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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 Who do you think will get the blame for this bizarre news cycle taking place: AstraZeneca for releasing outdated data or the NIH for putting this all on the public record?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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96% of COVID-19 cases are among those not fully vaccinated, B.C. health officials say – Global News

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Ninety-six per cent of the COVID-19 cases recorded from June 15 to July 15 were among people who were either only partially vaccinated or not vaccinated at all, B.C.’s health minister says.

“If you take all the cases from June 15 to July 15, 78 per cent of those cases are among those who are unvaccinated,” Adrian Dix said.

“I think the evidence will encourage more people to get vaccinated. That tells you people should need to get vaccinated. We are seeing new cases and they are largely in unvaccinated people.”

Read more:
B.C. reports over 100 new COVID-19 cases for first time in five weeks

The B.C. government will not require people to get the vaccine, but will not stop private businesses from doing so.

The seven-day rolling average for new cases rose from 42 new cases a day one week ago, to 73 new cases a day on Friday.

Most of the new cases are linked to indoor social gatherings at people’s homes, Dix said.


Click to play video: 'COVID-19: B.C. reports 89 new cases of virus, highest daily total in more than a month'



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COVID-19: B.C. reports 89 new cases of virus, highest daily total in more than a month


COVID-19: B.C. reports 89 new cases of virus, highest daily total in more than a month

“We are not going to deny access to services. Based on your vaccinated. That is our position. It will not be mandatory in that sense. There will be requirements in certain sense if people are not vaccinated,” Dix said.

“I think if you are going to have someone over to your house for dinner, you should ask them if they have been vaccinated, and it’s ok to tell them not to come if they haven’t been.”


Click to play video: 'COVID-19: B.C. government provides $36.5M to 83 anchor tourist attractions, higher vaccination rates mean lower cases'



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COVID-19: B.C. government provides $36.5M to 83 anchor tourist attractions, higher vaccination rates mean lower cases


COVID-19: B.C. government provides $36.5M to 83 anchor tourist attractions, higher vaccination rates mean lower cases

As of Friday, 80.3 per cent of eligible people 12 and older in B.C. have received at least one vaccine.

The province is hoping to hit 85 per cent immunization.

All five health authorities have been adopting additional strategies to supplement the mass immunization clinics, including pop-up clinics for first doses at parks, amusement parks, and beaches.

Read more:
COVID-19: B.C. reports no deaths but 89 new cases, highest daily total in over a month

Dr. Navdeep Grewal of the South Asian COVID-19 Task Force said the province or private businesses should consider vouchers for food or sports tickets to encourage immunization.

“I think it is that final 10 per cent (of the population) we need to get vaccinated, so we can avoid the fourth wave in the fall and winter,” Grewal said.

“We need to find out where they are gathering, give them the information they need, and then give them that first dose that is so needed.”

© 2021 Global News, a division of Corus Entertainment Inc.

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Run, don't walk, to the nearest clinic to get vaccinated before September, families told – CBC.ca

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Kids who are going back to local elementary and high schools in September must get their first COVID-19 shot by Saturday to ensure they’re eligible for their second dose and be fully vaccinated by Labour Day, according to the health unit. 

The Middlesex-London Health Unit (MLHU) says 73 per cent of those aged 12 to 17 in Middlesex-London already have their first shot, and just over a quarter have two doses. 

 “The uptake among this age group has been tremendous, right on board with some of our older population who was really eager to get vaccinated,” said Dr. Alex Summers, the associate medical officer of health for the MLHU. 

“We see eagerness for people to get vaccinated and we’re just delighted by that. 12 to 17-year-olds will be back in in-person activities, and that’s where they flourish, that’s where they want to be, and we want to be able to support them to do so in a way that COVID isn’t transmitting.” 

Vaccination is the “key ingredient” to maximizing the coming school year and making sure there are few disruptions. 

With school eight weeks away, Ontario health officials examine what the upcoming school year will look like. Overall, vaccine numbers are good but the data shows a lag in vaccination rates among eligible younger Canadians. If vaccine pickup does not improve before the beginning of the school year, Ontario’s Chief Medical Officer Dr. Kieran Moore is concerned about rising infections. 4:06

COVID-19 vaccines have yet to be approved for those under 12. 

“That’s why it’s really important to be gathering outdoors and making sure that everybody who is older than the age of 12 who is interacting with kids is vaccinated,” Summers said. “We can limit transmission among those who just can’t get the vaccine because they’re not old enough as we approach the school year.”

What exactly school will look like in September isn’t quite clear, but screening for symptoms, staying home when exhibiting symptoms, and wearing masks in classrooms are likely.

No appointments are required for COVID-19 vaccinations for anyone 12 or older for first or second doses at walk-in and mass vaccination sites. For more information on vaccinations and locations, visit the health unit’s website here.

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Air Canada anticipating recovery in demand as travel restrictions are eased – Yahoo Canada Finance

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Air Canada is anticipating a recovery in demand in the coming months as travel restrictions are eased and leisure passengers look to get away after being grounded by COVID-19.

Although overall bookings remain below pre-pandemic levels, customer interest began to increase in June with the elimination of quarantines for fully vaccinated returning Canadians and the removal of other travel restrictions.

“We can now optimistically say that we are turning a corner, and we expect to soon see correlated financial improvements,” CEO Michael Rousseau said Friday during a conference call.

“Indications are that the worst effects of the COVID-19 pandemic may now be behind us. Based on what we are seeing in other markets that are further along in reopening in Canada, we anticipate travel will resume at a quickening pace.”

Rousseau said bookings are steadily increasing for domestic, transborder and Atlantic markets as well as to sun destinations for the coming winter. Future bookings In some weeks of June were ahead of the same period in 2019.

“We expect the most recent announcements of the Government of Canada relaxing existing measures will further help strengthen the interest of our customers in flying again.”

Current demand is largely for leisure and visiting friends and family, but Air Canada expects to see a progressive return of corporate demand in September and October, added chief commercial officer Lucie Guillemette.

That could be aided by the ability of Canadian passengers to rely on COVID tests taken in Canada for trips of less than 72 hours.

“We are encouraged by some of the commentary from our peers in the United States with regards to overall business travel recovery,” she told analysts.

Guillemette said that rebuilding its U.S. operations as the largest foreign carrier is key to its recovery. That will also expedite the recovery of international long-haul operations as it seeks to achieve or exceed its share of the U.S. long-haul global market.

The Atlantic business will recover quicker than the Pacific or Latin America because of high vaccination rates, strong cultural and business connections with Europe and strong leisure interest from Canadians.

“We are already observing healthy demand signals for Europe into 2022,” she added.

The Montreal-based company says it lost $1.17 billion or $3.31 per diluted share, compared with a loss of $1.75 billion or $6.44 per share a year earlier.

Adjusted profits were $1.08 billion or $3.03 per share.

Revenues during the three months ended June 30 surged 58.8 per cent to $837 million from $527 million in the second quarter of 2020. Passenger revenues more than doubled to $426 million from a year ago which marked the first full quarter to be impacted by the pandemic. Cargo revenues increased 33 per cent to a record $358 million.

Air Canada was expected to post $2.76 per share in adjusted profits on $848.2 million of revenues, according to financial data firm Refitinitv.

The country’s largest airline increased its seat capacity by 78 per cent compared to the same time last year, and was down 86 per cent from the second quarter of 2019. It plans to increase available seat miles in the third quarter so capacity will be 65 per cent below the same period in 2019.

In August, its domestic capacity is expected to be about two-thirds of what it was in 2019.

“The third-quarter outlook pointed to healthy demand recovery and a significant improvement in daily cash burn,” Walter Spracklin of RBC Dominion Securities wrote in a report.

Air Canada says it has refunded about $1 billion for non-refundable tickets and expects to pay an additional $200 million in the third quarter, which will be covered by the federal government’s $1.4 billion refund credit facility.

The airline says it has recalled about 2,900 employees in June and July as it restores service this summer to destinations, particularly in Canada and the U.S. More workers will be called back for the fall season.

Air Canada has retained about half of its workforce, including the vast majority of pilots who have remained current and ready to fly when conditions warrant.

While it works to rebuild operations, the airline said it is also preparing to meet the challenges from increased competition stemming from expansion plans for Porter Airlines and Flair Airlines. Porter plans to add jet service from several gateways, including Toronto’s Pearson airport, in the second half of next year, while Flair is adding aircraft and routes.

“We certainly welcome healthy competition. but suffice to say, we will be ready to deal with that situation,” Rousseau said of Porter.

He also said the failed purchased of Transat may have been beneficial long-term, but it would have been very difficult to integrate while also focusing on the post-COVID recovery.

This report by The Canadian Press was first published July 23, 2021.

Companies in this story: (TSX:AC)

Ross Marowits, The Canadian Press

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