearlong catastrophe he identifies in the opening sentence. It includes interviews with Dr. Deborah L. Birx; Dr. Anthony S. Fauci; and Dr. Barney S. Graham, an immunologist whose research aided the development of several early vaccines and a monoclonal antibody treatment.
The article also includes fly-on-the-wall descriptions of White House meetings and the experiences of Dr. Ebony Hilton, a Virginia anesthesiologist who witnessed firsthand how the virus worsened racial disparities in health.
At roughly 31,000 words, the article is as long as a novella, roughly five times the length of a typical major magazine article.
Mr. Wright, a staff writer at The New Yorker for nearly three decades, initially turned in 76,000 words. I have an appetite to go into depth, he said in an interview. (He added, with a laugh: I get paid by the word.)
The Plague Year occupies the issues entire feature well the heart of the magazine, typically occupied by three or four long feature articles. The New Yorker had done that only a handful of times before, notably for John Herseys Hiroshima in 1946, for the first installment of Hannah Arendts Eichmann in Jerusalem in 1963 and for Mark Danners The Truth of El Mozote, a report on an atrocity in El Salvador, in 1993.
You really needed the real estate to do what he was out to do, said David Remnick, the editor of The New Yorker.
Mr. Wright won the Pulitzer Prize in 2007 for his nonfiction book on Al Qaeda, The Looming Tower.His novel The End of October, published last April, tells the story of a new strain of influenza breaking out. Mr. Wright did extensive research and reporting for his work of fiction; Dr. Graham, the National Institutes of Health immunologist featured in the New Yorker article, is thanked in the books acknowledgments.
Global Roundup
The pandemic has caused the highest number of excess deaths in the Netherlands since World War II, the CBS, the countrys independent national statistics bureau, said on Tuesday.
Up to last week, the Netherlands which has a population of roughly 17 million people reported 162,000 deaths, about 13,000 more than usual, according to the CBS, the statistics bureau, whose figures are used by the government and businesses in the Netherlands. During both waves of the virus, when European countries struggled to contain cases, the number of excess deaths in the country was notable. All excess deaths during the first wave in the spring were caused by the coronavirus, according to the statistics bureau, and an August heat wave also caused some excess deaths this year.
Over the summer, the country had barely any lockdown measures in place, and some people were able to go on vacation. But over the past few months, as the country has been facing and trying to fight a brutal second wave of the pandemic, 6,100 more people died than would have been expected. The Netherlands has also found cases of the British variant in the past week.
The pandemic has hit the Netherlands particularly hard. Earlier this month, Prime Minister Mark Rutte announced harsh new lockdown measures the strictest of the pandemic until at least Jan. 19 because of a dramatic increase in the number of infections, with figures up to around 9,000 per day, according to the government.
In other developments from around the globe:
A woman in hotel quarantine in Queensland, Australia, is the first person in the country found to have a new South African strain of the coronavirus that is thought to be more contagious, health officials said on Tuesday. The woman had traveled from South Africa and has been transferred to a hospital north of Brisbane.
Officials in India said on Tuesday that they had found six cases of the virus variant first detected in Britain. The Indian Union Health Ministry said the patients had traveled from Britain and have been isolated in government-run facilities, while their close contacts have been quarantined. India is one of dozens of countries that have temporarily banned flights from Britain.
The United States on Tuesday began vaccinating its 28,500 troops in South Korea, as the government there reported a single-day record for coronavirus deaths. Service members are receiving the Moderna vaccine, though it is not mandatory, U.S. Forces Korea said in a statement. There have been more than 450 coronavirus cases tied to U.S. forces serving in South Korea. The country, which is struggling to contain a third wave of infections, has had a total of 58,725 cases and 859 deaths, with 40 reported on Tuesday. South Korean officials say vaccinations for the public will begin in February.
The Philippines on Tuesday banned foreign travelers from 19 countries and territories until Jan. 15 in an effort to keep out a more virulent strain of the coronavirus that was first detected in Britain. In addition to Britain, which was already under a travel ban, the countries and territories affected are: Australia, Canada, Denmark, France, Germany, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Lebanon, the Netherlands, Singapore, South Africa, South Korea, Spain, Sweden and Switzerland. Passengers who arrived before Wednesday and Filipino citizens arriving from those places must quarantine at a designated facility for 14 days, according to a government advisory.
Venezuela signed a contract with Russia to begin a mass vaccination campaign using Russias Sputnik V vaccine, according to the main government-run television network, VTV. President Vladimir V. Putin announced in August that Russia had developed the worlds first coronavirus vaccine, even though it had not been tested in a major clinical trial, and Russia has offered it in recent weeks to teachers, medical workers, and others. This has led to widespread distrust of the vaccine among the Russian public.
Jason Gutierrez, Jennifer Jett, Livia Albeck-Ripka and Sameer Yasir contributed reporting.
Over the weekend, Bulgaria received the first shipment of 9,750 doses of the coronavirus vaccine. Before the vaccination rollout on Sunday, Bulgarian authorities turned to hot dog trucks to deliver the vaccine to different locations across the country.
Escorted by the police, several refrigerated vans delivered the doses to a number of cities. The Pfizer-BioNTech vaccine must be stored at extreme temperatures of minus 70 degrees Celsius to remain effective, and it can be kept at temperatures of 2 degrees to 8 degrees Celsius for up to only five days.
News about the unorthodox choice of transportation prompted a wave of mockery on social media.
Hot dog-themed memes, bearing the logo of Pfizer, with Photoshopped images and frankfurter-related puns and jokes have flooded Facebook and Twitter. One Facebook post included a picture of frankfurters stamped with the Pfizer logo.And an old, popular ad for this particular hot dog brand showing a shopkeeper in a butchers store holding a string of hot dogs was being shared online, but, this time, with an updated tagline: The vaccines are here.
The vaccination campaign begins at a time when Bulgaria has one of the highest Covid-19 death rates in the E.U. with more than 25 people per 100,000 dying from the virus over 14 days, according to the European Center for Disease Prevention and Control, and its health system has been struggling to cope with the flood of virus patients.
While some Bulgarians have mocked the creative way of transportation, others have expressed concern that the incident signals that the state is not well prepared to receive and store the first batch of the vaccines.
It doesnt matter if the trucks have images of hot dogs or Black Angus beef plastered on them, Mariya Sharkova, a lawyer specializing in health care, said. What matters is for the government to strictly follow the distribution and storage regulations.
She is concerned that the delivery of vaccines in food trucks may make the country legally liable, she said, since the vaccine manufacturer cannot be held responsible if transport and distribution protocols are not observed properly.
Bulgarian authorities knew, for a while now, exactly when the first vaccines were arriving, said Desislava Nikolova, a health editor, at the Bulgarian newspaper Capital Weekly. It perplexes me why the government needed to use a hot dog truck instead of a vehicle licensed for distribution of thermolabile medicines. According to Bulgarian law, transportation of pharmaceuticals follows strict rules and each vehicle needs to be licensed and registered with health authorities.
Kostadin Angelov, the health minister, assured Bulgarians that the hot dog trucks had met all of the requirements needed for storage of the vaccine, and said he found the hot dog inspired jokes inappropriate.
Seeking to exploit that aspect is unacceptable, he told reporters on Sunday shortly after becoming the first Bulgarian to be inoculated. Bulgaria is not the only country where private logistics companies provide transportation.
Mr. Angelov vowed that this first batch was an exception and the next deliveries of the vaccine would be distributed using transportation provided by the manufacturer.
Ms. Sharkova worries that the delivery incident might further worsen vaccine skepticism among some Bulgarians.
There are many people outside of the anti-vax movement who are hesitant to get vaccinated, she said. Instead of using the vaccine arrival to defuse their fears, the state has become a target of ridicule.
Coronavirus: Then & Now
As 2020 comes to a close, we are revisiting subjects whose lives were affected by the pandemic. When Thomas Fuller first spoke with the Clarks in March, they were passengers trapped on a cruise ship that was being kept at sea because of a coronavirus outbreak onboard.
OAKLAND, Calif. Never again! So said Cookie Clark, a retired real estate agent, as her Hawaiian cruise on the Grand Princess came to an end in San Francisco Bay in March.
With more than 20 people infected with the coronavirus onboard, the ship was a floating symbol of the nations disjointed reaction to the pandemic reaching American shores. President Trump had said he didnt want the ship to dock because it would increase the tally of infected people in the country. So the ship was kept circling for days off the California coast, while the authorities on shore debated what to do and the passengers and crew grew increasingly frustrated.
Im ready to get the hell off this ship, Ms. Clark said from her cabin.
The Grand Princess finally got clearance to dock on March 9, and sailed under the Golden Gate Bridge to a pier in the port of Oakland. When Ms. Clark and her husband, Joe, disembarked, they were taken to Travis Air Force Base along with other passengers, to be quarantined for two weeks in rudimentary conditions.
The ordeal might have been enough to make homebodies out of anyone, and thats the way Ms. Clark, 76, was feeling in March. But nine months later, she and her husband, 82, are itching to travel again.
The couple has been strict about social distancing during the pandemic. When they take walks outside their home in Oakdale, Calif., at the foot of the Sierra Nevada, they give neighbors and fellow pandemic hikers a wide berth. Ms. Clark lamented that they werent able to attend her granddaughters graduation from the University of California, Berkeley. And they have sworn off visits to the mall for the duration. But they are getting antsy.
Were older and were retired, and its just like weve lost the whole year, Ms. Clark said by telephone from her home.
Another cruise?
We would do it again, she said. Im sure.
One of the World Health Organizations senior officials warned on Monday that although the coronavirus pandemic has been very severe, it is not necessarily the big one.
Reflecting on the year in the W.H.O.s final media briefing of 2020, the head of the emergencies program, Michael Ryan, said that his words may come as a shock.
More than 1.7 million people worldwide have died this year from Covid-19, more than 81 million cases have been recorded and the spread of the coronavirus has been unrelenting in many countries.
These threats will continue, Dr. Ryan said. If theres one thing we need to take from this pandemic with all the tragedy and loss is that we need to get our act together. We need to get ready for something that may even be more severe in the future.
Dr. Ryan acknowledged that much progress has been made on improving how we communicate and govern during this pandemic, but, he said, this year was a wake up call and we must honor those weve lost by getting better at what we do every day.
Striking a similarly solemn tone, David Heymann, the chair of the W.H.O.s strategic and technical advisory group for infectious hazards, predicted that SARS-CoV-2, the novel coronavirus that causes Covid-19, would become endemic, like the other human coronaviruses such as SARS and MERS that have spread in recent years.
Coronavirus vaccination programs, the W.H.O. said, would be integral to saving lives and protecting vulnerable people.
Tedros Adhanom Ghebreyesus, the W.H.O.s director general, promised that the organization would not rest until those in need everywhere, in all countries, have access to vaccines and are protected.
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Covid-19 Live Updates: Latest News on Vaccine and Cases - The New York Times
CHICAGO A Chicago Public Schools teacher and assistant principal with cancer has died due to COVID-19 complications.
According to the Chicago Teachers Union, Mary Ann Folino spent 37 years in the district, and was known as a fierce advocate for students and teachers alike, never missing a picket line.
Folino taught at Waller and Clemente schools before spending time as principal and assistant principal at Schurz High School.
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CPS teacher with cancer dies of COVID-19 complications - WGN TV Chicago
Maine reported 439 new cases of COVID-19 on Monday, and three additional deaths, as vaccinations continue and public health officials brace for another potential surge stemming from Christmas holiday travel.
Since the pandemic began, 22,319 people in Maine have tested positive for COVID-19, and 326 have died.
Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said in a media briefing to expect a surge of new cases in January from the Christmas and New Years holidays, similar to the spike in COVID-19 infections Maine experienced in the weeks after Thanksgiving.
I am anticipating a high number of people returning to Maine who need to be tested, so I am expecting to see an increase in testing volume, Shah said. He said the testing increase will likely be driven by holiday travel, and people who feel ill after traveling and may have contracted COVID-19 at a holiday gathering.
Although the state testing lab was closed Christmas morning, Shah said, the lab has already caught up and there is no testing backlog that would lead to a jump in case numbers.
The seven-day daily average of new cases stood at 481.8 on Monday, compared to 419.4 a week ago and 190.2 a month ago.
Despite warnings to avoid travel over the holidays, the Transportation Security Administration screened 1.3 million travelers Sunday in the nations airports, a pandemic record. Traffic at Portland International Jetport during the holiday weeks was expected to be higher than in early to mid-December, but 50 to 60 percent lower than it was during the same period last year, jetport Director Paul Bradbury said last week.
Maines vaccine rollout continues, but Shah warned that mass vaccinations wont begin until 2021 and it may take several months before there is an impact on case numbers. He said a return to some form of normal could take a long time, and the new normal may not resemble life as it was in December 2019.
It (mass vaccination) is definitely the light at the end of a very long, twisting and turning and convoluted tunnel, Shah said.
Through Sunday, more than 17,000 Maine people predominantly health care workers on the front lines of the pandemic had been vaccinated, about 1.3 percent of the states population. Maine is immunizing people faster than most states, according to a vaccine tracker by Bloomberg News. When measuring those vaccinated as a percentage of the states total population, only West Virginia, Alaska, North Dakota and South Dakota had immunized more people per capita than Maine, with West Virginia leading the nation at 1.7 percent.
More shipments of the Moderna and Pfizer vaccines are expected this week, but Shah said the 19,125 doses Maine is likely to get would be 370 less than anticipated. Last week, Maine was shorted about 4,875 doses. Federal officials have told the state that the discrepancies are largely because Pfizer has been able to produce vaccine doses more quickly than it has been able to ship them out, Shah said.
Shah said thats having a ripple effect, and makes the logistics of vaccine distribution more difficult.
That is the second week in a row we are receiving less than what we were projected to receive, Shah said. When what we get doesnt match what we planned for, we have to go back to drawing board.
About 8,000 of the doses received this week will go to long-term-care facilities, and about 11,000 will go to hospitals, first responders and home health workers, Shah said.
By the end of this week, Maine will have received about 26,300 doses in all, according to the Maine CDC. Besides hospitals, long-term health care facilities and paramedics are also starting to receive the vaccines. All told, there are about 130,000 people who would be vaccinated in the first phase, which could take months.
The Portland Fire Department reported that 80 firefighters who are cross-trained as paramedics and EMTs were vaccinated last weekend, with an additional 80 slated to get the shot this week.
The deaths reported on Monday were three people from York County, a man in his 80s, a man in his 70s and a woman in her 70s.
Current hospitalizations in Maine numbered 181 on Monday, including 48 patients in intensive care.
Also Monday, Dr. Jessica Pollard, director of the Maine Office of Behavioral Health, reminded Maine people to seek mental health and substance use disorder care, health conditions that are often worsened during the stress of the holiday season. Pollard said a silver lining in the pandemic is that telehealth services for behavioral health have expanded, making them easier to access, and she hopes that trend will continue even after the pandemic has ended.
I encourage people not to wait (to seek care) until they feel really poorly. If youre struggling even a little bit, dont wait, Pollard said. Prevention is just as important for mental health as it is for other parts of health.
For access to behavioral health services, call the StrengthenME hotline at 221-8198, seven days per week, from 8 a.m. to 8 p.m. The StrengthenME service is free and confidential.
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State braces for surge of COVID-19 in the wake of the holidays - Press Herald
News Release
Monday, December 28, 2020
NIH- and BARDA-funded trial will enroll up to 30,000 volunteers.
The Phase 3 trial of another investigational coronavirus disease 2019 (COVID-19) vaccine has begun enrolling adult volunteers. The randomized, placebo-controlled trial will enroll approximately 30,000 people at approximately 115 sites in the United States and Mexico. It will evaluate the safety and efficacy of NVX-CoV2373, a vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax is leading the trial as the regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, are funding the trial.
Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts on the part of government, academia, industry and the community, said NIAID Director Anthony S. Fauci, M.D. The launch of this study the fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines.
The trial is being conducted in collaboration with Operation Warp Speed (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate development, manufacture and distribution of medical countermeasures for COVID-19. Some of the U.S. trial sites participating are part of the NIAID-supported COVID-19 Prevention Network (CoVPN). The CoVPN includes existing NIAID-supported clinical research networks with infectious disease expertise and was designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodiesfor preventing COVID-19.
Volunteers will be asked to give informed consent prior to their participation in the trial. They will be grouped into two cohorts: individuals 18 through 64 years old and those aged 65 and older, with a goal of enrolling at least 25% of all volunteers who are 65 years old or older. Trial organizers also are emphasizing recruitment of people who are at higher risk of severe COVID-19 disease, including those who are Black (including African Americans), Native American, or of Latino or Hispanic ethnicity, and people who have underlying health conditions such as obesity, chronic kidney disease or diabetes.
Weve come this far, this fast, but we need to get to the finish line, said NIH Director Francis S. Collins, M.D., Ph.D. That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.
After providing a baseline nasopharyngeal and blood sample, participants will be assigned at random to receive an intramuscular injection of either the investigational vaccine or a saline placebo. Randomization will be in a 2:1 ratio with two volunteers receiving the investigational vaccine for each one who receives placebo. Because the trial is blinded, neither investigators nor participants will know who is receiving the candidate vaccine. A second injection will be administered 21 days after the first.
Participants will be followed closely for potential vaccine side effects and will be asked to provide blood samples at specified time points after each injection and during the following two years. Scientists will analyze the blood samples to detect and quantify immune responses to SARS-CoV-2, the virus that causes COVID-19. Of note, specialized assays will be used to distinguish between immunity as a result of natural infection and vaccine-induced immunity. The trials primary endpoint is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second injection relative to placebo.
Novavaxs investigational vaccine, NVX-CoV2373, is made from a stabilized form of the coronavirus spike protein using the companys recombinant protein nanoparticle technology. The purified protein antigens in the vaccine cannot replicate and cannot cause COVID-19. The vaccine also contains a proprietary adjuvant, MatrixM. Adjuvants are additives that enhance desired immune system responses to vaccine. NVX-CoV2373 is administered in liquid form and can be stored, handled and distributed at above-freezing temperatures (35 to 46F). A single vaccine dose contains 5 micrograms (mcg) of protein and 50 mcg of adjuvant.
In animal tests, NVX-CoV2373 vaccination produced antibodies that blocked the coronavirus spike protein from binding to the cell surface receptors targeted by the virus, preventing viral infection. In results of a Phase 1 clinical trial published in the New England Journal of Medicine, NVX-CoV2373 was generally well-tolerated and elicited higher levels of antibodies than those seen in blood samples drawn from people who had recovered from clinically significant COVID-19. NVX-CoV2373 also is being evaluated in a Phase 2b trial in South Africa, now fully enrolled with 4,422volunteers, and data from a Phase 1/2 continuation trial in the United States and Australia is expected as early as first quarter 2021. Novavax also recently completed enrollment of more than 15,000 volunteers in a Phase 3 trial of the candidate vaccine in the United Kingdom, which is also testing two injections of 5 mcg of protein and 50 mcg of Matrix-M adjuvant administered 21 days apart.
An independent Data and Safety Monitoring Board (DSMB) will provide oversight to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of candidate vaccines supported through OWS are overseen by a common DSMB developed in consultation with the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.
Adults who are interested in joining this study can visit Coronaviruspreventionnetwork.org, Novavax.com/PREVENT-19 or ClinicalTrials.gov and search identifier NCT04611802.
About the COVID-19 Prevention Network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the global pandemic. Through the CoVPN, NIAID is leveraging the infectious disease expertise of its existing research networks and global partners to address the pressing need for vaccines and antibodies against SARS-CoV-2. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. The CoVPN is headquartered at the Fred Hutchinson Cancer Research Center. For more information about the CoVPN, visit: coronaviruspreventionnetwork.org.
About HHS, ASPR, and BARDA: HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. To learn more about federal support for the nationwide COVID-19 response, visit http://www.coronavirus.gov.
About Operation Warp Speed:OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
About the National Institute of Allergy and Infectious Diseases:NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on theNIAID website.
About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
NIHTurning Discovery Into Health
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Phase 3 trial of Novavax investigational COVID-19 vaccine opens - National Institutes of Health
A shove and a death threat: How the Serb Hall incident set back COVID-19 inspections in Milwaukee Milwaukee Journal Sentinel
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Harrisburg, PA - The Pennsylvania Department of Health today confirmed as of 12:00 a.m., December 29, that there were 8,545 additional positive cases of COVID-19, bringing the statewide total to 622,349.
There are 5,995 individuals hospitalized with COVID-19, near double the peak in the spring. Of that number, 1,174 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 18 December 24 stood at 15.1%.
The most accurate daily data is available on the website, with archived data also available.
As of 11:59 p.m. Monday, December 28, there were 267 new deaths reported for a total of 15,353 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 51,443 individualswho have a positive viral antigen test and are considered probable casesand 639 individualswho have a positive serology test and either COVID-19 symptoms or a high-risk exposure.
There are 3,244,103 individuals who have tested negative to date.
In nursing and personal care homes, there are 51,999 resident cases of COVID-19, and 9,410 cases among employees, for a total of 61,409 at 1,457 distinct facilities in all 67 counties. Out of our total deaths, 8,633 have occurred in residents from nursing or personal care facilities. A county breakdown can be found here.
Approximately 18,820 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. 29:
A spreadsheet of facilities that have received vaccine can be found here.
Statewide The Wolf Administration has since noon, Dec. 28:
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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As the latest coronavirus surge continues in the Bay Area, many people are turning to testing -- not only those who feel sick but also those who want to see if they're in the clear to celebrate New Year's Eve with family and friends.
A new pop-up, self-testing site is scheduled to open Tuesday morning at the Mitchell Park Library in Palo Alto. Starting at 10 a.m., people can show up for a free test they administer themselves under the supervision of a trained observer.
The Palo Alto testing site, one of a number of sites launching this week, gets results within 24 to 48 hours, except during high demand. And there is a lot of demand this week.
Bay Area hosptials are seeing a surge in patients who were likely exposed over Thanksgiving, pushing intensive care units to the brink. And whole many people are counting on testing to feel safe to gather with friends and family for New Years celebrations, doctors repeatedly have stressed that strategy is flawed.
"There is an incubation period, and there are these superspreader events, and there are asymptomatic people that can spread it too," pulmonologist Dr. Peter Chen said. "We dont know what the peaks going to be, and were already overwhelmed with the number of patients coming in."
Meanwhile, public health leaders and other first responders are reminding people that the emergency room is for emergencies and shouldnt be used as a testing site.
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New Bay Area COVID-19 Test Sites Open as Demand Increases - NBC Bay Area
