CategoryTesting

FDA authorizes first over-the-counter COVID-19 antigen test

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The U.S. Food and Drug administration on Tuesday authorized emergency use of the first over-the-counter COVID-19 antigen test, which can be used at home.

The test by Ellume offers a nasal swab analyzer that connects to a software application on users’ smartphone, and gives results in 20 minutes.

Anyone above two years of age, including those not showing symptoms, can take the test, the agency said.

The news follows authorization of the first prescription COVID-19 test for home use last month, and of a non-prescription test system allowing a lab to process nasal samples collected at home, last week.

The regulatory nods will help expand Americans’ access to testing, reduce the burden on laboratories and test supplies, and give more testing options, FDA Commissioner Stephen Hahn said in a statement.

https://www.reuters.com/article/health-coronavirus-fda-testing-idUSL4N2IV3O8HELP US SPREAD GOOD NEWS!

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‘We should be substantially back to normal’ by summer 2021, says Operation Warp Speed’s chief science advisor

Operation Warp Speed’s Chief Science Advisor Moncef Slaoui told CNBC that Americans can expect to get back to ‘normal’ by summer 2021, as families across the United States spend Thanksgiving apart this year in order to keep their loved ones safe. 

“We hope that we would have vaccinated 70% to 80% of the U.S. population by May or June of 2021, so I would hope that by summer, we should be substantially back to normal,” Slaoui said in a Wednesday evening interview on “The News with Shepard Smith”. 

Doctors and scientists, however, are reassuring Americans that there will be a reprieve. Two weeks after Thanksgiving, the FDA will meet to discuss whether to green-light Pfizer’s vaccine. If it does, the government plans to ship out 6.4 million doses to communities around the country.

Slaoui said that inoculating all Americans will be a “challenge” but he thinks it is achievable. “People need to know that every year between 140 million to 180 million doses of flu vaccine are produced, distributed, and inoculated in the U.S. population in a period that goes between the month of August and the month of, maybe, January,” Slaoui said. “So, we may be doubling that number over the period of time, but it’s not from scratch, which was very different from the testing.”

https://www.cnbc.com/2020/11/25/we-should-be-back-to-normal-by-summer-2021-says-operation-warp-speed-advisor.htmlHELP US SPREAD GOOD NEWS!

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Can dogs smell COVID? Here’s what the science says

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Canines seem to detect coronavirus infections with remarkable accuracy, but researchers say large-scale studies are needed before the approach is scaled up.

Around the world, canines are being trained to detect the whiff of COVID-19 infections. Dog trainers are claiming extraordinary results — in some cases, they say that dogs can detect the virus with almost perfect accuracy. Scientists involved with the efforts suggest that canines could help to control the pandemic because they can screen hundreds of people an hour in busy places such as airports or sports stadiums, and are cheaper to run than conventional testing methods such as the RNA-amplification technique PCR.

But most of these findings have not yet been peer reviewed or published, making it hard for the wider scientific community to evaluate the claims. Researchers working on more conventional viral tests say that initial results from dog groups are intriguing and show promise. But some question whether the process can be scaled up to a level that would allow the animals to make a meaningful impact.

On 3 November, groups working with the animals met in an online workshop called International K9 Team to share preliminary results from experiments and to improve how their research is coordinated.

“No one is saying they can replace a PCR machine, but they could be very promising,” says veterinary neurologist Holger Volk at the University of Veterinary Medicine Hanover in Germany, who is leading an effort to train and study COVID-sniffing dogs and did not speak at the event.

Many sniffer-dog scientists turned their attention to COVID-19 early in the pandemic. They have trained their canines to smell samples, most often of sweat, in sterile containers, and to sit or paw the floor when they detect signs of infection. Trials at airports in the United Arab Emirates, Finland and Lebanon are using dogs to detect COVID-19 in sweat samples from passengers; these are then checked against conventional tests. According to data presented at the K9 meeting, dogs in Finland and Lebanon have identified cases days before conventional tests picked up the virus, suggesting that they can spot infection before symptoms start.

https://www.nature.com/articles/d41586-020-03149-9HELP US SPREAD GOOD NEWS!

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Quarter of us may already be immune to coronavirus – without ever being infected

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One in four people may already be immune to coronavirus – without ever being infected, a new study has found.

Public Health England (PHE) followed nearly 2,850 key workers from the police, fire and health services to gauge levels of immunity to Covid-19.

Researchers found that by June, a quarter had high levels of T-cells which recognised the virus.

It suggested they had some level of protection against the bug, yet nearly half had never been infected.

The experts believe they may have developed a level of immunity from similar coronaviruses – like the one that causes the common cold.

They followed up with the study sample after four months and found that no-one with a high T-cell count had caught Covid.

Dr Peter Wrighton-Smith, the CEO of Oxford Immunotec, the company that developed the T-cell test for trial, said that the results show that relying on antibody testing alone to see who is immune to the virus could underestimate the number of people who have immunity.

T-cells target and destroy cells in the body that become infected by the virus.

Previous studies on immunity have centered on antibodies.

Antibodies neutralise a virus before it is able to enter the cells of the body.

Data from the study found that none of the participants with high T-cell responses became infected with the virus in the following four months.

This, the experts claim, suggests that part of the immune system can protect people from the virus.

https://www.thesun.co.uk/news/13249689/quarter-already-immune-coronavirus-without-ever-infected/HELP US SPREAD GOOD NEWS!

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Oxford vaccine shows ‘encouraging’ immune response in older adults

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The Oxford coronavirus vaccine shows a strong immune response in adults in their 60s and 70s, raising hopes that it can protect age groups most at risk from the virus.

Researchers say the Lancet phase two findings, based on 560 healthy adult volunteers, are “encouraging”.

They are also testing whether the vaccine stops people developing Covid-19 in larger, phase three trials.

Early results from this crucial stage are expected in the coming weeks.

Three vaccines – Pfizer-BioNTech, Sputnik and Moderna – have already reported good preliminary data from phase three trials, with one suggesting 94% of over-65s could be protected from Covid-19.

The UK has already ordered 100 million doses of the Oxford vaccine, manufactured by AstraZeneca, 40 million doses of the Pfizer-BioNTech vaccine and five million of the Moderna vaccine.

The challenge with developing a Covid vaccine is to trigger the body to fight back against the virus no matter how old someone is.

https://www.bbc.co.uk/news/health-54993652HELP US SPREAD GOOD NEWS!

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CureVac says its COVID-19 vaccine is suitable for standard fridge transport

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German biotec firm CureVac 5CV.DE said its experimental COVID-19 vaccine has been shown to remain stable at 5 degrees Celsius (41 F) for at least three months, making it potentially easier to distribute than some rivals’ compounds.

CureVac, which is close to launching Phase III testing of its vaccine, said the stability of the liquid vaccine was tested at its anticipated storage concentration, and it has been stored at 5 degrees Celsius C as well as below minus 60 degrees.

Tests also established stability at room temperature for up to 24 hours, CureVac said on Thursday.

Pfizer PFE.N and BioNTech BNTX.O on Monday were the first to release data showing that their vaccine worked in a large, Phase III clinical trial.

However, their vaccine needs to be stored at minus 70 degrees Celsius. Before it is administered, it can be kept in a fridge for up to five days, or in thermal shipping boxes for up to 15 days.

https://www.reuters.com/article/us-health-coronavirus-germany-curevac/curevac-says-its-covid-19-vaccine-is-suitable-for-standard-fridge-transport-idUSKBN27S1WDHELP US SPREAD GOOD NEWS!

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UK – Mass Covid tests trialled in Liverpool ‘cut transmission by 90% & can help us get back to normal ASAP’

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Pregnancy-style Covid tests could allow Brits to socialise again after trials in Liverpool show they can reduce transmission by 90 per cent.

The rapid turnaround tests will play a “major role” in returning life to normal, Oxford Uni scientists said today.

Testing shows the checks can effectively pick up more than three in four positive cases – the majority of which are currently being missed.

Experts say they are now looking at how the new technology, which can provide results in under 30 minutes, could be self-administered.

The kits, known as lateral flow tests, have been trialled across England to find out their effectiveness, including a city-wide pilot in Liverpool which was launched last week.

The tests involve a swab of the nose and throat, just like a PCR test.

It’s then inserted into a tube of liquid for a short period of time.

Drops of that liquid are then added to a strip – similar to a pregnancy test – and about half an hour later a result is shown.

Public Health England today said that their extensive clinical evaluation has proven them to be accurate and reliable enough for community-use.

Sir John Bell, professor of medicine at Oxford University, said: “‘The data in this validation report demonstrates that these inexpensive, easy to use tests can play a major role in our fight against Covid-19.

“They identify those who are likely to spread the disease and when used systematically in mass testing could reduce transmissions by 90 per cent.“

www.thesun.co.uk/news/13169865/mass-covid-tests-trialled-liverpool-cut-transmission-90/HELP US SPREAD GOOD NEWS!

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Russia Says Early Data Show Its Covid-19 Vaccine 92% Effective

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The developer of Russia’s flagship vaccine against Covid-19 said it shows a 92% efficacy rate in preventing cases of the illness, as the country pushes for a top slot in the fight against the coronavirus after a rival product by Pfizer Inc. reported a similar breakthrough.

The preliminary Phase 3 findings are based on results from 20,000 volunteers who were given the first dose, including more than 16,000 who also received a second injection, its developers Gamaleya Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund said in an announcement on Twitter Wednesday.

Russia, which said it was the first in the world to do so when it registered Sputnik V in August, has faced skepticism from scientists and pharmaceutical companies, who say that more testing is necessary to prove the inoculation is safe and effective.

https://www.bloomberg.com/news/articles/2020-11-11/russia-says-tests-prove-its-covid-19-vaccine-over-90-effectiveHELP US SPREAD GOOD NEWS!

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Mass testing for 67 local areas in England

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Mass testing for coronavirus will be rolled out to 67 more areas in England, the health secretary has said.

Areas including Nottinghamshire, Yorkshire and parts of the West Midlands will receive new rapid “lateral flow” tests.

Matt Hancock said he hoped the new tests would find Covid-19 “wherever it is, especially in those high prevalence areas”.

It follows the launch of a mass testing programme of people in Liverpool.

The Department of Health and Social Care said it was sending 600,000 of the rapid tests out to directors of public health in 67 areas – listed below – as part of plans to expand asymptomatic testing for Covid-19.

It added that it will be up to individual directors of public health to decide how the tests are used. It means, overall, 70 areas will have the new tests.

News of the scheme came as the head of England’s Test and Trace programme, Baroness Dido Harding, told MPs the service was not a “silver bullet” to tackle coronavirus.

The Conservative peer revealed that preliminary data showed a little over half of people – 54% – who were asked to self-isolate for 14 days said they had complied with the rules.

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The NHS will be ready from December to roll out the new coronavirus vaccine if it gets approved

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The NHS will be ready from December to roll out the new coronavirus vaccine if it gets approved, Health Secretary Matt Hancock has said.

Mr Hancock told MPs the news about the vaccine was an important step but “there are no guarantees”.

He also said “we don’t know” how many people will need to be vaccinated in order for life to return to normal.

And he announced that, from Tuesday, NHS staff will begin being tested twice a week.

On Monday, early results from the world’s first effective coronavirus vaccine showed it could prevent more than 90% of people from getting Covid.

The vaccine has been developed by pharmaceutical companies Pfizer and BioNTech and is one of 11 vaccines that are currently in the final stages of testing.

The companies now plan to apply for emergency approval to use the vaccine by the end of November – and a limited number of people may get the vaccine this year.

https://www.bbc.co.uk/news/uk-54882091HELP US SPREAD GOOD NEWS!

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