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What to make of AstraZeneca's vaccine data — and debate around them – STAT

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AstraZeneca’s up-and-down quest to develop a vaccine for Covid-19 stands out from what has otherwise been a remarkably straightforward process in the U.S. And the latest twist for AstraZeneca’s vaccine, involving a contentious back-and-forth with federal authorities, only adds confusion to an already muddled process.

STAT’s Helen Branswell recently joined the “Readout Loud” podcast to talk about AstraZeneca’s current predicament, the implications for vaccine confidence, and how this affects the global effort to beat back the pandemic by getting doses into arms.

Excerpts from the conversation have been lightly edited and condensed for clarity.

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When discussing the AstraZeneca situation, experts consistently reach for the word “unprecedented.” Is that accurate? And how shocking was this back-and-forth compared to the normal process of developing a vaccine? 

I think it was quite shocking. I don’t know that I could go as far as unprecedented. I haven’t looked for, you know, precedents.

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But typically, when a sponsor of an experimental product, whether that’s a vaccine or a drug, and a DSMB [data and safety monitoring board] are going back and forth, that happens behind the curtain. We don’t see that. And if there’s a disagreement between the two on how to read the data, they resolve that before anybody goes public with the data. So to have this situation where AstraZeneca made their statement and then the DSMB made it known that they had they disagreed with the analysis, or the way that AstraZeneca had done its analysis by focusing on earlier cases only, that was quite a stunning rebuke. This kind of stuff doesn’t normally happen in the public eye.

It’s been a bit of a rollercoaster this week. As of Thursday morning, it appears that all the alarm was over a 3 percentage point relative difference in vaccine efficacy — 79% in AstraZeneca’s interim data announced Monday, versus 76% from the more up-to-date analysis we got more recently. Who do you think will get the blame for this bizarre news cycle taking place: AstraZeneca for releasing outdated data or the NIH for putting this all on the public record?

I don’t think it looks good on either party, to be honest. Given that it’s only 3 percentage points, you would be tempted to say, oh, the NIH looks worse from this. But there’s been so much drama around this vaccine, so much uncertainty about the the data, that the company and Oxford University have generated … they had a lot of baggage coming into this fight. So I don’t think anybody walks away from this looking particularly great.

We knew that within 48 hours we are going to get an updated set of results. When you saw that the results were only 3 percentage points different from the original results, did that make you feel better about what might have happened, or did it make you scratch your head even more about why it happened? 

I think I would say both, in a way. At the end of the day, we’re all fascinated by this fight, the drama. But the reality is this is a really important vaccine and the world needs it and needs it to work. And what the data show is that it does work. And so 76% is quite a bit better than the 62% the Oxford group originally reported out of their three Phase 3s, the ones that they did in the U.K. and Brazil and South Africa. So this trial has given us information we really need and it’s really good news. So in that respect, that’s great.

“This vaccine project has had more plot twists and turns than an Agatha Christie novel.”

Helen Branswell, STAT senior writer on infectious disease

But I would love to know more about why the DSMB two days ago thought that the more accurate figure should have been somewhere between 69 and 74. And why now? I mean, you know, there’s there’s part of this story that we just don’t know yet. And I’m really curious about what it is.

The stateside controversy over the vaccine comes just days after a host of European countries briefly paused its distribution to investigate some rare potential side effects. Because this vaccine is being made at a not-for-profit price and it’s easier to store than many of the others, its inventors at Oxford University have called it a “vaccine for the world.” So from the world’s perspective, is this recent news damaging confidence in the vaccine?

Certainly it is damaging confidence in the vaccine in North America, potentially in Europe.

A lot of countries have given emergency authorizations to this vaccine. Whether they are all following this to the same degree that we are, I don’t know. But certainly a lot of people, friends of mine who are not journalists and who are not reporting on this, have been asking me about this vaccine. A lot of my family and friends are in Canada and a lot of them anticipate that this will be the vaccine they’re going to be offered and they feel like they don’t really know what to believe about it, to be honest.

What should AstraZeneca do to rebuild some of the trust and confidence? Or I guess more accurately, what can they do at this stage? 

No more drama. This vaccine project has had more plot twists and turns than an Agatha Christie novel. What they need to do is just generate and disseminate good, reliable data. That’s obviously been done. Going forward, they’re going to be putting in an application for an emergency use authorization. And the FDA is going to be crunching their raw data and it will tell the world what it thinks of how well this vaccine works. And that will be an extraordinarily important step in the process for this vaccine.

Speaking of which, the trial that we’re talking about was meant to support this application to the FDA, but the vaccine likely won’t go before the regulator until a month or two from now, by which point the U.S. might have enough supply of other Covid-19 vaccines to meet its needs. So what do you think the odds are that despite all this contentious debate, AstraZeneca is vaccine never actually gets distributed in the U.S.?

You know, I think that’s a possibility. I guess I’m not sure that we know at this point. One of the things we have to see is, at some point in time, people are going to have to start to vaccinate children and trials are going to need to be done to test the various vaccines and kids. And there is a strong likelihood, I think, that one or two of the vaccines might be more useful in children than others. If they’re less reactogenic, for instance. Parents don’t like to see their kids having a rough go of it after getting a vaccine. So if you can find a vaccine, one of the vaccines, or two of the vaccines that are less reactogenic in children, then those will probably be the ones that would be used.

So would I shut the door on the possibility that this vaccine might have some use in the United States? No. Do I think it’s a possibility that it won’t be used or won’t be used much in the United States? Yeah, I do think that’s a possibility. Just from the point of view of what you just what you said yourself, the U.S. may not need much of this vaccine or any of this vaccine by the time it’s available for use here.

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CANADA STOCKS – TSX falls 0.14% to 19,201.28

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* The Toronto Stock Exchange’s TSX falls 0.14 percent to 19,201.28

* Leading the index were Stantec Inc <STN.TO​>, up 3.4%, Imperial Oil Ltd​, up 3.3%, and Corus Entertainment Inc​, higher by 2.9%.

* Lagging shares were Aphria Inc​​, down 14.2%, Village Farms International Inc​, down 9.9%, and Aurora Cannabis Inc​, lower by 9.4%.

* On the TSX 91 issues rose and 134 fell as a 0.7-to-1 ratio favored decliners. There were 24 new highs and no new lows, with total volume of 228.0 million shares.

* The most heavily traded shares by volume were Toronto-dominion Bank, Royal Bank Of Canada and Suncor Energy Inc.

* The TSX’s energy group fell 0.32 points, or 0.3%, while the financials sector climbed 2.46 points, or 0.7%.

* West Texas Intermediate crude futures rose 0.52%, or $0.31, to $59.63 a barrel. Brent crude  rose 0.4%, or $0.25, to $63.2 [O/R]

* The TSX is up 10.1% for the year.

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Air Canada signs C$5.9 billion government aid package, agrees to buy Airbus, Boeing jets

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By David Ljunggren and Allison Lampert

OTTAWA/MONTREAL (Reuters) -Air Canada, struggling with a collapse in traffic due to the COVID-19 pandemic, reached a deal on Monday on a long-awaited aid package with the federal government that would allow it to access up to C$5.9 billion ($4.69 billion) in funds.

The agreement – the largest individual coronavirus-related loan that Ottawa has arranged with a company – was announced after the airline industry criticized Prime Minister Justin Trudeau’s Liberal government for dawdling. The United States and France acted much more quickly to help major carriers.

Canada‘s largest carrier, which last year cut over half its workforce, or 20,000 jobs, and other airlines have been negotiating with the government for months on a coronavirus aid package.

In February, Air Canada reported a net loss for 2020 of C$4.65 billion, compared with a 2019 profit of C$1.48 billion.

As part of the deal, Air Canada agreed to ban share buybacks and dividends, cap annual compensation for senior executives at C$1 million a year and preserve jobs at the current level, which is 14,859.

It will also proceed with planned purchases of 33 Airbus SE 220 airliners and 40 Boeing Co 737 MAX airliners.

Chris Murray, managing director, equity research at ATB Capital Markets, said the deal took into account the “specific needs of Air Canada in the short and medium term without being overly onerous.”

He added: “It gives them some flexibility in drawing down additional liquidity as needed.”

Transport Minister Omar Alghabra said the government was still in negotiations with other airlines about possible aid.

Canada, the world’s second-largest nation by area, depends heavily on civil aviation to keep remote communities connected.

Opposition politicians fretted that further delays in announcing aid could result in permanent damage to the country.

Air Canada said it would resume services on nearly all of the routes it had suspended because of COVID-19.

‘SIGNIFICANT LAYER OF INSURANCE’

The deal removes a potential political challenge for the Liberals, who insiders say are set to trigger an election later this year.

The government has agreed to buy C$500 million worth of shares in the airline, at C$23.1793 each, or a 14.2% discount to Monday’s close, a roughly 6% stake.

“Maintaining a competitive airline sector and good jobs is crucially important,” Finance Minister Chrystia Freeland told reporters, adding the equity stake would allow taxpayers to benefit when the airline’s fortunes recovered.

The Canadian government previously approved similar loans for four other companies worth up to C$1.billion, including up to C$375 million to low-cost airline Sunwing Vacations Inc. The government has paid out C$73.47 billion under its wage subsidy program and C$46.11 billion in loans to hard-hit small businesses.

Michael Rousseau, Air Canada‘s president and chief executive officer, said the liquidity “provides a significant layer of insurance for Air Canada.”

Jerry Dias, head of the Unifor private-sector union, described the announcement as “a good deal for everybody.”

Unifor represents more than 16,000 members working in the air transportation sector.

But the Canadian Union of Public Employees, which represents roughly 10,000 Air Canada flight attendants, said the package protected the jobs of current workers rather than the 7,500 members of its union who had been let go by the carrier.

($1=1.2567 Canadian dollars)

(Reporting by David Ljunggren in Ottawa and Allison Lampert in Montreal; Additional reporting by Julie Gordon in Ottawa and Munsif Vengattil in Bengaluru; Editing by Dan Grebler and Peter Cooney)

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U.K. advises limiting AstraZeneca in under-30s amid clot worry

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LONDON —
British authorities recommended Wednesday that the AstraZeneca COVID-19 vaccine not be given to adults under 30 where possible because of strengthening evidence that the shot may be linked to rare blood clots.

The recommendation came as regulators both in the United Kingdom and the European Union emphasized that the benefits of receiving the vaccine continue to outweigh the risks for most people — even though the European Medicines Agency said it had found a “possible link” between the shot and the rare clots. British authorities recommended that people under 30 be offered alternatives to AstraZeneca. But the EMA advised no such age restrictions, leaving it up to its member-countries to decide whether to limit its use.

Several countries have already imposed limits on who can receive the vaccine, and any restrictions are closely watched since the vaccine, which is cheaper and easier to store than many others, is critical to global immunization campaigns and is a pillar of the UN-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.

“This is a course correction, there’s no question about that,” Jonathan Van-Tam, England’s deputy chief medical officer, said during a press briefing. “But it is, in a sense, in medicine quite normal for physicians to alter their preferences for how patients are treated over time.”

Van-Tam said the effect on Britain’s vaccination timetable — one of the speediest in the world — should be “zero or negligible,” assuming the National Health Service receives expected deliveries of other vaccines, including those produced by Pfizer and Moderna.

EU and U.K. regulators held simultaneous press conferences Wednesday afternoon to announce the results of investigations into reports of blood clots that sparked concern about the rollout of the AstraZeneca vaccine.

The EU agency described the clots as “very rare” side effects. Dr Sabine Straus, chair of EMA’s Safety Committee, said the best data is coming from Germany where there is one report of the rare clots for every 100,000 doses given, although she noted far fewer reports in the U.K. Still, that’s less than the clot risk that healthy women face from birth control pills, noted another expert, Dr. Peter Arlett.

The agency said most of the cases reported have occurred in women under 60 within two weeks of vaccination — but based on the currently available evidence, it was not able to identify specific risk factors. Experts reviewed several dozen cases that came mainly from Europe and the U.K., where around 25 million people have received the AstraZeneca vaccine.

“The reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine,” said Emer Cooke, the agency’s executive director. “The risk of mortality from COVID is much greater than the risk of mortality from these side effects.”

Arlett said there is no information suggesting an increased risk from the other major COVID-19 vaccines.

The EMA’s investigation focused on unusual types of blood clots that are occurring along with low blood platelets. One rare clot type appears in multiple blood vessels and the other in veins that drain blood from the brain.

While the benefits of the vaccine still outweigh the risks, that assessment is “more finely balanced” among younger people who are less likely to become seriously ill with COVID-19, the U.K’s Van-Tam said.

“We are not advising a stop to any vaccination for any individual in any age group,” said Wei Shen Lim, who chairs Britain’s Joint Committee on Vaccination and Immunization. “We are advising a preference for one vaccine over another vaccine for a particular age group, really out of the utmost caution rather than because we have any serious safety concerns.”

In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine.

Britain, which relies heavily on AstraZeneca, however, continued to use it.

The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic.

Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee, said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences.

“We can’t afford not to use this vaccine if we are going to end the pandemic,” he said.

In some countries, authorities have already noted hesitance toward the AstraZeneca shot.

“People come and they are reluctant to take the AstraZeneca vaccine, they ask us if we also use anything else,” said Florentina Nastase, a doctor and co-ordinator at a vaccination centre in Bucharest, Romania. “There were cases in which people (scheduled for the AstraZeneca) didn’t show up, there were cases when people came to the centre and saw that we use only AstraZeneca and refused (to be inoculated).”

Meanwhile, the governor of Italy’s northern Veneto region had said earlier Wednesday that any decision to change the guidance on AstraZeneca would cause major disruptions to immunizations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot.

“If they do like Germany, and allow Astra Zeneca only to people over 65, that would be absurd. Before it was only for people under 55. Put yourself in the place of citizens, it is hard to understand anything,” Luca Zaia told reporters.

The latest suspension of AstraZeneca came in Spain’s Castilla y Leon region, where health chief Veronica Casado said Wednesday that “the principle of prudence” drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary.

French health authorities had said they, too, were awaiting EMA’s conclusions, as were some officials in Asia.

On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings.

The Korea Disease Control and Prevention Agency said it would also pause a vaccine rollout to school nurses and teachers that was to begin on Thursday, while awaiting the outcome of the EMA’s review.

But some experts urged perspective. Prof Anthony Harnden, the deputy chair of Britain’s vaccination committee, said that the program has saved at least 6,000 lives in the first three months and will help pave the way back to normal life.

“What is clear it that for the vast majority of people the benefits of the Oxford AZ vaccine far outweigh any extremely small risk,” he said. “And the Oxford AZ vaccine will continue to save many from suffering the devastating effects that can result from a COVID infection.”

Source: – CTV News

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