AstraZeneca stock falls as drugmaker pauses vaccine trial after volunteer’s ‘unexplained illness’


Shares in AstraZeneca fell on Wednesday after the drugmaker said it has paused late-stage trials of its coronavairus vaccine candidate following an unexplained illness in one of the trials’ volunteers.

AstraZeneca
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said it was a “routine action” and that unexplained illnesses can happen “by chance” in large trial and must be independently reviewed.

In an emailed statement, AstraZeneca said: “As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee.”

It added that it is working to expedite the review of the single event to minimize any potential impact on the trial timeline. “We are committed to the safety of our participants and the highest standards of conduct in our trials.”

A report in the New York Times said that the volunteer in the U.K. trial received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord. “However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is still unknown,” the NY Times said. The British drugmaker declined to the comment on the location and the diagnosis.

Shares in AstraZeneca
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which fell 6% in New York in after-hours trading on Tuesday after STAT first reported that the trial had to be stopped, were down 1% in early European trading.

Analysts at Citigroup said the risk of a serious adverse event (SAE), potentially vaccine-related, was always “a high probability event” in one of the multiple large Covid-19 trials.

“We have limited information on the single SAE aside from it occurred in the UK trial and the patient is expected to recover albeit almost certainty currently hospitalised,” the analysts wrote in a research note on Wednesday.

“[Tuesday’s] development may negatively impact timelines for other Covid-19 vaccine sponsors. While AZN’s current share price is discounting little economic value from Covid-19, we expect an initial negative stock and broader market reaction today in response to the news,” the analysts added. But they cautioned that they are “hesitant” to draw any conclusions in the absence of further information.

Analysts at Jefferies said they envisage a short-term stock correction “which may prove misplaced”.

On Tuesday the CEOs of nine companies, including AstraZeneca, BioNTech
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,
Johnson & Johnson
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Moderna
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and Novovax
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made a joint pledge to “stand with science” on coronavirus vaccines, making clear that they would not move forward with such products before demonstrating their safety and efficacy.

AstraZeneca’s halts covers studies in the U.S. and other countries and could derail the plans of President Donald Trump, who reportedly hopes to fast-track approval of the vaccine in a bid to make it available to Americans before November’s election.

The news comes just two days after Britain’s health secretary Matt Hancock said the vaccine, which is being developed in collaboration with the University of Oxford, would “most likely” be available in the first few months of 2021.

Read: AstraZeneca vaccine ‘most likely’ to roll out in the U.K. early next year

On Wednesday, British Prime Minister Boris Johnson is set to announce new measures aimed at curbing the spread of the virus after a sharp rise in daily coronavirus cases in the country.

Since Sunday, there have been 8,396 new cases reported – with 2,460 reported on Tuesday alone, according to government data. There were also 32 deaths reported, though these will not relate to the most recent rise in cases.

The new rules will include banning social gatherings of more than six people in England from Sept. 14. The new rule applies to private homes, indoors and outdoors, and places such as bars and cafes, but will not apply to schools and workplaces.

Michael Hewson, chief market analyst at CMC Markets UK, said, it was only a matter of time before a setback like this were to happen, given the complexities of trying to get a vaccine to a virus that is still very new.

“We already know from the number of flu vaccines that an immunization program is not a magic bullet, and with the UK looking to re-tighten social gathering restrictions from the beginning of next week, investors will have to come to terms with the idea that the path out of the current crisis is likely to be choppy and much more prolonged than previously thought,” Hewson said.

Read:U.K. signs deals with BioNTech, Pfizer, and Valneva for COVID-19 vaccines

The U.K. has placed orders for six experimental vaccines, taking its potential stockpile to 340 million doses. In August, the government announced in August that it will buy 90 million doses of potential Covid-19 vaccines from Johnson & Johnson and U.S. drug developer Novavax.



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AstraZeneca vaccine ‘most likely’ to roll out in the U.K. early next year


U.K. health secretary Matt Hancock on Monday said a COVID-19 vaccine would “most likely” be available in the first few months of 2021, as the country recorded a sharp rise in daily coronavirus cases.

Speaking on national news radio station LBC, Hancock said the government has already started production of the U.K. government’s initial order of 30 million doses of its coronavirus vaccine, which is being developed by pharmaceutical giant AstraZeneca
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in collaboration with the University of Oxford.

“We have got 30 million doses already contracted with AstraZeneca, in fact they are starting to manufacture those doses already, ahead of approval, so that should approval come through — and it’s still not certain but it is looking up — should that approval come through, then we are ready to roll out,” Hancock told LBC.

“The best-case scenario is that happens this year. I think more likely is the early part of next year — in the first few months of next year is the most likely,” he added.

U.S. President Donald Trump is reportedly considering plans to fast-track approval of AstraZeneca’s vaccine in a bid to make it available to Americans before November’s election.

The vaccine hasn’t been approved for use and is still undergoing late-stage clinical trials in the U.K., Brazil and South Africa.

Read:AstraZeneca coronavirus vaccine heads to late-stage study

Hancock’s comments come after the U.K. recorded a surge in the number of people testing positive for coronavirus. On Sunday, a further 2,988 cases of coronavirus were reported in the country, the highest number reported on a single day since May 22, and a rise of 1,175 on Saturday, according to the U.K. government’s coronavirus dashboard.

Two deaths were recorded within 28 days of a positive COVID-19 test in the previous 24 hours, taking the total to 41,551, the government said.

The rise in cases prompted Professor Gabriel Scally, a former National Health Service regional director of public health for the south west, to tell the Guardian that the government had “lost control of the virus.

Hancock on Monday denied the government was losing control, but said that this weekend’s rise in cases was “concerning.” He urged younger people to adhere to social distancing measures, saying that under-25s, particularly those aged 17 to 21, accounted for a large number of positive cases.

The spike in cases comes as people are returning to work and school, and as universities prepare to reopen.

“It is concerning because we have seen a rise in cases in France, in Spain, in some other countries across Europe — nobody wants to see a second wave here,” Hancock told LBC.

“It just reinforces the point that people must follow the social distancing rules, they are so important,” he said, adding, “But we’ve also bought vaccine ahead of it getting approved from a whole different series of international vaccines as well.”

Read:U.K. strikes two COVID-19 vaccine deals for 90 million doses

In August, the U.K. announced that it will buy 90 million doses of potential COVID-19 vaccines from Johnson & Johnson
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and U.S. drug developer Novavax
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.

Some people with coronavirus are being asked to travel hundreds of miles to get tested, according to the BBC.

Labour’s shadow health secretary, Jonathan Ashworth, on Sunday tweeted that the increase in COVID cases is “deeply worrying” and demanded Hancock give a statement to the House of Commons to explain the increase in cases and why some people are still being told to drive hundreds of miles to have a test.





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Is Bacardí taking aim at Captain Morgan (or Starbucks) with its latest offering?


Spiced rums are very cocktail-friendly — basically, just add one mixer (cola, juice, iced tea, you name it) and you’ve got yourself a party.


Photo by Bacardi

 

The bottle: Bacardí Spiced Rum, $12.99

The back story: These days, when Americans reach for a bottle of rum, it’s often one with an added boost of flavor. The Distilled Spirits Council of the United States, an industry trade group, reports that 55% of the rum market is now made up of rums that have been infused with spices, fruit or other flavorings.

All of which sets the stage from the latest offering from rum giant Bacardí — namely, Bacardí Spiced. Actually, it’s not so much a new bottle as a repackaging of Oakheart, a spiced rum that it introduced in 2011, says Lisa Pfenning, Bacardí’s North American vice president. The idea, she says, is for the bottle to “better fit” into the larger Bacardí family. But we can’t help wonder if putting “spiced” front and center allows the 158-year-old company to compete more directly with Captain Morgan Original Spiced Rum
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the behemoth in the category. Pfenning doesn’t get into such specifics, but she notes that “some of the larger players” in spiced rum “have shown vulnerability over the past few years.”

Either way, there is no set definition of what constitutes a spiced rum. “Every rum maker follows a different recipe,” Pfenning says. In Bacardí’s case, it begins with taking an aged rum, then adding what the brand calls a “unique blend” of spices. The release of the repackaged bottle is being timed with the fall — certainly, it’s a season all about flavoring, as in the ubiquitous pumpkin spice (Starbucks
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already has its latte out).

What we think about it: We generally prefer rums that are flavored like, well, rum — meaning ones with nothing added. But America is a flavor nation, so we understand why the market is moving in this direction. Bacardí Spiced is about as low-key as a spiced rum can get — we taste some vanilla, some nutmeg, maybe a hit of cinnamon, but nothing that overwhelms the palate. There’s also a very slight degree of smokiness — the liquid is aged in charred American oak barrels, Bacardí points out. Some might find the rum too lacking in flavor to truly be called spiced, but we like its subtleness.  

How to enjoy it: Spiced rums are very cocktail-friendly — basically, just add one mixer (cola, juice, iced tea, you name it) and you’ve got yourself a party. But we were pleasantly surprised how this rum held up on its own — say, with a cube or two of ice — as a mellow autumn sip.



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Here’s the ethics case for deliberately infecting volunteers with COVID-19 to speed up a vaccine


Despite the urgent need to beat COVID-19, health officials may be delaying the development of an effective vaccine.

Authorities in the U.S. and elsewhere are yet to authorize an ethically charged research procedure called “human challenge trials.” Challenge trials entail deliberately infecting volunteers with the disease –– which explains the official reticence — but they could substantially expedite the development of a vaccine.

The debate over human challenge trials has been raging for months among health professionals and academics. But only now — some eight months into the pandemic — are authorities in the U.S. beginning to consider them in a bid to speed up the vaccine-development process.

Sitting and waiting

A vaccine has to go through multiple stages before it can be rolled out. After establishing its ability to trigger an immune response and its safety, developers must test it for efficacy. Inefficient vaccines may not justify the tiny risk inherent even in safe vaccines, may be enormously wasteful, may divert resources from better alternatives and may harm immunization rates.

There are two principal ways with which to measure efficacy. Under the conventional method, researchers vaccinate tens of thousands of volunteers and then passively wait for some of them to get infected. The frequency of infection is then compared to a non-vaccinated control group.

In the second method, human challenge trials, a much smaller group of volunteers is intentionally infected after receiving the experimental vaccine or a placebo. This allows for a much faster and efficient determination of vaccine efficacy.

To date, more than 33,000 people from 151 countries have volunteered to be part of such a procedure. But there is no official authorization for human challenge trials for COVID-19 in the U.S. or other Western countries. This means that vaccine developers are forced to vaccinate many more volunteers — typically about 30,000 are involved for each candidate vaccine — and then release them into the general population, with the hope that enough data would soon accumulate.

This is where we presently are in the U.S.: waiting for enough participating volunteers to catch the virus by happenstance.

Paradoxically, these giant and expensive studies — American taxpayers have already spent billions of dollars on vaccine development — are slowed down by government efforts to minimize infection rates through quarantines, closures, masks usage or social distancing. Back in May, leading developers of potential COVID-19 vaccines, including the biotechnology company Moderna and Oxford University, issued a warning that low-level infections among their volunteers may delay the development of their vaccines.

It is possible, of course, that the conventional studies will yield the required data. But there is a distinct possibility that challenge trials could speed up things.

Medical ethics

Opposition to human challenge studies for COVID-19 is based, first and foremost, on ethical considerations. Since at present there is no cure for COVID-19, intentional infection can result in death or serious impairments. It is therefore argued by people like Michael Rosenblatt, a former dean of Tufts University School of Medicine and a present adviser to Moderna, that the risks are too high, and that volunteers cannot give a valid “informed consent” for intentional infection.

The argument that willing adults cannot consent to risking their health for the greater good is, we believe, inconsistent with how society views other acts of volunteerism. Volunteer firefighters, for example, also face unknown dangers. Moreover, few countries refrain from risking the health and lives of their young citizens on the world’s battlefields, if they deem that the common good requires such sacrifice. And while COVID-19 human challenge trials would include only volunteers, most battlefields also include people who are forced into service.

Delaying a vaccine may also endanger volunteering health-care workers. Current estimates put the number of U.S. health-care workers’ deaths from COVID-19 at around 1,000. Health-care volunteers continue risking their lives as long as vaccine development is delayed.

The opposition to human challenge trials derives from justified sensitivity to medical experiments on humans, and the horrific history of such experiments — which often ignored the interests and rights of their subjects. These included the experiments performed by the Nazis on prisoners or the notorious Tuskegee Study of untreated syphilis, which was conducted on unsuspecting African Americans. And of course, even medical experiments that subjects consent to can go terribly wrong.

Lives at stake

But rapid development of an effective vaccine could save hundreds of thousands of lives worldwide. At present, more than 5,000 people die of COVID-19 each day. At that rate, every month of delay in vaccine availability costs 150,000 lives.

The indirect costs are tremendous as well. For example, the United Nations recently announced that pandemic-linked hunger is tied to 10,000 child deaths each month. From these perspectives, the arguments against human challenge trials appear far less convincing.

We believe that the decision to allow human challenge trials for COVID-19 should not be examined solely through the narrow lens of medical ethics — with its cardinal principal of doing no harm to the individual patient or the volunteer. The COVID-19 epidemic is a global disaster, and decisions concerning it should be made with the wider perspectives of public health and general morality.

In other words, the decision may be more suitable for high-level policymakers than for medical ethics committees.

In April, some American lawmakers did weigh in: 35 members of the U.S. House of Representatives sent a letter to the heads of the U.S. Food and Drug Administration and the Department of Health and Human Services, voicing support for human challenge trials. So far, however, this effort has had no effect.

There is no doubt that human challenge trials carry significant risks for volunteers; but they also carry the chance of significant benefits for humanity. Instead of regarding these volunteers as uninformed, society may do better to valorize their altruism and heroism.

We believe that, given present circumstances, human challenge trials for COVID-19 are not morally wrong: To the contrary, they express humanity’s most noble values.

Now read: This Seattle man volunteered to be injected with an experimental COVID-19 vaccine: ‘It was kind of my duty as a healthy individual to step up’

Ofer Raban is a professor of constitutional law at the University of Oregon in Eugene. Yuval Dor is a biology professor at Hebrew University of Jerusalem. This was first published by The Conversation — “The ethical case for allowing medical trials that deliberately infect humans with COVID-19“.



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The 10 coolest things about the new Ford Bronco


After years of speculation, numerous leaks, and an original launch date pushed back by the ongoing pandemic, Ford
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finally pulled the wraps off the revived Bronco.  And right away it’s looking like it’s going to turn the adventure vehicle segment on its head. A dedicated off-roader with heaps configurability and new features, the Bronco brings loads of excitement to an already red-hot off-road space, and here we’ll highlight 10 of our favorite things about it.

The original Ford Bronco made its debut back in 1966 as a competitor to the Jeep CJ-5. With its simplistic design, removable roof, and go-anywhere capability, it achieved an iconic status over the years, and the new one looks to pick up where that original Bronco left off. The design of the 2021 model is heavily influenced by the original, with a flat hood, flat doors, and an overall boxy shape, but with modern accouterments, like LED lighting, active safety tech, beadlock capable wheels, available 35-in off-road tires, and much, much more.

There’s a two-door version

The Ford Bronco 2-door.


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This may not seem like that big of a deal, but don’t take a two-door SUV for granted here in 2020. These truncated off-roaders offer a better breakover angle and are considerably more maneuverable on the trail, making them the bodystyle of choice for serious off-road enthusiasts. While they were popular decades ago, two-door off-road vehicles are a rarity today, and virtually every one that has been attempted recently, outside of the venerable Jeep Wrangler of course, has been quietly discontinued within a few years. If any vehicle can buck the trend, it’s the Bronco. No pun intended, of course.

The roof and doors come off, but the mirrors stay on


Ford

Clearly targeted at the Jeep Wrangler, the Bronco features a removable roof and doors, just like its Toledo-built rival. Unlike Jeep though, Ford has gone to lengths to make the Bronco’s roof and doors easier to handle. Like the Wrangler, both two- and four-door Broncos are available with a three-piece hardtop with two removable panels over the driver’s and passenger’s seats.

But the Bronco also offers an optional four-piece hardtop that adds an additional removable panel over the second row, allowing for an open-top experience for all passengers without requiring the removal of the bulky rear piece.

Additionally, unlike the Wrangler which has a cross beam located just above the second row, the Bronco’s rear crossbeam is located over the cargo area, leaving nothing but open sky over the heads of second row passengers. As for the Bronco’s doors, they come without window frames, making them lighter, easier to carry, and perhaps most important of all, capable of being stored in the cargo area, which allows for impromptu door removal.

Also on MarketWatch: American muscle: We compare a Chevy Camaro to Dodge Challenger

Additionally, unlike the Wrangler, which sees its mirrors located on the front doors themselves, the Bronco’s mirrors come affixed to the A-pillars, meaning that you don’t lose them when you remove the doors

You can get it with a seven-speed manual transmission

The Bronco will launch with two available engines. The entry-level engine is the same 2.3-liter turbocharged four-cylinder found in the Ranger, and makes the same 270 horsepower and 310 lb-ft of torque it does in Ford’s midsize pickup. This engine comes paired to either a ten-speed automatic, or a clever seven-speed manual, the lowest gear of which is a special ultralow crawler gear, meant for technical off-roading. Upper-level models get Ford’s 2.7-liter turbocharged V6, which will make 310 horsepower and 400 lb-ft of torque. This engine comes paired exclusively with the ten-speed auto.

It’ll launch with loads of accessories

Given the Bronco’s customizability, Ford has made it known that they’ll be introducing a whole line of accessories for the Bronco prior to it going on sale. Think lighting, wheels, tow hooks, winch mounts, roof racks, limb risers (those wires that run from the front corners up to a roof rack), doors with cutouts, fenders, lift kits, rock sliders, bumpers, and more. On top of that, the aftermarket is champing at the bit, with companies from Hennessey Performance to ARB certain to introduce a full line of Bronco products. Rest assured that there’ll be plenty of options for customization.

Base and Black Diamond trims come with steel wheels


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Another seemingly minor point, but in the era of bigger and bigger wheel diameters, it’s nice to see an automaker embracing simplicity, especially in the form of subtle, utilitarian wheel designs. In the off-road space, it’s not uncommon to replace factory rims with smaller, more durable wheels, so it’s great to see Ford offering a set of simple, timeless steel wheels from the factory (for what it’s worth, Land Rover is doing something similar with the new Defender as well). Additionally, the Bronco is said to accept wheels as small as 16-in, which allows for more sidewall, and sidewall is your friend when venturing off-road.

There’s more off-road tech than you could dream of


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In its most capable form, the Bronco will pack an unprecedented array of off-road tech; more than you can get on the Jeep Wrangler. Four-wheel drive is standard, and in addition to two-high, four-high, and four-low modes, the Bronco’s four-wheel drive system will come with an auto mode, capable of switching from two- to four-wheel drive on the fly whenever the system senses slippage.

The Bronco will be available with locking front and rear differentials, making it just one of three vehicles offered with independent front suspension and a front locker, the other two being the Chevrolet Colorado ZR2 and Mercedes-Benz G-Class.

Read: The best SUVs for less than $40k

Like it’s rival from Jeep, the Bronco will also offer an available disconnecting front sway bar, but the Bronco uses a much more sophisticated design than the Wrangler in that it can disconnect under full load. Additionally, the Bronco has an edge on the Wrangler when it comes to breakover and departure angles, ground clearance, and water fording capability (the Wrangler barely beats it out on approach angle). The Bronco is also said to have greater wheel travel than its chief rival, despite its use of an independent front suspension.

Finally, the Bronco will offer a ‘Trail Turn’ assist mode, and up to seven different traction modes, including Sand, Rock, and our favorite from the F-150 Raptor, Baja.

There’s something called the Sasquatch package

It’s fair to say that the most drool-worthy Bronco is any one that’s riding on 35-in tires. To get these, you’ll have to opt for what Ford is referring to as the ‘Sasquatch Package’, and it’s available on all trim levels. In addition to 35-in tires, the ’Squatch Pack gets you 17-in beadlock-capable wheels, Bilstein position-sensitive monotube shocks, a 4.7 final drive ratio, high-clearance fender flares, and every off-roader’s favorite – locking front and rear differentials. We can’t help but wonder if the name of this package isn’t a subtle reference to the legendary Ford F-150-based monster truck known as Bigfoot.

The software is as cool as the hardware

In addition to its killer mechanical features, the Bronco will pack a new fourth-generation version of Ford’s Sync infotainment system, which will include mainstream features like Android Auto and Apple CarPlay, along with a unique trail mapping feature that allows drivers to plan, program, and follow off-road trail itineraries, and then share them via an integrated social feature. Through the system, you can also access a number of different mapping services, including Trails Offroad, AccuTerra, and FunTreks. Additionally, the Bronco is available with a massive 12-in infotainment screen, and a 360-degree camera system, great for everything from tight parking spots to navigating Hell’s Revenge in Moab.

There’s a crossover version

The Ford Bronco Sport


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Ford seems to be setting up the Bronco nameplate to become its own subbrand of off-roaders within the company’s greater lineup, and has thus introduced a small crossover dubbed the Bronco Sport alongside the primary Bronco. While the flagship Bronco comes with a body-on-frame construction and a solid rear axle, the Bronco Sport rides on the same unibody platform as the Escape, and features a fully-independent suspension. Its closest rivals are the Jeep Compass and Cherokee.

Also see: Ford promises you can return your car within the first year if you lose your job—here’s how it works

While it won’t offer the configurability of the main Bronco, expect the Bronco Sport to offer decent fuel economy, more comfortable on-road driving manners, and a lower price, while being about the most capable body-on-frame crossover there is when it comes to venturing off-road.



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