European regulators are set to start an accelerated review of a Covid-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc, according to a person with knowledge of the situation, in a sign the shot could be the first to seek approval in the region.

The European Medicines Agency is expected to announce the “rolling review” as soon as this week, according to the person, who didn’t want to be identified because the decision is still private. Such assessments are used in emergencies to allow regulators to see trial data while the development is ongoing to speed up approvals of drugs and vaccines that are urgently needed.

The move would be a key step forward for the Oxford-AstraZeneca shot after trials were halted earlier this month due to concerns about a participant in the U.K. study who became ill. The partners, along with companies such as Pfizer Inc. and Moderna Inc., are sprinting ahead with experimental shots as governments look for a way out of the global crisis.

While the British regulator cleared the Oxford-Astra trial to restart less than a week after it was paused, U.S. authorities have yet to give the go-ahead for trials to resume in the country. Studies in South Africa, Brazil and India have also restarted.

The EMA’s head of vaccines, Marco Cavaleri, said in July the agency would start rolling reviews of potential candidates after the summer. The approach means that a final approval could be granted a matter of days after the review period ends. Cavaleri said at the time the first approval of a vaccine could come by the end of the year.

In emergencies like a pandemic, a rolling review avoids delays so that an EMA recommendation and approval from the European Commission can be sought as quickly as possible. The agency started such an evaluation of remdesivir to treat Covid-19 in April, while trials were ongoing, and the drug was given conditional approval three months later.

https://www.bloomberg.com/news/articles/2020-09-30/oxford-astra-covid-vaccine-review-said-to-start-in-europe

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Health Canada has given the green light to a rapid COVID-19 testing device that can produce results in just 15 minutes.

The latest diagnostic tool called ID NOW COVID-19 was added to the authorized medical devices list on September 30. 

The big yes comes one day following the federal government's announcement that it would buy around 7.9 million of the new tests from the U.S.-based firm for distribution in Canada.

https://www.narcity.com/news/ca/health-canada-has-approved-a-new-covid19-test-with-results-in15-minutes

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Regeneron Pharmaceuticals Inc on Tuesday said its experimental two-antibody cocktail reduced viral levels and improved symptoms in non-hospitalized patients with mild-to-moderate COVID-19, the disease caused by the novel coronavirus.

When asked whether the company would apply for emergency use authorization from the U.S. Food and Drug Administration, the company said it plans to “rapidly” discuss the early trial results with regulatory agencies, including the U.S. Food and Drug Administration.

Results for the first 275 trial patients showed the greatest effect in patients who had not mounted their own immune response prior to treatment, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response, Regeneron said.

For seronegative patients, median time to symptom alleviation was 13 days for the placebo group, 8 days for the high-dose group, and 6 days for the low-dose group.

https://www.reuters.com/article/health-coronavirus-treatment-regeneron/regeneron-says-its-covid-19-treatment-reduces-viral-levels-improves-symptoms-idINL1N2GQ1I1

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Moderna's coronavirus vaccine appears to create as strong an immune response in older people as it does in younger adults. That's a positive sign as many vaccines don't work as well in the elderly.

A small study published Tuesday in the New England Journal of Medicine found the Moderna COVID-19 vaccine elicited an immune system response almost as strong in people over 56 as in adults between the ages of 18 and 55.

"This is very promising but it's also somewhat surprising," said David Dowling, an immunologist and professor at Harvard Medical School, who studies vaccines.

Older people are at higher risk for severe illness from COVID-19, according to the Centers for Disease Control and Prevention. People 50 to 64 years old are four times more likely to be hospitalized and 30 times more likely to die from COVID-19 than people between the ages of 18 and 29. Those aged 65 to 74 are five times more likely to be hospitalized and 90 times more likely to die. The older the person, the higher the risk.

"The immune responses were very comparable to that of the young adults," said Dr. Evan Anderson, a professor of infectious disease at Emory University Medical School and lead author on the paper. 

Having a vaccine that works well for older people could make a big difference in COVID-19 vaccine distribution. There have been fears any vaccine approved might not work as well in the elderly. 

https://eu.usatoday.com/story/news/health/2020/09/29/modernas-covid-19-vaccine-may-work-equally-well-older-adults/3575377001/

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An on-the-spot coronavirus test that gives results in 15 to 30 minutes is set to be rolled out globally.

The rapid kits work in a similar way to a pregnancy test and display two blue lines when testing positive for Covid-19.

They work by taking a nasal swab and inserting the sample into a cartridge that looks for antigens - or proteins found on the surface of the virus.

They differ from the current nasal/throat swabs and finger prick tests because they don't need a lab to produce results.

It means they are able to detect coronavirus infection within minutes, compared to the hours of days necessary for the genetic tests, known as PCR tests, to turnaround results.

Former prime minister Tony Blair has called on the Government to adopt the rapid antigen tests, saying they could enable an extra 300,000 coronavirus tests to be carried out every day within a few weeks.

However Baroness Dido Harding, the head of NHS Test and Trace, warned companies and individuals could be forced to foot the bill for the swift turnaround tests as they were too unreliable for use within the health service.

But she said those without symptoms might choose to pay for the tests to act as a kind of Covid-19 passport to allow them to take part in non-socially distanced activities.

https://www.thesun.co.uk/news/12795926/on-spot-covid-test-results-minutes-globally/

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Results from Trinity Health Of New England’s clinical trial involving the use of donor convalescent blood plasma to treat those with advanced cases of coronavirus disease 2019 suggests the treatment is safe, with potential for positive clinical outcomes for those infected.

“Our results suggest that convalescent plasma is safe and has the potential for positive impact on clinical outcomes including recovery and survival if given to patients early in the course of COVID-19,” said Dr. Latha Dulipsingh, one of the trial’s investigators, in a statement.

Dulipsingh is director of the Center for Diabetes and Endocrinology Center within the regional system as well as chair of its review board.

The Hartford-based system, part of multi-state Trinity Health, received approval in April from the U.S. Food and Drug Administration to launch its own clinical trial studying the safety and efficacy of administering blood plasma from patients who have recovered from COVID-19 to patients considered severely or critically with it.

Trinity’s study involved 38 patients who were referred by their health care provider and who were either severely ill with COVID-19, that is, experiencing some difficulty breathing and showing lower levels of oxygen in their blood, or critically ill, with symptoms like respiratory failure. Their mean age was 63, and 53% were male; 34%, black; 34%, Hispanic, and 32%, white.

According to the report, patients who received convalescent plasma early in the progression of their disease, that is, at the severe stage, had significantly lower hospital mortality - 13% versus 55% - and shorter hospital stays - 15.4 versus 33 days - compared to patients treated at the critical stage in the presence of acute respiratory distress syndrome.

Other factors said to be “significantly associated with good clinical outcomes” in the trial included shorter durations between symptoms onset and convalescent plasma administration and hospital admission and administration of convalescent plasma.

https://www.masslive.com/news/2020/09/donor-plasma-shows-treatment-potential-for-covid-19-if-given-early-trinity-health-study-suggests.html

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Russia has sent a first batch of its Sputnik V COVID-19 vaccine to Belarus for clinical trials, the first such delivery of the jab abroad, Russian sovereign wealth fund RDIF said on Monday.

Volunteers in Belarus would begin receiving the Russian vaccine from Oct. 1, the Russian Direct Investment Fund which is backing the vaccine developer, said.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-bel/russia-supplies-covid-19-vaccine-to-belarus-for-clinical-trials-idUSKBN26J1OF

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A nasal spray is under development that could nip a coronavirus infection in the bud, with promising results already seen in ferrets, researchers have revealed.

With coronavirus infections surging around the world, the race is on to develop a vaccine. But researchers are also looking for other ways to tackle Covid-19.

Now scientists have released the results of initial work on a drug-like molecule they say interacts with cells in the nasal cavity to activate the body’s innate immune system.

While immune responses triggered by vaccines involve the generation of antibodies and T-cells geared towards particular pathogens, the innate immune system responds to a wide range of microbes.

In a study that has yet to be peer-reviewed, the team behind the research, which includes scientists at Public Health England, revealed how they administered INNA-051 into the noses of three groups of six ferrets, in various doses, while a fourth group of six ferrets was given a placebo. Ferrets are an important animal model for Covid-19.

The day after administering a second dose of INNA-051 or placebo, the team exposed the ferrets to the virus that causes Covid-19, and the animals were monitored for 12 days via nasal and throat samples.

Five days after the ferrets were exposed to the coronavirus, the quantity of viral RNA – the genetic material of the virus – recovered from throat swabs was reduced by 96% among those given INNA-051 compared with those given the placebo.

Toxicology studies and human trials are now needed to explore whether INNA-051 is safe and effective against the virus in humans.

https://www.theguardian.com/world/2020/sep/28/scientists-work-on-nasal-spray-that-could-stop-covid-virus-replicating

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