Category: Covid-19 Vaccine

Pfizer and BioNTech are moving to enlarge the Phase 3 trial of their Covid-19 vaccine by 50%, which could allow the companies to collect more safety and efficacy data and to increase the diversity of the studys participants.

The companies said in a press release that they would increase the size of the study to 44,000 participants, up from an initial recruitment goal of 30,000 individuals.

The U.S. Food and Drug Administration will have to approve the change before it goes into effect.

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The companies continue to expect that a conclusive readout on efficacy is likely by the end of October, the press release said. The Pfizer and BioNTech study is likely to be among the first in the U.S. to report efficacy data from a Phase 3 trial.

Expanding the trial will likely make it easier for the company to demonstrate whether the vaccine is effective against SARS-CoV-2, the virus that causes Covid-19. The companies also said that the change will allow the study to include a more diverse population. The companies said the study will now include adolescents as young as 16, people with stable HIV, and those with hepatitis C or hepatitis B.

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The companies said that the trial is expected to reach its initial target of 30,000 patients next week. Moderna, which started its trial on the same day as Pfizer, said on Sept. 4 that it is working to increase the diversity of trial participants in its study, even if those efforts impact the speed of enrollment.

The Pfizer/BioNTech study could finish sooner than Modernas, even though the two began on the same day, for other reasons, as well. Both vaccines require a second shot; Pfizers is given after three weeks, while Modernas is given after four. The Pfizer trial also starts to count cases of Covid-19 sooner after participants receive their shots than the Moderna study.

But the Pfizer/BioNTech vaccine could also prove to be one of the most difficult of the experimental vaccines to distribute, should they prove effective. The vaccine must be kept at a temperature of -70 degrees Celsius.

There has been political pressure to move a vaccine quickly, with President Trump saying that one could be available before election day. Last week, several drugmakers, including Pfizer, issued a pledge not to move a vaccine forward sooner than was justified by the results of their clinical trials.

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Pfizer and BioNTech announce plan to expand Covid-19 vaccine trial - STAT

When a safe and effective COVID-19 vaccine becomes available, it's a complex process to distribute it and make it accessible to everyone who needs it.

Distributing a vaccine will require scaling up manufacturing, logistically planning storage and prioritizing who gets it first, says Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins University Bloomberg School of Public Health.

The Centers for Disease Control and Prevention has contracted distribution to McKesson Corporation, a pharmaceutical company that distributes 150 million vaccine doses per year. McKesson will work with the CDC to distribute the vaccine across the U.S. to public health departments, hospitals, pharmacies and large health care organizations, he says.

Another key part of distribution is maintaining whats called the cold chain. Almost all vaccines need to stay cold, he says, and some newer ones such as Modernas messenger RNA vaccine may require even lower temperatures than usual.

With concerns mounting about distribution to lower and middle-income countries in sub-Saharan Africa and Asia, its not yet clear how the process of administering a vaccine manufactured in the U.S. would work, he says. The Trump administration is cutting ties with the World Health Organization, specifically, a program called COVAX a joint effort between the WHO, Gavi, The Vaccine Alliance, and the Coalition for Epidemic Preparedness and Innovation, to ensure equitable distribution on a global scale.

My own sense is that a vaccine manufactured in the United States will probably be prioritized for people within the United States, Moss says.

If a vaccine is manufactured outside the U.S., Moss predicts other countries will prioritize groups within their borders such as health care and essential workers and people at risk for the disease like the elderly. An ongoing conversation and plan are needed to ensure the vaccine gets to people who need it, he says.

There are efforts to try to avoid vaccine nationalism, where countries that develop a vaccine are using it only in their own country, he says. And it's going to be a very tricky political decision to determine how vaccines will be allocated within the country and then shared more globally.

With people all over the world desperate for access to a vaccine, the race for one marks an unprecedented situation, he says. A few things set the COVID-19 vaccine apart from the most comparable past pandemic in recent history, the H1N1 influenza virus in 2009.

Concerns about widespread transmission and mortality from H1N1 sparked the need for a global vaccine, he says, but the death toll and spread of the disease never reached the same level as COVID-19.

And when H1N1 hit, both researchers and the public already had experience with influenza immunization, he says. With COVID-19, companies like Moderna are working with new types of vaccines such as the messenger RNA or another leading candidate called an adenovirus vector vaccine, where a gene from the spark protein of SARS-CoV-2 is inserted into an adenovirus and administered, he says.

Here, we're trying to develop new vaccines to a new virus, he says. And some of the vaccine platforms or the way these vaccines are being manufactured is quite different than ways that we've done so in the past.

On top of working with multiple new types of vaccines from several different countries, a recent poll suggests only half of Americans plan to get a vaccine.

Long-term immunity to the virus should protect people who receive the vaccine from those who refuse it, Moss says, but this is uncertain. The bar for acceptable vaccine effectiveness is as low as protecting half to 75% of the people who receive it, he says.

Researchers also dont know how long the vaccine will protect people, he says. An ideal vaccine would shield almost everyone who receives it for a long time, he says, but if only half of those people are protected and that protection is short-lived, yes, then they would need to worry about those who do not get the vaccine transmitting COVID-19 to others.

As manufacturing capacity increases, the vaccine will become available to the general public but this could take until mid to late 2021, Moss says.

There's no doubt that early on there will not be sufficient quantity of vaccine doses to vaccinate everyone who wants to get vaccinated, he says.

Julia Corcoranproduced and edited this interview for broadcast withPeter O'Dowd.Allison Haganadapted it for the web.

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General Public Won't Receive COVID-19 Vaccine Until Mid To Late 2021, Doctor Predicts - Here And Now

Coronavirus 2019-nCoV vials(Photo: solarseven, Getty Images/iStockphoto)

Navajo Nation officials said Friday they will participate in the Pfizer-BioNTech COVID-19 vaccine trials. Trials will be conducted at various health care centers across the Navajo Nation on a volunteer basis.

The vaccine trials come after theNavajo Nation, which once held the highest COVID-19 infection rate in the country,has seen a decline in its numbers. On Sept. 8, officials reported zero new cases for the first time since the pandemic started.

The total number of COVID-19 cases reported from the Navajo Nation is 9,933 as of Sept. 10.

"Several COVID-19 vaccine clinical trials are making progress across the U.S. and it's important that the Navajo people have an opportunity to participate in a Phase 3 trial," Navajo Nation President Jonathan Nez said in a press release.

"The clinical trials will be done on a patient-volunteer basis, meaning that no one will be forced to participate unless they are fully willing to do so."

The Navajo Nation Human Research Review Board approved the Pfizer-COVID-19 Vaccine Study on Aug.27, according to Jared Touchin, communications director for the Navajo Nation Office of the President and Vice President.

The study will be led by theJohn Hopkins Center for American Indian Health and is the first COVID-19 vaccine study on the Navajo Nation.

"COVID-19 has disproportionately affected tribal communities. In the Southwest, tribal members have experienced some of the highest rates of the COVID-19 disease in the country," said Navajo Department of Health Executive Director Dr. Jill Jim in a press release.

"Supporting national strategies to develop a vaccine addresses health equality to guide local decision making about vaccine selection and vaccine use," she added.

Enrollment for the study will begin in mid-September and participation will include individuals between the ages of 19 to 85who are healthy or have a stable underlying health condition.

Participants will be given two doses of approved vaccine and will be monitored over a two-year period. Eligible participants who join the study must not have had a prior COVID-19 infection.

"This is because people who have recovered from COVID-19 will likely have antibodies," the press release states.

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There are no approvedvaccines against COVID-19, but there many under development. The federal government announced a goal of delivering 300 million doses of a safe, effective vaccine for COVID-19 by January 2021 in a plan called Operation Warp Speed.

For COVID-19 vaccine trials, the FDA has issued guidance that "strongly encourages the enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities," and has encouraged the inclusion of other high-risk groups such as those with underlying diseases in late-stage vaccine trials as well as pregnant women or women of child-bearing age.

The inclusion of these groups can have important implications for understanding how treatment may affect various groups differently since genetics or other factors influence how well a treatment works.

Before signing up for any COVID-19 study, Jason Robert, an Arizona State University bioethicist who focuses on how to practice safe and ethical science, said people should fully understand the risks and shouldn't volunteer for the wrong reasons.

"Scientists are doing this for the good of the whole, not the individual," he said. "It might be our civic duty to participate in these studies, but don't do it because you think you're going to get better."

Navajo people who are interested in participating in the Pfizer COVID-19 Vaccine Study through the John Hopkins Center for American Indian Health can contact site managers in Chinle;Shiprock, New Mexico;and Gallup, New Mexico.

"We have overseen numerous phase 3 clinical trials with an experienced, dedicated staff who have specialized training in research ethics, Good Clinical Practice, HIPAA compliance, specimen collection, and who are able to conduct high-quality studiesthat meet strict FDA requirements," Dr. Laura Hammitt with John Hopkins Center for American Indian health stated in the press release.

The Chinle site can be reached at 928-674-5051, Shiprock at 505-368-4030, and Gallup at 505-722-6372.

The Navajo Nation is hosting a live online town hall meeting on Sept. 21.Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious DiseasesDirectorwill joinNez and Vice President Myron Lizer to discuss the COVID-19 response efforts and trial vaccines.

Republic bioscience reporter Amanda Morris contributed to this report.

Reporter Shondiin Silversmith covers Indigenous people and communities in Arizona. Reach her at ssilversmi@arizonarepublic.comand follow her Twitter @DiinSilversmith.

Support local journalism.Subscribe to azcentral.com today.

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Navajo Nation officials announce participation in COVID-19 vaccine trials - The Arizona Republic

Experts doubt COVID-19 vaccine will be ready soon, despite Trump assurances  FOX 8 Live WVUE

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Experts doubt COVID-19 vaccine will be ready soon, despite Trump assurances - FOX 8 Live WVUE

Shares of Vaxart Inc. VXRT, +46.79% jumped 15.6% in premarket trading on Monday after the company said it had received the go-ahead from the Food and Drug Administration to begin testing its experimental oral COVID-19 vaccine in a Phase 1 clinical trial. Vaxart said it expects to begin recruiting participants for the open-label study sometime this month. Shares of the preclinical company have soared 1,412.1% so far this year, while the S&P 500 SPX, +1.27% is up 3.4%.

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Vaxart's stock rallies 15% after it gets clearance to begin human trials of COVID-19 vaccine candidate - MarketWatch

A Chinese pharmaceutical company has injected hundreds of thousands of people with experimental Covid-19 vaccines, as its Western counterparts warn against administering mass vaccinations before rigorous scientific studies are complete.

China National Biotec Group Co., a subsidiary of state-owned Sinopharm, has given two experimental vaccine candidates to hundreds of thousands of people under an emergency-use condition approved by Beijing in July, the company said this week. Separately, Chinese drugmaker Sinovac Biotech Ltd....

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China Injects Hundreds of Thousands With Experimental Covid-19 Vaccines - The Wall Street Journal

Many companies are working to develop a vaccine for COVID-19, but one key player in Irving is focusing on another part of the public health response: how to deliver those hundreds of millions of doses as soon as theyre available.

McKesson Corp., which relocated its corporate headquarters from San Francisco last year, recently was named a central distributor for the vaccines and related supplies.

The company will be reimbursed $178 million from the government to build new distribution centers and beef up existing distribution systems. When it delivers the vaccine to providers aiming to inoculate most Americans, McKesson could bring in another $238 million, one analyst conservatively projected.

The numbers are relatively small for a company whose revenue topped $231 billion in fiscal 2020 more than AT&T and Exxon Mobil over the past year. Still, the stakes are enormous because of the personal and economic destruction of the coronavirus, along with the politics over the public health crisis.

Yet one analyst isnt worried about the risk for McKesson. The nations largest pharmaceutical distributor delivers about 1 in 3 prescription drugs in North America, and its been down this road before.

In 2009 and 2010, it distributed over 126 million doses of the H1N1 vaccine. That effort was considered a success despite some problems with manufacturers creating enough vaccines in the early months.

This is what McKesson does, and this is what theyve been doing forever, said Jonathan Palmer, senior health care analyst for Bloomberg Intelligence. A lot of work is being done behind the scenes to build the capacity to make this happen. Its just a question of when and how.

McKesson has not said much about its plans except to make clear its not driving the train.

The government will direct all of the administration of the vaccine, Britt Vitalone, McKessons chief financial officer, said during an investor call on Wednesday. They will also direct the vaccines that will be distributed in the program, and it will be the governments decision if they choose to bring other distributors into the process.

Vitalone was asked about the differences with the COVID-19 effort, including the expected volume and pricing of the vaccines. He said the Centers for Disease Control and Prevention was taking a similar approach.

But its still fairly early in the process, Vitalone said. There are still some things that are unknown. And if you draw in a correlation, I would just say the operational approach is similar, but thats all that we can really disclose at this time.

At least eight vaccines are expected to enter late-stage development this year, and an effort to speed up the process has created controversy. President Donald Trump has suggested that a vaccine could arrive by Election Day, but CEOs for nine major drug companies pushed back this week.

They said they would not seek regulatory approval before the safety and efficacy of the vaccines were established. It was an extraordinary statement intended to bolster public confidence amid Trumps rush to a breakthrough.

The coronavirus has caused over 190,000 deaths in the United States, and the economic damage has been severe and widespread. Every aspect of the vaccine response will be in the spotlight, including distribution.

Its a daunting prospect to vaccinate the entire country with a two-dose vaccine, said Dr. Amesh Adalja, a senior scholar at the Center for Health Security at Johns Hopkins University. "No matter how well we do with preparedness, unforeseen obstacles are going to emerge. Using companies that are already familiar with the supply chain, like McKesson, is one way to minimize the difficulties.

The partnership with McKesson is a very favorable development, said Adalja, who focuses on infectious disease and pandemics.

McKesson and two chief rivals, AmerisourceBergen and Cardinal Health, account for about 90% of the market. Acquisitions have been a big part of McKessons growth strategy, and the company spent almost $16 billion on deals over the past decade.

The giant distributors' scale allows them to negotiate lower prices with drug manufacturers, which is important in a mature business with low margins. McKessons adjusted operating margins have averaged 1.7% for the last 10 years, Morningstar analyst Soo Romanoff wrote in an August report. Yet he raised his valuation on the stock because distributors are faring better than others in health care.

Providers have been pressed to rely on their supply chain partners to navigate the operating challenges during the pandemic, Romanoff wrote.

McKesson, AmerisourceBergen and Cardinal Health are often in the news because of opioid-related lawsuits. In its latest annual report, McKesson said it was a defendant in over 3,000 legal proceedings related to opioids. In the past two years, it spent $383 million on opioid-related expenses, and the big payout is still to come.

Almost a year ago, state attorneys general outlined a framework for a global settlement. It called for $18 billion to be paid over 18 years by the three major distributors. McKessons share would be $6.9 billion, according to its annual report.

In Wednesdays call, when Vitalone was asked for an update, he said he couldnt provide new information: I think the focus has really been on the pandemic, Vitalone said.

Some vaccines require cold storage, which complicates distribution. And its not clear which groups will get treatment first and which distribution points will be used.

Ultimately, several hundred million doses are expected to be shipped in the U.S., and tracking and registering the activity will be crucial.

We havent seen anything like this in modern history, and everybodys going to look at the U.S. distribution system for lessons, said Adalja of Johns Hopkins. The stakes are very high to get this right.

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When a COVID-19 vaccine is ready, McKesson will deliver it as it did with H1N1 over a decade ago - The Dallas Morning News

Democratic vice presidential nominee Kamala HarrisKamala HarrisThe Hill's Campaign Report: 19 years since 9/11 | Dem rival to Marjorie Taylor Greene drops out | Collin Peterson faces fight of his career | Court delivers blow to ex-felon voting rights in Florida Kasich to Meghan McCain: Concern over abortion 'dwarfed' by need to beat Trump Harris pays tribute to 9/11 victims, first responders in Virginia MORE said she would not take President TrumpDonald John TrumpSenate panel seeks documents in probe of DHS whistleblower complaint Susan Collins: Trump 'should have been straightforward' on COVID-19 Longtime House parliamentarian to step down MOREs word about the efficacy of a potential coronavirus vaccine released before the November election.

In an interview with CNN set to air in full on Sunday,the California senatorsaid she was not confident that health officials would get the last word on the effectiveness of a vaccine.

If past is prologue that they will not. Theyll be muzzled, theyll be suppressed, they will be sidelined because hes looking at an election coming up in less than 60 days, and hes grasping for whatever he can get to pretend that hes been a leader on this issue when hes not,she said.

I will say that I would not trust Donald Trump, and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he's talking about, she added.

BASH: "Lets just say theres a vaccine that is approved and even distributed before the election. Would you get it?"

HARRIS: "Well, I think thats going to be an issue for all of us. I will say that I would not trust Donald Trump... I will not take his word for it." #CNNSOTU pic.twitter.com/jhxtdvaMF1

The remarks come amid concerns that the administration is pushing for a vaccine to be produced prior to Election Day to boost the presidents reelection bid. CNN reported Thursday that Trump has pressured officials to accelerate the development of a vaccine to portray the sense that the end of the COVID-19 pandemic is near.

The Centers for Disease Control and Prevention (CDC) also asked state governors last week to fast-track applications for building permits for vaccine distribution sites that would be up and running in early November before Election Day.

Polling has shown voters remain skeptical of Trumps word on a coronavirus vaccine, with only 14 percent in a Politico-Morning Consult surveylast month saying that thatd be more likely toreceivea COVID-19 vaccination if the president recommended it.

By comparison, 46 percent said theyd take one on the advice of their family,while 43 percent said they would on the advice of the CDC or Anthony FauciAnthony FauciOvernight Health Care: McConnell: Chance for coronavirus deal 'doesn't look that good right now' | Fauci disagrees with Trump that US rounding 'final turn' on pandemic | NIH director 'disheartened' by lack of masks at Trump rally Fauci: Return to pre-coronavirus normality will be 'well into 2021' Fauci disagrees with Trump that US rounding 'final turn' on pandemic MORE, the nations leading infectious disease expert.

Too much of the evidence points to the Trump administration pressuring the [Food and Drug Administration] to approve a vaccine by Election Day to boost the Presidents re-election campaign, Senate Minority LeaderCharles SchumerChuck SchumerMcConnell: Chance for coronavirus deal 'doesn't look that good right now' The Hill's 12:30 Report - Presented by Facebook - Biden, Pence elbow bump at NYC Sept. 11 ceremony FDNY says Treasury withheld .7M from 9/11 first responder fund MORE(D-N.Y.) said in a statement this week, referencing a report fromThe Washington Postaddressing the concerns.

All Americans want a safe and effective vaccine as soon as possible, but if these important life and death decisions appear political, it will only undermine Americans confidence in a vaccine and prolong the pandemic, he added.

Officials have worked to downplay worries, with Fauci this week suggesting hed trust health officials if theysaid a vaccine is safe.

I mean, I will look at the data, and I would assume, and Im pretty sure its going to be the case, that a vaccine would not be approved for the American public unless it was indeed both safe and effective. And I keep emphasizing both safe and effective. If thats the case ... I would not hesitate for a moment to take the vaccine myself and recommend it for my family, he said.

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Harris on getting any COVID-19 vaccine before election: 'I would not trust Donald Trump' | TheHill - The Hill

AstraZeneca halts a vaccine trial to investigate a participants illness.

The pharmaceutical company AstraZeneca halted global trials of its coronavirus vaccine on Tuesday because of a serious and unexpected adverse reaction in a participant, the company said.

The trials halt, which was first reported by Stat News, will allow the British-Swedish company to conduct a safety review. How long the hold will last is unclear.

In a statement, the company described the halt as a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.

In large trials like the ones AstraZeneca is overseeing, the company said, participants do sometimes become sick by chance, but such illnesses must be independently reviewed to check this carefully.

The company said it was working to expedite the review of the single event to minimize any potential impact on the trial timeline and that it was committed to the safety of our participants and the highest standards of conduct in our trials.

A person familiar with the situation, and who spoke on the condition of anonymity, said that the participant had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZenecas vaccine, is unclear.

AstraZenecas vaccine, known as AZD1222, relies on a chimpanzee adenovirus that has been modified to carry coronavirus genes and deliver them into human cells. Although the adenovirus is generally thought to be harmless, the coronavirus components of the vaccine are intended to incite a protective immune response that would be roused again should the actual coronavirus try to infect a vaccinated individual.

Adenoviruses, however, can sometimes trigger their own immune responses, which could harm the patient without generating the intended form of protection.

AstraZenecas vaccine is currently in Phase 2/3 trials in England and India, and in Phase 3 trials in Brazil, South Africa and more than 60 sites in the United States. The company intended for its U.S. enrollment to reach 30,000.

AstraZeneca is one of three companies whose vaccines are in late-stage clinical trials in the United States.

Britain, seeing a sudden spike in new cases, will ban most gatherings of more than six people beginning next week, Prime Minister Boris Johnson is expected to announce on Wednesday.

We need to act now to stop the virus spreading. So we are simplifying and strengthening the rules on social contact making them easier to understand and for the police to enforce, Mr. Johnson said in a statement on Tuesday.

The new measure, which will be subject to fines beginning at 100 pounds, will apply to both indoor and outdoor gatherings, including parks. It is not expected to apply to workplaces, weddings, funerals or team sports.

A surge in cases this week and confusion over the current rules prompted the new measure, which is expected to take effect on Monday. About 3,000 new cases were reported on both Sunday and Monday of this week, the highest daily figures since May. About 2,500 more new cases were reported on Tuesday.

The current rules allow up to 30 people for certain types of gatherings, sowing confusion and making it difficult for officials to enforce.

In an interview with Sky News on Wednesday morning, Health Secretary Matt Hancock said that the new rules would not be implemented until Monday because people needed time to read them.

Every single person in the country needs to know what they are so we can together keep a grip on the virus, he said.

Mr. Hancok was asked by Sky News whether the decision by the pharmaceutical company AstraZeneca to halt global trials of its coronavirus vaccine would set back the vaccine development process.

Not necessarily, he said. It depends on what they find when they do the investigation.

There have been 41,586 deaths and at least 352,500 confirmed cases in the United Kingdom as of Wednesday morning, according to government data.

In other developments around the world:

On the Greek island of Lesbos, a fire forced thousands of migrants to flee a camp where they had been living under a coronavirus lockdown, The Associated Press reported early Wednesday, citing the local authorities. The restrictions were imposed last week on the Moria camp after a 40-year-old asylum seeker tested positive for the virus.

Chinas biggest air show, originally planned for November in the southern city of Zhuhai, has been canceled because of the pandemic, its organizer said on Wednesday. The cancellation of the biennial China International Aviation and Aerospace Exhibition follows that of Britains Farnborough Airshow in July and comes amid a steep downturn in the industry.

Indias Health Ministry said on Tuesday that it planned to open classrooms for high school students on a voluntary basis, and only with their parents approval, starting from Sept. 21. The vast majority of schoolchildren will continue to study online. The Taj Mahal will also open for tourism on Sept. 21, with access restricted to 5,000 people per day. India has more than 4.3 million cases overall and reported nearly 90,000 new infections on Tuesday.

Ontario, Canadas most populous province, said on Tuesday that it would take a four-week pause before it considers loosening restrictions or allowing further economic reopening. Taking a pause in further reopening will help avoid broad-scale closures and shutdowns, said Christine Elliott, Ontarios health minister. Schools across the province began reopening on Tuesday. Ms. Elliott acknowledged that schools would most likely become vectors for the virus, and said that the provinces top priority was protecting them from transmission in the community. Ontario has reported more than 43,000 coronavirus cases, according to a Times database, including 852 in the past week.

The director of the Tour de France tested positive and will quarantine for a week, the race reported on Tuesday. The director, Christian Prudhomme, had not been in direct contact with any riders, the race said, and no riders tested positive. The race started as usual on Tuesday morning. Four support staff members also tested positive. The race had said that teams would be ejected from the Tour if two members tested positive, but each of the four were from different teams. European news media reported that Mr. Prudhomme was asymptomatic. The Tour is entering its second week of three racing around France. Despite virus concerns, large crowds have turned up to watch.

Amid a surge in new cases, Turkey is requiring masks to be worn in all public places, including offices, factories and open-air spaces such as parks and beaches. The country is also reinstating limits on public transportation after images of jam-packed minibuses began circulating on social media and fights over masks broke out between drivers and passengers.

The United Nations refugee agency announced the first confirmed cases of the virus among Syrians in refugee camps in Jordan. UNHCR Jordan said that two Syrians in the Azraq camp had tested positive and were transferred to an isolation site near the Dead Sea, and that their contacts were being tested and quarantined. The camp is home to more than 36,000 people, more than 60 percent of whom are children. There are more than 650,000 registered Syrian refugees in Jordan, with most living in cities, not inside camps.

Despite a steady decline in daily cases and deaths, Egypt surpassed the 100,000 mark for total known virus cases on Tuesday. The Arab worlds most populous country, with over 100 million people, Egypt endured a partial lockdown between March and June that included a nighttime curfew; the closure of airports, restaurants and cafes; and the suspension of prayers at all places of worship. But life on the streets has been returning to normal, with most of those restrictions lifted.

Nine drugmakers pledge to thoroughly vet any coronavirus vaccine.

Nine drug companies issued a joint pledge on Tuesday that they would stand with science and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy.

The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on large, high quality clinical trials and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved, the companies said.

President Trump has repeatedly claimed that a vaccine could be available before Election Day, Nov. 3, heightening fears that his administration is politicizing the race by scientists to develop a vaccine and potentially undermining public trust in any vaccine approved.

Well have the vaccine soon, maybe before a special date, the president said on Monday. You know what date Im talking about.

Three of the companies that signed the pledge are testing their candidate vaccines in late-stage clinical trials in the United States: Pfizer, Moderna and AstraZeneca. But only Pfizer has said that it could apply to the F.D.A. for emergency approval as early as October, while the other two have said they hope to have a vaccine by the end of the year.

Late last week, Moncef Slaoui, the top scientist on Operation Warp Speed, the federal effort to quickly bring a vaccine to market, warned in an interview with National Public Radio that the chance of successful vaccine results by October was very, very low.

In the nine companies statement on Tuesday, they did not mention Mr. Trump, saying only that they have a united commitment to uphold the integrity of the scientific process.

The other six companies that signed the pledge were BioNTech, which is a development partner in Pfizers vaccine; GlaxoSmithKline; Johnson & Johnson; Merck; Novavax; and Sanofi. Plans for the pledge were first made public on Friday.

For millions of American schoolchildren, particularly in the Northeast, the Tuesday after Labor Day traditionally signals the end of summer vacation and a return to their classrooms. But this year, instead of boarding buses and lugging backpacks, most of those students are opening their laptops at home as schools commence the fall term virtually amid the pandemic.

Classes started Tuesday in some of the nations largest districts, including Chicago, Houston, Dallas and Baltimore, along with many suburbs of Washington, D.C. But almost all began the year remotely, with some still hoping to hold classes in-person several weeks from now.

In New York City, the nations largest district, teachers and staff members returned to schools on Tuesday, but the citys 1.1 million students wont arrive until Sept. 21 10 days later than initially planned. Mayor Bill de Blasio announced the shift a week ago after many educators said classrooms would not be ready to reopen this week.

In other parts of the country, including several states in the South and Midwest, schools have been open for more than a month now, resulting in a series of student quarantines and temporary shutdowns in some districts. Others seem to have reopened without major outbreaks although reporting is uneven, making cases difficult to track.

While some educators spent the summer break seeking improved online instruction, concerns have grown over the academic impact of the pandemic, which has widened racial and economic achievement gaps. In Texas, more than 100,000 children never participated in remote learning assignments last spring, according to an analysis of state data by The Dallas Morning News, and 19,000 students dropped out of contact with teachers entirely.

Several large districts in Texas that opened remotely on Tuesday have said they plan to shift to some form of in-person instruction in the coming months, if case numbers allow.

For some districts, technical glitches are also hampering instruction. The Virginia Beach school districts first day got off to a rocky start on Tuesday as an internet outage left students and parents unable to access online classes. This outage is affecting schools up and down the East Coast, the district announced in a Facebook post on Tuesday morning.

Some JPMorgan Chase employees and customers misused federal virus aid, a memo shows.

Some JPMorgan Chase employees and customers misused federal coronavirus aid money, according to an internal memo reviewed by The New York Times.

The memo, which was sent by the banks operating committee on Tuesday, said that officials had found instances of customers misusing Paycheck Protection Program loans, unemployment benefits and other government programs.

The committee, a group of senior leaders that includes its chief executive, Jamie Dimon, as well as its chief risk officer and its general counsel, did not describe any specific misconduct by employees, but it said that, in general, some of the activities officials had identified could be illegal.

We are doing all we can to identify those instances, and cooperate with law enforcement where appropriate, they wrote.

Banks played a central role in distributing much of the $2.2 trillion in aid created by the federal government under the CARES Act to help Americans deal with the economic effects of the coronavirus. They were in charge of vetting businesses seeking aid money, and they also had a hand in distributing unemployment benefits that included an extra $600 a week in federal funds.

There was never a hope of keeping fraudsters away from the money entirely, and many lenders are scrutinizing customers activities. Some determined criminals created fake businesses to take advantage of the forgivable loans offered by the Paycheck Protection Program, while others got funds using stolen identities. JPMorgan, the countrys largest bank, handed out more than $29 billion in P.P.P. loans, the most by any lender.

It is not clear how widespread the misconduct among JPMorgans employees and customers had been or how it compared with other banks.

News of the memo was reported earlier by Bloomberg.

Senate Republicans plan to move forward with a scaled-back stimulus package.

As senators returned to Washington on Tuesday, their leader, Mitch McConnell, Republican of Kentucky, announced that the Senate would vote to advance a scaled-back stimulus plan, which is expected to reinstate lapsed federal unemployment benefits at $300 per week half their previous level and allocate $105 billion for schools and funds for testing and the Postal Service, according to Republican aides familiar with the discussions.

The plan is an effort to intensify pressure on Democratic leaders, who want to fully restore the $600 unemployment benefits and have refused to consider any measure below $2.2 trillion.

It does not contain every idea our party likes, Mr. McConnell said in a statement. I am confident Democrats will feel the same. Yet Republicans believe the many serious differences between our two parties should not stand in the way of agreeing where we can agree and making law that helps our nation.

He added, I will make sure every Senate Democrat who has said theyd like to reach an agreement gets the opportunity to walk the walk.

The Republicans bill would carry a price tag of $500 billion to $700 billion, far less than the $3.4 trillion measure Democrats passed in the House and smaller than the $1 trillion measure Senate Republicans introduced in July. A procedural vote advancing the legislation could come as early as this week, Mr. McConnell said. Democrats are likely to block it.

In a joint statement, Speaker Nancy Pelosi of California and Senator Chuck Schumer of New York, the minority leader, rejected the proposal, declaring it laden with poison pills Republicans know Democrats would never support.

This emaciated bill is only intended to help vulnerable Republican senators by giving them a check the box vote to maintain the appearance that theyre not held hostage by their extreme right-wing that doesnt want to spend a nickel to help people, the two Democrats said.

Caught maskless in Indonesia? You may have to play dead.

Some offenders caught without a mask were required to lie down in a coffin. Others were ordered to sit in the back of a hearse.

As Indonesias coronavirus caseload surges past 200,000, some officials are finding creative ways to drive home the message that wearing a mask is necessary to prevent new infections.

In East Jakarta, the authorities punished several people with time in a coffin.

The coffin is a symbol to remind people not to underestimate the coronavirus, said Budhy Novian, head of East Jakartas public order agency. Its our effort to convey the message to the people: the Covid-19 number is high and it causes death.

But officials halted the practice after critics pointed out that onlookers were violating social distancing rules by crowding around to gawk and take photos.

Indonesia, the worlds fourth most populous country, passed 200,000 reported cases on Tuesday. New cases have been averaging more than 3,000 a day for two weeks, according to a New York Times database, and the death toll of 8,230 is the highest in East Asia.

Indonesia has one of the lowest rates of testing in the world, and its positivity rate is nearly 14 percent, slightly higher than Swedens and well above the 5 percent that the World Health Organization has given as a rough benchmark for relaxing social distancing measures. (A rising positivity rate can point to an uncontrolled outbreak; it can also indicate that not enough testing is occurring.)

Some independent experts suspect that Indonesias actual number of cases is many times higher than 200,000.

President Joko Widodo who first admitted withholding information about the virus to prevent panic, and later said the public must learn to live with it now says that protecting public health is the nations highest priority.

The key to our economy, for the economy to be good, is good health, he said this week. This means that our focus is still, number one, on health.

In Jakarta, the capital, officials erected a coffin-themed monument last week to highlight the rising death toll and remind people to follow coronavirus protocols.

Flouting the requirement to wear a mask in public in Jakarta is punishable by a fine of up to $67 for repeat offenders, a substantial sum for many residents.

In a South Jakarta neighborhood, local authorities recently drove a pickup truck through the streets carrying a coffin, flanked by people dressed as medical personnel. An officer called out over a loudspeaker that anyone caught without a mask would be required to spend five minutes inside.

In East Java Provinces Probolinggo Regency, an area hit hard by the virus, the authorities offered violators a choice of punishments, including sitting in a hearse next to a coffin, doing push-ups or cleaning streets, said Ugas Irwanto, the security coordinator for the regencys Covid-19 task force.

So far, he said, about 75 people had been caught and punished. Some were too scared to sit in the hearse, he said, and chose to pick up a broom instead.

Trump returns to a familiar theme: denouncing virus restrictions.

As the presidential campaign entered the post-Labor Day sprint to the finish line, President Trump returned to a familiar theme this week: minimizing the threat posed by the virus, sometimes in ways that contradict the advice of federal health authorities.

Mr. Trump took to Twitter on Tuesday morning to insist that New York City must stop the Shutdown now and then to claim that virus restrictions in other states were only being done to hurt the economy prior to the most important election, perhaps, in our history.

A day earlier he criticized a reporter for wearing a mask at a White House news conference, despite guidance from the Centers for Disease Control and Prevention that everyone should wear a mask in public settings and when around people who dont live in your household.

And at an outdoor gathering on Tuesday in North Carolina with a large crowd, where many of his supporters did not wear masks, he accused Joseph R. Biden Jr., again, of undermining scientists with anti-vaccine rhetoric because he has raised questions about whether Mr. Trump was rushing a vaccine out to help his political chances in November.

It was part of a familiar pattern for Mr. Trump, who back in March began pushing for states to reopen by Easter, on April 12. (More than 160,000 people have died of the coronavirus in the United States since Easter, according to a New York Times database.) In mid-April Mr. Trump sided with protesters who were chafing at virus restrictions, calling to LIBERATE several states including Minnesota and Virginia, which both saw cases rise in subsequent weeks. And in June he held an in-person campaign rally in Tulsa, Okla., which local health officials said likely contributed to more cases there.

The outbreak in the United States is one of the worst in the world: it has the most reported total cases, more 6.3 million, and the most reported deaths, more than 189,000, according to a New York Times database. And it has lagged other wealthy nations when it has come to taming the virus.

When many parts of the country were reeling from the virus in the spring, West Virginia was enviably quiet. It was the last of the 50 states to have a confirmed case, and its daily tallies of new cases remained low, topping 100 only once before July. But as summer comes to an end, the states fortunes have changed significantly for the worse.

Cases started climbing in July and, after a brief dip in late August, have been shooting upward since. The state announced more cases in the seven-day period ending Monday than in any other week of the pandemic.

And on one important front, Gov. Jim Justice warned at a news briefing on Tuesday, West Virginia is now worse off than any other state in the country: the number of new infections that researchers estimate are arising from each single case, a measure of spread called Rt.

We have told you a million times, were the oldest state, the most vulnerable state, the state with the most illnesses, the state with the most breathing problems, Mr. Justice said, apparently referring to research that shows West Virginias population is at particularly high risk of serious illness. We have also told you to wear your mask. And there are still some who are not wearing their mask.

After reopening for in-person instruction last month, West Virginia University announced on Monday that nearly all classes at its Morgantown campus would move online for the next two and a half weeks, because the number of confirmed cases on campus has spiked upward. The university has suspended 29 students after reports surfaced of large fraternity parties held over the holiday weekend in violation of quarantine orders.

The surrounding county has one of the worst outbreaks in the state, and is one of nine counties where elementary and secondary schools are beginning this year with entirely remote learning.

Dr. Clay Marsh, the governors coronavirus czar and the vice president for health sciences at W.V.U., said the surge was almost inevitable. Covid found its way to West Virginia, just like it found its way to every place in the world, he said in an interview.

The state has been aggressive in many ways, he said, closing its schools before New York State did, ordering universal testing at nursing homes in May and imposing a statewide mask mandate in early July.

But the virus chiseled away nonetheless: showing up in nursing homes, churches and prisons; traveling in with vacationers; and spreading quickly at newly reopened bars and restaurants.

Dr. Marsh said he was especially concerned about the foothold the virus appears to have gained in some coal-mining counties in the south of the state, where health care resources are fewer and conditions like black lung are prevalent. The sources of outbreaks in these smaller communities are less clear than in college towns, making them harder to combat.

We have done well, but we are seeing the vagaries of Covid-19, Dr. Marsh said. I dont think anybody escapes it.

Elsewhere in the U.S.:

As part of a move by New York City to promote compliance with the states 14-day quarantine requirement for many travelers, the citys sheriff, Joseph Fucito, said Tuesday that in late August his office began stopping buses before they arrived at the Port Authority Bus Terminal. Officials are boarding the buses and asking passengers to fill out the states required travel form with their contact information and quarantine plans. Under consideration was an expansion of the operation to buses that enter the city through places other than the Port Authority Bus Terminal, he said.

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Covid-19 Live Updates: Congress Returns to an Impasse Over Pandemic Aid - The New York Times

When Will We Have a Vaccine? Understanding Questions and Answers about Covid-19 Vaccination  nejm.org

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When Will We Have a Vaccine? Understanding Questions and Answers about Covid-19 Vaccination - nejm.org