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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Trump is openly sabotaging the election, and here’s how you can stop him


There’s really no other way to say it: the president of the United States is trying to sabotage the U.S. election by denying the Postal Service money it needs to process voting by mail. It’s not subtle, and it’s not seriously disputed that he’s trying to do this—in fact, President Donald Trump came right out and admitted what he’s doing

It is welcome news that Postmaster General and Trump megadonor Louis DeJoy has announced that the Post Office “will deliver the nation’s election mail on time” — but it is astounding that it was necessary to issue this statement. DeJoy’s statement is essentially the equivalent of a bank telling customers it has enough money to meet any demands from depositors—it’s the kind of thing that, one would think, would normally go without saying.

The reason DeJoy felt compelled to issue this “the sky is still blue” statement is because voters have gotten concerned that they couldn’t trust the Postal Service to carry out its normal function. These concerns did not materialize out of thin air: USPS had recently told 46 states and DC that it couldn’t guarantee delivery of last-minute ballot requests in time for the election, and there were reports of delays in mail delivery

Sadly, it’s worth updating and applying Ronald Reagan’s old “trust, but verify” maxim to both DeJoy and Trump—although for this crew, we have to call it “don’t trust, but be absolutely sure to verify.” 

Senators should hold DeJoy’s feet to the fire if he testifies before the Homeland Security and Government Affairs committee this Friday. They should make sure they receive updates before the election in order to ensure that DeJoy fulfills his promise of on-time delivery in the context of the election. 

Senators should also gather information from rank-and-file postal employees in order to find out whether more changes are needed—for example, a reversal of DeJoy’s “bans on overtime and extra delivery trips.” They should also make sure USPS has the money it needs to carry out its mission. Treasury Secretary Steven Mnuchin echoes his boss in saying aid supported by Democrats isn’t necessary: senators should determine for themselves whether this is indeed the case.

But we should also recognize that, even if DeJoy keeps to his word and the Postal Service has all the funding it needs, at least two other problems remain. 

First, damage to voter confidence may already have been done. Second, there is no indication that Trump has given up on his efforts to sabotage the election.

It’s clear that Trump’s strategy has at least three related goals: 1) suppress the mail-in vote, which he believes will favor his opponent, Joe Biden; 2) allow Trump to claim victory on Nov. 3 if he’s leading in the early returns while mail-in ballots remain to be counted; and 3) if none of that works and Biden wins anyway, baselessly plant enough doubt in the minds of his supporters that they will incorrectly believe the election was illegitimate.

This perfidious effort to manipulate the election is nothing new and will come as no surprise to anyone who has been following Trump’s twisted electoral strategy and, indeed, his political career. 

In 2016, Trump welcomed Russian assistance aimed at improving his chances in the election. When that episode was exposed, a number of Trump’s associates were convicted of crimes

Breaking news: Trump campaign’s contacts with Russia posed ‘grave’ risk in 2016, bipartisan Senate intelligence report concludes

Last year, Trump tried to pressure Ukraine’s president into illicitly tilting the electoral scales in Trump’s favor by falsely smearing Joe Biden. When that plot was exposed, Trump was impeached. 

But Trump is resourceful when it comes to trying to stay in power, and impeachment didn’t stop him from looking for ways to gain an underhanded advantage in the election (Sen. Susan Collins’s hopes notwithstanding). 

People who have become attached to the notion of constitutional democracy can be forgiven if they are worried. But it’s essential to take a deep breath, maintain perspective and not panic. 

Trump’s actions reflect his desperation. He is trailing in the polls and knows he could use a boost—even an ill-gotten one. The fact that Trump is relying on a deeply immoral, possibly illegal scheme to shore up his chances at re-election does not guarantee he will succeed—far from it.

One thing we have in our favor—those of us who feel strongly about free and fair elections—is that Trump’s plan has been exposed with nearly three months to go before the election takes place. That means we have time to take a deep breath and make a plan for preserving our democracy against Trump’s despicable efforts to take it away.

Trump wants Biden voters to lose faith in the process and to incorrectly believe that there’s no point to voting by mail. DeJoy’s statement may help shore up some of that voter confidence—but, no matter what Trump, DeJoy or anyone else does, there are steps we can all take to make sure our vote is counted—no matter who we choose to vote for.

Voting experts tell us there are concrete, specific actions all voters—no matter who they vote for—can take to make sure their vote counts (as Michelle Obama alluded to in her powerful speech last night). Here are a few important points to keep in mind, depending on the rules in your state (and please be sure to confirm information with your state and local election officials):

  • If your state allows voting by mail and you need to request a mail ballot, don’t wait—request it now. When you receive your ballot, again, don’t wait—return it as soon as you can. One voting rights expert calls the strategy of moving promptly with mail-in ballots a good way to “flatten the absentee ballot curve”. You can track your ballot online to receive confirmation that it was received and accepted.
  • As voting expert Michael McDonald says, “You don’t have to be afraid if your mail ballot does not arrive or [you decide you] don’t want to vote [by mail]. You can always vote in-person. Election officials have safeguards to ensure no duplicate votes. You may need to bring your mail ballot (if you have it) or vote a provisional ballot.”

Trump has tried to scare voters out of using the mail by falsely making them think they may have to worry about their vote getting in on time. He knows this is naked deception—he’s apparently using the mail himself to vote in Florida’s primary, as he has in the past. Trump’s actions are an act of desperation, the acts of an amoral man who knows he is trailing in the polls and will do whatever he can to try to gain an edge. 

Whether you use the mail or another available option (depending on where you live) you have the power here, not Trump. That’s what it means to have a democracy—power resides in “We the people”. 

It will require a little planning and now is certainly not a time to procrastinate when it comes to the most cherished right in a democracy. People in Belarus are risking and in some cases enduring torture to stand up for a free and fair election. Thankfully, we don’t need the same level of courage to make our democracy work. If his efforts to undermine confidence in the Postal Service don’t work, Trump will surely try something else—but he’s running out of time. 

If we are careful, if we are responsible, and if we don’t give in to Trump’s scare tactics, we have all the tools we need to make sure our vote is counted—which is the last thing Trump wants, as his cartoon villain actions make clear.

Chris Edelson is an assistant professor of government in American University’s School of Public Affairs. He has written two books on presidential power. Follow him at @ChrisEdelson on Twitter.





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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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