Tag: Testing

Categories
Health

What to Know About Testing and Vaccine Necessities for Journey

What to Know About Testing and Vaccine Requirements for Travel

Celebrity Cruises, due to be the first U.S. cruise ship to resume operations on June 26 from Fort Lauderdale, Florida, said it was optimistic that a solution would be found in time. Guests 16 and over must be vaccinated while children are tested at the terminal.

Carnival Cruises announced Monday that its first ship would set sail from the port of Galveston, Texas on July 3 and would only be available for vaccinated passengers. Norwegian, which will operate cruises from Miami starting in August, said it would request it by October 31st and has threatened to skip the ports of Florida if the state doesn’t allow cruise lines an exception to the law banning vaccination.

Christine Duffy, President of Carnival Cruise Line, said in a statement on June 7th that “the current CDC requirements for cruises with an unvaccinated guest base will make it very difficult to deliver the experience our guests have come to expect, especially given that it is the great number “. from families with younger children who sail with us. “

“So our alternative is to operate our ships from the US with vaccinated guests in July,” she said.

But even if you are vaccinated, you need to consider the requirements of the country where the cruise is disembarking. The Caribbean island of St. Maarten, for example, where Celebrity Cruises started sailing on June 5th, requires a negative test in addition to proof of vaccination.

This also depends on where you are going, but a good rule of thumb is to have your physical vaccination card (if you have one) and proof of a negative test if necessary.

Mr. Alexander, the travel agent, recommends bringing the original documents with you. While a number of digital health certificates – showing vaccine status and test results – are in the works, he said, they are not yet widely accepted. You should also check that your document is in the correct language. For example, the UK requires test results to be in English, Spanish or French.

Categories
World News

China’s Guangzhou fights Delta Covid variant with lockdowns, mass testing

China's Guangzhou fights Delta Covid variant with lockdowns, mass testing

People wait in lines for nucleic acid tests in Guangzhou, China on May 26, 2021.

Visual China Group | Getty Images

GUANGZHOU, China – Authorities in southern China’s Guangdong Province are conducting mass tests and have closed areas to control a flare-up of coronavirus cases in Guangzhou.

The city has cited the delta variant of the coronavirus, which was first discovered in India, as the driver behind the surge in cases reported since late May. The Delta Tribe is known to be highly transmissible.

Guangzhou, a city of over 15 million people and the provincial capital, reported 96 of the over 100 cases in Guangdong Province in this latest outbreak.

China, where the coronavirus first emerged last year, has quickly got the epidemic under control and has had very few cases in the past 12 months. However, clusters have emerged in parts of the country, including major cities such as the capital Beijing and the financial center of Shanghai.

The cases in Guangzhou may be even more worrying as it is the delta strain of the coronavirus, which can spread very quickly.

Lock

A 75-year-old woman in Liwan, a district of Guangzhou to the west of the city, was the first confirmed case of the Delta variant on May 21. She went to a restaurant and eventually infected her husband. The most recent infections started from there and have since spread to other areas of the city.

Liwan, still the hardest hit district, has strictly closed certain streets. Some areas do not allow people into a certain zone and residents are not allowed to leave their building. Checkpoints have been set up 24 hours a day to monitor movement in and out of these areas.

Restaurants and entertainment venues have also been closed.

But the virus has also spread to other parts of the city and province. Foshan, a city southwest of Guangzhou, has reported cases. On June 6th, six members of the same family in Guangzhou’s Nansha District tested positive for the coronavirus. On Sunday, a positive case was found at the Chinese technology center in Shenzhen, home to companies like Huawei and Tencent.

In other areas of Guangzhou that are less affected by the recent accumulation of cases, some restaurants and bars have started offering take-away meals.

Mass tests, travel restrictions

After the first case was found, Guangzhou first conducted mass tests in Liwan, which have since been expanded to other areas.

In the central business district known as Zhujiang New Town, residents were asked between Friday and Sunday to take a test at a location near their homes.

One such test site, which was set up on a street full of bars and restaurants, had huge lines on Friday.

Guangzhou performed over 16 million tests at midnight between May 26 and June 5.

In Guangzhou, the authorities have imposed stricter travel restrictions. Some metro stations in the city are closed. The authorities have asked people not to leave the city. However, if residents must leave the province, they should have a negative nucleic acid test within 48 hours of their departure. Previously, travelers had a 72-hour window.

Hundreds of domestic flights from Guangzhou’s Baiyun International Airport have also been canceled.

Driverless cars that carry supplies

Guangzhou has become a hub for driverless automakers to test their vehicles on public roads. And since Liwan is blocked, these companies transport goods to Liwan with their autonomous vehicles.

Guangzhou-based WeRide has used its autonomous bus to transport groceries to Liwan. Pony.ai, another autonomous driving company, has sent its vehicles to Liwan with supplies.

Chinese internet giant Baidu also used its autonomous vehicles to bring food and medical personnel to the affected areas.

Categories
Health

Theranos is historical past, however massive blood testing breakthroughs are coming

Theranos is history, but big blood testing breakthroughs are coming

Medical researchers say within a few years major breakthroughs in blood testing technology that use immune system response and genetic analysis to identify disease quickly and cost-effectively will be on the market.

picture alliance | picture alliance | Getty Images

One morning last May, Tayah Fernandes’s mother Shannon realized her four-year-old daughter was seriously unwell, and rushed her to the nearest ER in the English city of Manchester. The coronavirus had crashed onto Britain’s shores weeks earlier, and emergency doctors were initially uncertain how best to treat Tayah’s constellation of symptoms, which included stomach pains and a bright red rash.

They gave her antibiotics for a suspected bacterial infection, but her condition only worsened, her fever spiking. For her parents, for any parents, this was the ultimate medical nightmare; doctors in the dark for days over the cause of their daughter’s illness.

Eventually, after further blood tests, physicians decided Tayah was suffering from an unusual inflammatory syndrome that pediatric infectious disease specialists had only just started to see, but suspected had links to Sars-COV-2.

Young patients across the U.K. and U.S. were arriving in intensive care units with symptoms similar to another disease doctors already recognized, called Kawasaki. But they had no guarantee that the same course of treatment — injecting a solution of donors’ antibodies into the bloodstream — would prove successful.

In Tayah’s case the antibodies solution, known as immunoglobulin, worked, to her parents’ relief. But at around that same time last May a team of researchers at Imperial College, London confirmed through complex analyses of blood samples, taken from patients like Tayah, that this was indeed a new disease, distinct from Kawasaki.

Hunting inside immune system response to bacteria, virus

A related breakthrough in that same laboratory, focused specifically on the way individual genes behave, could have seismic implications for a multi-billion dollar diagnostics sector that has received unprecedented attention from patients, regulators and the business world over the course of this pandemic.

A new method for identifying a specific illness from blood samples relies on the correlation between the activity in small set of genes, which represents the immune response, and specific pathogens that cause a specific disease — just as the poliovirus causes polio, the coronavirus (SARS-COV-2, a pathogen) causes Covid-19. Scientists believe that by studying a small number of genes, they can quickly discern which pathogen is in a patient’s system, what disease they have, and so how best to treat them. 

Companies from small research university spin-offs to industry giants like Abbott Laboratories and Danaher’s Cepheid are looking to build on two decades of research into the way our own immune systems naturally respond to foreign substances in our bodies, including pathogens like bacteria or viruses. A current technology like Cepheid’s GeneXpert technology is able to distinguish between the different RNA of various viruses, such as SARS-COV-2, or a particular influenza strain, but experts say it’s become increasingly clear that our body’s immune systems can be faster, more accurate detection systems. 

Historically, doctors have had to rely on a patient’s case history and symptoms to narrow down the cause of an illness and develop a treatment plan. More recently, laboratory inspections at the molecular level such as the Cepheid technology have allowed clinicians to identify specific pathogens in nasal mucus, throat swabs or blood samples that might have caused an illness. But hunting for bacteria or a virus in this way can be time-consuming, costly and sometimes simply ineffective. The specific RNA signature of a virus can be hard to detect.

Abbott and Cepheid did not respond to requests for comment.

More from CNBC’s Healthy Returns

The team at Imperial College, London, working separately but at the same time as several counterparts around the world, are now convinced that future diagnoses can soon be conducted using table-top tests that will take just a matter of minutes.

These tests would not explicitly screen for a specific pathogen, but instead, allow scientists and medical professionals to simply watch how specific genes in the body are behaving as an indication of how an immune system is already responding to a pathogen that may not be easily otherwise detectable. 

Imperial College professor Mike Levin currently leads an ongoing European Union-funded study focused on this potential, called “Diamonds.” In recent years he and other scientists have shown how the observed activity in a small number of our genes can work as a kind of shorthand for our body’s immune response to a pathogen. If a handful of specific genes out of thousands in a blood sample are seen to be activated — or the opposite, inhibited — it can indicate that a person is preparing to fight off a specific pathogen.

We think this is a completely revolutionary way of doing medical diagnosis.

Imperial College professor Mike Levin

Levin and colleagues already have a proof of concept for this diagnostic approach after studies involving thousands of patients with fever caused by tuberculosis, and hundreds of Kawasaki patients. And his Imperial College team’s work with the “Diamonds” study are starting to bear fruit and could help identify the distinct immunological markers of illnesses like the coronavirus-linked multi-system inflammatory syndrome in children like Tayah Fernandes, now commonly known as MIS-C. 

When Covid-19 turned up in multiple locations, with MIS-C in its wake, it presented Levin and his researchers with an unprecedented opportunity to test this technique on an entirely new disease.

In the future, these tests — by relying on huge amounts of data and machine learning — should be able to produce multi-class rather than just binary results. This means they could confirm not only if a pathogen is bacterial or viral, or whether someone has a specific disease or not, but could distinguish which one of a multitude of illnesses is afflicting their patient.

In short, Levin expects that by examining the behavior of a relatively small number of genes, clinicians will be able to assign patients to all the major disease classes within an hour.

“We think this is a completely revolutionary way of doing medical diagnosis,” Levin said. He expects the research will provide the basis for new technology, but has no financial interest in any business related to it. 

Rather than what he calls the “stepwise process” of first eliminating bacterial infections, treating for the most common conditions, and then doing more investigation, “this idea is the very first blood test can tell you, has the patient got an infection or not an infection, and what group of infection that is, right down to the individual pathogens.”

Purvesh Khatri, an associate professor at the Stanford Institute for Immunity, Transplantation and Infection and Department of Medicine, says our immune systems have been evolving for millennia to combat pathogens, and so it may prove more effective, and efficient, to examine the response of our bodies.

“We didn’t have a technology, until now, that could measure a set of genes in a rapid point of care way,” he said. “But in the last couple of years, there have been enough technologies available that now allow us to measure a few genes in a rapid multiplex point of care assay way.”

While neither the FDA nor any European regulators have approved these kinds of gene-based pathogen detection systems, Khatri, who is helping launch a related commercial venture, says they’re coming soon. “In the next year or two, there will be several that will be available on the market.”

Stay connected with Healthy Returns

For a front row seat at CNBC Events, you can hear directly from the visionary executives, innovators, leaders and influencers taking the stage in “The Keynote Podcast.” Listen now, however you get your podcasts.

For more exclusive insights from our reporters and speakers, sign up for our Healthy Returns newsletter to get the latest delivered straight to your inbox weekly.

Categories
Health

U.S. begins research testing mix-and-match Covid vaccine doses

U.S. begins study testing mix-and-match Covid vaccine doses

A healthcare doctor prepares a dose of Johnson & Johnson’s Coronavirus Disease (COVID-19) vaccine for a commuter during the opening of MTA’s public vaccination program on the 179th Street subway station in the Queens borough of New York City in front. USA, May 12, 2021.

Shannon Stapleton | Reuters

The National Institutes of Health announced Tuesday that they had started an early-stage clinical trial looking into what happens when an adult fully vaccinated with a type of Covid-19 vaccine like Pfizer’s is boosted with another vaccination about three to four months later.

The study will enroll approximately 150 adults who have received any of the three Covid vaccination regimens currently available under the Food and Drug Administration’s emergency approval: Johnson & Johnsons, Moderna, or Pfizer.

Federal health officials said people who have not yet received an approved vaccine are also eligible to enroll in a separate group for the study. These volunteers will receive two doses of the vaccine from Moderna and will receive a booster dose of one of the three vaccines around 12 to 20 weeks later, officials said.

“Although the vaccines currently approved by the US Food and Drug Administration offer strong protection against COVID-19, we must prepare for the possibility that booster vaccinations will be required to counter declining immunity and step up with an evolving virus said Dr Fauci, director of the National Institute of Allergy and Infectious Diseases, a member of the NIH.

“The results of this study are intended to inform public health policy decisions about the potential use of mixed vaccination schedules in the event that booster doses are indicated,” he added.

The study is taking place as drug makers and some scientists are now saying that people will likely need a booster dose of the Covid-19 vaccines and possibly additional vaccinations every year, just like they did with seasonal flu.

Pfizer and Moderna’s Covid-19 vaccines currently require two doses three to four weeks apart, while Johnson & Johnson vaccines only require one prick. All three vaccines have been shown to be highly effective against Covid, although company executives now expect this strong protection to wear off over time.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said last month that Covid-19 booster vaccinations could be required for fully vaccinated individuals within a year.

“So, hopefully, you know, it would be nice if it turned out it would be a year before someone needed a refresher,” said Marks on the 18th of school and junior journalists.

“But we still don’t know,” he added. “It could be more, it could be a little less, but … that’s just something we need to find out over time.”

Each vaccine group in the NIH study will enroll about 25 people ages 18 to 55 and about 25 people ages 56 and older.

Twelve to 20 weeks after their initial vaccination, participants in the study will receive a single booster dose of the Moderna vaccine.

Categories
Health

Mount Sinai Seeks to Develop Faculty Virus Testing Program

Mount Sinai Seeks to Expand School Virus Testing Program

Every week, students at KIPP Infinity Middle School, in West Harlem, file into a large auditorium and take their places on the designated floor markings, making sure to stand six feet apart. Then they pull down their masks and fill sterile tubes with their spit.

The school’s teachers try to make the experience fun, running competitions to see who can fill their tube fastest and holding dance contests while students wait for their classmates to finish.

“It’s kind of enjoyable,” said Bradley Ramirez, a seventh grader at the school who likes math and Minecraft. “It’s way better than just sticking a stick up your nose.”

Bradley and his classmates are participants in a coronavirus testing pilot program created by the Mount Sinai Health System, the nonprofit Pershing Square Foundation and KIPP NYC, a network of 15 local charter schools. Since early March, the program has conducted more than 13,000 saliva-based tests of KIPP students, teachers and staff members, identifying several dozen cases of the virus.

Now Mount Sinai and Pershing Square are hoping to expand. On Tuesday they announced the Mount Sinai Covid Lab initiative, inviting additional charter schools, as well as local businesses and organizations, to sign up for the saliva-based testing program. They are putting the finishing touches on a new laboratory that they say will be capable of processing as many as 100,000 coronavirus tests a day and are preparing a formal proposal to take the program to New York City’s public schools this fall.

The announcement comes the day after Mayor Bill de Blasio said that the city planned to fully reopen schools, eliminating remote learning, in the fall.

“The way you keep a school safe, the way you make teachers feel comfortable with the reopening of schools, the way you make parents feel comfortable sending their kid, is you have a testing program,” said William A. Ackman, a hedge fund manager who founded the Pershing Square Foundation.

The testing program originated in December, when Mr. Ackman decided that he wanted to find a way to get New York City children back to school and approached Mount Sinai with a proposal: What if he provided funding for the hospital to build a laboratory that could process 100,000 coronavirus tests a day? The hope was that the lab could devote some of that capacity to corporate clients, such as businesses that wanted to test their employees, and use the revenue to fund wide-scale testing for New York City schoolchildren.

Mount Sinai quickly agreed. “We began on a concerted effort that people at Mount Sinai have really rallied around,” said Dr. David Reich, president and chief operating officer of Mount Sinai Hospital. “It’s just one of those projects where you never have to worry about people wanting to show up for your Zoom meeting — they’re all there, and they’re all smiling.”

The Pershing Square Foundation, whose trustees are Mr. Ackman and his wife, Neri Oxman, agreed to provide $20 million, and Mount Sinai began to convert an old laboratory space at its downtown campus into a high-volume coronavirus test processing center.

At the time, scientists at Mount Sinai’s Icahn School of Medicine were among a number of groups across the country that were working to develop saliva-based coronavirus tests. The gold standard diagnostic tests are known as P.C.R. tests, which can detect even minute amounts of the virus in biological specimens. During the early months of the pandemic, these tests generally required medical professionals to stick a swab deep into a patient’s nasopharynx, a procedure that can be deeply uncomfortable and put clinicians at risk.

Saliva-based P.C.R. tests, many scientists came to believe, would be safer and less invasive. They would also be much more suitable for young children than the deep, nasopharyngeal swabs. “A brain scoop, for a kid? Really? That’s a no-no,” said Dr. Alberto Paniz-Mondolfi, a pathologist at Mount Sinai who led development of the new saliva test.

As the partnership between Mount Sinai and Pershing Square began to take shape, Dr. Paniz-Mondolfi and his colleagues accelerated their work, validating their saliva test in 60 adult patients. But they knew that in the real world, children could not always be relied upon to follow clinical procedures to the letter.

“When we start getting this from the schools, we’re going to have pieces of pretzels, old gum floating in the saliva,” Dr. Paniz-Mondolfi said.

Updated 

May 25, 2021, 8:22 p.m. ET

So Dr. Paniz-Mondolfi and his colleagues asked their own children to make a sacrifice for science: to snack on an array of junk food, including pizza and Oreos, and then spit into some testing tubes. Using these samples, the researchers confirmed that even if a student’s sample was contaminated with one of these foods, the tests should still work properly.

“This was practical science, designed by parents to get their kids back to school,” Dr. Paniz-Mondolfi said.

Then it was time to pilot the tests in a real school environment. In January, Mount Sinai connected with KIPP NYC, which had been offering remote instruction since last spring. But it was hoping to reopen its schools in March, and administrators knew they would need to do some kind of in-school virus testing.

“One of the biggest fears that we had was around what it would mean to keep students safe,” said Glenn Davis, the principal of KIPP Infinity Middle School.

Mount Sinai and KIPP NYC agreed to begin a pilot saliva-testing project at five schools. The testing program, which eventually grew to include nine KIPP schools, was free for the schools and mandatory for all students who opted to return to in-person learning. (Some families chose to continue with remote education.)

Students, teachers and staff members are tested once a week. Medical assistants from Mount Sinai supervise the saliva collection and pack the bar-coded tubes into coolers for transportation back to the laboratory. (The samples are currently being processed at an existing Mount Sinai lab, but will be sent to the new lab when it opens next month.)

During the pilot project, 99.2 percent test results were returned within 24 hours, Mount Sinai says. Students or staff members who test positive typically have to quarantine for 10 days.

If a student tests positive, Mount Sinai also offers to send a team of “swabbers” to his or her home to administer free coronavirus tests to their family members and close contacts.

“We’ve detected a few mini outbreaks in that fashion, and hopefully prevented them from spreading by virtue of this screening program in the schoolkids,” Dr. Reich said.

Between March 10, when the pilot project began, and May 9, Mount Sinai conducted 13,067 tests and identified 46 coronavirus cases, a positivity rate of 0.4 percent. There have been no false positives and no known false negatives, Mount Sinai says.

The Mount Sinai team has submitted the data to the Food and Drug Administration, hoping to receive an emergency use authorization for the test.

Later this week, Mount Sinai will submit a formal proposal to New York City to take its testing program to the city’s public schools when they reopen in the fall. Mount Sinai declined to disclose the terms of the proposal, including what it plans to charge schools for the tests, but says it hopes to attract commercial clients to help defray, or possibly even eliminate, costs for schools.

In the meantime, it is approaching other charter school organizations in the city about using its tests during their summer sessions and programs.

“We can’t just sit there when this lab goes live in June and say, ‘OK, we’re waiting for September,’” Dr. Reich said. “Before the fall, we need to be doing a lot of tests.” The lab will initially have the capacity to run 25,000 tests a day, with the ability to scale up to 100,000 if there is sufficient interest.

For its part, KIPP NYC plans to expand the program to all of its schools in the fall, although the testing frequency may change, said Efrain Guerrero, managing director of operations for KIPP NYC. “I think parents see it and staff see it as just an additional safety measure that they appreciate,” he said. “For us it’s a no-brainer to continue to test at some frequency.”

Olga Ramirez, Bradley’s mother, had not initially wanted him to return to in-person learning. “I was very afraid at first,” she said. But Bradley, who desperately wanted to go back to school, managed to convince her, with the help of an informational video about the Mount Sinai testing program.

Ms. Ramirez now thinks that returning to school was the right decision. Bradley’s virus tests have all come back negative, and his grades are up since returning to in-person learning.

“I’ve seen his grades improve quite a lot, and I feel that my son is in good hands,” she said. She’s not alone, she added. “There’s so many mothers who are feeling the way I do.”

Elda Cantú contributed translation.

Categories
Health

Air flow and Testing Can Assist Maintain U.S. Faculties Open in Fall, Research Counsel

Ventilation and Testing Can Help Keep U.S. Schools Open in Fall, Studies Suggest

Several measures to mitigate Covid-19 – including improving ventilation, requiring adults to wear face masks, and taking frequent surveillance tests – can help keep schools open and students safe, according to two new studies.

The studies, released on Friday, come as many school districts work out their plans for the fall. They also follow guidelines from the Centers for Disease Control and Prevention that all schools teaching students from kindergarten through 12th grade will continue until the end of the 2020-2021 school year following the agency’s latest move to admit vaccinated people Implement guidelines for wearing masks should not use masks indoors. The agency also upheld its proposals to monitor physical distancing and test for coronavirus infections.

In one of the new studies, researchers from the CDC and the Georgia Department of Public Health surveyed 169 elementary schools in Georgia that offered face-to-face learning last fall. The group asked schools about their pandemic responses and collected data on the coronavirus cases discovered between November 16 and December 11 before vaccines were used in the United States.

The researchers found that the incidence of the virus in schools that had improved their ventilation – by opening windows or doors or using fans – was 35 percent lower than in schools that did not use these practices. In schools that combined better ventilation with air filtration – for example through the use of HEPA filters – the fall rates were 48 percent lower.

The researchers found that all teachers and staff had to wear masks to reduce the incidence of the virus by 37 percent. Schools that required students to wear masks had a 21 percent lower incidence of the virus, but that reduction was not statistically significant, the scientists found. This may be due to the fact that adults are more likely to transmit the virus than children, or simply to a small sample size.

“Since the universal and correct use of masks can reduce SARS-CoV-2 transmission and is a relatively inexpensive and easy to implement strategy, the results of this report suggest that the universal and correct use of masks is an important Covid-19 -Prevention strategy in schools is a multi-component approach, ”write the researchers.

A second study, conducted by researchers from the Utah Department of Health and the University of Utah, tracked the implementation of two coronavirus screening programs in state schools. A program that ran in January 2021 allowed schools with outbreaks to conduct school-wide testing instead of switching to distance learning.

“The schools could either do what they did the fall, switching to remote control for two weeks to break the chains of transmission, or they could test all of them,” said Dr. Adam Hersh, one of the study’s authors and a pediatric infectious disease expert at the University of Utah. “And those who tested negative could return to face-to-face learning, and those who tested positive would obviously be isolated.”

In a second testing program, students had to be tested for the coronavirus every 14 days in order to participate in sports or other extracurricular activities. Both initiatives relied on rapid antigen tests, which are less sensitive but cheaper and faster than standard PCR tests.

That year, between January 4 and March 20, 28 high schools in the state reported sizeable outbreaks. Fifteen schools decided to switch to distance learning for two weeks, while the other 13 decided to run surveillance tests instead. Of the 13,809 students who were tested as part of this screening, only 0.7 percent were positive, the scientists reported. All 13 schools remained open.

“This is a huge achievement from a public health perspective,” said Kendra Babitz, coronavirus testing coordinator for the Utah Department of Health and one of the study’s authors. “Testing is and should be a mitigation strategy that schools use to prevent the transmission of SARS-CoV-2 in schools,” she added, referring to the virus that causes Covid-19.

Over the winter, 95 percent of school sports events took place on schedule, the researchers found, although they didn’t compare that number to a control group of schools without screening programs. “This is similar to what happens in the normal season,” said Dr. Hersh. “The show could go on.”

Categories
Business

Emergent CEO says FDA is holding over 100 million J&J Covid vaccine doses for additional testing after botched doses

Emergent CEO says FDA is holding over 100 million J&J Covid vaccine doses for further testing after botched doses

Robert Kramer, CEO of Emergent BioSolutions

Scott Mlyn | CNBC

The FDA is holding over 100 million vaccine doses of Johnson & Johnson Covid-19 for further testing after the agency found multiple security breaches at the Emergent BioSolutions facility that helped make the gunshots, said Robert Kramer, CEO of Emergent, on Wednesday to lawmakers.

The US hired J&J to run the Baltimore facility last month after learning that Emergent, a federal company that made key ingredients for J&J and AstraZeneca, contaminated the two shots. Kramer testified before House lawmakers Wednesday that the conditions at the Baltimore plant allegedly were responsible for the destruction of millions of J&J Covid-19 shots.

During the hearing before the House Select Coronavirus Crisis Subcommittee, Rep. Steve Scalise, R-La., Kramer asked how many doses of J&J vaccine are held by the Food and Drug Administration but are not contaminated.

“There are a significant number of doses that we have made. Again we are making the mass drugs,” Kramer told lawmakers. “It has been reported by a number of news outlets that there are likely over 100 million doses of the J&J vaccine we make that are now under FDA review for possible release and availability.”

Kramer later stated that the regulator requested additional testing of the cans.

“The FDA, to the best of my knowledge, evaluates the doses made for mass drug use, most of which were provided to J&J,” Kramer said. “As far as I know, there was a request for additional testing on all of these lots and doses that J&J had made available to the FDA. And they are currently being evaluated.”

J&J declined to comment on the number of doses. The FDA did not immediately respond to a request for comment.

This is a developing story. Please try again.

Categories
Health

Airstrike Damages Gaza’s Solely Covid-19 Testing Lab, Officers Say

Airstrike Damages Gaza's Only Covid-19 Testing Lab, Officials Say

Since Covid-19 first appeared in the blocked Gaza Strip, the authorities have only been able to conduct a relatively small number of coronavirus tests due to the lack of medical care.

Now the only laboratory in Gaza processing test results is temporarily inoperable after an Israeli air strike nearby on Monday, Gaza officials said.

The strike, which targeted a separate building in Gaza City, sent splinters and debris flying across the street and damaged the laboratory and administrative offices of the Hamas-led health ministry, said Dr. Majdi Dhair, Director of the Department of Preventive Medicine at the Ministry.

A ministry official was hospitalized and in serious condition after being hit in the head by a splinter, said Dr. Dhair on Tuesday in a telephone interview.

“This attack was barbaric,” he said. “There’s no way to justify it.”

The Israeli army did not immediately respond to a request for comment on the strike. Since Israel began its bombing campaign in Gaza on May 10, the army has declared that its air strikes are aimed exclusively at militants and their infrastructure.

Dr. Dhair said he believed the equipment in the lab was intact, but stressed that it would take at least a day to clean up the damage and prepare him to run coronavirus tests again. In the meantime, the medical teams would stop doing tests.

Rami Abadla, director of the Infection Control Department of the Gaza Ministry, said the laboratory will also temporarily not be able to process results for other tests related to HIV, hepatitis C and other diseases.

Over the past week, Gaza authorities tested an average of 515 Palestinians for the virus every day. According to official data, only 1.9 percent of the two million people in Gaza were fully vaccinated on Monday, compared with 56 percent in Israel.

After an increase in cases in April, mainly due to the highly communicable coronavirus variant first identified in the UK, new infections in Gaza have recently dropped to manageable levels, health experts said. But with Israeli air strikes destroying buildings, causing widespread damage and killing more than 200 people by Monday, United Nations officials have warned coronavirus cases could re-emerge.

Unvaccinated Palestinians crowded into schools operated by the United Nations Relief Society in Gaza, turning them into de facto air raid shelters. Matthias Schmale, the head of operations at the UN agency, said last week that these schools “could become mass disseminators”.

Mr Schmale and the World Health Organization’s chief official in Gaza, Sacha Bootsma, also said that all vaccinations stopped when hostilities broke out and that any vaccine supply in the territory had been delayed by the closure of the border crossings in the Gaza Strip.

Categories
Business

Mexican Factories Accused of Labor Abuses, Testing U.S.M.C.A.

Mexican Factories Accused of Labor Abuses, Testing U.S.M.C.A.

WASHINGTON – The AFL-CIO and other groups on Monday filed a complaint with the Biden government over alleged labor law violations at a group of auto parts factories in Mexico. This will be an early test of the new North American trade agreement and its deals with OSH.

The complaint is focused on the Tridonex auto parts factories in the town of Matamoros, just across the border with Brownsville, Texas. The AFL-CIO said workers there had been harassed and fired for their efforts to organize with an independent union, SNITIS, instead of a company-controlled union. Susana Prieto Terrazas, a Mexican labor lawyer and SNITIS leader, was arrested and jailed last year in an episode that received a lot of attention.

The trade deal, the deal between the United States, Mexico and Canada, was negotiated by the Trump administration to replace the North American free trade agreement and went into effect last summer. While negotiated by a Republican government, the deal had significant input from Congressional Democrats, who controlled the House and insisted on stricter labor and environmental standards to vote for the pact, which required Congressional approval.

The trade pact called on Mexico to make profound changes to its work system, where bogus collective bargaining agreements, so-called protection agreements, concluded with no worker involvement and with low wages, were prevalent.

The complaint is placed under the trade agreement under a novel “rapid response” mechanism that enables complaints of labor violations to be filed against an individual factory and penalties to be imposed on that factory. The complaint was made by the AFL-CIO, Service Employees International Union, SNITIS, and Public Citizen’s Global Trade Watch.

“USMCA is asking Mexico to end the protection union government and its corrupt dealings with employers,” said Richard L. Trumka, president of the AFL-CIO, in a statement using the acronym for the trade deal. “The ongoing harassment of Susana Prieto and SNITIS members is a textbook violation of the labor laws that Mexico is committed to complying with.”

The trade deal aims to improve working conditions and pay workers in Mexico, which proponents say would benefit American workers by discouraging factory owners from moving operations from the US to Mexico in search of cheaper labor. Enforcing the pact is one of the greatest trade challenges facing the Biden government.

Tridonex is a Philadelphia-based subsidiary of Cardone Industries and controlled by Toronto-based Brookfield Asset Management, the AFL-CIO said. In 2016, Cardone announced plans to move its brakes division to Mexico and lay off more than 1,300 workers in Philadelphia. This is evident from news and public records.

The complaint contains several allegations of labor violations, including that workers were unable to elect their union leaders or ratify their collective agreement, and that more than 600 workers were dismissed by their employer for retaliation. She also accuses Tamaulipas State of denying workers the right to vote for the union they represent.

“There couldn’t be a clearer case,” said Mary Kay Henry, international president of the Service Employees International Union, which represents Cardone employees in Philadelphia.

In a statement, Cardone said it was “obliged to conduct labor practices, cultivate constructive relationships with workers and fully respect the universal principle of freedom of association and the right to collective bargaining”.

In business today

Updated

May 10, 2021, 1:30 p.m. ET

“We are committed to fully complying with all applicable labor laws and regulations regarding our Tridonex facilities in Matamoros, Mexico,” the statement said. “Should an investigation be initiated to discuss this further, we would appreciate it and be fully transparent and responsive in handling all government information requests.”

The quick response mechanism in the trade agreement enables the United States to take action against a single factory in Mexico if workers there are denied the right to freedom of association and collective bargaining. It was one of the provisions that the Democrats highlighted as an improvement on the final deal over the original version of the Trump administration’s trade deal.

If the United States decides there is enough evidence that workers’ rights are being denied, it would urge Mexico to conduct a review of the allegations. After this step, a panel could be set up to investigate the matter. As part of the quick response process, the factory could face fines and repeat offenders could even prevent their goods from entering the US.

Mexico approved a revision of its labor laws in 2019, but it will be rolled out gradually over several years, and implementation of the changes remains a major question mark.

A report released in December by an independent committee set up by the United States to monitor job changes said Mexico has made progress but significant obstacles remain. The report found that the protection contract system was still in place and that most unionized workers were still unable to democratically elect their leaders.

United Steelworkers’ director of international affairs and chairman of the board, Ben Davis, said the complaint filed Monday had “all elements of the structural problem we are facing over labor rights in Mexico.” The quick response mechanism is a way to hold companies accountable.

‘This is the first time we have had something like this in a trade agreement,’ he said, ‘and so we think it’s pretty important that it’s used, used effectively and hopefully something that we can apply. ” in other places. “

Democrats in Congress welcomed the complaint. “We expect and urge the Biden administration to use all available resources to take aggressive enforcement action in this case,” said Richard E. Neal from Massachusetts, chairman of the House Ways and Means Committee, and Earl Blumenauer from Oregon , Chairman of the panel’s trade subcommittee, said in a statement.

It remains to be seen how the Biden administration will react to the complaint. One administration official said the administration would “carefully examine” complaints about quick response mechanisms.

United States Trade Representative Katherine Tai was previously the chief trade adviser to the powerful Ways and Means Committee. In this post, she played a key role in the negotiations between the House Democrats and the Trump administration over the revision of the trade deal.

Ms. Tai has said enforcement of the agreement is a priority and the first meeting of the commission overseeing the pact – made up of Ms. Tai and her colleagues from Canada and Mexico – is due to take place next week for the Mexican embassy in Washington, according to a spokeswoman .

At a Senate hearing last month, Ms. Tai said there were “a number of concerns about Mexico’s compliance with USMCA commitments,” without giving details.

“We have done our best to use the most effective enforcement tools we know,” she said at another point in the hearing. “And they might not be perfect, but we won’t know how effective they’ll be if we don’t use them.”

Categories
World News

China is stepping up its diplomatic bravado, testing how arduous Biden will push again

China is stepping up its diplomatic bravado, testing how hard Biden will push back

Senior US government officials examine China’s growing diplomatic bravery and growing military assertiveness with the intensity of elite athletes pondering their most resourceful rival’s feature films.

From the CIA to the White House and from the Pentagon to Foggy Bottom, these officials report a far greater willingness on the part of China to go on the offensive in the first 100 days of the Biden administration. The Chinese stand ready to face real and imaginary problems facing the United States and its allies, even as warnings and military activity escalate in Taiwan.

The new message from Beijing was consistent: the Biden government is trying to undermine China’s rise and promoting a false and dangerous portrayal of competition between democratic and autocratic systems. Therefore, countries around the world must decide whether to follow the divisive but declining United States or embrace a rising, unified and nonjudgmental China.

Between the lines, Chinese President Xi Jinping says that human rights violations and democratic failures are internal issues that cannot be discussed. In addition, Chinese officials stand ready to publicly attack the US record for racism and democracy, as does Beijing’s top diplomat Yang Jiechi in an unprecedented 16-minute diatribe to mark the first high-level US-China talks of the Biden government in March to open 18 in Anchorage, Alaska.

“There has recently been a tendency to liken China and the United States to ‘democracy versus authoritarianism’ to … put labels on countries,” said Wang Yi, the Chinese foreign minister who built on the Alaska Embassy last week at the Council on Foreign Relations. “But democracy is not Coca-Cola, which tastes the same as syrup made by the United States around the world.”

Wang said: “If democracy and human rights are used to conduct value-based diplomacy, meddle in the internal affairs of other countries, or stir up confrontation, it will only lead to turmoil or even disaster.”

His use of the term “catastrophe” caught the attention of his audience and made it clear what he meant by that.

“The Taiwan issue is the most important and sensitive issue in China-US relations,” he said, arguing that it should also be in US interests to oppose Taiwan’s independence and separatist instincts. “Playing the ‘Taiwan Card’ is a dangerous move, like playing with fire.”

Such rhetorical and possibly strategic changes do not occur by chance in (yes) authoritarian China. So it is both urgent and necessary to understand their meaning and respond appropriately. Given the contradicting mix of hubris and uncertainty in recent Chinese policies and actions, this will not be easy.

On the one hand, President Xi Jinping predicts growing national confidence that this is China’s historic moment. Xi hopes to build on what he sees groundbreaking in this centenary year of the Chinese Community Party that emerged from the pandemic and declared the end of absolute poverty in the country.

At the same time, Xi is responding to new challenges posed by the Biden government, which is rapidly escaping Covid-19 by delivering a formidable vaccine distribution and pumping $ 4 trillion, as well as considering stimulus and infrastructure development in the economy. US growth this year could be equal to or greater than China’s at a remarkable 6.5%.

The leaders of the two countries seem to agree that “we are at a turning point in history,” as President Biden said at a joint congressional session this week. “We are in competition with China and other countries to win the 21st century.”

Put it differently earlier this year, President Xi spoke to a Communist Party school meeting: “The world is undergoing profound changes that have not been seen in a century, but the time and the situation are in our favor. Here comes our determination and our trust. “”

In Biden, however, Xi sees a more methodical and coherent leader than his predecessor, more willing to work within institutions and with allies.

Biden convened the first Quadruple Security Dialogue Summit on March 12, attended by Japanese, Australian and Indian leaders. Japanese Prime Minister Yoshihide Suga became the first foreign leader to visit the White House since Biden took office on April 16, and the two leaders made the first joint statement in support of Taiwan since 1969.

Chinese leaders were also surprised on March 22nd when the United States, European Union, Britain and Canada sanctioned Chinese officials for human rights violations against the Uyghur minority in Xinjiang. Beijing’s response was an immediate and seemingly counterproductive response to punitive measures against EU citizens that were broader. The price for his tough message is that the European Parliament has put the recently announced China-EU investment deal on hold.

There appear to be three immediate targets for China’s current approach: the domestic audience, US partners and allies, and the developing world.

The priority of any authoritarian leader is political survival. President Xi appears to have strengthened his hand within the Chinese Community Party and weakened potential rivals by rallying nationalistically around Hong Kong and Taiwan and portraying the United States as a power determined to reverse China’s rise.

The second goal for Chinese valor is a preventive effort to reach U.S. allies and partners before the Biden administration has had enough time to get a bigger common cause off the ground. Wherever necessary, it wants to show that there will be a heavy price to pay for those who accept Washington at Beijing’s expense.

A US official cites a Chinese proverb to explain this strategy: “Kill a chicken to scare the monkey.” President Xi’s third target is the developing countries, where China’s progress has been greatest. The aim is to portray China as a more reliable and consistent partner in its development, with its own inspiring track record of modernization and commitment to staying out of the domestic affairs of other countries (and indeed providing the monitoring tools to other authoritarians) at the Staying in power).

At the same time, of course, China is also testing the Biden government. The aim is not to win Washington, where consensus on the Chinese challenge has grown. Rather, it is about testing the Biden government’s willingness to act on a range of issues – from technology controls to human rights – but especially on Taiwan.

Beijing is betting from previous experience that President Biden’s bark will be worse than its bite. If you are convinced of this, you can count on even more Chinese bravery and assertiveness in the next four years.

Frederick Kempe is a best-selling author, award-winning journalist, and President and CEO of the Atlantic Council, one of America’s most influential think tanks on global affairs. He worked for the Wall Street Journal for more than 25 years as foreign correspondent, assistant editor-in-chief and senior editor for the European edition of the newspaper. His latest book – “Berlin 1961: Kennedy, Khrushchev, and the Most Dangerous Place in the World” – was a New York Times bestseller and has been published in more than a dozen languages. Follow him on Twitter @FredKempe and subscribe here to Inflection Points, his view every Saturday of the top stories and trends of the past week.

More information from CNBC staff can be found here @ CNBCopinion on twitter.