Category: Corona Virus Vaccine

GAITHERSBURG, Md. (WJZ) Novavax is one of nine pharmaceutical companies pledging to make the safety of vaccinated people the top priority in the development of the first COVID-19 vaccines.

The Gaithersburg-based company claims to follow science, and not a political push, for a timeline of when its safe to release a vaccine.

CORONAVIRUS COVERAGE:

To read more, visit cbsnews.com.

For the latest information on coronavirus go to theMaryland Health Departments websiteor call 211. You can find all of WJZs coverage oncoronavirus in Maryland here.

Visit link:

Novavax, Other Pharmaceutical Companies Pledge To Hold Off On Coronavirus Vaccine Until Its Proven To Be Safe - CBS Baltimore

WASHINGTON It was the third week of August, the Republican National Convention was days away, and President Trump was impatient.

White House officials were anxious to showcase a step forward in the battle against the coronavirus: an expansion of the use of blood plasma from recovered patients to treat new ones. For nearly two weeks, however, the National Institutes of Health had held up emergency authorization for the treatment, citing lingering concerns over its effectiveness.

So on Wednesday, Aug. 19, Mr. Trump called Dr. Francis S. Collins, the director of the N.I.H., with a blunt message.

Get it done by Friday, he demanded.

It wasnt done by Friday, and on Sunday, regulators at the Food and Drug Administration still had not finished a last-minute data review intended to ease N.I.H. doubts.

But on Sunday night, the eve of the convention, the president announced, with the F.D.A.s approval, that plasma therapy would be available for wider use, and he declared that it could reduce deaths by 35 percent, vastly overstating what the data had shown about the benefits.

Mr. Trumps call to Dr. Collins was a flash point in a pressure campaign by the White House to bend the nations public health agencies to his desire to show progress in the fight against a pandemic that has killed more than 192,000 people in the United States. And it was just one in a series of moments that have left scientists and regulators across the public health bureaucracy increasingly worried that the White House could exert greater pressure to approve a vaccine before Election Day, even in the absence of agreement on its effectiveness and safety.

On the night of the plasma announcement, Dr. Collins was told to show up at the White House, where he was given a coronavirus test and then shunted to the Roosevelt Room as Mr. Trump and others spoke to journalists in the briefing room.

There, Dr. Collins and Dr. Peter Marks, one of the top regulators at the Food and Drug Administration and the person most directly responsible for maintaining the independence and scientific rigor of the vaccine approval process, watched helplessly as the president and other top administration officials oversold plasmas effectiveness, creating a public relations debacle that reverberated for days.

Dr. Collins left the White House after the announcement. But Dr. Marks, who had pushed for the plasma approval, was escorted to the Oval Office to spend a few minutes with Mr. Trump and his top aides, who were celebrating with cupcakes with white icing. In an interview on Friday, Dr. Marks said he was a little bit in a state of shock to find himself there being thanked by the president for his work on the plasma approval.

Although he described it as a brief interaction that really didnt have any substance, health officials who had heard about the encounter said they feared it could create the impression that the guardrails between politics and science were being further eroded at a time when the public is already concerned about political pressure in assessing the safety of vaccines and treatments.

Some of those present were taken aback when Mr. Trump, who a day earlier had tweeted about a deep state at the Food and Drug Administration blocking quick approvals of treatments and vaccines to hurt him politically, jokingly asked whether Dr. Stephen M. Hahn, the F.D.A. commissioner, was doing a good job.

With Election Day just over seven weeks away, Washington is witnessing the collision of two worlds: a community of largely anonymous government scientists and doctors who operate in a culture guided by research, data sets and peer review, and a president famously disdainful of science, politically wounded by his failures to contain the coronavirus and now determined to cast himself as moving as fast as possible to provide Americans with vaccines and treatments.

Government scientists and pharmaceutical companies have begun taking extraordinary steps to counter any impression that they could sacrifice public safety to political expediency, pledging publicly that they are committed to impartial scientific decisions about fighting the coronavirus.

Dr. Hahn has publicly committed to vetting any vaccine approval through an advisory committee of outside experts. In an attempt to add more rigor to the agencys decision-making process, he said this week that the Food and Drug Administration intended to issue new guidance on the standards used to justify emergency use of a vaccine.

We will not jeopardize the publics trust in our science-based, independent review of these or any vaccines, Dr. Hahn said on Twitter on Friday. Theres too much at stake.

The administration has come under withering criticism for not acting aggressively enough to confront the virus and failing, for example, to push through bureaucratic red tape in the pandemics early stages to develop diagnostic tests that would work. White House officials say the president is now doing exactly what his opponents have assailed him for not doing: exerting pressure to develop safe and effective drugs and vaccines as quickly as possible because people are sick and dying, not because of the timing of the election.

The rushed plasma approval rollout is far from the only aspect of the government response to the virus that was shaped by pressure from the White House. The Centers for Disease Control and Prevention have repeatedly waffled on how much testing is recommended and for whom, and according to emails first reported on Friday by Politico, political appointees at the Department of Health and Human Services have tried to revise or delay C.D.C. reports on the coronavirus they believed were unflattering to the president. The Food and Drug Administration first gave emergency authorization for use of hydroxychloroquine to treat Covid-19 after Mr. Trump promoted it, only to be forced to reverse itself.

But the battle over approval of convalescent plasma is particularly telling because it involves many of the players who would figure in a far more momentous decision over whether to authorize an emergency approval for a vaccine.

Over the summer, the debate over plasma evolved from a purely scientific discussion about its merits to a kind of political loyalty test, laid bare in presidential remarks in the days before the announcement.

In a news briefing on Aug. 19, Mr. Trump complained that people over there an apparent reference to the Food and Drug Administration wanted to limit plasma treatment until after the election. In a Twitter post three days later, he accused deep state officials at the agency of slow-walking approvals of Covid-19 vaccines and treatments to harm him politically.

Like other approaches to dealing with the virus, convalescent plasma was a subject of scientific debate and disagreement. The pale yellow liquid that remains after blood is stripped of its red and white cells, it has been used since the 1890s to treat infectious diseases, including the flu, SARS and Ebola.

Regulators at the Food and Drug Administration, which approves new treatments, were willing to evaluate convalescent plasma for emergency approval on the basis of tens of thousands of case studies from a federally supported Mayo Clinic program. Dr. Collins and other officials at the N.I.H. wanted its benefits tested with randomized trials, for which scientists across the country had struggled to recruit patients. Although N.I.H. did not have regulatory authority, the administration wanted agreement among all the health agencies on moving ahead with expanded use of plasma.

In June, Dr. Marks alerted Dr. Deborah L. Birx, the White House coronavirus response coordinator, that early data from the Mayo Clinic program looked promising. Mark Meadows, the White House chief of staff, quickly began agitating for emergency approval, senior administration officials said.

Throughout the summer, the White House has kept a close eye on the Food and Drug Administrations progress with therapies and possible vaccines. The president himself calls Dr. Hahn on his cellphone about once a week, according to a senior administration official.

Mr. Meadows is also in regular contact with Dr. Hahn, who sometimes makes unscheduled visits to Mr. Meadowss corner suite in the West Wing.

Dr. John C. Fleming, a top adviser to Mr. Meadows, holds a weekly meeting with Dr. Hahn, Dr. Marks, Dr. Janet Woodcock, a top F.D.A. drug official, and Eric D. Hargan, the deputy health secretary. Jared Kushner, the presidents senior adviser and son-in-law, was also closely involved in tracking progress on vaccines and treatments.

For weeks, F.D.A. regulators, backed by Dr. Hahn, insisted the data from the plasma research was not strong enough to justify approving wider use. By Aug. 12, though, they were ready to move ahead, deciding plasma met the comparatively low bar for emergency authorization in which the potential benefits outweighed the risks.

N.I.H. officials were still arguing for a clinical trial, but the scientists arrived at a compromise: The Food and Drug Administration would analyze the data again with fresh results from the Mayo Clinic program.

Frustrated by the delay, Mr. Trump pressed his case with Alex M. Azar II, his health secretary.

Two allies of Mr. Kushners got involved: Brad Smith, a deputy assistant to the president, and Adam Boehler, the chief executive of the U.S. International Development Finance Corporation and a former Trump administration health official.

They talked to Dr. Hahn and Mr. Azar about data that they said showed that plasma from the Mayo Clinic program was available to only three-fourths of the hospitals treating Covid-19 patients, leaving 900 hospitals without access to the therapy. While emergency approval was held up, they noted, Americans were dying.

Matters came to a head on Aug. 19 after The New York Times published an article saying the plasma approval was on hold because of the N.I.H. objections. F.D.A. and White House officials were furious that N.I.H. officials had publicly aired their objections despite negotiations to resolve the conflict over data. Mr. Trump called Dr. Collins demanding that plasma be approved within two days.

Dr. Birx and other top health officials also lashed out at Dr. Collins, asking him to publicly clarify his position, according to senior administration officials with knowledge of one tense meeting that week.

At the Food and Drug Administration, officials were expecting to finish the new analysis for the N.I.H. and to announce emergency approval of plasma as early as Monday, Aug. 24.

But on the preceding Thursday, they were told that was too late: The decision had to be announced on Sunday, the day before the start of the Republican National Convention, ostensibly because making the announcement during the gathering would appear to be politically driven.

Another obstacle emerged that weekend: New Mayo Clinic data was missing key entries and could not be used, foiling the reanalysis.

White House officials said they were told by Mr. Azar and Dr. Hahn that they were ready to make the announcement on Sunday. The presidents communications team quickly put together an event in the White House briefing room, with Mr. Trump flanked by Dr. Hahn and Mr. Azar. The F.D.A. called the approval another achievement in the administrations battle against the pandemic.

The rush contributed to serious mistakes. Dr. Hahn misinterpreted agency data and claimed that plasma reduced the mortality rate of Covid-19 patients by 35 percent a substantial exaggeration of what the research actually showed.

Immediately after the announcement, however, the mood in the Oval Office was celebratory. Cupcakes were served. Photographs were taken.

Before him on the Resolute Desk, the president had multiple copies of that days Wall Street Journal. He noted with pleasure a prominent article stating that he had forever changed the Republican Party.

Katie Thomas contributed reporting from Chicago, and Mark Mazzetti from Washington.

See original here:

Trump Pressed for Plasma Therapy. Officials Worry, Is an Unvetted Vaccine Next? - The New York Times

Trump appointees at the Health and Human Services Department have meddled in the C.D.C.s weekly disease reports.

Political appointees at the Department of Health and Human Services have repeatedly asked the Centers for Disease Control and Prevention to revise, delay and even scuttle reports on the coronavirus that they believed were unflattering to President Trump.

Current and former senior health officials with direct knowledge of phone calls, emails and other communication between the agencies confirmed on Saturday a report in Politico late Friday that the C.D.C.s public Morbidity and Mortality Weekly Reports have been targeted by senior officials in the Health and Human Services communications office.

The reports, which one former top health official called the holiest of the holy in agency literature, are written largely for scientists and public health experts, to update them on trends in infectious diseases, not only the coronavirus but also other outbreaks around the country. They are guarded so closely by agency staff that political appointees only see them just before they are published.

The reports became the subject of intense scrutiny this summer by Michael Caputo, a Republican political operative and former Trump campaign official the White House installed as the top spokesman at the department in April, despite his having no background in health.

Mr. Caputo himself said on Saturday the Politicos report was largely accurate, but he denied that there was any overt pressure involved. He said that the primary person involved in critiquing the reports, Paul Alexander, an assistant professor of health research at McMaster University in Canada whom he hired to advise him on the science of the pandemic, simply offered direct reactions to the drafts of the C.D.C.s Morbidity and Mortality Weekly Reports.

He digs into these M.M.W.R.s and makes his position known, and his position isnt popular with the career scientists sometimes, Mr. Caputo said of Mr. Alexander. Thats called science. Disagreement is science. Nobody has been ever ordered to do anything. Some changes have been accepted, most have been rejected. Its my understanding that thats how science is played.

In emails obtained by Politico and confirmed to The Times by a health official with direct knowledge of them, Mr. Alexander accused C.D.C. scientists of attempting to hurt the president, referring to the weekly reports as hit pieces on the administration. Mr. Alexander asked Dr. Robert R. Redfield, the C.D.C. director, to edit reports that had already been published that he believed overstated the risks of the virus for children and undermined the administrations efforts to encourage school reopenings.

The meddling from H.H.S. concerned Dr. Redfield, according to one former senior health official, who often pushed back when Mr. Caputo called to pester him about the reports.

Inside the C.D.C., employees expressed outrage and demoralization on Saturday over the reports of interference.

The University of Oxford said it was moving ahead in the United Kingdom with trials of a coronavirus vaccine it developed in partnership with the pharmaceutical company AstraZeneca, after passing a safety review that was prompted when a participant in the United Kingdom appeared to have developed a serious neurological condition.

The trials were placed on hold less than a week ago, as researchers investigated whether the vaccine may have been the cause. A safety panel reviewed the findings and notified the governments Medicines Health Regulatory Authority, which then confirmed it was safe to restart the trials in Britain.

A statement from the university on Saturday did not mention the prospects for trials that have been suspended held in India, Brazil, South Africa and the United States.

The statement also did not offer any clarity about the patients condition. We cannot disclose medical information about the illness for reasons of participant confidentiality, the statement said. A statement from AstraZeneca added that the relevant information would be shared with all trial investigators and participants and would also be disclosed on global clinical registries, according to the clinical trial and regulatory standards.

To date, roughly 18,000 individuals worldwide have already received this particular vaccine. AstraZeneca is one of just three companies with vaccines in late-stage clinical trials in the United States.

While late-stage trials are designed to test whether vaccines are indeed safe across large populations, the university said it anticipated that some participants would experience adverse effects.

In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety, it said in a statement.

Scientists largely praised AstraZenecas decision to pause trials and defer to a thorough review by an independent board of experts. The suspension appeared to be the second time that AstraZeneca has halted vaccine trials because of questions surrounding severe neurological symptoms in recipients.

A report published Friday by the Centers for Disease Control and Prevention found that young children at three child-care facilities in Utah transmitted the virus to staff members, family and the surrounding community, even while some of the children were asymptomatic.

The findings undermine some previous assertions about the likelihood that the very young could spread the virus. Studies from South Korea and other countries have suggested that children under 10 are less likely to spread the virus than adults.

The new research, published Friday, traced cases at three Salt Lake City facilities, including one in which an 8-month-old contracted the virus and transmitted it to both parents.

Researchers reviewed the contact-tracing data related to outbreaks at the child-care facilities between April 1 and July 10. The study found that during that time at least 184 people, 74 adults and 110 children, had been exposed to someone with the virus in those facilities. At two of the facilities, the children were all younger than 10; the third had an age range up to 13.

Of the 184 people exposed, 31 later tested positive for the virus, including 13 children. The study reported that 12 of those children had passed the virus along to at least 12 of their 46 contacts outside the centers. Six of these cases occurred in mothers and three in siblings of the pediatric patients, the study said. At least one parent was hospitalized.

The study had several critical limitations:

The testing strategy changed over time. For at least part of the study only symptomatic individuals were tested, which may have led to an undercount of cases.

Each of the three facilities was closed for some portion of the study period, during a statewide lockdown, limiting is use in suggesting patterns for child-care facilities at large.

Between April and July 10, when the study was conducted, guidance from public health experts shifted drastically, most notably regarding face coverings. In Utah, a mask mandate was not issued until July 23 and never applied to children in a child-care setting.

The studys authors recommended that workers at child-care facilities wear masks at all times, especially when children are too young to wear them, and emphasized the importance of regular testing with timely results.

During the surge of Covid-19 cases this spring that filled the Brooklyn Hospital Centers emergency room and intensive care unit with the critically ill and the dying, the staff went in day after day, trying to save as many lives as they could.

A photographer for The Times, Victor J. Blue, created a series of portraits of these hospital workers during that grueling first wave. He and Sheri Fink, the reporter who spent days inside the hospital then, later interviewed them with a colleague, Catrin Einhorn, as they braced for a second wave.

From the doctors and nurses to the workers serving behind the scenes, all understood their roles were both critical and potentially fatal. Fighting the pandemic required sacrifice and courage from workers of all stripes, in the laundry room and the supply depot, the laboratory and the security desk, all the way to the chief executives office.

Many spoke in battle metaphors. The virus seemed to come from all sides, they said, and threatened to spare no one. They talked about the front line, and being called to duty, and training for war.

Even when I think about it right now, said Dr. Kiran Zaman, a critical care fellow, it gives me goosebumps. It was a very scary, very overwhelming experience. It was a nightmare.

More than 1,000 protesters gathered in Auckland, New Zealand, on Saturday for a freedom rally aimed at opposing the countrys lingering lockdown a demonstration that included a woman who, for critics of the lockdown, has come to exemplify the harshness of the nations approach to the pandemic.

Known simply as LK, the woman was sentenced last month to 14 days in jail for leading her three children out of a quarantine facility to attend a funeral for the childrens father after they had tested negative for the virus. On Saturday, she appeared but did not speak.

She is one New Zealander who has suffered a considerable loss because of the governments responses to Covid-19, said one of the days speakers.

Auckland is still under Alert Level 2.5, meaning that social gatherings of more than 10 people are not allowed.

But with only two new cases of community transmission reported on Saturday and 108 active cases nationwide critics are questioning whether the New Zealand government has been too slow to ease restrictions. Weekly protests against the lockdown have been growing.

We want our rights and freedom back, Jami-Lee Ross, a leader of Advance NZ, a new fringe political party that says it stands for freedom and sovereignty. He told the crowd that living in lockdown was wrong and needed to stop.

The authorities were mostly passive. As the crowd marched peacefully through downtown Auckland, carrying signs and chanting we do not consent, police officers wearing masks simply watched.

A recent Brock University study of 451 adults ages 20 to 82 in the United States found that people who believed they had contracted the coronavirus werent always honest about it. Thirty-four percent of participants who had tested positive said they had denied having symptoms when asked by others, and 55 percent reported some level of concealment of their symptoms.

Twenty-five percent of participants reported that they had in some way concealed their physical distancing practices. That rate increased among those with Covid-19, according to the study, published last month in The Journal of Health Psychology.

Women were more likely to disclose health symptoms than men were, researchers said, and older adults were more honest about their virus status and behaviors.

But the exact reasoning behind lying during the pandemic is complicated and may be related to the environment, according to David M. Castro, a psychotherapist and adjunct professor of psychology at Adelphi University and the City College of New York.

I think that so much is barred from someone right now, Dr. Castro said. Theres a lot of loneliness, a lot of depression stemming from loneliness.

Robert Feldman, a professor of psychological and brain sciences at the University of Massachusetts Amherst and author of The Liar in Your Life: The Way to Truthful Relationships, said his research showed that people typically tell three lies within the first 10 minutes of meeting someone else.

Its part of what we do as members of society, he said. We tell people that were feeling well when were not feeling so well.

Canada reported zero deaths linked to Covid-19 in a 24-hour period on Friday night, according to government data, even as the number of new cases in the country has ticked slowly upward as restrictions ease and schools reopen for in-person classes.

There had been at least 135,600 confirmed coronavirus cases in Canada as of Friday evening, according to the government. The number of new cases being reported daily has fallen significantly from an early May peak of nearly 3,000 cases, and now averages a few hundred a day. But as of Thursday, the average number of new daily cases was up nearly 50 percent compared with a few weeks earlier.

Four Canadian provinces Alberta, British Columbia, Ontario and Quebec account for most of the cases that the country has reported over the past week. Those provinces also accounted for all of the 23 virus-deaths reported over the same period. This week, Ontario, Canadas most populous province, said it would take a four-week pause before considering loosening restrictions or allowing further economic reopening.

Canada has previously reported zero Covid-19 deaths in 24-hour periods, although measuring that can be imprecise because of delays in reporting. The average number of daily reported deaths over the past week is three.

In the United States, as of Thursday the average number of daily reported deaths over the past week was 702.

Other pandemic developments around the world:

India again broke a record for daily new cases, reporting 97,750 on Saturday, according to a Times database. The previous record, set Friday, was 96,551.

About 70 cars crammed into a downtown Los Angeles parking lot surrounded by high rises and a smattering of food trucks on Thursday night to watch Concrete Cowboy, a father-son film starring Idris Elba and set in northern Philadelphias Black cowboy community.

In terms of movie premieres, it was unorthodox.

It is a dream come true, Ricky Staub, the 37-year-old white filmmaker making his directorial debut, said while standing in front of a huge screen. I dont know when you dream of releasing your movie its at a drive-in, but I never dreamed that my first movie would be an all-Black western set in Philly.

Mr. Staub had ambitious plans when Concrete Cowboy landed coveted spots in the Telluride and Toronto film festivals. The plans all changed when Telluride was canceled because of the pandemic and Toronto opted for a hybrid model that features in-person screenings for Canadian audiences and a virtual version for everyone else.

For small indie films like Concrete Cowboy, the loss of traditional film festivals means not having a chance to build word-of-mouth momentum that could be the difference between becoming an unlikely Oscar darling or another also-ran in the video-on-demand market.

At the Venice Film Festival, held in person with certain safety restrictions, One Night in Miami the directorial debut of the Oscar-winning actress Regina King has already generated early awards chatter. Amazon recently bought it in a bidding war.

Under bright blue skies, nearly 2,000 students gathered this month for the start of school at Hanyang No. 1 High School in Wuhan, the Chinese city where the coronavirus first emerged.

Medical workers stood guard at school entrances, taking temperatures. Administrative officials reviewed the students travel histories and coronavirus test results. Local Communist Party cadres kept watch, making sure teachers followed detailed instructions on hygiene and showed an anti-epidemic spirit.

Im not worried, a music teacher at the school, Yang Meng, said in an interview. Wuhan is now the safest place.

As countries around the world struggle to safely reopen schools, Chinas Communist Party is harnessing the power of its authoritarian system to offer in-person learning for about 195 million students in kindergarten through 12th grade at public schools.

In many ways, China is applying the same heavy-handed model to reopen schools that it has used to bring the virus under control. To stop the epidemic, the authorities imposed harsh lockdowns and deployed invasive technologies to track residents, raising public anger in some places and concerns about the erosion of privacy and civil liberties.

Chinas leader, Xi Jinping, said in a speech on Tuesday that the countrys progress in fighting the virus, including the opening of schools, had fully demonstrated the clear superiority of Communist Party leadership and our socialist system.

The Chinese system moves by itself, said Yong Zhao, a scholar at the University of Kansas who has studied education in China. The system is run like a military: It just goes for it, no matter what anyone thinks.

California is at the center of increasing concerns about extensive fraud in a federal program that provides unemployment benefits to freelancers, part-time workers and others lacking a safety net in the pandemic.

At the same time, there is growing evidence of problems keeping track of how many people are being paid through the program. The Labor Department has reported about 15 million claims for benefits nationwide. A comparison of state and federal records by The New York Times suggests that total may overstate the number of recipients by five million or more.

The program, Pandemic Unemployment Assistance, is part of a $2.2 trillion relief package enacted in March. In the latest Labor Department tally, the program accounted for nearly half the total recipients collecting jobless benefits of any kind.

It appears that nearly seven million people are collecting Pandemic Unemployment Assistance benefits in California alone, far more than its population would suggest. The states own data suggests that the number may be less than two million. Experts on the unemployment system say such discrepancies seem to reflect multiple counting of individual applications as states rushed out payments.

But a surge in new claims in California is attributed not to accounting, but to fraud.

Fraud is not uncommon in hastily assembled disaster programs, but signs of trouble with this program have been surfacing for months as people who did not file claims found benefits issued in their names. A growing number of states have signaled that the problems with the program go beyond the routine.

Colorado said on Thursday that in a six-week stretch this summer, 77 percent of new claims under the program were not legitimate.

Reporting was contributed by Noah Weiland, Sheryl Gay Stolberg, Abby Goodnough, Ben Casselman, Damien Cave, Patricia Cohen, Helene Cooper, Conor Dougherty, Rebecca Halleck, Javier C. Hernndez, Jonathan Huang, Mike Ives, Apoorva Mandavilli, Zach Montague, Dan Powell, Nelson D. Schwartz, Nicole Sperling, Jim Tankersley, Derrick Bryson Taylor and Carl Zimmer.

See the original post here:

Live Covid-19 Cases and Deaths: Updates and Tracker - The New York Times

A large, United Kingdom-based Phase 2/3 study testing a Covid-19 vaccine being developed by AstraZeneca has been restarted, according to a statement from the company. News that the trial is resuming comes four days after the disclosure that it had been paused because of a suspected serious adverse reaction in a participant.

A spokesperson for AstraZeneca told STAT that at this point, only the trial in the U.K. has been resumed. The company is also conducting Phase 2/3 or Phase 3 trials in the U.S., Brazil, and South Africa.

The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic, the spokesperson, Michele Meixell, wrote in an email.

advertisement

Saturdays statement from AstraZeneca said the independent U.K. investigation into the event has concluded and it advised the Medicines Health Regulatory Authority, Britains equivalent of the Food and Drug Administration, that it was safe to resume the trial. The MHRA concurred and gave the green light for the trial to restart.

The illness that triggered the international pause, which occurred in a woman who was in the vaccine arm of the U.K. trial, has not been officially disclosed, though AstraZeneca CEO Pascal Soriot told a group of investors on Wednesday that her symptoms were consistent with transverse myelitis, a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems.

advertisement

The AstraZeneca statement said information about the illness the woman suffered cannot be disclosed. Oxford University, where the vaccine was developed, said in a separate statement that the nature of the illness cannot be revealed for reasons of participant confidentiality.

As part of the review process, independent boards overseeing trials of a number of other Covid-19 vaccines were analyzing their own data, looking for cases. There are at least 35 vaccines in clinical trials around the world, nine of which are in Phase 3, the final stage of testing.

Its not uncommon for clinical trials to be paused. This is the second known hold of studies of the AstraZeneca vaccine. A woman in the U.K. trial was diagnosed with multiple sclerosis in July, but that event, which triggered the first pause, was deemed not to be related to the vaccine.

An AstraZeneca spokesperson previously described the decision as a routine action which has to happen whenever there is a potentially unexplained illness in a trial. Still, the pause drew extraordinary attention because of the urgent need for progress on Covid-19 vaccines in the midst of the pandemic.

Excerpt from:

AstraZeneca resumes Covid-19 vaccine trials in the UK - STAT

As we get closer to a COVID-19 vaccine, it's exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.

Dr. Anthony Fauci, chief of the National Institute of Health and Infectious Disease, has tried to set realistic expectations when discussing the importance of a vaccine. "We don't know yet what the efficacy might be. We don't know if it will be 50% or 60%," Fauci said during a Brown University event in August.

"I'd like it to be 75% or more," Fauci said, but he acknowledged that may not be realistic.

The Food and Drug Administration has said that once a vaccine is shown to be safe and at least 50% effective, it could be approved for use in the U.S.

So what does 50% efficacy mean?

"When we talk 'vaccine effectiveness,' what we're talking about is, 'How effective was the vaccine at preventing actual disease?' " explains scientist L.J. Tan, chief strategist of the nonprofit Immunization Action Coalition.

In other words, Tan says, "If you vaccinate 100 people, 50 people will not get disease."

This may not sound like an impressive rate of infection prevention, but there are other potential benefits to individuals and the community from getting vaccinated.

"It's possible that the [COVID-19] vaccine will reduce the severity of disease" in the other 50% who do get sick, says physician Bill Miller of The Ohio State University College of Public Health. "It may mean that people are less likely to be hospitalized, require ICU care or die."

"That's certainly the case with the influenza vaccine," Miller adds. "People who get the vaccine may still get the flu, but, for the most part, their disease is milder than if they hadn't had the vaccine."

Michael Ison, an infectious disease physician at Northwestern University Feinberg School of Medicine, echoes that sentiment. While it's true that 50 out of 100 people who get the vaccine could still end up getting infected with the coronavirus, "hopefully, the majority will have milder disease," Ison says. But he cautions there's a lot to learn in that regard, given that the studies of COVID-19 vaccine candidates are still very much underway.

"We really need to get some information from the trials that are ongoing to best understand what the impact will be," he says. Ison is a member of the research team at Northwestern that is conducting studies on COVID-19 and on influenza vaccines.

And here's the next reality check: The extent to which any vaccine that emerges will help halt the COVID-19 pandemic depends on how many people get the immunization.

In order to put this pandemic in the rearview mirror, a large percentage of the population needs to either be vaccinated or gain immunity via an infection with the virus (a much riskier route that would include many more deaths).

When a large portion of the population has immunity to the virus because of this sort of "herd immunity," it's unlikely to keep spreading. Even people who haven't been vaccinated (such as very young babies and those with compromised immune systems) are protected once this level of immunity in a population is achieved, because the illness has little opportunity to spread within the community most people who run into the virus in this scenario are immune.

For the coronavirus, Ison says, " 'herd immunity' is seen when we have somewhere between 60% to 70% of the population having some degree of protection."

So here's a little math if 20% of the U.S. population ends up getting exposed to the virus and developing an infection before we have a vaccine (as is estimated to be the level of immunity in the New York City metro area right now), then we would still need an additional 40% of the population to gain protection via a vaccine.

And in order to get 40% of a population immune through vaccination if you have a vaccine with 50% efficacy "you're going to have to vaccinate 80% of the population," says Carlos del Rio, an infectious disease expert at Emory University. "So it's not going to happen right away."

For starters, Michael Ison says, there are logistical challenges to getting everyone vaccinated, given the mammoth undertaking of manufacturing and distributing a vaccine.

"It's going to take us months to get the entire population vaccinated if they are willing to get vaccinated," he says which is another big "if." An NPR/PBS/Marist poll in August found that more than a third of Americans 35% say they won't get vaccinated when a vaccine comes available.

What's more, most of the candidate vaccines now being tested would require two separate doses to trigger their most effective protection, Ison says. So at a minimum, he notes, you've got a full month between the two doses of vaccine and a short period of time after the second dose before someone who was been vaccinated would be protected.

It's also still not known how long the immunity gained through any of the current COVID-19 vaccine candidates will last or to what extent the virus might mutate or change in a way that makes that vaccine less effective.

"What we will only know once we have the vaccine [approved and rolled out] is how effective it is, how long lasting the protection is and how much pressure it applies to the virus to change, to escape the pressures of the vaccine," Ison says.

Despite all these remaining unknowns, it is safe to say that any such vaccine against the coronavirus could play a significant role in reducing the spread of the virus.

"If a vaccine is 50% effective, that's still good," Miller says. That means that you have a good possibility of being protected. He says we should think about its effectiveness the way we do about the benefits of cancer treatments, for example.

"In some severe cancers, we'd be pretty happy to get a drug that gets us to 50% effectiveness," he notes.

Why do we need to test a proposed vaccine in so many people?

For now, it's important to see the experimental trials of each vaccine candidate through to the end, Miller says. The phase three trials will tell us a lot about the safety of a vaccine as well as its effectiveness.

The large studies now underway are being conducted as double-blind, placebo-controlled trials, which is considered the gold standard in scientific research. This means half the participants get the real vaccine and "half the patients get a placebo a water shot," Ison says. And nobody not the researchers nor the participants will know until after the study is complete who got the placebo and who got the real vaccine.

"What we would like to see is that there's a difference in the rate of COVID-19 with a much lower rate in patients who get the vaccine than in the patients who get the placebo," Ison says. But it takes time and a lot of people to see that sort of effect and to answer questions about safety.

The vaccine makers are aiming to enroll about 30,000 people in each trial.

"Side effects of vaccines [can be] very rare, so you need a lot of people to see if the vaccine causes any unexpected problems," Bill Miller explains. "These side effects must also be monitored carefully post-marketing to ensure that every important problem is identified."

Ison notes that there's another benefit to a large study it helps researchers know how strong the immune response to a vaccine needs to be to be protective.

Will the vaccine protect older people? And what if I'm heavy?

With age, the immune system often mounts a lesser response to vaccination; that's why, for example, adults 65 and older can opt for a high-dose flu shot that's thought to help bolster their protection. And scientists also know from prior research that the flu vaccine is less effective in people who carry a lot of extra weight. Ison says it's too soon to know if obesity or age will be a factor in the immune response to the COVID-19 vaccine candidates now being considered for use.

In research results so far, he says, "the small, phase one data shows that you can generate antibody responses even in older adults, but it'll be these larger studies that will tell us [whether] we need to use higher doses or more doses of the vaccine in certain cases." Results from phase three trials of safety and effectiveness are expected in the coming months.

Here is the original post:

Why A COVID-19 Vaccine That's Only 50% Effective Could Still Help Stop The Pandemic : Shots - Health News - NPR

Jose Luis Pelaez Inc/Getty Images

Jose Luis Pelaez Inc/Getty Images

Black patients are some of the most reluctant to participate in clinical trials, according to FDA statistics. And their inclusion in the coronavirus vaccine trials has been a stated priority for the pharmaceutical companies involved, since African American communities, along with Latinos, have suffered disproportionately from the pandemic.

But the trials are moving at a pace that is unprecedented for medical research, with the Trump administration's vaccine acceleration effort dubbed "Operation Warp Speed." Yet recruiting minority participants into these ongoing trials requires sensitivity to a legacy of mistrust based on past and current medical mistreatment, and that trust-building cannot be rushed.

So far at least, participation by minority volunteers in coronavirus trials has increased only slightly, compared to usual low levels and targeted outreach efforts to recruit more have been slow to launch.

Dr. Vladimir Berthaud and Dr. Rajbir Singh are leading a COVID-19 vaccine trial site at Meharry Medical College in Nashville, starting with the Novavax vaccine in October. They're just now beginning the recruitment process, starting with a presentation to Dr. Berthaud's long-time HIV patients. Blake Farmer/ WPLN hide caption

Some of that outreach is taking place at historically black colleges and universities, which are trusted institutions for many Black Americans. At Meharry Medical College in Nashville, researchers have started by setting up in-person meetings with patients they already know. Last Wednesday, half-a-dozen patients gathered in a cramped conference room on campus. They snacked on turkey sandwiches and potato chips and listened to the pitch from their physician, Dr. Vladimir Berthaud.

"What's the best hope to get rid of this virus?" he asks them.

"Vaccination," they reply.

Then Berthaud follows up: "So raise your hand if you would like to take the vaccine?"

Some hands shoot up, but not all.

"I ain't going to be the first one, now," says Lanette Hayes.

Katrina Thompson says she does eventually want to get a shot for protection against the coronavirus. She explains that she's especially worried about all the residents of her apartment building who don't seem to be doing the basics of covering their coughs.

"The word 'vaccination' don't scare me," she says. "The word 'trial' do."

Black Americans have reason to be suspicious beyond the well-known Tuskegee experiments where Black men with syphilis were deceived and mistreated as part of an experiment that went on for decades. Even today, many Black Americans report ongoing mistreatment by medical providers.

Dr. Berthaud is recruiting patients for a clinical trial site he will oversee here in Nashville, and he would like more than 300 people of color to enroll. Berthaud, who is Black and from Haiti, appeals to a sense of duty.

"If you don't have enough people like you in those vaccine trials, you will not know if it works for you," he tells them. "You will not know."

Robert Smith of Nashville listens to his long-time physician, Dr. Vladimir Berthaud of Meharry Medical College, explain the importance of Black patients participating in clinical trials for the COVID-19 vaccine. Berthaud is leading the project at the historically black medical school. Blake Farmer/ WPLN hide caption

For most of the current coronavirus vaccine trials, recruitment mainly takes place online which often results in mostly white people enrolling.

That's why Meharry researchers are wooing Black patients with a personal invitation to take part. The problem is, they're not recruiting for the phase three trials currently underway. Meharry's first trial, for a vaccine candidate by Novavax, doesn't launch until October.

Meanwhile, other pharmaceutical companies are nearly done recruiting. Moderna says it chose nearly 100 trial sites for their "representative demography."

The company did not respond to requests for comment but is publicizing demographic statistics about the clinical volunteers every week. They're somewhat better than the typical clinical trial but still not a good representation of the diversity of the U.S.

For the coronavirus vaccine in particular, the National Institutes of Health has suggested minorities should be over-represented in testing perhaps at rates that are double their percentage of the U.S. population.

"We say we want to have everybody included, but really the effort for the vaccinations in a sense are starting the same way they've always been," says Dr. Dominic Mack of Morehouse School of Medicine in Atlanta. He's working with the NIH to make sure people of color are included in COVID-19 research.

Mack says there are no shortcuts if medical research is going to reflect the diversity of the U.S. It takes time to build trust and meaningful relationships with people who have endured a history of abuse or neglect by medical providers, and exclusion from biomedical research and decision making.

"Now, that being said, the only thing we can do is what we're doing," he says by which he means respectful, not rushed, outreach and dialogue.

The primary effort, called the COVID-19 Prevention Network, taps into four existing clinical trial networks that were designed to advance HIV research. Those networks are based in Seattle, Atlanta, Los Angeles and Durham, N.C.

One project announced this week will be led by Rev. Edwin Sanders II of the Metropolitan Interdenominational Church in Nashville. It will involve seven "faith ambassadors" and 30 "clergy consultants" in the African American community, who will work to help dispel myths and increase trust in the clinical trial process.

But Sanders cautions this is not about a hard sell. He says it's not his job to preach trial participation from a pulpit.

"We are not out beating the drum," he says, acknowledging that congregants may have legitimate concerns. "I am not going to do anything more than make sure people are able to make an informed choice."

There is a danger that lunging for big diversity goals could even spark a backlash, meaning minorities might be even less willing to participate, says professor Rachel Hardeman who studies health equity at the University of Minnesota.

It's important that the doctors doing the asking look like the people they're appealing to, she says.

"It's racial concordance," she explains. "It offers this feeling of, 'you know who I am, you know where I come from, you have my best interests at heart.' "

Dr. Rajbir Singh in one of the patient rooms at Meharry Medical College where volunteers will start receiving the Novavax coronavirus vaccine in October, as part of a phase three trial. Meharry, which is a historically Black medical school, wants to enroll more than 300 patients at this site and is planning special events to reach communities of color. Blake Farmer/ WPLN hide caption

Historically Black medical institutions in the U.S. are uniquely positioned to do this work. While they haven't been on the leading edge of the vaccine trial recruitment, they intend to play an important part.

The president of Nashville's Meharry Medical College, Dr. James Hildreth, is, himself, an infectious disease researcher. But instead of overseeing the trial site being hosted on his campus, Hildreth has a more modest goal in mind: He plans to participate as a patient, and urge others to join him.

"I think my role is more important in advocating for people to be involved in vaccine studies than to be one of the leaders of the study," he says.

So at Meharry, Dr. Berthaud is the principal investigator. As lunch wraps up in the crowded conference room, he's managed to win over even the holdouts.

"Where is the line?" asks Robert Smith. "Where do we sign?"

Smith, with his young grandson in tow, didn't raise his hand at first when asked if he'd take the vaccine. But after listening to Dr. Berthaud, Smith agrees to participate in the clinical trial for no other reason than the trust he has in Berthaud, his long-time physician.

"He's not only my doctor; he's proven that he cares about me," Smith says.

Convincing hundreds or thousands of Black Americans to sign up will be difficult. But even for those who don't participate, researchers hope their outreach efforts will at least result in more minorities ultimately agreeing to take the approved vaccine when it's available.

This story was produced in a partnership between NPR, Kaiser Health News and Nashville Public Radio.

Continued here:

Vaccine Trials Are At 'Warp Speed.' But Minority Recruitment Isn't : Shots - Health News - NPR

TheWest Virginia Department of Health and Human Resources (DHHR) reports as of 10:00 a.m., on September 11,2020, there have been 471,517 total confirmatorylaboratory results received for COVID-19, with 12,174 totalcases and 263 deaths.

DHHR hasconfirmed the deaths of an 86-year old female from Logan County, a 90-yearold male from Kanawha County, a 93-year old male from Raleigh County, a 77-yearold male from Putnam County, a 59-year old male from Fayette County, and a 79-yearold male from Kanawha County. As we honor the lives of these West Virginians,we also remember those Americans who perished on this solemn anniversary nineteenyears ago, said Bill J. Crouch, DHHR Cabinet Secretary.

CASESPER COUNTY: Barbour(35), Berkeley (856), Boone (170), Braxton (9), Brooke (104), Cabell (620),Calhoun (21), Clay (30), Doddridge (15), Fayette (439), Gilmer (19), Grant(147), Greenbrier (114), Hampshire (93), Hancock (136), Hardy (75), Harrison(312), Jackson (224), Jefferson (398), Kanawha (1,839), Lewis (37), Lincoln (130),Logan (536), Marion (235), Marshall (139), Mason (126), McDowell (76), Mercer(357), Mineral (148), Mingo (291), Monongalia (1,581), Monroe (142), Morgan(43), Nicholas (62), Ohio (313), Pendleton (45), Pleasants (15), Pocahontas(55), Preston (143), Putnam (371), Raleigh (403), Randolph (229), Ritchie (9),Roane (38), Summers (25), Taylor (112), Tucker (15), Tyler (15), Upshur (57),Wayne (307), Webster (7), Wetzel (46), Wirt (8), Wood (329), Wyoming (73).

Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. As case surveillance continues at the localhealth department level, it may reveal that those tested in a certain countymay not be a resident of that county, or even the state as an individual inquestion may have crossed the state border to be tested.Such is the case of Mason,Monroe, Pendleton, and Wyoming counties in this report.

Pleasevisit the dashboard located at http://www.coronavirus.wv.gov for more information.

Read the original post:

COVID-19 Daily Update 9-11-2020 - West Virginia Department of Health and Human Resources

Fauci cautions the virus could disrupt life in the U.S. until maybe even towards the end of 2021.

The United States should not expect a return to normal until well into 2021, maybe even towards the end of 2021, Dr. Anthony S. Fauci, the nations top infectious diseases expert, said on Friday.

In an interview with Andrea Mitchell Reports on MSNBC, Dr. Fauci addressed when people would most likely be able to do things again that they had done before the pandemic, such as going to an indoor movie theater with impunity. While a vaccine may be available by the end of the year, he said, by the time you mobilize the distribution of the vaccinations, and you get the majority or more of the population vaccinated and protected, thats likely not going to happen till the mid or end of 2021.

Dr. Fauci was also asked about comments he had made on Thursday in a panel discussion at Harvard Medical School, where he said we need to hunker down and get through this fall and winter because its not going to be easy. Ms. Mitchell pointed out that this conflicted with what President Trump had said at the White House on the same day, that the country had rounded the final turn on the virus.

I have to disagree, Dr. Fauci said of Mr. Trumps optimistic read on the situation.

Were plateauing at around 40,000 cases a day and the deaths are around 1,000. He raised concerns that Labor Day could make that number rise again, as Memorial Day and the Fourth of July had done before.

But in any case, he said what we dont want to see is going into the fall season when people will be spending more time indoors and thats not good for a respiratory borne virus you dont want to start off already with a baseline thats so high.

As of Thursday, there had been an average of 35,629 cases per day over the previous week, a decrease of 16 percent from the average two weeks earlier, according to a Times database. Case numbers remain persistently high across much of the country, though reports of new cases have dropped considerably since late July, when the country averaged well over 60,000 per day.

But even as many of the countrys most populous states saw vast improvement and as the Northeast kept case reports low new infections were rising by late summer across parts of the Midwest and South.

Deaths, though still well below their peak levels in the spring, averaged around 700 per day in mid-September, more than were reported in early July.

From Asia to Africa, China promotes its vaccine candidates to win friends.

China is still most likely months away from mass producing a vaccine that is safe for public use. But the country is using the prospect of the drugs discovery in a charm offensive aimed at repairing damaged ties and bringing friends closer in regions China deems vital to its interests.

Latin American and Caribbean nations will receive loans to buy the medicine, and Bangladesh will get over 100,000 free doses from a Chinese company.

In the Philippines, where China is competing with the United States for influence, President Rodrigo Duterte told lawmakers in July that he had made a plea to Chinas leader, Xi Jinping, for help with vaccines. He also said he would not confront China over its claims to the South China Sea.

A day later, Wang Wenbin, a spokesman for Chinas Foreign Ministry, said China was willing to give the Philippines priority access to a vaccine.

Chinas vaccine pledges, on top of earlier shipments of masks and ventilators around the world, help it project itself as a responsible player and could also help it push back against accusations that the ruling Communist Party should be held accountable for its initial missteps when the coronavirus first emerged in China in December.

The Trump administration has roundly attacked Beijing over its handling of the virus crisis, as well as over accusations that Chinese-directed hackers have tried to steal vaccine research to gain an edge. The Justice Department indicted two Chinese suspects accused of targeting pharmaceutical companies in July.

China is a leader in the global race for a Covid-19 vaccine, and four out of the eight late phase clinical trials are for Chinese vaccines. The country began testing experimental vaccines on soldiers and employees of state-owned companies in July, and the testing has quietly expanded to include health care and aviation workers. Chinese vaccine makers have built factories that can produce hundreds of thousands of doses.

The United States has three vaccine candidates in late-stage trials, with Pfizer saying it could apply for emergency approval as early as October and Moderna saying it hopes to have a vaccine by the end of the year. AstraZeneca, a British-Swedish company that received U.S. government funding to develop its vaccine, paused its late-stage global trials this week because of a serious suspected adverse reaction in a participant.

But Chinese vaccine companies that have gone abroad to conduct clinical trials have also generated controversy amid fears that local residents are being treated like guinea pigs. And some political experts worry about the leverage that China could wield over countries that accept vaccines.

Should we be suspicious, or should we be grateful? asked Muhammad Zulfikar Rakhmat, an academic at Universitas Islam Indonesia, who researches Chinas foreign policy in Indonesia.

The other way the virus will kill: hunger.

Long before the coronavirus swept into her village in the rugged southeast of Afghanistan, Halima Bibi knew the gnawing fear of hunger. It was a relentless source of anxiety as she struggled to nourish her four children.

Her husband earned about $5 a day, hauling produce by wheelbarrow from a local market to surrounding homes. Most days, he brought home a loaf of bread, potatoes and beans for an evening meal.

But when the virus arrived in March, taking the lives of her neighbors and shutting down the market, her husbands earnings plunged to about $1 a day. Most evenings, he brought home only bread. Some nights, he returned with nothing.

We hear our children screaming in hunger, but there is nothing that we can do, said Ms. Bibi, speaking by telephone from a hospital in Kabul, where her 6-year-old daughter was being treated for severe malnutrition. That is not just our situation, but the reality for most of the families where we live.

As the global economy absorbs the most punishing reversal of fortunes since the Great Depression, hunger is on the rise. Those confronting potentially life-threatening levels of so-called food insecurity in the developing world are expected to nearly double this year to 265 million, according to the United Nations World Food Program.

The largest numbers of vulnerable communities are concentrated in South Asia and Africa, especially in countries that are already confronting trouble, including military conflict, extreme poverty and climate-related afflictions like drought, flooding and soil erosion.

How China brought nearly 200 million students back to school.

Under bright blue skies, nearly 2,000 students gathered this month for the start of school at Hanyang No. 1 High School in Wuhan, the Chinese city where the coronavirus first emerged.

Medical workers stood guard at school entrances, taking temperatures. Administrative officials reviewed the students travel histories and coronavirus test results. Local Communist Party cadres kept watch, making sure teachers followed detailed instructions on hygiene and showed an anti-epidemic spirit.

Im not worried, a music teacher at the school, Yang Meng, said in an interview. Wuhan is now the safest place.

As countries around the world struggle to safely reopen schools this fall, Chinas Communist Party is harnessing the power of its authoritarian system to offer in-person learning for about 195 million students in kindergarten through 12th grade at public schools.

It has mobilized battalions of local officials and party cadres to inspect classrooms, deployed apps and other technology to monitor students and staff, and restricted their movements. It has even told parents to stay away for fear of spreading germs.

Chinas leader, Xi Jinping, said in a speech on Tuesday that the countrys progress in fighting the virus, including the opening of schools, had fully demonstrated the clear superiority of Communist Party leadership and our socialist system.

In many ways, China is applying the same heavy-handed model to reopen schools that it has used to bring the virus under control. To stop the epidemic, the authorities imposed harsh lockdowns and deployed invasive technologies to track residents, raising public anger in some places and concerns about the erosion of privacy and civil liberties.

With schools, the governments effort has in some places been met with similar frustrations. Teachers, who are at times doubling as medical workers, checking for fevers and isolating sick students, say they are exhausted by the new protocols. Students have complained that some policies, such as lockdowns on university campuses, are excessive.

The Chinese system moves by itself, said Yong Zhao, a scholar at the University of Kansas who has studied education in China. The system is run like a military: it just goes for it, no matter what anyone thinks.

A C.D.C. study investigates a possible link between dining out and exposure to the virus.

A new study suggests that restaurant dining may have increased the risk of exposure to the virus for some patrons, but several researchers said that the links between contracting the virus and eating out should be viewed with caution, because the study did not distinguish between patrons who dined at indoor or outdoor facilities, and didnt rely on contact tracing.

The study, released by the Centers for Disease Control and Prevention, analyzed 314 patients and found that those who tested positive for the virus were twice as likely to have eaten at a restaurant in the previous two weeks as those who tested negative.

We want people to understand as society opens back up where the risks are for Covid-19, said Dr. Wesley Self, a doctor and researcher at Vanderbilt University and an author of the study.

Dr. Self said he believed in retrospect that the researchers should have made the distinction between indoor and outdoor dining.

Gov. Andrew M. Cuomo announced on Wednesday that New York City would lift its prohibition on indoor dining on Sept. 30, allowing restaurants to operate at one-quarter indoor capacity. In July, the governor and Mayor Bill de Blasio halted a plan to resume indoor dining, citing concerns about a resurgence of the virus. (The conditions of outdoor dining are considered less risky.)

Last month, data from a number of states and cities showed that community outbreaks had centered on restaurants and bars. Contact tracers in Maryland found that 12 percent of new cases in July were traced to restaurants, and in Colorado, 9 percent of outbreaks were traced to bars and restaurants. The patients in the new study were treated at 11 hospitals in California, Colorado, Maryland, Massachusetts, Minnesota, North Carolina, Ohio, Tennessee, Utah and Washington.

Some researchers have urged caution in interpreting the findings of the new C.D.C. study.

The way folks have interpreted this study is that going to a restaurant causes Covid, said Zack Cooper, an associate professor of public health at the Yale School of Public Health. That isnt what this type of study is designed to show. What this shows is people who have Covid were more likely to have been in restaurants.

Dr. Cooper said dining in restaurants was probably associated with increased risk because it puts people in proximity with others who are not exercising caution in limiting their exposure to the virus. He said researchers needed to be careful in studying the risks of common activities, given the challenges for the general public in interpreting statistical findings.

In an interview with CNN on Friday, Dr. Fauci was asked what the studys findings meant for people who wanted to dine out. He said that he would not completely rule out going to a restaurant.

But, he said, restaurant owners should be aware that, particularly if youre in a zone where you have a significant degree of infection, you either do outdoor dining or if its indoor, you dont do it at 100 percent capacity.

Canada reported zero deaths linked to Covid-19 in a 24-hour period on Friday night, according to government data, even as the number of new cases in the country has ticked slowly upward as restrictions ease and schools reopen for in-person classes.

There have been at least 135,600 confirmed coronavirus cases in Canada as of Friday evening, according to the government. The number of new cases being reported daily has fallen significantly from an early May peak of nearly 3,000 cases, and now averages a few hundred a day. But as of Thursday, the average number of new daily cases was up by nearly 50 percent compared with a few weeks earlier.

Four Canadian provinces Alberta, British Columbia, Ontario and Quebec account for more than 4,000 of the 4,439 cases that the country has reported over the past week. Those provinces also accounted for all of the 23 deaths related to Covid-19 that were reported over the same period. This week, Ontario, Canadas most populous province, said that it will take a four-week pause before it considers loosening restrictions or allowing further economic reopening.

Over all, at least 9,163 deaths in the country have been linked to Covid-19. Quebec accounts for more than half of them, with 5,774, followed by Ontario, with 2,813.

Canada has previously reported zero Covid-19 deaths in 24-hour periods, although measuring that can be imprecise because of delays in reporting. The average number of daily reported deaths over the past week is three.

By contrast, as of Thursday the average number of daily reported deaths over the past week in the United States was 702.

Colleges are now hot spots, as nursing homes and meatpacking plants were earlier in the pandemic.

It began as a trickle of coronavirus infections as college students arrived for the fall semester. Soon that trickle became a stream, with campuses reporting dozens, and sometimes hundreds of new cases each day.

Now the stream feels like a flood. In just the past week, a New York Times survey has found, American colleges have recorded more than 36,000 additional infections, bringing the total of 88,000 cases since the pandemic began.

Not all those cases are new, and the increase is partly the result of more schools beginning to report the results of more testing. But The Times survey of 1,600 colleges also shows how widely the contagion has spread, with schools of every type and size, and in every state reporting infections.

Only about 60 of the campus cases have resulted in death mostly of college staff members and only a small number have resulted in hospitalizations. But public health experts say the rising number also underscores an emerging reality: Colleges and universities have, as a category, become hot spots for virus transmission, much as hospitals, nursing homes and meat packing plants were earlier.

Hoping to salvage some sense of normalcy along with lost revenue from housing fees and out-of-state tuition many schools invested heavily in health measures to bring at least some students back to campus.

But outbreaks have forced course correction after correction.

The State University of New York at Oneonta sent students home after the virus spun out of control in less than two weeks, with more than 500 cases. And the University of Illinois at Urbana-Champaign mounted one of the most comprehensive safety plans, requiring more than 40,000 students to be tested for the virus twice a week, and barring them from campus buildings without app verification that the latest test was negative. But, some students continued partying after they received a positive test result, and hundreds were infected.

A lockdown brought the number of new cases at the university down again. But its surge pushed its metro regions toward the top of the list of U.S. areas with most cases per capita, as did spikes at universities in Oxford, Miss., and Athens, Ga.

Officials in Oregons state corrections system this week began moving hundreds of inmates out of the path of the wildfires creeping toward some of their prisons. But the introduction of large groups of prisoners into different facilities may be exposing them to another risk contracting the virus.

Juan Chavez, a lawyer with the Oregon Justice Resource Center, a nonprofit legal advocacy group, said that relocated inmates were sleeping on mattresses crammed close together, but its picking your poison between the virus and the fires. He added that he fears the relocated inmates could contribute to a superspreader event for the virus in the prisons.

But few other options exist for the Oregon Department of Corrections, which has evacuated four prisons so far.

Inmates will be housed with others from their home institution whenever possible, and officials are aware of the potential virus spread, said Jennifer Black, a spokeswoman for the prison system.

The virus has already ravaged the state prison population. In June, the governor commuted the sentences of 57 inmates who were vulnerable to the virus. There have been 829 confirmed cases in prison system facilities, including staff members and inmates, according to the departments records. Six people have died.

At the Oregon State Penitentiary, 36 staff members and 143 inmates have tested positive.

Helene Cooper, a Pentagon correspondent with The New York Times, was selected to participate in a vaccine trial for Moderna, a biotech company based in Massachusetts. Ms. Cooper, who covered the Ebola outbreak for The Times in 2014, shared her experience in a personal essay. Following are some excerpts.

I signed up for a Covid vaccine trial, I texted a group of friends, all reporters with smart mouths on them. But one response gave me pause.

I admire your dedication to the cause, my friend Mark Mazzetti told me. But he was clear in his text: You gotta be really careful given your underlying condition. You could be given a placebo and sent to hang out in hot spots.

I hadnt thought of the placebo part of the vaccine trial when I signed up. I am a Type 1 diabetic a chronic autoimmune disorder I have had since I was 15, with asthma to boot, so I am firmly in the high-risk category. That had been made clear to me by Dr. Fauci himself in early March when I ran into him in the green room for NBCs Meet the Press.

What happens if I get Covid? I had asked him.

Im not saying youre a dead duck, he replied, but I cannot stress enough that you really need to not get it.

So last Wednesday, I arrived at George Washington University Hospital at the appointed time in all my triple-risk glory: Black woman, Type 1 diabetic, asthmatic. I hadnt slept the night before.

France is facing a worrying surge in cases, the government said on Friday, warning that the new cases were rapidly increasing and that hospitals were seeing an uptick in admissions.

Many expected new restrictions, especially after the governments scientific council said earlier this week that the authorities would have to take difficult measures.

But the authorities did not announce new rules, vowing instead to improve the countrys immense testing program which has been plagued by delays in recent weeks and urging the French to continue social distancing measures.

The country registered about 54,000 new cases over the past 7 days less than Spain, but far more than other neighboring countries like Italy or Germany. Nearly 31,000 people in France have died of the virus.

On Thursday, there were nearly 10,000 new confirmed cases, a record since the beginning of the epidemic. The surge is due partly to widespread testing, but the positivity rate for those tests has also increased it was at 5.4 percent this week, up from 1.5 in late July meaning that the virus is picking up speed.

Jean Castex, the French prime minister, said in a televised address on Friday that authorities were particularly worried about a renewed increase in the number of hospitalizations, especially of elderly people.

This shows there is no Maginot line, said Mr. Castex, referring to national fortifications built in the 1930s. Even if the virus is still mostly spreading among younger people, he said, it inevitably ends up reaching more vulnerable segments of the population.

In other developments around the world:

Myanmar has locked down half of its largest city, Yangon, and halted travel between regions in an effort to halt the spread of the virus. Myanmars leader, Daw Aung San Suu Kyi, urged the public to follow health protocols in a nationally televised address on Thursday. The number of confirmed cases has gone up fivefold in less than three weeks, reaching 2,422 on Friday, with 14 deaths, according to a Times database.

India again broke a record for daily new cases, reporting 97,750 on Saturday, according to a Times database. The previous record, set Friday, was 96,551.

North Korea has deployed crack troops along its border with a shoot-to-kill order to prevent smugglers from introducing the coronavirus into its isolated and malnourished population, the United States top general in South Korea, Gen. Robert B. Abrams, said on Thursday. North Korea insists that it has not confirmed a single case of Covid-19. But outside experts are skeptical, citing the countrys decrepit public health capabilities and the long border it shares with China, where the epidemic first erupted.

New studies underscore the gravity of Britains surge.

A series of studies released on Friday offered the strongest evidence yet that the coronavirus is surging again in Britain, suggesting that the country may be following other European nations in seeing significant new spikes of the virus.

Scientists from Imperial College London said that the prevalence of coronavirus infections doubled every eight days from late August to early September in England, a significant quickening of the spread.

The scientists tested a random sample of 150,000 people and estimated that the so-called reproduction number a measure of how many people on average a single patient will infect was 1.7, indicating a growing outbreak. An R number below 1 would indicate a dwindling outbreak.

The governments own scientific advisory group offered a more conservative estimate of the viruss spread it said the R number was between 1 and 1.2 in Britain but still said that the epidemic is growing.

The British government reported 3,539 new daily cases on Friday, lifting its seven-day average well over 2,500, a level last seen in May. Its total caseload has surpassed 361,000, with more than 41,600 deaths.

Heeding the surge, Prime Minister Boris Johnson announced this week that the government would ban gatherings of more than six people. But with students now returning to school and Britons socializing inside more as the weather cools, scientists said that might not be enough.

This is a massive blow to the governments strategy to contain the spread of Covid-19, Simon Clarke, an associate professor at the University of Reading, said of the Imperial College London study.

Mr. Johnson has been encouraging people to go back to work, eat out at restaurants, patronize pubs and send children back to school. Many Britons have also remained resistant to wearing face masks in crowded places.

Britains new contact-tracing app will be introduced in England and Wales on Sept. 24, Mr. Johnsons government announced on Friday. The government had previously been criticized over the long delay; earlier versions were scrapped months ago.

Halsey Beshears, Floridas secretary for the Department of Business and Professional Regulation, announced on Twitter on Thursday that the state would allow bars to operate at half capacity starting Monday. He rescinded an executive order from June that had banned drinking at bars as the state experienced a surge.

The rest is here:

Covid-19 Live Updates: As Colleges Restart, Even the Very Prepared Face Outbreaks - The New York Times

Since the discovery of the virus that causes COVID-19, the daily news cycle has been flooded with updates about how the pathogen spreads, what the bug does to the body and what solutions might finally bring an end to the pandemic.

But staying up-to-date on all the latest coronavirus news can be a challenge. To help keep you informed, we at Live Science have compiled a short list of standout news stories from the week these are the ones that really caught our attention.

Related: 20 of the worst epidemics and pandemics in history

AstraZeneca and Oxford University have paused their trial of a COVID-19 vaccine after a participant developed a suspected adverse reaction.

This kind of hold is a "routine action" taken during clinical trials; whenever a trial participant develops an unexplained illness, the company stops administering the vaccine while an independent committee determines whether the reaction is related to the vaccine. In large clinical trials that include tens of thousands of people, participants can fall ill by chance, so each case of illness must be carefully reviewed to determine whether the vaccine triggered the reaction.

Related: Here are the most promising coronavirus vaccine candidates out there

In this instance, the participant developed neurological symptoms often associated with transverse myelitis, a condition where the spinal cord becomes inflamed. The participant is now recovering in the hospital and should be discharged soon, but her diagnosis still needs to be confirmed, AstraZeneca CEO Pascal Soriot told investors during a private call on Sep. 9, according to Stat News.

The AstraZeneca trials were paused once before when a different participant developed neurological symptoms. However, that first patient was later diagnosed with multiple sclerosis and the committee determined that the illness was not related to the vaccination.

When the coronavirus infects heart cells in a lab dish, the pathogen snips heart muscle fibers into tiny fragments, according to a new study. However, scientists don't yet know if the virus launches the same attack against the heart inside the human body.

Heart muscle cells, known as cardiomyocytes, are made up of small units called sarcomeres that line up end-to-end to form long, thin muscle fibers. But when exposed to SARS-CoV-2 in a lab dish, sarcomeres get sliced and diced into tiny bits. If this happened to a person's heart, it wouldn't be able to beat normally.

Related: The mysterious connection between the coronavirus and the heart

To see if the virus might behave similarly in the body, the study authors looked at autopsied heart tissue from three COVID-19 patients. They found that the sarcomere filaments from the patients were also disordered and rearranged, but not in exactly the same way as cells in the lab dish.

In both the lab dish experiments and autopsied tissue, some heart muscle cells appeared to be missing their DNA, which would effectively leave those cells "brain dead" and unable to function, the authors said. The scientists are now studying how the virus actually causes these changes in cells, whether they happen in the human body, and whether the damage can be prevented or reversed with medications.

Some people who catch COVID-19 develop disorientating neurological symptoms, like confusion, brain fog and delirium now, a new study provides the first solid evidence that the virus might directly infect brain cells.

The study authors examined brain tissue from a patient who died of COVID-19, as well as two mouse models of the disease and clusters of brain cells in a lab dish, known as organoids. They found that the virus enters brain cells via the ACE2 receptor that sits on the cell surface. Lung tissue contains copious numbers of ACE2 receptors, and therefore many gateways for the virus to enter; the brain contains far fewer, but even so, the virus can still slip inside, the authors found.

Once inside, the coronavirus uses the internal machinery of brain cells to multiply, while also starving nearby cells of oxygen, which helps the virus reproduce. The researchers still need to determine how often the virus infects brain cells in patients with COVID-19, since some neurological symptoms may arise from elevated inflammation in the body and not directly from brain infection. In addition, we still don't know how the virus reaches the brain in the first place; the virus may pass through the barrier of tissue between the bloodstream and the brain, known as the blood-brain barrier, or enter through the nerves of the nose or eyes.

Originally published on Live Science.

Read more here:

Coronavirus news of the week (VIDEO) - Live Science

Viruses love bats. The flying nocturnal mammals make outstanding hosts because just like people they live in large, dense groups; their air travel spreads germs between populations; and their longevity enables a virus to persist for years in an individual animal.

The big difference is that bats remarkable immune systems tame and tolerate many viruses, including the coronavirus responsible for COVID-19, that cause havoc when they spread to humans.

We should look at what bats are doing to control the virus and emulate that in some way, said Bernard Crespi, professor of evolutionary biology at Simon Fraser University in Canada, one of a growing group of scientists finding clues to the pandemic through bat immunology.

Immunology lies at the heart of scientific and medical investigation of COVID-19. Every effort to explain the extraordinarily varied course of the disease, to treat it with drugs and prevent it with vaccines, depends on understanding how the virus outwits the human immune system or vice versa.

In the popular imagination, immunity means resistance to a disease, while to scientists it is something much more nuanced and complex. Immunologists think of it more as a question of degree: How rapid was an individuals initial response to a pathogen? Did the persons cells recognize it from past exposure and kick into action more quickly? How many antibodies did it produce, and were they the right ones?

Coronaviruses have been evolving in bats for thousands or millions of years. They have moved into people very recently perhaps as recently as last year in the case of SARS-CoV-2, the virus responsible for COVID-19.

A greater number of dangerous zoonotic diseases have spread to humans from bats, often via an intermediate animal host, than from all other mammals put together. This roll call of vicious viruses includes Ebola, Marburg and Nipah, as well as the coronaviruses that cause SARS, MERS and now COVID-19.

Viruses are much more virulent when they spread to humans from bats than from other mammals, said Crespi. Yet they seem to do little harm to the bats themselves.

The explanation lies in the way these flying mammals control infections. The biggest differences from other animals are in the innate immune system, the first line of defense against invading pathogens, said Catherine Blish, a viral immunologist at Stanford University. In particular, bats produce larger amounts of interferons, molecules that play a key role in activating the wider immune response and in preventing the virus from replicating.

Coronaviruses such as SARS-CoV-2 evolved to spread and thrive in bats by subverting interferons, said Crespi: The virus is carrying out a stealth attack, switching off the systems that the body uses to show that it is infected.

Bat-derived viruses are also unperturbed by another aspect of the human innate response developing a fever to make the body less hospitable to germs.

The incredible exertion of flying causes bats body temperature to rise to a high fever twice a day, something that pathogens that have co-evolved with bats for millennia have grown accustomed to, said Andrew Cunningham, deputy science director at the Zoological Society of Londons Institute of Zoology.

Recent research suggests that in many seriously ill COVID-19 patients, the virus causes their immune responses to mistime and then go berserk. The body responds to the infection too late, unleashing an indiscriminate barrage of interferons and other immune signalling molecules called cytokines. This cytokine storm activates an excessive inflammatory response, flooding the patient with antibodies and blood cells that destroy human tissues without stopping the infection.

Interferons were hailed as potential wonder drugs in the 1970s and 80s. They have not lived up to that billing, though they are an important treatment for multiple sclerosis. But some believe their role in modulating the immune system could be important in the fight against COVID-19.

Synairgen, a spinoff company from the U.K.s Southampton University, announced July 20 that its inhaled beta interferon greatly reduced the risk of severe lung disease in COVID-19 patients who were admitted to the hospital.

Stephen Holgate, co-founder of Synairgen and professor of immunopharmacology at Southampton, said the interferon seemed to act in time to prevent patients immune systems from going into harmful overdrive. The company is undertaking a second clinical trial to find out whether earlier inhalation of interferon would prevent hospitalization.

When innate immunity, the initial defense against infection, is working properly as it does in most people infected with SARS-CoV-2 who develop mild or no symptoms of disease the second stage, adaptive immunity, kicks in after a few days.

Adaptive immunity is the part of the system that has received the most attention during the pandemic. It includes T-cells, B-cells and the antibodies they produce. All have evolved to search out and destroy specific antigens protein molecules on invading pathogens and remember these in case of future infection.

While the adaptive immune system is at work, messenger cells and chemicals rush to areas of the body where these specialized blood cells are stored and warn them about the arrival of a virus. A few of these cells may already be programmed to attack the virus, and if they are present, they will reproduce rapidly and launch an offensive.

Danny Altmann, professor of immunology at Imperial College London, said COVID-19 has produced a high level of public interest in his field of adaptive immunity. Only the emergence of AIDS in the 1980s came close.

The parts of T- and B-cells that recognize antigens and latch on to the virus are their receptors.

We have made a phenomenal genetic investment in being able to produce a vast number of different receptors for recognizing different pathogens, said Altmann.

Scientists are beginning to study the almost miraculous diversity of immune cells generated by a process of genetic recombination called V(D)J, in which the body joins together three components to make receptors that can tackle new pathogens.

This can produce billions of differently shaped receptors. Each individual is likely to have between 10 million and 100 million different T- and B-cells, depending on the condition of the immune system and how many antigens the person has encountered through life.

When you are exposed to a virus, your immune system selects the arrangements that can best deal with the infection, copies them and expands these clones very rapidly, said Felix Breden, a geneticist at Canadas Simon Fraser University.

He is scientific manager of iReceptor, an international consortium funded by the EU and Canada that is building a genetic database of immune cell receptors from COVID-19 patients. It already contains 200 million DNA sequences provided by seven research teams in various countries.

Adaptive Biotechnologies, a Seattle-based company, has developed a similar open database in partnership with Microsoft, called ImmuneCode, which has mapped the response of T-cells from 1,000 COVID-19 patients to specific antigens on SARS-CoV-2.

Looking at the response to SARS-CoV-2, you find what we call public receptors, with genetic sequences shared by many people, and private ones that are seen infrequently, said Lance Baldo, chief medical officer of Adaptive Biotechnologies.

We are beginning to see patterns in the data, added Baldo. Data sharing will greatly accelerate research into anti-COVID therapeutics and vaccines. If you are developing a vaccine, you want it to produce immune cells with genetic sequences that show up in as many COVID-19 patients as possible.

Within an infected individual, it takes time to build up B- and T-cell division and antibody production, said Altmann. To achieve the full immune response to COVID-19, you need to get to day 11 or 12 after infection.

After that, the big question is how long the immune response will protect against further exposure to the virus. Following several unconfirmed reports of reinfection with SARS-CoV-2, the first confirmed case was published last month by researchers at the University of Hong Kong.

A 33-year-old man who had been hospitalized with moderate COVID-19 symptoms in March in Hong Kong tested positive again in August, when he was screened at the airport upon returning from a trip to Spain. The scientists proved that he had been reinfected, rather than the coronavirus remaining in his body, by taking genetic fingerprints on each occasion. These showed that the second virus had 24 differences from the first more than could have occurred through mutations while hanging on within one individual.

Immunologists were not surprised by the reinfection news and expect further cases to be confirmed in the months to come. They were reassured that the man showed no symptoms of disease on the second occasion, suggesting that his immune system primed by the first infection had controlled the virus more successfully when it met it again.

It may not even be necessary to have encountered SARS-CoV-2 for the adaptive immune system to offer some protection against COVID-19. One of the biggest surprises is that there seem to be some memory T-cell responses in people who had never been infected with SARS-CoV-2, said Jennifer Juno, a viral immunologist at the University of Melbourne.

This cross-reactivity occurs because related coronaviruses, which have been circulating in people for centuries or millennia and very rarely cause illness worse than a common cold, are similar enough to recognize SARS-CoV-2. But there is not enough evidence yet to assess either the extent of cross-reactivity in populations across the world or the extent to which they might protect against COVID-19.

Vaccines are of course a far more systematic and deliberate way to prevent disease from a virus one has not encountered before. Many companies and countries are racing to develop COVID-19 vaccines, at a total cost running to billions of dollars, and dozens are at various stages of clinical testing, though none has gotten far enough to provide clear evidence of safety and efficacy.

A well-designed vaccine could provide better immunity than natural infection with the virus, immunologists say, but the first generation of COVID-19 vaccines may be good enough only to ameliorate symptoms, rather than to prevent infection altogether.

Meanwhile, SARS-CoV-2 is itself evolving as it spreads through its new hosts: humans. Coronaviruses mutate more slowly than flu but faster than many other viruses.

Scientists are observing some genetic changes, particularly in the spike protein that SARS-CoV-2 uses to enter human cells, which may make it more infectious and at the same time easier for the immune system to recognize and tackle. But none has transformed the nature of the virus.

When a virus crosses the species barrier, there is strong Darwinian pressure to adapt to its new environment. Evolutionary theory suggests that viruses do not want to kill their hosts but to spread through them as efficiently as possible while doing little harm, said Gavin Screaton, head of medical sciences at the University of Oxford.

In the long term, they may adapt to the host and become less infectious, he said. The four coronaviruses that today cause cold-like symptoms may have been more virulent pathogens when they first moved into humans two from bats; two from rodents.

Peter Openshaw, professor of experimental medicine at Imperial College London, said there is much scientific speculation about whether SARS-CoV-2 will weaken and attenuate into something like the common cold.

Whatever happens, he added, we have an amazing opportunity to watch in real time as a virus evolves after it has jumped species.

Immunologists will learn valuable lessons from COVID-19 for the inevitable next pandemic following the leap of a lethal virus from a bat (or a rat) into humans.

The Financial Times Ltd. 2020. All rights reserved. FT and Financial Times are trademarks of the Financial Times Ltd. Not to be redistributed, copied or modified in any way.

See more here:

What bats can teach us about developing immunity to COVID-19 - Los Angeles Times