Doubts over ‘rapid turnaround’ Covid tests pledged by Johnson

The “rapid turnaround” coronavirus tests the prime minister announced on Saturday are not approved for the public to interpret themselves without an expert’s help and so will not provide results in the promised 15 minutes, the Guardian has learned.



Boris Johnson wearing a suit and tie: Photograph: WPA/Getty Images


© Provided by The Guardian
Photograph: WPA/Getty Images

Boris Johnson’s briefing about this week’s national lockdown in England included the promise of a mass rollout of “tests that you can use yourself to tell whether or not you are infectious and get the result within 10 to 15 minutes”, which would be made available at universities and across whole cities.

He said the army would be deployed to roll out the “many millions of cheap, reliable and above all rapid turnaround tests” everywhere they were needed.

Three of these rapid antigen tests, called lateral flow tests, have passed an assessment by Porton Down with Oxford University. The government has bought one of them. The health secretary, Matt Hancock, announced the government had signed a deal for 20 million, from the company Innova Tried and Tested, on 19 October.

But the Innova tests are not for people without symptoms, such as university students or people wanting to get on a plane or go to the theatre. They are designed for people who already have Covid symptoms. And the devices, which look like a pregnancy test, are intended to be read by a healthcare professional.

The company is clear about their limitations on the instructions for use, which can be found on its website. The tests analyse throat and nose swabs “from individuals who are suspected of Covid-19 by their healthcare provider, within the first five days of the onset of symptoms”. The test is designed for use by trained lab and healthcare staff, it says.



Boris Johnson wearing a suit and tie: Boris Johnson announced the promise of a mass rollout of the tests, to be made available at universities and across cities.


© Photograph: WPA/Getty Images
Boris Johnson announced the promise of a mass rollout of the tests, to be made available at universities and across cities.

Johnson hopes the tests will help show the way out of the pandemic. They will be deployed in a wide range of situations, he said, “from helping women to have their partners with them in labour wards when they’re giving birth, to testing whole towns and even whole cities.

“The army has been brought in to work on the logistics and the programme will begin in a matter of days, working with local communities, local government, public health directors and organisations of all kinds to help people discover whether or not they are infectious, and then immediately to get them to self-isolate and to stop the spread.”

Prof Jon Deeks from Birmingham University and a member of a working group of the Royal Statistical Society, which is looking at coronavirus tests, said they were not ready for this type of use.

“At the moment, if you were bought this test, you would not be using it for this purpose,” he told the Guardian.

Lateral flow tests are now being offered to students at two universities – Durham and De Montfort – in

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Johnson & Johnson to test coronavirus vaccine in children

Pharmaceutical giant Johnson & Johnson has plans to begin testing its coronavirus vaccine on children, according to Reuters

Reuters reported on Friday the company soon plans to test the experimental vaccine candidate on people aged 12 to 18. 


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“We plan to go into children as soon as we possibly can, but very carefully in terms of safety,” Jerald Sadoff, senior advisor with Johnson & Johnson’s vaccine division, said during a meeting held by the Centers for Disease Control and Prevention (CDC) Friday, according to Reuters. 

Sadoff said the company also has plans to test the vaccine in children younger than 12 if it’s shown to be safe among those 12 to 18. 

Most COVID-19 vaccine trials are focused on whether the shots are safe and effective in adults. Pfizer, which has manufactured one of the four vaccine candidates currently in phase three trials in the U.S., recently started testing its vaccine candidate in children. 

While far fewer children have been sick with COVID-19 compared to adults, they can still become infected with the virus and spread it around to others. 

Johnson & Johnson kicked off phase three trials of its vaccine last month, aiming to enroll 60,000 participants. The company had to pause the trial earlier this month after a participant suffered a stroke. An independent committee investigated the incident and determined the incident was not related to the vaccine and the trial resumed this week. 

It’s not unusual for some participants to become ill during large scale vaccine trials and most resume shortly after they’re put on pause so cases can be evaluated for safety.


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After pausing for safety concerns, AstraZeneca and Johnson & Johnson have resumed their U.S. vaccine trials.

Late-stage coronavirus vaccine trials run by AstraZeneca and Johnson & Johnson have resumed in the United States after the companies said Friday that serious illnesses in a few volunteers appeared not to be related to the vaccines.

Federal health regulators gave AstraZeneca the green light after a six-week pause, concluding there was no evidence the experimental vaccine had directly caused neurological side effects reported in two participants. The AstraZeneca news was first reported by The Wall Street Journal.

Johnson & Johnson said that its trial, which had been on pause for 11 days, would restart after a company investigation determined that a “serious medical event” in one study volunteer had “no clear cause.” To maintain the integrity of the trial, the company said, it did not check whether the volunteer received the vaccine or the placebo.

Dr. Luciana Borio, a former acting chief scientist at the Food and Drug Administration, welcomed the announcements, citing the urgent need for multiple vaccines to remain in the race for a product that could protect the global population from the coronavirus, which has already killed more than a million people worldwide.

“The demand for safe and effective Covid vaccines exceeds any single manufacturer’s production capacity,” Dr. Borio said. “We really need several in the field.”

An F.D.A. spokesperson declined to comment on Friday afternoon.

AstraZeneca and Johnson & Johnson are two of the four companies now in late-stage clinical trials in the U.S. for experimental coronavirus vaccines. Both companies are using adenoviruses, which typically cause harmless colds. The adenovirus is engineered so that it can chauffeur a coronavirus gene into human cells.

Their two high-profile competitors, Moderna and Pfizer, also in advanced trials, are instead using a technology based on genetic material known as mRNA. Delivered into human cells, the mRNA prompts the production of coronavirus proteins, triggering an immune response.

AstraZeneca moved swiftly into clinical trials, enrolling thousands of volunteers for its vaccine trials around the world in countries including Brazil, India, South Africa and Britain. A large, late-stage trial kicked off in the United States at the end of August. But all the trials were halted days later, on Sept. 6. A volunteer who had received the vaccine in the United Kingdom reportedly experienced symptoms of transverse myelitis, or inflammation of the spinal cord, triggering a global pause to the company’s efforts.

The incident sparked some concern among experts, who noted that a similar adverse neurological event, reported months ago, had occurred in another vaccinated volunteer. While this earlier event prompted its own pause in AstraZeneca’s trials, an independent safety board ultimately determined it was unrelated to the vaccine, allowing studies to resume.

Following the second AstraZeneca halt in September, trials abroad rapidly resumed in most countries. But the American hiatus persisted, with few details released as to why.

According to two vaccine experts familiar with the situation who were not authorized to discuss it publicly, the F.D.A. did not directly tie the vaccine to the two neurological illnesses, although it could

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AstraZeneca and Johnson & Johnson to resume COVID-19 vaccine trials as U.S. daily cases top 71,000

On Friday, both AstraZeneca and Johnson & Johnson announced that their coronavirus vaccine trials are set to resume in the U.S. after hitting pause when volunteers became sick. The Food and Drug Administration gave the green light after investigations found no link between those cases and the vaccine.

The announcement comes as the U.S. recorded more than 71,000 coronavirus cases on Thursday, which is the highest single-day increase since July, according to figures from Johns Hopkins University. A total of 41 states are reporting an increase in average new cases, and 15 states have reported record hospitalizations in the last week.

“This really does become a moment where all Americans have to recognize that each of us individually has a responsibility if we want to turn this around,” said Dr. Francis Collins, director of the National Institutes of Health.

In hot spot Wisconsin, new cases are up nearly 40% compared to two weeks ago. Wisconsin resident Ava Pennicuik, 15, is still suffering from hot flashes and extreme fatigue three months after recovering from COVID-19.

“I still feel sick sometimes. Some days are good and then some days aren’t,” said Pennicuik. “Like one day I’ll have a really bad day and also super dizzy and tired, and I’ll have to take a nap, and the other day, like, I can just do stuff, like, normally.”

The latest data from researchers at the University of Washington says wearing face masks in public could save nearly 130,000 lives in the U.S. this fall and winter.

Katelyn Evans, 16, became the first teen to get an injection as part Pfizer’s COVID-19 vaccine study at Cincinnati Children’s Hospital, the Associated Press reported. It’s part of a push to safely inoculate school-age children.  

“I figured, you know, the more people they test, the more information they get and the sooner they can put out a vaccine to keep everyone safe,” said Evans.

Since the pandemic began, more than half a million American children have been infected with COVID-19. While vaccine trials continue to move forward, the first shots are unlikely to be recommended for kids. Vaccines can’t be given to children unless they’ve been tested in their age group, the AP reported.

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Johnson & Johnson, AstraZeneca coronavirus vaccine trials set to resume

The AstraZeneca vaccine trial, on hold in the United States since early September, also got the greenlight Friday to restart from the Food and Drug Administration, according to a company statement.

When a potential adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data and safety monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy usually restrict details from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons for such halts.

In the Johnson & Johnson trial, which was paused on Oct. 12, a man who received a vaccination suffered a stroke that may have been triggered by an infection. To conclude it was not likely to be related to the shot, investigators probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.

The investigation found “no clear cause” of the incident, according to a company statement. It also found no evidence the vaccine triggered the event, the details of which were not disclosed by the company. The independent board that monitors the trial recommended lifting the pause.

“With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it,” Paul Stoffels, chief scientific officer of Johnson & Johnson said in an interview. He did not offer any details of the illness, citing patient privacy.

The company is testing the only vaccine that aims to protect people with a single shot; other prospective vaccines require a return visit and second shot three to four weeks after the first to trigger a protective immune response.

It was the second late-stage vaccine trial put on hold in recent weeks; the vaccine being developed by AstraZeneca and the University of Oxford was halted on Sept. 6 after a British participant developed a neurological problem. While the AstraZeneca study had resumed in the rest of the world, it did not get clearance to restart in the U.S. until Friday.

AstraZeneca spokeswoman Michele Meixell did not provide further information on the illness, but said the FDA reviewed data from the trials running around the world before concluding it was safe to restart. She said the company was adding a new expert panel “to provide advice on diagnosis and causality assessment of neurological events,”in addition to continuing standard company oversight and the independent data and safety committee.

Pausing and unpausing clinical trials happens routinely, and experts have said that the public should be confident the process worked as intended to protect the health and safety of participants.

“We see this all the time during clinical research,” said Carlos del Rio, an infectious diseases physician at Emory University School of Medicine. “As long as the data and safety monitoring

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Johnson & Johnson coronavirus vaccine trial will resume soon

The Johnson & Johnson coronavirus vaccine trial, paused due to an unexplained illness in a participant, will resume very soon. An independent committee investigated the case of a man in the trial who suffered a stroke and concluded it was not related to the vaccine, according to two individuals familiar with the trial who spoke on the condition of anonymity.



a sign on the side of a road: Signs direct volunteers for a coronavirus vaccine trial at a trailer compound in National City, California in early October. (REUTERS/Mike Blake)


© Mike Blake/Reuters
Signs direct volunteers for a coronavirus vaccine trial at a trailer compound in National City, California in early October. (REUTERS/Mike Blake)

The study, the only late-stage human test of a coronavirus vaccine that requires just a single shot, was paused by Johnson & Johnson on Oct. 12. It was the second late-stage trial to pause; testing of the vaccine being developed by AstraZeneca and the University of Oxford has been on hold in the United States since early September after a a British participant developed a neurological problem.

Moncef Slaoui, the head of Operation Warp Speed, told Bloomberg that both trials could resume as early as this week, pending clearance from the Food and Drug Administration.

When an adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data safety and monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy restrict specific details of adverse events from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons behind trial pauses.

In the Johnson & Johnson trial, a man who received a vaccination suffered a stroke that may have been triggered by an infection.

To come to the conclusion that the event was not related to the vaccination, the investigation probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.

Johnson & Johnson spokesman Jake Sargent declined to comment.

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Magic Johnson And Cigna Team Up To Improve Minority Healthcare

LOS ANGELES, CA — Magic Johnson and health insurance giant Cigna have teamed up to fight health disparities in POC communities within Los Angeles. The pair launched an initiative to support minority and female-owned businesses, by providing customized health care plans for issues that disproportionately affect people of color.

The initiative will focus on health issues such as asthma, heart disease, diabetes and high-risk pregnancies. Cigna will also invest $3 million in local charities working to improve health equity in Los Angeles.

“Minority and women entrepreneurs and business owners are vital to creating a strong economy and vibrant communities — and we need to do even more to support them right now,” Johnson said. “It’s important for these businesses to survive and be able to employ Black, Hispanic and other employees of color, while offering benefits to combat the health disparities that have taken a toll on our communities. Together with Cigna, we are providing the tools and information needed to improve the health and productivity of their workforce.”

Numerous studies have shown how the coronavirus pandemic has hit Black and Brown communities much harder than others. According to the California Department of Public Health, 48% of people who died from coronavirus were Latino, despite the community being only 38% of the state’s population.

“Today’s intersection of health, economic and racial crises motivated us to take definitive action to partner with these small and mid-size businesses by improving the health and productivity of their workforce — many of whom are from underserved communities,” said Mike Triplett, president of Cigna’s U.S. Commercial business. ‘We are excited to team up with the legendary Earvin ‘Magic’ Johnson to bring our new initiative to the market.”

Specialized plans include access to local providers who excel in treating underserved communities, virtual care options and home delivery, and whole-person health services.

City News Service and Kenan Draughorne contributed to this report.

This article originally appeared on the Los Angeles Patch

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Sage adviser says Boris Johnson ‘not being cautious enough’

Prof John Edmunds: 'I think we are not being as cautious as I would like us to be.' (Parliamentlive.tv)
Prof John Edmunds: ‘I think we are not being as cautious as I would like us to be.’ (Parliamentlive.tv)

One of the government’s top coronavirus advisers has said Boris Johnson is not being cautious enough and warned his three-tier local lockdown strategy will not work.

Prof John Edmunds, a member of the Scientific Advisory Group for Emergencies (Sage) argued Tier 3 lockdowns – the most severe under Johnson’s system – are unlikely to reduce the reproduction (R) rate below 1, meaning there will still be high community infection rates.

He argued a “circuit breaker” national lockdown, something which Sage recommended last month but Johnson resisted, would hold COVID-19 incidence at a “lower level” and reduce hospital admissions.

It comes a day after the government reported a surge in COVID deaths. There were 241 deaths announced on Tuesday, up from 80 on Monday. This was the highest daily number in four months.

Appearing before the House of Commons science and technology committee on Wednesday, Prof Edmunds said of Johnson’s strategy: “I think we are not being as cautious as I would like us to be. I think it’s pretty clear cases have been going up quite fast.

“What worries me a little bit is where the strategy leads to at the moment, the targeted tiered strategy. If you think it through, where that leads to is a high level of incidence everywhere.

“Let’s say Tier 3 works and keeps the reproduction number at about 1 – I don’t think anyone thinks this is going to reduce it to less than 1.

“That means that in Liverpool and Manchester and the north west [areas which are in Tier 3], it will keep the incidence at this high level which is putting hospitals under strain and causing significant numbers of deaths. We’re going to keep it at that high level now for the foreseeable future.”

Watch: How will England’s three-tier local lockdown system work?

R represents the average number of people each COVID-19 positive person goes on to infect. When the figure is above 1, an outbreak can grow exponentially.

He said the Midlands and London could soon go into Tier 3, again only reducing R to 1.

“What that means by logical extension of this,” Prof Edmunds went on, “is that we all end up at a high level of incidence where hospitals are really under stretch and we have large numbers of deaths.

“That for me is the logical conclusion of this strategy that we’re following and I would not follow that strategy.”

He said a “very stringent” circuit breaker national lockdown could “half” COVID incidence, rather than “hold” it.

It comes after Prof Jonathan Van-Tam, the deputy chief medical officer for England, warned an increase in deaths is “baked in” with the second wave of new infections.

Some 21,331 UK-wide cases were recorded on Tuesday, with a seven-day average of 18,231.

Prof Van-Tam warned at the Downing Street press conference on Tuesday: “The key point is that having

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