A compact extracorporeal membrane oxygenation (ECMO) system built for mobility was greeted with enthusiasm at theSociety of Thoracic Surgeons(STS) virtual meeting.
The Breethe Oxy-1 machine was designed for prolonged use in critically ill patients, providing veno-venous or veno-arterial support in either bedside or portable modes. Another notable feature of Breethe is the divided gas path design that separates oxygenation from carbon dioxide removal, according to Bartley Griffith, MD, of University of Maryland School of Medicine in Baltimore.
At the STS meeting, the ambulatory ECMO system informally won the "Shark Tank" session with 42% of audience votes.
Abiomed had acquired the device in May 2020. In October, the company received FDA 510(k) clearance for the Breethe to be used for ECMO in cardiogenic shock or respiratory failure for a maximum of 6 hours at a time.
Throughout the pandemic, critical care specialists have stressed the potential benefit of ECMO in COVID-19 patients with severe respiratory failure. Not all patients who receive ECMO survive, however, and there are not nearly enough machines for potential candidates.
Griffith described the young woman who was the first person to use the Breethe device in December 2020. She was able to walk down the hallway after having been on traditional ECMO in the ICU, he said.
Ultimately, Breethe was designed for someone like her "to run into the cafeteria when she's hungry," he told the audience.
Other competitors at STS "Shark Tank" included:
An aortic cross-clamp with a detachable head that applies force evenly for a less traumatic clamp.
A smartphone app that aids communication during organ procurement and transplantation for improved personnel productivity, shorter case times, and fewer organs wasted.
The StrokeShield left atrial appendage occluder that leaves no peri-device flow or residual space.
An augmented reality system that adds vitals, imaging data, and more to a surgeon's view; additionally, those wearing the headset can have the camera recording live and take annotations in real time.
A novel specimen extraction sleeve that can fit large tissue samples through small incisions during minimally invasive surgery.
"It's encouraging to see heart surgery is still alive and thriving with very innovative ideas," said session co-moderator William Cohn, MD, of Johnson & Johnson and the Center for Device Innovation at the Texas Medical Center in Houston.
AstraZeneca has said it has had “constructive talks” with European leaders in a bid to cool the row over vaccine supplies to the EU.
The vaccine is expected to be approved by European regulators tomorrow, but this has been overshadowed by an announcement that the company will not be able to produce the 300 million doses the EU ordered by the end of March.
Low yields at AZ’s European sites led to a political row and yesterday escalated further with European Commissioner for Health Stella Kyriakides calling for shots manufactured in the UK to be diverted to the continent.
Following a meeting with the company last night Kyriakides said there was still a “lack of clarity on the delivery schedule” of the jabs.
She requested a “clear plan from AstraZeneca for the fast delivery of the quantity of vaccines that we reserved for Q1”.
A more upbeat spokesperson for AstraZeneca said in a statement: “Our CEO Pascal Soriot was pleased to participate in a meeting with the EU’s Vaccine Steering Board.
“We had a constructive and open conversation about the complexities of scaling up production of our vaccine, and the challenges we have encountered.
“We have committed to even closer coordination to jointly chart a path for the delivery of our vaccine over the coming months as we continue our efforts to bring this vaccine to millions of Europeans at no profit during the pandemic.”
Her comments followed a lengthy interview with Italy’s la Repubblica newspaper, where Soriot outlined some of the issues that have caused the shortfall in the vaccines.
According to Soriot production from the company’s European supply chain is around two months behind the UK.
He pointed out that the UK signed its contract three months before the EU and as a result production in Europe is significantly behind as the system is not yet fully up and running.
Lower than expected yields have also been an issue, although Soriot said things will begin to improve as the process is fine-tuned.
From February onwards the plant will be able to make 100 doses per month and Soriot noted that most vaccine operations will produce around 100 million doses per year.
Soriot also said that the contract stipulates a “best effort” to get the doses to the EU by that deadline, something that the EU disputes.
However with the contract covered by a confidentiality clause there is a lack of publication to verify claims by either party.
Growing older doesn't have to mean “game over,” at least according to a new survey from AARP that findsvideo games are booming among people age 50 and older. The research also found that video games are more popular among older women than older men.
In just three years, the number of older adults who play video games frequently has grown from 40.2 million gamers in 2016 to 50.6 million gamers in 2019, the study found.
"Video games have gone mainstream as [older] gamers find pleasure and functional utility in gaming,” the study says. “Over one-third constantly try new games. With increased access and use, older adults are using gaming to connect socially, stay mentally sharp, reduce stress and just to have fun."
For the report, AARP conducted an online survey in June of 3,737 people age 50 and older. The survey defined a video game as any interactive digital entertainment played via a computer, a game console (like the Xbox or PlayStation), or a phone or tablet.
Forty-seven percent of the respondents who said they play video games also said they played them daily, an increase of 7 percentage points since the 2016 survey. The average amount of time older adults spent playing a game was 5 hours per week, the research found.
The biggest spike in game play among older adults was among those age 50-59, the same generation that grew up playing Atari and Ms. Pac-Man decades ago. Game play for that group was 49 percent in the 2019 survey, up from 40 percent three years ago. For adults age 60-69, game play grew three percentage points, from 41 percent in 2016 to 44 percent in 2019. Among those age 70 and older, there was a two-percentage point increase in game play, from 37 percent to 39 percent.
While they are playing for fun, these adults also are adding up to big business. The survey offers a snapshot of an audience that is likely to have a growing effect on the video game industry at large, using their spending power to shape which types of games are made and become successful. According to the report, gamers 50 and older spent an estimated $3.5 billion on gaming within the six-month timeframe from January to June 2019, up from $523 million in 2016.
"Continued growth in the number of older gamers means increased spending power, particularly on content,” the report says.
The study also found a big difference in game play by gender. The survey found that 49 percent of women age 50 and older were gamers, while just 40 percent of men were. Women are playing video games more often, too, with 53 percent of them say they play video games every day, while just 39 percent on men said the same in the 2019 survey.
Most people age 50 and older who play video games do so on their phones or other mobile devices (73 percent, up from 57 percent in 2016). Puzzle and logic games were the most popular type of game (49 percent of respondents), followed closely by card and tile games — minus the gambling — with 47 percent.
A group of 10 U.S. Senate Republicans plan to unveil a proposed compromise on COVID-19 relief legislation on Monday, saying they believe their proposal can win bipartisan support.
In a letter to President Joe Biden released on Sunday, the 10 lawmakers asked for a meeting with the White House, saying they wished to “work in good faith” with the new administration.
Britain’s government is working on a recovery plan for the country’s COVID-battered economy, a source said on Sunday, as ministers direct their attention to trying to restore growth for businesses hit hard by the pandemic.
Prime Minister Boris Johnson and finance minister Rishi Sunak have broken with the traditional, pro-market instincts of their Conservative Party and are on course to spend 280 billion pounds of public money in the current financial year to support jobs and businesses.
The government source said the finance ministry and cabinet office were working on a recovery plan after the Sunday Times reported that the government would provide a long-term blueprint that is likely to mean high state spending for a decade.
The Sunday Times also said Sunak would use his March 3 budget to extend government relief, including the furlough job protection scheme, business support loans, cuts in value-added tax, and perhaps the cut to stamp duty on property purchases which is due to expire at the end of March, until the virus is under control.
Earlier this month, a leading British employers group called for another 7.6 billion pounds of immediate government help, saying they could not wait until the March budget.
The Sunday Times said Sunak would also announce that the support programmes will be phased out, probably this autumn, in favour of “a plan for jobs” to kick-start employment and a “plan for growth” to promote new industries.
Columbia University researchers and Regeneron have independently confirmed findings; data included in bioRxiv paper and submitted for peer-reviewed publication
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that researchers in Dr. David Ho'sColumbia University lab and Regeneron scientists have independently confirmed that REGEN-COVTM (casirivimab and imdevimab antibody cocktail) successfully neutralizes the circulating SARS-CoV-2 variants first identified in the UK (B.1.1.7) and South Africa (B.1.351). Columbia's findings were included in a paper posted to bioRxiv and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to antibody neutralization.
Both teams of researchers assessed in vitro neutralization potency of numerous COVID-19 antibodies (including those that have received emergency authorization and those still in development) against various mutated strains of the virus. Although some antibody therapies were no longer effective against some of these variants, the REGEN-COV antibody cocktail continued to neutralize all variants tested. REGEN-COV, which consists of the highly potent neutralizing antibodies imdevimab (REGN10987) and casirivimab (REGN10933), retained its potent neutralizing capability against the B.1.1.7 variant, with both antibodies retaining their potency. REGEN-COV also retained its highly potent neutralizing capacity against the B.1.351 variant; imdevimab retained its potency against this variant, and, while casirivimab potency was reduced, it was still comparable to the potency that other single antibodies in development have against the original virus.
News from U.S. manufacturer Moderna that its COVID-19 vaccine is still “expected to be protective” against a virus variant first detected in South Africa came as a relief to scientists and the public. But the 25 Januaryannouncementincluded a caveat: Antibodies triggered by the vaccine appear to be a little less potent against the new variant, named B.1.351, than the one the vaccine was developed for. So researchers were perhaps even more relieved to hear the company will start development of booster shots tailored to B.1.351 and other variants.
“These are exactly the steps that I hoped to see,” says virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center. “It may well not be necessary to have a vaccine update in the fall, but taking these steps now is the right course of action.” Other vaccinemakers are also contemplating updates.
Scientists have grown increasingly concerned that new coronavirus variants may worsen the pandemic. B.1.1.7, first detected in England and now spreading globally, has been shown to be more transmissible; on 22 January, the U.K. government said it may be deadlier as well. B.1.351 and a very similar variant named P.1 that originated in Brazil’s Amazonas state are suspected of evading immunity in people who were vaccinated or previously infected.
Now, researchers from Moderna and the Vaccine Research Center at the U.S. National Institutes of Health have tested the potency of antibodies from eight people who had received the company’s vaccine against a retrovirus modified to express the mutated spike proteins of B.1.351 and B.1.1.7. In a preprint, they report that antibodies neutralized the virus in both cases. But for B.1.351, the levels needed were six times higher than for virus expressing the original protein.
A similar study by virologist David Ho of Columbia University, under review at Nature and posted as a preprint on bioRxiv, found that the serum of 22 people vaccinated with Moderna’s vaccine or a similar one from Pfizer was six to nine times less potent against B.1.351, and serum from 20 previously infected people was 11 to 33 times less potent. Researchers in South Africa, meanwhile, have found that antibodies from six recovered patients were six to 200 times less effective at neutralizing B.1.351.
Such drops sound alarming, but the vaccines produced by Pfizer and Moderna trigger very high levels of antibodies, which likely compensates for the decline in potency, says Florian Krammer, a vaccine researcher at the Icahn School of Medicine at Mount Sinai. Besides, antibodies are only one part of the immune response; the vaccines also trigger T cells. Krammer is “quite optimistic” that both vaccines will still protect against B.1.351 and P.1. “However, this is worrisome for vaccines that are not as potent in inducing neutralizing antibodies as the two mRNA [messenger RNA] vaccines.”
Others agree the results don’t spell doom yet. “Given the high starting point, it’s conceivable [vaccine efficacy] could drop only slightly,” Bedford says. Immunity is not binary, adds Jeremy Farrar, head of the Wellcome Trust: “It doesn’t suddenly turn on and turn off.” A drop in antibody potency could have more subtle effects, such as immunity waning a bit faster, he says. The results with sera from recovered patients also suggest the risk of reinfection with COVID-19 may be rising, especially for people who produced low levels of antibodies during their first encounter with the virus, says Stephen Goldstein, a virologist at the University of Utah. “Most of these people I expect to still have good protection from serious disease. It’s on a spectrum, though.”
It may well not be necessary to have a vaccine update in the fall, but taking these steps now is the right course of action.
Moderna says it will start phase I trials of two booster strategies: a third dose of its current vaccine, or of a slightly different one in which the mRNA has been tweaked to incorporate B.1.351’s mutations. They may be given to volunteers 6 to 12 months after the initial immunization, Moderna Chief Medical Officer Tal Zaks said in a call with investors. Pfizer, in an email to Science, wrote that it, too, is “laying the groundwork to respond quickly if a future variant of SARS-CoV-2 is unresponsive to existing vaccines.” Novavax, which is in late-stage trials with a vaccine based the spike protein, says it is “testing sera against the new strains.”
Georgetown University virologist Angela Rasmussen says it’s “very wise” to start to prepare boosters now. “It’s also wise to begin thinking about how they will be distributed,” she adds. “For example, will they be allocated to regions with evidence that B.1.351 is circulating?” Regulators still need to spell out what trials they would require for updated vaccines. At a press conference on Monday, World Health Organization official Bruce Aylward said work to define a regulatory pathway was “kicking off right now.”
Scientists also need to agree on faster ways to address any concerns about immune escape variants, says Farrar, and standardize the way they test antibodies’ potency: “We need harmonization of the assays, so we can compare the results and it doesn’t matter which lab you’re in.” Animal experiments need to be coordinated as well. Vincent Munster, a virologist at the U.S. National Institute of Allergy and Infectious Diseases, says he has already vaccinated hamsters and will challenge them with virus variants in the next couple of weeks. “These studies take a lot of coordination and we are discussing the need for a more planned approach to prepare for other novel variants emerging,” Munster says.
The most timely answers on B.1.351 may come from humans, however. Efficacy trials of several vaccines, including the Pfizer one, are ongoing in South Africa; Tulio de Oliveira, a virologist at the University of KwaZulu-Natal, says researchers are now sequencing the virus from 150 study participants who became infected. “We’re going have the results in 36 hours,” he says. But only after the trial is unblinded next week will researchers know how many of these infections occurred in people who received the vaccine instead of a placebo.
Ho’s paper also sheds some light on how B.1.351 escapes the immune response. The team produced retroviruses with spike proteins incorporating each of B.1.351’s nine mutations separately, as well as all at once. A mutation named E484K accounted for much of the effect, they found. “E484K is really the bad boy here,” Goldstein says. Brazil’s P.1 variant has the same mutation, which might be a sign that the virus has few other tricks to evade immunity, he says: “The virus has a lot of room to evolve but not infinite room. We may have come upon one of the worst possible mutations already.”
But other researchers say the plethora of recent changes is a warning sign that the coronavirus may have more surprises in store—and that the world needs to administer existing vaccines as fast as possible. “I think we need to stop the virus from replicating however we can,” Ho says. “Otherwise, it will keep accumulating more mutations.”
