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California’s Covid surge forces trial delay of Theranos Elizabeth Holmes

California's Covid surge forces trial delay of Theranos Elizabeth Holmes

Elizabeth Holmes, founder and former executive director of Theranos, arrives for a hearing in the U.S. District Court in the Federal Building of Robert F. Peckham in San Jose, California on Monday, November 4, 2019.

Yichuan Cao | NurPhoto | Getty Images

A surge in coronavirus cases in California has resulted in a four-month delay in criminal proceedings against Elizabeth Holmes, the former CEO and founder of the competitive health tech company Theranos.

In an order late Friday evening, US District Judge Edward Davila set a new hearing for the case for July 13, 2021.

“The court was vigilant to keep abreast of the nation and state impact of the COVID-19 pandemic, as well as daily life on San Francisco Bay,” the tripartite ruling reads. “Unfortunately, the court finds that the impact on our lives is grave. California is in the midst of an unprecedented increase in cases and hospitalizations.”

The judge found that California had more than 1.76 million confirmed cases of Covid-19 and 22,160 deaths as of Friday. He also indicated that the Santa Clara County hospitals where the trial would take place are nearing maximum capacity.

Davila said these terms would “affect the jury and public confidence in a personal process that is expected to take several months”.

The move comes two weeks after the judge established a reconfigured courtroom, face mask requirements for study participants, and air filtration systems to move Holmes’ trial forward.

Prosecutors say they have ample evidence that Holmes ran a multi-million dollar program to scam investors, doctors and patients about the accuracy of Theranos’ blood testing technology.

Holmes, once hailed as the next Steve Jobs, pleaded guilty to a dozen criminal offenses – expecting 20 years in prison if convicted.

“The court recognizes that continuation of the trial will cause great inconvenience to victims who wish to spend their day in court, as well as to the defendant who wants a speedy defense against the charges,” he said.

The verdict came in the wake of Holmes’ struggle to prevent prosecutors from using their personal communications with their former lawyer, David Boies, while in Theranos.

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Covid Information: The way to Get By way of the Pandemic

Covid Guide: How to Get Through the Pandemic

While the majority of Americans don’t get their shots until the spring, the introduction of the vaccine is a hopeful sign of better days. We have Dr. Anthony S. Fauci and several epidemiologists and health and science writers from The Times asked about their predictions for the coming months. Here is some of what they had to say.

When can we go to the cinema or the theater?

“It depends on the uptake of the vaccine and the level of infection in the community. If you go into April, May, June and really put a press on trial and try to vaccinate everyone within a few months as you go from the second to the third quarter of the year then you could probably go to movies, go to the theater, do what they want. However, given what we hear about people’s desire to be vaccinated, we are unlikely to receive this level of uptake. If it turns out that only 50 percent are vaccinated, it will be much, much longer before we get back to the normality we would like to see. “- Dr. Fauci

What did you learn from living in a pandemic?

“When I stay home with my kids, I’ve learned that life with fewer errands and activities to participate in is kind of nice. I think we will reduce our family obligations in the future. “- Jennifer Nuzzo, Associate Professor, Johns Hopkins

What’s one thing you’ll never take for granted again?

“I will not take it for granted to travel to my extended family.” – Alicia Allen, Assistant Professor at the University of Arizona

Will we ever go to a big, crowded indoor party without a mask again?

“If the level of infection in the community seems significant, you will not be having friends parties in congregational settings. When the level of infection is so low that the risk is tiny, you’ll go back to the normal gathering, throwing parties, and doing that. If we want to get back to normal, my message comes down to this: if the vaccine is available, get vaccinated. “- Dr. Fauci

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Moderna Covid vaccine FDA accepted for emergency use

Moderna Covid vaccine FDA approved for emergency use

The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine – the second to be approved for use in the US after Pfizer and BioNTech – strengthens the US dose supply. The potentially life-saving shots are badly needed to fight the pandemic that left more than 300,000 Americans dead and hospitals overwhelmed.

With the FDA’s approval for the emergency on Friday, the federal government’s plan to distribute approximately 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the country next week will be approved.

“We’ll probably see gunshots in the arm early next week, I hope Monday or Tuesday,” said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, on the “Today” show on Friday morning.

President Donald Trump said in a tweet: “Congratulations, the Moderna vaccine is now available!”

In addition to Moderna’s vaccine, the U.S. is planning to ship 2 million doses of Pfizer’s vaccine after 2.9 million doses were cleared for shipping this week, General Gustave Perna, who oversees logistics for the Operation Warp Speed ​​vaccination project, said Monday . Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is the first product to be approved by the FDA.

“With the availability of two vaccines to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic, which causes large numbers of hospitalizations and deaths in the US every day,” said FDA Commissioner Dr. Stephen Hahn said in a statement.

US officials hope to vaccinate at least 20 million Americans by the end of the year – mostly healthcare frontline workers and nursing home residents. The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has given states an overview recommending that health workers and nursing homes be prioritized. However, states may distribute the vaccine at their own discretion.

States are already reporting confusion about vaccination plans. In the past few days, state officials said they learned that their second shipment of Pfizer’s vaccine would be smaller than expected or delayed. In Florida, for example, Republican Governor Ron DeSantis said the federal government had told him the state would receive 205,000 Pfizer vaccine doses next week and 247,000 the following week. Those shipments are now on hold, DeSantis said at a press conference Tuesday, and it is unclear when they will arrive.

Moderna’s vaccine, like Pfizer’s, uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data released last month shows that Moderna Covid’s vaccine is more than 94% effective at preventing, safe and appearing to fight off serious diseases. For maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved Moderna’s vaccine for people aged 18 and over. Such authorization by the agency is not the same as a full authorization, which requires more data and can usually take several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval and can revoke an EEA for a drug at any time if it doesn’t work as intended or if it proves unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no evidence of benefit” in coronavirus patients.

The FDA announcement comes after a key agency advisory body voted 20-0 with one abstention on Thursday to recommend the emergency vaccine. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

Prior to the vote, some committee members stressed their approval of Moderna’s vaccine was not in favor of full FDA approval, and reiterated that the agency needed to review more data on safety and efficacy.

During the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health workers who were taking Pfizer’s vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency is looking into the problem.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “Right now we don’t have enough data to make a definitive recommendation one way or another.”

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.

The FDA said while this isn’t necessarily a side effect, it does recommend monitoring people who receive Pfizer’s or Moderna’s vaccine shots for possible cases of Bell’s palsy, a condition that causes sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.

According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week it would buy another 100 million doses of Moderna’s vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower “pandemic prices” this month. The company said it was under discussion for larger volume agreements that will have a lower price.

– CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.

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Covid vaccinations ‘received’t be chaos,’ assures Walgreens govt

Covid vaccinations ‘won’t be chaos,’ assures Walgreens executive

Rick Gates, senior vice president of pharmacy and healthcare at Walgreens, told CNBC that getting vaccines to the general public was “not a mess” as the FDA approved Moderna’s Covid-19 vaccine for emergency and plans got under way for the states to reach nearly 6 million doses by early next week.

“What you will see is that we will think very carefully about how we plan appointments, how we work with the communities we are in, in the states we are in, in priority populations to ensure that there won’t be long queues at pharmacy doors and that people will have safe, convenient and efficient ways to get vaccines, “said Gates.

Pfizer’s Covid-19 vaccine was launched in long-term care facilities on Friday, and Walgreens pharmacists gave many of those vaccinations. The federal government has agreements with Walgreens and other pharmacies, including CVS, to vaccinate millions of people across the country. In a Friday night interview with The News with Shepard Smith, Gates described how the organization’s pharmacists are trained to prepare them to effectively administer the Covid-19 vaccine.

“The safety protocol we gave our pharmacists to learn how to look for allergic reactions, how to make sure they monitor patients after vaccination, are all part of the normal process,” said Gates.

So far, according to publicly available data from 20 states, the United States has vaccinated at least 66,000 people, and that number is expected to increase dramatically as more states report their numbers. Gates acknowledged that there is a lot of organization involved in the vaccination process, but underlined that “Vaccines are what we do very consistently and that monitoring patients after a vaccine is a very common thing we do through flu shots, Shingrix or other vaccines think out there. “

Host Shepard Smith asked Gates how Walgreens would handle turning away people who come to their pharmacies to get vaccinated but are not part of a priority population. Gates said vaccines are planned in advance and not given a “walk-up” format like the flu shots. He added that Walgreens pharmacies across the country will be working with states and the Centers for Disease Control and Prevention to ensure those in need of vaccines get them. Gates added that there would also be reminders for people to get their second dose.

“For the community. We’ll have all sorts of reminders and phone calls if we have to, to make sure Americans know they need that second dose and the right time for that dose,” Gates said.

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F.D.A. Clears Moderna’s Covid Vaccine

F.D.A. Clears Moderna's Covid Vaccine

The Food and Drug Administration on Friday authorized the coronavirus vaccine made by Moderna for emergency use, allowing the shipment of millions more doses across the nation and intensifying the debate over who will be next in line to get inoculated.

The move will make Moderna’s vaccine the second to reach the American public, after the one by Pfizer and BioNTech, which was authorized just one week ago.

The F.D.A.’s decision sets the stage for a weekend spectacle of trucks rolling out as expert committees begin a new round of discussions weighing whether the next wave of vaccinations should go to essential workers, or to people 65 and older, and people with conditions that increase their risk of becoming severely ill from Covid-19.

Jockeying for the next shots in January and February has already begun, even though there is still not enough of the two vaccines for all the health care workers and nursing home staff members and residents given first priority. Uber drivers, restaurant employees, morticians and barbers are among those lobbying states to include them in the next round along with those in the more traditional categories of the nation’s 80 million essential workers, like teachers and bus drivers.

The rapid progress from lab to human trials to public inoculation has been almost revolutionary, spurred by the nation’s urgent need to blunt the pandemic that has broken record after record in U.S. deaths, hospitalizations and economic losses. In the last week alone, there has been an average of 213,165 cases per day, an increase of 18 percent from the average two weeks earlier. And the daily death toll in recent days has surpassed 3,200.

Dr. Anthony S. Fauci, the nation’s top infectious disease expert, called the advent of two vaccines “an historic moment.”

“This to me is a triumph of multiyear investment in biomedical research that culminated in something that was not only done in record time, in the sense of never before has anybody even imagined you would get vaccines to people in less than a year from the time that the sequence was made known,” Dr. Fauci said.

“This is an example of government working. It worked really well,” he added.

Moderna, a company based in Cambridge, Mass., worked with Dr. Fauci’s agency at the National Institutes of Health to create a vaccine that, along with Pfizer-BioNTech’s, shepherds in a new technology based on genetic material called messenger RNA or mRNA. In clinical trials in tens of thousands of volunteers, the vaccines proved 94 to 95 percent effective. Each requires two shots.

Both products are reaching an anxious public before vaccines made with traditional approaches, and have become even more critical as other companies’ efforts have faltered in recent months.

The emergency authorization kicks off a swift and complex drive to distribute some 5.9 million doses of the Moderna vaccine around the country, with shipping to begin on Sunday and deliveries starting on Monday. The first Moderna vaccinations could then be given hours later.

Because Moderna’s vaccine, unlike Pfizer-BioNTech’s, does not need extreme-cold storage and is delivered in smaller batches, states are hoping to provide it to less populated areas, reaching rural hospitals, local health departments and community health centers that were not at the top of the distribution list.

Three places that did not receive the Pfizer-BioNTech vaccine — the Marshall Islands, Micronesia and Palau — will receive the Moderna vaccine for that reason, according to a federal health official familiar with the government’s distribution plans.

And in contrast to Pfizer’s rollout last week, the Moderna vaccine deliveries will be managed by the federal government under the funding of Operation Warp Speed, the administration’s program to develop and distribute vaccines as fast as possible.

Supplies of a second vaccine cannot come soon enough. Several governors and state health officials said on Friday that they were dismayed to learn they would be getting less of the Pfizer-BioNTech vaccine next week than the federal government had promised.

Dr. Mark Levine, commissioner of the Vermont Department of Health, said in a Friday briefing: “All my colleagues in the region are reporting a 25 to 35 percent decrease in their allocation for next week. As we were walking in, I learned as many as 975 doses out of an expected 5,850 doses would not be coming in when we expected. That doesn’t mean we won’t be getting all of those doses. It just means they won’t be coming in when we expected.”

He added, “What everyone around the country is upset about, in addition to just the number, is there’s been no communication, so there’s no understanding of what this really means.”

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:

    • If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
    • When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
    • If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
    • Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
    • Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

Gov. Charlie Baker of Massachusetts said on Friday, “We’re certainly frustrated,” referring to the reduced number of Pfizer-BioNTech doses his state would receive next week — 42,900 instead of 59,000. Demand for the vaccine is high.

“So far, hospitals are reporting overwhelming acceptance from doctors, nurses and other workers who are eligible to be vaccinated,” he said.

Pointing out how hard hit Wisconsin has been, Gov. Tony Evers complained that the state was receiving significantly less of the Pfizer-BioNTech vaccine than it had been promised — 35,100 doses instead of 49,725. In a statement on Friday, he said, “We call on the federal government to send us more vaccine without delay.”

Because Moderna’s vaccine requires two doses, federal officials are holding another 5.9 million doses for shipment four weeks after the first wave, as the doses are spaced a month apart. The federal government also plans to reserve more than 500,000 doses in case of problems with the initial shipment.

Officials expect to inform states next week the number of doses they plan to send in the second wave of shipments.

The emergency authorization Friday was the product of an F.D.A. review process that compressed an extraordinary amount of work into weeks, and occurred at the same time regulators were poring over materials for the Pfizer-BioNTech vaccine.

The overlap led to a grueling schedule for the reviewers. Large teams organized into specialties — epidemiology, statistics and manufacturing among them — and reviewed Moderna’s application day and night once the company submitted its data in late November.

Among the review’s components were teams that examined company production facilities and clinical trial sites to affirm that records corresponded to the materials Moderna had submitted to federal regulators.

The F.D.A.’s advisory panel also had to consider new information — reports of severe allergic reactions, two in Britain and two in the United States, in people who received the Pfizer-BioNTech vaccine after it was authorized. Although that vaccine is not identical to Moderna’s, they are similar. The agency and the Centers for Disease Control and Prevention are investigating the cases, but say the vaccines can be safely administered to most people who have allergies, with careful monitoring.

The F.D.A.’s authorization also represented a capstone to a sprawling government-led effort that began in January, when scientists at the National Institutes of Health and Moderna designed the vaccine within two days of China’s releasing the genetic sequence of the new virus.

The company had never brought a product to market, giving it an underdog status as its vaccine was tested on the same timetable as Pfizer-BioNTech’s. Moderna enjoyed an unusually intimate relationship with Operation Warp Speed, which has monitored its supply on an almost hourly basis this year. The company benefited from nearly $2.5 billion in federal funds used to buy raw materials, expand its factory and enlarge its work force by 50 percent.

Public health experts and federal officials still estimate that it will be at least six months, if not longer, before most Americans can be vaccinated. And that depends on whether other vaccines in trials are successful and receive emergency approval.

The federal government is counting on building supplies from vaccines under development by several others — one from Johnson & Johnson, one from Sanofi of France and GlaxoSmithKline of Britain, and another from the British-Swedish drug maker AstraZeneca and the University of Oxford.

On Saturday and Sunday, experts advising the C.D.C. will take up Moderna’s vaccine and ultimately vote on the next tiers of people who should get the vaccines. The committee vote on Sunday will most likely set off a frenzy of difficult decision-making at the state level that could be further complicated by bumps in the vaccine production process.

Behind the scenes is McKesson, based in Irving, Texas, one of the country’s largest distributors of drugs and medical supplies. The company has a long history of distributing vaccines and is the largest distributor of the seasonal flu vaccine in the United States.

McKesson also played a central role in the opioid epidemic and is part of a group of companies closing in on a potential $26 billion settlement with state and local governments.

The company will be the main distributor of the Moderna vaccine. Pfizer-BioNTech itself is distributing its vaccine, which needs to be kept at minus 94 degrees Fahrenheit.

McKesson is also producing kits that include the supplies needed to administer both vaccines.

McKesson is assembling the kits at two of its distribution centers, one near Louisville, Ky., a major hub for UPS, and another near Memphis, where FedEx is based.

While McKesson has its own fleet of trucks, it is largely relying on FedEx and UPS to ship the kits and vaccines.

Each kit includes needles, syringes, alcohol prep pads, face shields and surgical masks, administration sheets for health care providers, and vaccination record and reminder cards for patients.

McKesson has outfitted at least two of its distribution centers with specially designed, 10,000-square-foot freezers designed to store millions of doses of the Moderna vaccine. Altogether, McKesson has added more than 3.3 million square feet of space to manage the project.

When the time comes to send the Moderna doses out, McKesson will pack the doses into coolers it sourced from Cold Chain Technologies, a company in Franklin, Mass. Those coolers will be packed with coolant packs, and then sent to administration sites via FedEx and UPS. The coolers also contain monitoring devices that indicate whether the vaccines ever got too warm.

McKesson has hired more than 1,000 people to help with the effort, and expects to hire up more than 2,500 more in the months ahead.

David Gelles, Katherine J. Wu, Sharon LaFraniere and Reed Epstein contributed reporting.

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HHS releases sweeping new report on U.S. Covid outbreak in transfer towards transparency

HHS releases sweeping new report on U.S. Covid outbreak in move toward transparency

The Department of Health and Human Services released a comprehensive new report on the state of the U.S. Covid-19 outbreak on Friday, releasing data previously only available to government employees.

The new “Community Profile Report” uses data collected by various agencies, including the Centers for Disease Control and Prevention, and the HHS Protection System to show the severity of the outbreak in different states and even counties. The first report shows that 35 states are “red,” indicating a major outbreak.

The report also names “selected high-exposure areas” where the number of new cases is increasing rapidly along with the percentage of positive tests. For example, Nashville, Tennessee, Tulsa, Oklahoma, and Somerset, Pennsylvania are high-pollution areas in the first report.

The report also identifies “Rapid Riser Counties” and displays several heatmaps that contain various statistics that are used to determine how bad the local outbreak is in counties across the country. It records, among other things, the death rates, the percentage of positive tests and hospital admissions in Covid.

It is the most comprehensive picture of the US outbreak released by the federal government about nine months after the virus spread across the country. It is a reminder that such data was withheld from the public for months while it was distributed among federal and some state officials.

Jose Arrieta, who served as the chief information officer for HHS when the government launched HHS Protect, the agency’s Covid-19 hospital data warehouse, said the new report was “certainly a step in the right direction” toward transparency. Arrieta resigned in August.

“A number of agency staff, including myself when I was there, pushed for transparency,” he said in a telephone interview on Friday. “I appreciate the fact that the data is being shared.”

Dr. Janis Orlowski, Chief Health Care Officer of the Association of American Medical Colleges, is a member of the working group for White House Health Advisor Dr. Deborah Birx, on improving HHS protection. She said she and other members had been pushing for more data to be released over the past few weeks.

“We pushed for transparency, transparency, transparency … and they are doing a good job,” she said. “I like that it’s transparent and that epidemiologists and other people can look at it and say that’s fine, but it would really be better if we knew X, Y or Z.”

HHS spokeswoman Katie McKeogh said in a statement to CNBC that at least some of the data is in one form or another in scattered reports, but this new report brings it all together.

“As you know, there are different reporting processes at the local, state and state levels, and it has taken time and effort to build consistency between these systems to present the data as you see it today,” she said in a statement opposite CNBC. “This report has been extremely valuable to the federal response and we hope it will be helpful to state and local health departments, hospitals, businesses and the public as well.”

Much of the data in the report has been distributed to governors and state officials by the White House coronavirus task force to guide local Covid-19 strategy. Many of the reports, which in public statements often paint a worse picture of the outbreak than federal officials, were received from reporters.

The new public reports are a major step towards transparency in a federal response that is largely characterized by its opaque data collection.

“We hope that making this data public will help Americans make personal choices to slow the spread,” a group of federal officials who campaigned for the report said in a statement titled “Our data is yours Data”. The group includes Heather Strosnider, Co-Head of Integrated Surveillance at CDC, Kelly Bennett, Co-Head of Integrated Surveillance in the Assistant Secretary’s Office for Preparedness and Response, Amy Gleason of US Digital Service and Kevin Duvall, Assistant Head of Data Officer at HHS .

“HHS believes in the power of open data and transparency,” they wrote. “Publicly publishing the reports that our own response teams use and using the information by others outside of the federal response will only make the data better.”

A federal conflict over data transparency began this summer when the CDC’s data infrastructure proved inadequate to meet the requirements of the Covid pandemic. For example, federal officials needed daily data on the number of Covid patients in each hospital in order to be able to make potentially life-saving decisions about the allocation of scarce resources.

Instead of working on a quick overhaul of the CDC system, HHS rolled out a new data collection system called HHS Protect this summer with the help of federal companies, including Palantir. While many in the public health sector recognized the limitations of the CDC’s data collection system, some saw it as a move by the Trump administration to phase out the CDC amid a crisis.

Orlowski said the detail of the new public report is a demonstration of what HHS Protect is capable of and a testament to the progress the U.S. has made in collecting public health data during the pandemic.

“Never waste a crisis,” said Orlowski. “As long as we don’t increase the burden on the hospital, I believe we must continue to do so.”

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Unemployment Claims Present Toll of Rising Covid Instances: Reside Updates

Vacant retail shops in Columbus, Ohio. The rate of jobless claims has been rising as coronavirus cases remain high across the country.

Here’s what you need to know:

Credit…Maddie McGarvey for The New York Times

Rising Covid-19 cases are taking a steep toll on economic activity, battering the labor market even as new vaccines offer a ray of hope for next year.

The number of Americans filing initial claims for unemployment insurance remained high last week, the Labor Department reported Thursday. After dropping earlier in the fall, claims have moved higher, and they remain at levels that dwarf the pace of past recessions.

There were 935,000 new claims for state benefits, compared with 956,000 the previous week, while 455,000 filed for Pandemic Unemployment Assistance, a federally funded program for part-time workers, the self-employed and others ordinarily ineligible for jobless benefits.

On a seasonally adjusted basis, the number of new state claims was 885,000, an increase of 23,000 from the previous week.

Consumer caution, coupled with new restrictions on business activity like indoor dining, has pummeled the hospitality industry, lodging, airlines and other service businesses. The debut of a coronavirus vaccine this week offers the prospect of relief, but until mass inoculations begin next year, the economy will remain under pressure.

“Businesses are closing, and as a result, we are seeing job losses mount — and that’s exactly what we were fearful of going into the winter,” said Rubeela Farooqi, chief U.S. economist at High Frequency Economics. “It’s going to be a challenging few months, no doubt.”

At the end of November, more than 20 million workers were collecting unemployment benefits under state or federal programs, Labor Department data indicates.

With the weakening economy as the backdrop, Republican and Democratic leaders in Congress continued talks on Wednesday on another pandemic relief bill, something that economists have warned is overdue. Without action, two key programs for unemployed workers will expire this month, cutting off benefits to millions.

“We are not moving in the right direction,” said Gregory Daco, chief U.S. economist at Oxford Economics. “With the looming expiration of benefits, it’s even more worrisome.”

Data released on Wednesday showed a 1.1 percent drop in retail sales in November, a disappointing start to the crucial holiday season. Gus Faucher, chief economist at PNC Financial Services, expects economic growth to be weak for the next few months before picking up later in 2021.

“Until we get a lot of people vaccinated, the economy will face a difficult test,” he said. “I don’t know if we will see an outright contraction or the loss of jobs, but the pace of improvement will slow markedly.”

Christian Smalls leads a workers strike at the Amazon fulfillment center on Staten Island in May.Credit…Gabriela Bhaskar for The New York Times

The National Labor Relations Board said on Thursday that it had found merit in a complaint that Amazon wrongfully fired a warehouse worker in retaliation for organizing colleagues concerned about pandemic safety conditions.

Kevin Petroccione, a congressional liaison for the National Labor Relations Board, said if Amazon did not settle, the board would file a formal complaint against the company.

Amazon did not respond to a request for comment. The finding was earlier reported by Vice.

The charge of unfair labor practices was brought by Gerald Bryson, who worked at Amazon’s warehouse in Staten Island, N.Y. Mr. Bryson had joined with other workers, including one named Christian Smalls, in a protest over safety concerns in late March after the pandemic struck. Amazon immediately fired Mr. Smalls. About a week later, Mr. Bryson protested again in the parking lot of the building.

Amazon fired Mr. Bryson about two weeks later, saying he had violated the company’s vulgar language policy during a confrontation with another worker in the second protest, according to Frank Kearl, Mr. Bryson’s lawyer.

In June, Mr. Bryson filed a case with the National Labor Relations Board, effectively saying that Amazon selectively enforced its vulgar language policy as an excuse to retaliate against Mr. Bryson for his organizing. Mr. Kearl said the agency told him of the finding late last month.

If Amazon does not reach a settlement, which could include back pay or reinstating Mr. Bryson’s job, the agency plans to file a complaint to be heard by an administrative law judge. It filed a similar retaliation complaint against Amazon in a case of a worker in Pennsylvania who protested conditions during the pandemic. That case is pending.

Do you work in an Amazon warehouse and have a labor issue? We want to hear from you. Contact the reporter of this article at karen.weise@nytimes.com.

Nearly a year after the coronavirus outbreak, the full impact of the pandemic on the U.S. economy remains unclear. Some of the most obvious indicators are in conflict: As some companies report enormous profits, the number of unemployed Americans is nearly 10 million more than it was in February, and hundreds of thousands are expected to have filed new unemployment claims last week.

The Times interviewed a rage of economists and experts who suggested looking at eight measures to understand the state of the economy that President-elect Joseph R. Biden Jr. will face on Jan. 20.

  • Wages: That wages and salaries have bounced back quickly is a sign that things are on track for a rapid recovery. During the last recession — which Mr. Biden and then-President Barack Obama inherited in 2009 — drops of wages and salaries took years to recover.

  • Unemployment for Black men: The current crisis has had a particularly negative, persistent impact on employment for Black men, who face an unemployment rate of 11.3 percent, five percentage points higher than the unemployment rate for white men.

  • Long-term unemployment: The number of Americans who are still in the labor force but have been unemployed for more than six months has been increasing since April. A sociologist with a left-leaning think tank said the rise in long-term unemployment, coupled with the fact that millions of workers have left the labor market altogether since February, indicated “a very serious problem in connecting people who are able to produce needed goods and services with the opportunity to do so.”

  • Housing costs: Home prices and rents have risen during the pandemic. But while the rising costs have strained low-income renters, the rise in housing prices typically signals strong economic growth.

  • New businesses: Even as countless businesses have been forced to close over the course of the pandemic, the increase in business applications over the last year is a sign that the economy may be adapting rather than totally seizing.

  • Spending on goods: Though the pandemic has altered Americans’ day-to-day lives, it hasn’t halted their spending as much as some feared it would. Consumption has shifted toward goods over services — buying alcohol from stores instead of from bars, for example — bucking a generational trend toward a service economy.

  • Food scarcity — More families across the country are unable to meet their basic needs for housing and food security, according to a Census Bureau survey.

Speaker Nancy Pelosi in the Capitol. After months of stalemate, congressional leaders were on the verge of cementing a stimulus deal.Credit…Anna Moneymaker for The New York Times

Top Democrats and Republicans in Congress haggled on Thursday over the remaining hurdles to an emerging $900 billion stimulus deal, with Democrats making a last-ditch effort to use the package to deliver more emergency aid to states struggling amid the pandemic.

With Congress running out of time to deliver another round of relief to Americans and stave off a government shutdown on Friday, Speaker Nancy Pelosi reported more momentum toward a compromise that could be ready as early as today.

“We made some progress this morning,” Ms. Pelosi, of California, told reporters at the Capitol. Asked if a final agreement would be announced within the day, she said: “We’ll let you know.”

The plan under discussion would provide a dose of badly needed relief after months of stalled negotiations and amid a national public health crisis that has killed more than 307,000 people.

That includes a new round of stimulus payments, probably $600, to American adults; a temporary infusion of enhanced federal jobless aid of around $300 per week; and rental and food assistance. It would also revive a loan program for struggling small businesses and provide funding for schools, hospitals and the distribution of the vaccine.

With plans to merge a final agreement with a sweeping omnibus government funding package, Congress may have to approve another stopgap spending measure to avert a government shutdown on Friday while negotiators put the finishing touches on the stimulus deal. Senator Mitch McConnell, Republican of Kentucky and the majority leader, warned Republicans on Wednesday that they should prepare to remain in Washington through the weekend.

“I hope it wouldn’t be more than 24 or 48 hours,” Senator John Thune of South Dakota, the No. 2 Republican, said of a possible stopgap bill, adding, “I really think this is coming to a close.”

Ms. Pelosi, Senator Chuck Schumer of New York, the minority leader, and Steven Mnuchin, the Treasury secretary, spoke late Wednesday evening to continue ironing out differences over the measure, a spokesman for Ms. Pelosi said, and they planned to continue talks on Thursday.

In order to reach an agreement, Republicans appear to have dropped their demand for a sweeping coronavirus liability shield for businesses in exchange for Democrats agreeing to exclude a direct funding stream for state and local governments that are facing fiscal crises, according to two officials familiar with the discussions.

But Democrats were pushing to provide billions of dollars for governors to use for health-related expenses during the pandemic — including vaccine distribution — and extend emergency federal assistance for states and local governments through the Federal Emergency Management Agency. Republicans who have fiercely opposed sending more aid to states and cities were resisting the moves, concerned about leaving FEMA with enough money for future natural disasters and about the lack of restrictions on how the funds are spent.

Some Republicans — in particular Senator Patrick J. Toomey, Republican of Pennsylvania — were pushing to curtail the Federal Reserve’s emergency lending authority, which Democrats argue would hamper the Biden administration’s ability to continue supporting the country’s economic recovery. After the Federal Reserve used such authority earlier this year after the enactment of the $2.2 trillion stimulus law, Mr. Mnuchin clawed back the remaining funds in part to offset the cost of another stimulus bill.

There is also a push to include billions of dollars in relief for theaters and venues, something that lawmakers in both parties support.

Zach Montague contributed reporting.

By: Ella Koeze·Source: Refinitiv

  • A generally upbeat mood prevailed in global stock markets on Thursday, as lawmakers from both parties in Washington signaled they were close to reaching a deal on an economic aid package, an extraordinary shift in tone from both Republicans and Democrats, and more people received a coronavirus vaccine.

  • Investors are also looking toward an economic recovery sometime next year with one coronavirus vaccine already approved in several countries, and a second close to receiving emergency approval.

  • Still, the pandemic is far from over and continuing to take a staggering human and economic toll. Claims for state unemployment insurance illustrated this on Thursday, with 935,000 filing new claims last week, the Labor Department said.

  • The market gains on Thursday were relatively small: the S&P 500 rose about half a percent in early trading. The Stoxx Europe 600 gained 0.5 percent, while the FTSE in Britain was flat. Most Asian indexes closed the day with gains.

  • In Washington, talks continued on a $900 billion stimulus plan that would provide a new round of direct payments to millions of Americans as well as additional unemployment benefits, food assistance and rental aid. Republicans and Democrats alike signaled that they were ready to coalesce around the main elements, though a final agreement hasn’t been reached.

  • The Federal Reserve chair, Jerome H. Powell, on Wednesday made a point of saying the central bank was in no mood to begin scaling back its efforts to bolster the economy. He said the Fed’s policy decisions were intended to show that policymakers would “deliver powerful support to the economy until the recovery is complete.” He said the economy would face near-term challenges, but would likely bounce back quickly once vaccines were widely available, perhaps by midyear.

Baiju Bhatt and Vladimir Tenev, Robinhood’s co-founders, in 2018. Millions of investors have turned to the app in recent years.Credit…Reuters

The Securities and Exchange Commission on Thursday said that Robinhood, the stock trading app, had misled its customers about how it was paid by Wall Street firms for passing along customer trades, the latest enforcement action against the popular platform.

Robinhood agreed to pay a $65 million fine to settle the charges, the latest blow to the company whose popularity has surged since its founding, offering commission-free trading and an easy-to-use app. Critics have said that the company relied on practices that hurt its rapidly growing base of customers, who tend to be younger and less experienced.

The charges announced on Thursday apply to Robinhood’s disclosures from 2015 to late 2018, the regulator said.

The S.E.C. had charged Robinhood with “repeated misstatements that failed to disclose the firm’s receipt of payments from trading firms for routing customer orders to them, and with failing to satisfy its duty to seek the best reasonably available terms to execute customer orders,” it said in a statement.

“Robinhood provided misleading information to customers about the true costs of choosing to trade with the firm,” Stephanie Avakian, director of the S.E.C.’s enforcement division, said in a statement. “Brokerage firms cannot mislead customers about order execution quality.”

As part of the settlement, Robinhood did not admit or deny the allegations. But Dan Gallagher, its chief legal officer, said that the company was committed to helping meet its customers’ needs. “The settlement relates to historical practices that do not reflect Robinhood today,” he said in a statement.

Millions of investors have turned to Robinhood in recent years, lured by the simple fact that the site allows investors to trade without paying commissions. Much of the retail brokerage industry has since followed suit, resulting in a surge of retail trading activity this year.

Because they do not charge commissions, brokerage firms like Robinhood make money by charging high-speed trading firms for the right to execute their clients’ orders, a practice called payment for order flow. The trading firms are willing to pay Robinhood because they can eke out incremental gains on individual trades, which because of their speed and scale add up to large amounts of money.

But that also means that the high-speed trading firms determine the price one of Robinhood’s clients would pay for shares, or what they might receive for selling stock.

The S.E.C. said that for several years, the company had failed to be transparent with customers about its use of payment for order flow. It also said that the brokerage firm had violated a duty to get customers the best possible prices for their orders, tying that failure to the high payment rates it received from trading firms in exchange for customers’ trades.

In its order summarizing the settlement, the S.E.C. said that although the company was publicly declaring that its customers were getting trading terms as good as or better than what rivals offered, internal reviews showed that was far from the case.

The federal charges come a day after regulators in Massachusetts accused Robinhood of aggressively courting and manipulating inexperienced investors and then failing to protect them. In a complaint, the Massachusetts secretary of the commonwealth, William F. Galvin, said that Robinhood focused on signing up young traders with perks like free shares, and then used “gamification” marketing techniques to persuade them to trade often.

Matt Phillips and Gregory Schmidt contributed reporting.

Google received a kernel of good news on Thursday when European Union authorities approved its acquisition of the fitness-tracking company Fitbit after a lengthy review to determine whether the $2.1 billion takeover violated antitrust laws.

European regulators had been under pressure to block the deal, first announced last year, but allowed it to move forward after Google agreed not use the health and fitness data collected from Fitbit’s wearable devices and services to target ads at internet users. Google also agreed to continue providing its free Android software to competing makers of fitness and health devices.

The announcement comes as Google faces two antitrust lawsuits in the United States. On Wednesday, 10 state attorneys general accused the Silicon Valley giant of abusing its power in digital advertising. In October, the Justice Department accused the company of using illegal tactics to maintain dominance for its search engine.

The European Commission, the E.U.’s executive body, has brought three antitrust cases against Google in recent years. The company is appealing the fines.

The central bank left its benchmark interest rate at 0.1 percent and did not increase its purchases of government bonds. Credit…Andrew Testa for The New York Times

The Bank of England, which has been battling not only a pandemic but the threat of a disruptive exit from the European Union, made no changes to its monetary policy Thursday amid signs that both threats could be receding.

The central bank left its benchmark interest rate at 0.1 percent and did not increase its purchases of government bonds. In November, at its last meeting, the bank’s Monetary Policy Committee expanded the bond purchases, a way of holding down market interest rates, by £150 billion. The bank said Thursday it would continue to aim for total asset purchases of £895 billion, or $1.2 trillion.

The bank also extended by six months a program that allows commercial banks to borrow money at or close to the benchmark interest rate, if they funnel the money to small and midsize businesses.

Successful development of vaccines against the coronavirus are “likely to reduce the downside risks to the economic outlook from Covid,” the Monetary Policy Committee said in a statement. But the committee also said growth would be “a little weaker” than policymakers expected in November because of sharper lockdowns.

Negotiators for Britain and the European Union continued to meet in Brussels on Thursday, and there were indications they had narrowed their differences, potentially averting a no-deal Brexit that would be bad for both economies, but especially Britain’s.

In one example of the potential damage, the German automaker BMW warned that it would have to significantly raise prices for cars sold in Britain if there were no deal. Nicolas Peter, the company’s chief financial officer, told German media on Wednesday that BMW would also have to raise the price of British-made Minis sold in Europe because of import and export tariffs.

  • Unilever, a major advertiser, said it would resume spending in January on U.S. ads on Facebook, Instagram and Twitter but would continue to monitor the social media platforms for hate speech, misinformation and postelection “polarization.” The company stepped away in June but said on Thursday that it was “encouraged by the platforms’ new commitments and reporting to monitor progress.”

  • Ten state attorneys general on Wednesday accused Google of illegally abusing its monopoly over the technology that delivers ads online. The state prosecutors said that Google overcharged publishers for the ads it showed across the web and edged out rivals who tried to challenge the company’s dominance. They also said that Google had reached an agreement with Facebook to limit the social network’s own efforts to compete with Google for ad dollars. Google said the suit was “baseless” and that it would fight the case.

  • Tyson Foods has fired seven workers accused of being involved in a betting pool over how many employees would get the coronavirus, the company said Wednesday. The son of a meatpacking worker who died in April filed a suit claiming that the manager of the Waterloo, Iowa, pork plant organized a “cash buy-in, winner take all” betting pool. In all, about 1,000 workers at the plant — about a third of the work force — tested positive for the virus. Tyson had hired the law firm Covington & Burling to conduct an independent investigation of the matter, led by Eric H. Holder Jr., the former U.S. attorney general.

The Pandemic’s Toll

Credit…Audra Melton for The New York TimesCredit…Audra Melton for The New York Times

There remains widespread confusion about a key element of the plan to protect some of the most vulnerable Americans against the coronavirus, report Rebecca Robbins and Jessica Silver-Greenberg for The New York Times: how nursing homes will get consent to vaccinate residents who aren’t able to make their own medical decisions.

Some states are starting vaccinations in their nursing homes this week, but a broader nationwide effort will start in earnest on Monday as CVS and Walgreens employees begin to arrive at tens of thousands of nursing homes and assisted-living facilities to vaccinate staff and residents.

A CVS executive said such residents’ legal representatives will be able to provide consent to nursing homes electronically or over the phone, but officials at multiple large nursing home chains said they were not aware of that.

If residents or their representatives have not given consent before CVS or Walgreens employees show up, it is not clear whether or when they will have another chance to be inoculated.

There is no federal requirement for people to give consent before getting vaccinated, but it is standard practice and is often needed for billing purposes. States have different requirements about how medical consent can be given and what information needs to be provided to the person who is consenting. Guidance from the Centers for Disease Control and Prevention is that residents or their representatives should receive a fact sheet about the coronavirus vaccine and then consent to receiving it.

Executives from CVS and Walgreens said in interviews that they had been planning the vaccination campaign for months and were confident it would work. “If there are concerns or challenges, we certainly are open to work with facilities to try to minimize any disruption that they may have,” said Rick Gates, a Walgreens executive leading the company’s planning.

Categories
Business

French President Emmanuel Macron checks optimistic for Covid

French President Emmanuel Macron tests positive for Covid

French President Emmanuel Macron, wearing a protective face mask, watches as he makes a statement alongside Estonian Prime Minister Juri Ratas after his meeting at the Elysee Palace on October 28, 2020 in Paris, France.

Chesnot | Getty Images News | Getty Images

French President Emmanuel Macron tested positive for Covid-19, his office announced on Thursday, prompting several other European officials to go into quarantine. It comes just days after France began easing restrictions on the pandemic.

The diagnosis was made “as soon as the first symptoms appeared,” Elysee Palace said in a brief statement that did not provide details of his symptoms. “In accordance with health directives that apply to everyone, the President of the Republic will isolate himself for 7 days.”

Macron, who turns 43 next week, will continue to work remotely, the statement added.

His 67-year-old wife, Brigitte, will also self-isolate, but she has not reported any Covid symptoms, her office said.

French Prime Minister Jean Castex (55), Spanish Prime Minister Pedro Sanchez (48), Portuguese Prime Minister Antonio Costa (59) and European Council President Charles Michel (44) said they were being quarantined because they were in the past Days of contact with Macron.

Sanchez, who had lunch with Macron on Monday, said he would cease all public activities until Christmas Eve.

Macron also met with Angel Gurria from the OECD this week. The French president hosted a cabinet meeting on Wednesday.

Covid curfew

France has registered more cases of the coronavirus than any other European nation, trailing only the US, India, Brazil and Russia for the highest number of infections in the world.

According to the Johns Hopkins University, more than 2.4 million people in France have been infected with Covid, including 59,472 deaths.

Champs-Elysees Avenue and the Arc de Triomphe can be seen after the Christmas lights were turned on on November 22, 2020 in Paris, France.

Xinhua News Agency | Xinhua News Agency | Getty Images

Earlier this week, Macron relaxed a six-week ban on movement with a curfew from 8 p.m. to 6 a.m. until mid-January, with the exception of Christmas Eve.

The public health measures stipulate that museums, theaters, cinemas, bars and restaurants must remain closed at least until January.

French ski resorts will also remain closed, but Macron said the hugely popular tourist attractions may reopen “on favorable terms” from next month.

Johnson from Great Britain wishes Macron a “speedy recovery”

Macron is one of several world leaders who tested positive for the coronavirus this year, including US President Donald Trump, Brazilian President Jair Bolsonaro and British Prime Minister Boris Johnson.

Johnson, who was admitted to intensive care during his personal battle with Covid in April, said via Twitter that he was sorry to hear Macron tested positive for Covid and wished him a speedy recovery.

The UK’s post-Brexit transition period ends on December 31, and there is pressure on talks between the UK and the EU to reach a trade deal by then.

The EU and the UK Parliament have to ratify an agreement if there is an agreement.

One of the sticking points was fishing rights, with Macron pushing for guaranteed access to British fishing waters. The UK has now insisted that a new fisheries agreement must be based on the understanding that “British fishing grounds are primarily for British boats”.

Categories
Health

FDA authorizes Abbott’s fast $25 Covid take a look at for at-home use

FDA authorizes Abbott's rapid $25 Covid test for at-home use

Abbott Laboratories BinaxNow kit

Abbott Labs

The Food and Drug Administration announced on Wednesday that it has approved Abbott Labs’ rapid Covid-19 test for home use, despite doctors having to prescribe the test for patients.

The test, which is an antigen test that gives results in about 15 minutes, was previously only approved for trained personnel. With the new release, however, patients can test themselves at home with the virtual support of a doctor. It is the third test approved in the US that “can be used entirely at home,” said Dr. Jeff Shuren, director of the FDA Center for Devices and Radiological Health, in a statement.

Abbott has partnered with telemedicine provider eMed to deliver the test, which is called BinaxNOW and costs $ 25 for home use, at home and oversee the collection and testing process. Patients collect the sample themselves with a nasal swab and an app helps control the testing process and deliver results, Abbott said.

Anyone 15 years or older who is suspected of having Covid-19 by their doctor and who is within the first seven days of symptoms appearing can take the test, according to the FDA. The test can also be used on people 4 years and older, although an adult must collect the sample, the agency said.

“The FDA continues to approve COVID-19 tests, which will give more Americans access to more testing flexibility and options,” said FDA Commissioner Dr. Stephen Hahn in a statement. “The BinaxNOW COVID-19 Ag home test will have a significant manufacturing base and have the potential to support testing for millions of people.”

Abbott expects to run 30 million tests at home in the first quarter of 2021 and another 90 million in the second quarter. The FDA noted that antigen tests are not as accurate as many molecular tests.

“As the pandemic has developed, the need for rapid tests has grown. Unfortunately, we still hear that many people cannot access tests as quickly as they need,” said Robert Ford, Abbott President and CEO, in one Explanation. “That’s why Abbott is bringing our BinaxNOW rapid test and our NAVICA platform home.”

The FDA first approved the test for use by trained personnel in August, touting it as the first Covid-19 test, costing about $ 5 and providing results in minutes on a test card without laboratory equipment, similar to a pregnancy test. The US quickly bought 150 million of the tests for $ 750 million to expand testing capacity.

However, it costs $ 25 to use the test at home, more than what it costs in medical facilities, Abbott said Wednesday.

“The FDA’s approval of the BinaxNOW card test for home use means we should be running tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their homes,” said Alex Azar, Minister of Health and human services, in a statement on Wednesday.

Approval comes after the FDA approved Ellume’s home Covid test on Tuesday. This product has been approved for use on individuals aged 2 years and over and does not require a prescription.

Categories
Health

Well being Care Employee Had Critical Allergic Response After Pfizer’s Covid Vaccine

Health Care Worker Had Serious Allergic Reaction After Pfizer's Covid Vaccine

WASHINGTON – Two health care workers at the same Alaska hospital developed reactions just minutes after receiving the coronavirus vaccine from Pfizer this week, including a worker who was supposed to stay in the hospital until Thursday.

Health officials said the cases would not disrupt their plans to launch vaccines and that they would share the information for the sake of transparency.

The first worker, a middle-aged woman with no history of allergies, had an anaphylactic reaction that began 10 minutes after receiving the vaccine at the Bartlett Regional Hospital in Juneau on Tuesday, a hospital official said. She had a rash over her face and trunk, shortness of breath, and an increased heart rate.

Dr. Lindy Jones, the hospital’s emergency room medical director, said the worker was first given a shot of adrenaline, a standard treatment for severe allergic reactions. Her symptoms subsided, but then came back and she was treated with steroids and an adrenaline drop.

When the doctors tried to stop the drip, her symptoms reappeared, so the woman was taken to the intensive care unit, which was observed all night, and then taken off the drip early Wednesday morning, Dr. Jones.

Dr. Jones had said earlier Wednesday that the woman should be discharged that evening, but the hospital said late Wednesday that she would be staying one more night.

The second worker received his shot Wednesday and developed eye swelling, lightheadedness and a sore throat 10 minutes after the injection, the hospital said in a statement. He was taken to the emergency room and treated with adrenaline, Pepcid, and Benadryl, though the hospital said the reaction wasn’t anaphylaxis. The worker was back to normal within an hour and was released.

The hospital, which had given a total of 144 doses on Wednesday night, said both workers didn’t want their experience to negatively impact others who line up for the vaccine.

“We have no plans to change our vaccination schedule, dosage, or treatment regimen,” said Dr. Anne Zink, Alaska’s chief medical officer, in a statement.

Although the Pfizer vaccine was shown to be safe and 95 percent effective in a clinical trial of 44,000 participants, the Alaska cases are likely to heighten concerns about possible side effects. Experts said developments could lead to calls for stricter guidelines to ensure recipients were carefully monitored for side effects.

Dr. Paul A. Offit, a vaccine expert and a member of an outside advisory panel that recommended the Food and Drug Administration approve Pfizer’s emergency vaccine, said the appropriate precautions have already been taken. For example, he said, requiring recipients to remain in place for 15 minutes after receiving the vaccine helped ensure that the woman was treated quickly.

“I don’t think this means we should take a break,” he said. “Not at all.” But he said the researchers need to find out “which component of the vaccine is causing this response”.

Dr. Jay Butler, a leading infectious disease expert with the Centers for Disease Control and Prevention, said the situation in Alaska showed that the surveillance system was working. The agency has recommended that the vaccine be given in environments where oxygen and adrenaline are available to treat anaphylactic reactions.

Millions of Americans are expected to be vaccinated with the Pfizer vaccine by the end of the year. As of Wednesday evening, it was unclear how many Americans had received it so far. Alex M. Azar II, the secretary for health and human services, said his department would release these data “several days or maybe a week later.”

The Alaska woman’s response was believed to be similar to the anaphylactic reactions two health workers in the UK had after receiving the Pfizer BioNTech vaccine last week. How they both recovered.

These cases are expected to occur Thursday, when FDA scientists are due to meet with the agency’s external panel of experts to decide whether regulators should recommend Moderna’s Covid-19 vaccine for the emergency.

Although the Moderna and Pfizer-BioNTech vaccines are based on the same technology and are similar in their ingredients, it is not clear whether an allergic reaction to one vaccine would occur with the other. Both are made up of genetic material called mRNA, which is trapped in a bubble of oily molecules called lipids, although they use different combinations of lipids.

Dr. Offit said the bladders in both vaccines are coated with a stabilizing molecule called polyethylene glycol, which he saw as a “prime candidate” for causing an allergic reaction. He stressed that further research was needed.

Pfizer’s study did not identify serious adverse events from the vaccine, although many participants experienced pain, fever, and other side effects. The Alaskan reactions were thought to be related to the vaccine because they came on so quickly after the shot.

A Pfizer spokeswoman, Jerica Pitts, said the company doesn’t have all the details of the Alaska situation but is working with local health officials. The vaccine contains information that indicates that medical treatment should be available in the event of a rare anaphylactic event, she said. “We will closely monitor any reports suggestive of serious post-vaccination allergic reactions and update the labeling language as necessary,” said Ms. Pitts.

After workers in the UK fell ill, authorities there warned against giving the vaccines to anyone with a history of severe allergic reactions. They later clarified their concerns and changed the wording of “severe allergic reactions” to mean that the vaccine should not be given to anyone who has ever had an anaphylactic reaction to a food, medicine, or vaccine. That type of response to a vaccine is “very rare,” they said.

Pfizer officials said the two Britons who had the reaction had severe allergies in the past. A 49-year-old woman has had egg allergies in the past. The other, a 40-year-old woman, had a history of allergies to several drugs. Both wore EpiPen-like devices to inject adrenaline in the event of such a reaction.

Pfizer has said that its vaccine does not contain egg ingredients.

The UK update also said a third patient had a “possible allergic reaction” but did not describe it.

In the United States, federal regulators on Friday gave adults ages 16 and older full approval for the vaccine. Healthcare providers have been warned not to give the vaccine to anyone with a “known history of a severe allergic reaction” to any component of the vaccine. This is a standard warning for vaccines.

Due to the UK cases, FDA officials have announced that they will require Pfizer to step up surveillance for anaphylaxis and provide data on it once the vaccine continues to be used. Pfizer also said that it was recommended that the vaccine be given in environments with access to anaphylaxis treatment equipment. Last weekend, the CDC said people with severe allergies could be safely vaccinated, with close monitoring 30 minutes after receiving the shot.

Anaphylaxis can be life-threatening, with difficulty breathing and drops in blood pressure that usually occur within minutes or even seconds of contact with a food or drug or even a substance such as latex that the person is allergic to.

Carl Zimmer contributed to the reporting.