Coronavirus

[Verdinut]

Since the clot cases were in younger individuals, Macron has taken it upon himself to stop vaccinating people 55 and under with the AstraZeneca vaccine. This whole episode in Europe was political and not a safety issue. I have to say, SWERD is just plain wrong about this. I understand that he is not well versed in EU thinking and Shenanigans, but I have watched them for years. I knew right away this was not a safety issue, but EU politics.

Dr Karl Weiss, Chief Division of Infectious Diseases at the Jewish General Hospital in Montreal, also recommends using the Covishield vaccine only on people 65 and over.

 

[Verdinut]

An interesting article in the Atlantic paper:

3 Ways the Pandemic Has Made the World Better

COVID-19 has inflicted devastating losses. It has also delivered certain blessings.

www.theatlantic.com

 

[panteragstk]

Opthalmologist.

Man, where did my autocorrect get that from. Thanks.

 

[Irvrobinson]

More good news:

AstraZeneca vaccine found to be 79% effective in U.S. trial, 'no increased risk' of blood clots

The safety and efficacy analysis of the vaccine was based on 32,449 participants in a phase 3 trial.

www.cnbc.com

 

[Irvrobinson]

Of course, it does seem as if the EU is actively looking to find ways to muck up the machinery:

UK and EU vaccine dispute deepens as Brussels considers new export controls

Tensions are high between the U.K. and the European Union as the 27-member bloc considers restricting exports of Covid vaccines across the English Channel.

www.cnbc.com

 

[Irvrobinson]

One final tidbit of good news, as least in the US:

U.S. production of COVID-19 vaccine dramatically speeds up

COVID-19 vaccine manufacturers are ramping up production, churning out far more doses a week than earlier in the year, progress that is accelerating mass...

www.marketwatch.com

 

[Swerd]

These quotes are from a long Washington Post article about the soap-opera like saga of the AstraZeneca vaccine:
https://www.washingtonpost.com/world/astrazeneca-vaccine-challenges-europe-pandemic/2021/03/21/d8568076-88f0-11eb-8a67-f314e5fcf88d_story.html
This article walks through a history of many events beginning last year in March. I was able to open this link without logging in. I hope those who are interested in reading this long article can do so as well. But I also made a summary (below). First, some quotes from the article to introduce things:

“AstraZeneca’s (AZ’s) coronavirus vaccine was supposed to be the shot that dug the world out of the pandemic: a cheap, easy-to-administer dose that would protect not just citizens of wealthy nations but also those in the most vulnerable countries.”

“Instead, the inoculation, a collaboration between University of Oxford researchers and one of the world’s biggest drug companies, has been plagued with missteps as other vaccine rollouts gain speed. First, there was confusing basic science, then, missed delivery targets. Now, a confidence-sapping pause in Europe that followed reports of rare blood clots among a handful of the vaccinated.”

“Had the rollout of the AZ vaccine been handled differently, it might have been available far more widely by now, blunting a new wave of death and disease that is threatening lives around the world. Countries that have administered it widely, such as the UK, credit AZ with helping drive a dramatic drop in hospitalizations and deaths. But public confidence in the company’s vaccine has taken a major hit, slowing its acceptance and delaying the battle against the pandemic.”

 

[Swerd]

And now part 1 of my summary:

• Nowhere have the consequences been clearer than in Europe, which bet heavily on AZ vaccine doses but has received just a third of what was promised. “AZ has unfortunately underproduced and underdelivered,” European Commission President Ursula von der Leyen told reporters last week. “And this painfully, of course, reduced the speed of the vaccination campaign.”
  
  
• The AZ vaccine surfed a wave of hype last spring. A front-page article in the New York Times declared that the Oxford vaccine was “sprinting fastest” and had leaped ahead of everyone else. Oxford scientist Sarah Gilbert said at the time she was 80% confident the vaccine would succeed – before a single person had received a shot in a clinical trial.
  
  “From the very beginning, the Oxford group had one press release after another, bragging how wonderful everything was,” said Hildegund C.J. Ertl, a scientist who works on the same vaccine technology at the Wistar Institute in Philadelphia and has collaborated with the Oxford scientists. “Talking about how wonderful something is before you’ve shown it is completely counterproductive. It was a big PR disaster.”
  
  
• Adrian Hill, a key member of the Oxford team that developed the vaccine, argued that the early communication on the shot was accurate – and partly a response to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who predicted a coronavirus vaccine could be ready in 12 to 18 months. “We disagreed. We said we’d shoot for September, and it’ll be this year. If that’s boastful, I’m sorry, but that was right,” Hill said in an interview. “We were frankly saying this could be done much faster.”
  
  
• In May, months before rival vaccine makers Moderna or Pfizer launched large clinical trials, Oxford and AZ announced they would test their vaccine in 10,000 people in Britain.
  
  
• Shortly after, the USA announced it would spend up to $1.2 billion for 300 million doses from the company that would begin to be available in October – the biggest initial US order for a vaccine. But before shots could be administered in the USA, the FDA insisted that the AZ vaccine be tested in a 30,000-person trial where 15,000 received the vaccine. The FDA chose this to ensure that efficacy results from multiple American vaccine trials would be roughly comparable. That new AZ trial didn’t begin until the end of August.
  
  
• Even as AZ’s trials raced forward, they hit snags. Rare neurological symptoms occurred in 3 people, 2 of whom received doses of the study vaccine, causing trials to be suspended worldwide to explore whether those might have been caused by the vaccine. There was no evidence of a connection, but the pause went on for weeks in the US, setting the trial back.
  
  
• Then some participants in the UK trial unexpectedly received a 1st dose only half as strong as initially planned. The explanations about why it happened were confusing, contradictory, and slow to emerge. The problem appeared linked to an Italian subcontractor that used a different technique to measure the vaccine’s active ingredient.
  
  Adrian Hill said researchers received regulators’ approval to give a new dose to trial recipients, and claimed that there was no mistake. After the dosing error was revealed, the AZ team gave different explanations. Andrew Pollard, one of the lead Oxford research scientists, told The Washington Post last month: “It’s framed as an error, but actually it’s a scientific observation.” This dosage issue later became a point of confusion when AZ released trial results to the world in November. In the half-dose group, the efficacy of the vaccine shot up to 90%, compared with 62% in volunteers who received the full 2-dose regimen.
  
  The Oxford scientists were frank that they couldn’t explain why the unconventional dosing group had superior protection and said they were exploring explanations. Ultimately, it became clear that instead of a 4-week gap between shots, some participants in the half-dose group had received shots as much as 3 months apart, which might explain the difference.
  
  US scientists expressed frustration about trying to understand how well the AZ vaccine works and how to best use it, given the existing data and confusing communications.
  
  “AZ has had some bad press, most of it undeserved, but some of it deserved,” said Paul Hunter, a professor of medicine at the University of East Anglia in Britain.

 

[Swerd]

Part 2:

• Perhaps most important, some scientists say, the AZ team decided not to emphasize recruitment of older people for their initial UK clinical trials, and so no robust conclusion could be made about how well the vaccine protected people older than 65 – the group most at risk of serious illness.
  
  
• AZ defended its trials, saying its scientists were being cautious. But clinical trials by Pfizer & Moderna included plenty of older volunteers. That absence of data led some European countries to recommend against giving doses of the AZ vaccine to older citizens.
  
  
• Adrian Hill said if he could do things over, he wouldn’t change much – with the exception of potentially looking at the data even earlier, so that a vaccine could have been shown effective in August. He questioned why the AZ vaccine had to be subjected to further trials before being authorized in the US. (In my honest opinion, Hill was arrogant & dishonest – he knew very well that the US FDA would require the larger trial and why they wanted it.)
  
  
• Europe bought into AZ’s promises that its vaccine would be a swift, effective solution, making it the centerpiece of a collective purchasing strategy negotiated for the EU’s 450 million residents. The EU bet heavily on AZ: 300 million doses in a mid-August contract, more than other vaccines. EU officials expected AZ’s vaccine to be ready first. But as fall edged into winter – and as a deadly second wave washed away complacency – that started looking like a bad bet.
  
  
• AZ’s vaccine was approved in the EU at the end of January 2021, 6 weeks later than rivals, at a time when a more contagious variant of the coronavirus was spreading across the continent. Compounding the already-delayed rollout, AZ’s CEO Pascal Soriot had an unwelcome surprise. The EU was supposed to receive 90 million doses by the end of March but would get only 30 million. Later, AZ said its second-quarter delivery would fall short, too.
  
  
• Predictably, Europe erupted. There had been little warning – and in the UK, which approved the AZ vaccine a month earlier than the EU, there had been no supply issues. EU leaders wanted to know why. Much flag waving and political posturing ensued, on both sides of the argument.
  
  “Everybody is getting kind of a bit, you know, aggravated or emotional about those things,” AZ’s Soriot told Italy’s La Repubblica newspaper in an interview published Jan. 26. “It’s not a commitment we have to Europe. It’s a best effort.”
  
  Von der Leyen, who as European Commission president had presided over the vaccine negotiations, imposed new rules that drug manufacturers needed to ask for permission before exporting EU-made vaccines outside of the bloc’s territory. Italy threatened to sue AZ for breach of contract. Latvian Foreign Minister Edgars Rinkevics vowed to “get nasty” in a late-January interview with The Post.
  
  
• Even as the EU fought to get access to the AZ vaccine, leaders were undermining public confidence in the shot – a contradictory process that culminated with the pause in vaccinations last week. In Denmark, Germany, Norway and elsewhere, regulators spotted reports of serious or fatal blood clots among young people who had been given doses of the AZ vaccine. They were just a handful – in Germany, 7 people at the beginning of the week, out of 1.6 million people given doses of the vaccine in a month.
  
  
• But the lurching back & forth damaged public perceptions. Even before the uncertainty about the blood clots, teachers and medical workers unions in multiple countries had demanded the Pfizer vaccine instead of AZ’s.
  
  
• Amid the turmoil, some countries abandoned their AZ purchases. New Zealand this month decided not to use its AZ order, opting to vaccinate exclusively with Pfizer’s vaccine and donate other manufacturers’ doses to countries that don’t have their own access. South Africa sold its AZ doses after its researchers concluded it provides only “minimal protection” against mild to moderate covid-19 cases caused by the variant discovered in the country.
  
  
• Other countries are still seeking out AZ doses. Australia and Canada are trying to buy more. And the USA sent some of its stockpile to Canada and Mexico last week, amid growing questions about the future of the doses in U.S. vaccination plans.
  
  
• In the USA, an accelerating inoculation campaign is being fueled by 3 vaccines in increasingly plentiful supply: Pfizer, Moderna and J&J, raising questions about the need for another option. AZ’s fate depends on the 30,000-person, late-stage clinical trial being conducted at multiple sites in the United States. Fortunately, the results released today were good. It certainly looks like the AZ vaccine will be approved by the FDA.
  
  
• President Biden has said there will be enough vaccine doses from Pfizer, Moderna and J&J by the end of May to inoculate all US adults. However, it is not clear what role, if any, the AZ vaccine will have in the US.

 

[Irvrobinson]

I do have to wonder how AstraZeneca could be so administratively incompetent, again. I hope these suspicions are unfounded.

AstraZeneca may have included outdated information in Covid vaccine trial, U.S. health agency says

The statement comes just one day after the findings of a large U.S. trial showed the Oxford-AstraZeneca vaccine was safe and highly effective.

www.cnbc.com

 

[panteragstk]

I do have to wonder how AstraZeneca could be so administratively incompetent, again. I hope these suspicions are unfounded.

AstraZeneca may have included outdated information in Covid vaccine trial, U.S. health agency says

The statement comes just one day after the findings of a large U.S. trial showed the Oxford-AstraZeneca vaccine was safe and highly effective.

www.cnbc.com

I've dealt with them on a corporate level about 8 years ago, and they weren't all that smart then. I had hoped they had changed considering their role.

 

[Swerd]

I do have to wonder how AstraZeneca could be so administratively incompetent, again. I hope these suspicions are unfounded.

AstraZeneca may have included outdated information in Covid vaccine trial, U.S. health agency says

The statement comes just one day after the findings of a large U.S. trial showed the Oxford-AstraZeneca vaccine was safe and highly effective.

www.cnbc.com

I just read the CNBC report with raised eyebrows. I've followed many clinical trials and have never known of a Data Safety Monitoring Board speaking out in public like that.

AstraZeneca (AZ) has not yet submitted any of it's clinical trial data to the FDA. Both the FDA and the NIAID (if they sponsored or partially sponsored this trial) do see regular (monthly? weekly?) reports of enrollment, safety, and response data as the trial runs. That data is considered preliminary and not final. But if a drug company submits data that is noticeably different than those running reports, they will be asked about it. There better be convincing reasons why the final data differed. AZ has plenty of experience in working with the FDA – I'd be very surprised if they submitted wrong data to the FDA.

Not surprisingly, AZ's stock price has taken hits on Wall Street.

 

[Irvrobinson]

I just read the CNBC report with raised eyebrows. I've followed many clinical trials and have never known of a Data Safety Monitoring Board speaking out in public like that.

AstraZeneca (AZ) has not yet submitted any of it's clinical trial data to the FDA. Both the FDA and the NIAID (if they sponsored or partially sponsored this trial) do see regular (monthly? weekly?) reports of enrollment, safety, and response data as the trial runs. That data is considered preliminary and not final. But if a drug company submits data that is noticeably different than those running reports, they will be asked about it. There better be convincing reasons why the final data differed. AZ has plenty of experience in working with the FDA – I'd be very surprised if they submitted wrong data to the FDA.

Not surprisingly, AZ's stock price has taken hits on Wall Street.

Talk about snatching defeat from the jaws of victory...

In the US at least, it does look like massively increased production of the Pfizer, Moderna, and J&J vaccines have made the AZ vaccine irrelevant from a distribution standpoint. In fact, US officials now seem much more concerned about the ~30% of the population stupidly refusing to get vaccinated than they are approving new alternatives. If anything, the J&J vaccine is the real spoiler, being a single shot. When I got my first Pfizer shot I was talking with the technician who injected me, and she commented that most of her colleagues wished the J&J vaccine was the only one, because it's only one shot, it doesn't have the PITA deep refrigeration and thawing requirements of the Moderna and Pfizer vaccines, and juggling multiple vaccines with multiple distribution strategies and different requirements was a headache. If AZ ever gets their corporate act together their vaccine may ultimately be the savior of the developing world, but if they keep screwing up I wouldn't be surprised if the single shot simplicity of the J&J vaccine and its easy refrigeration requirements wins out.

 

[Irvrobinson]

On a lighter note (literally), I wish I could have been vaccinated at this site:

Yo-Yo Ma brought his cello with him to get his COVID-19 shot — and then played a surprise concert

The impromptu performance from the world-renowned cellist included "Ave Maria" and parts of Bach's Cello Suite No. 1.

www.cbsnews.com

 

[Swerd]

Talk about snatching defeat from the jaws of victory...

Agreed.

All large clinical trials go through an internal audit before anything is published or submitted to the FDA. These audits look for patients or vaccine recipients who don't fit the trial's patient population characteristics as stated in detail by the trial's protocol. Their results cannot count in the efficacy tally. They also examine all unusual cases that might have an impact on the trial's efficacy, especially if a vaccinated person was hospitalized for Covid-19. Similarly, they closely examine all the severe or unexpected adverse events. Any hospitalization or fatality must be carefully assessed to determine if the adverse event or death could be related to the vaccine.

The FDA expects to see these audits. And they are familiar with preliminary data that looks better than the final audited data. But if they see major differences they will want to see a summary of the audit details.

This is only a guess, but I have to wonder if AZ executives were in such a hurry to announce good news, that they released the preliminary data before the final audited data was ready?

 

[Swerd]

In fact, US officials now seem much more concerned about the ~30% of the population stupidly refusing to get vaccinated than they are approving new alternatives.

I recently read an encouraging report from Big Stone Gap, in Russel County in southwest Virginia. Last November, 80% of votes cast there were for Trump. But after a few corona virus deaths in January among local family members plus a prominent state senator, lawyer and cattle farmer, a turning point may be happening. People now want the vaccine.
https://www.washingtonpost.com/local/virginia-trump-country-coronavirus-vaccine/2021/03/21/c153bd98-872a-11eb-8a8b-5cf82c3dffe4_story.html

"A similar about-face could be unfolding across mountainous far southwestern Virginia, which has some of the highest coronavirus vaccination rates in the state, despite national surveys showing rural Republicans are the most reluctant to receive it."

 

[cpp]

I recently read an encouraging report from Big Stone Gap, in Russel County in southwest Virginia. Last November, 80% of votes cast there were for Trump. But after a few corona virus deaths in January among local family members plus a prominent state senator, lawyer and cattle farmer, a turning point may be happening. People now want the vaccine.
https://www.washingtonpost.com/local/virginia-trump-country-coronavirus-vaccine/2021/03/21/c153bd98-872a-11eb-8a8b-5cf82c3dffe4_story.html

"A similar about-face could be unfolding across mountainous far southwestern Virginia, which has some of the highest coronavirus vaccination rates in the state, despite national surveys showing rural Republicans are the most reluctant to receive it."

And in the news yesterday Trump was telling everyone to get vaccinated and today, he said he should have done what Fauci said " Too late Trumpo
Trump on Fauci: 'I listened to him, but I didn't do what he said'

 

[Trell]

I recently read an encouraging report from Big Stone Gap, in Russel County in southwest Virginia. Last November, 80% of votes cast there were for Trump. But after a few corona virus deaths in January among local family members plus a prominent state senator, lawyer and cattle farmer, a turning point may be happening. People now want the vaccine.
https://www.washingtonpost.com/local/virginia-trump-country-coronavirus-vaccine/2021/03/21/c153bd98-872a-11eb-8a8b-5cf82c3dffe4_story.html

"A similar about-face could be unfolding across mountainous far southwestern Virginia, which has some of the highest coronavirus vaccination rates in the state, despite national surveys showing rural Republicans are the most reluctant to receive it."

The sad thing is that they had to experience this loss first.

 

[Mikado463]

What you libs fail to understand is that if Trump had not acted as the complete knucklehead he is he would have easily still be in office !

 

[Trell]

What you libs fail to understand is that if Trump had not acted as the complete knucklehead he is he would have easily still be in office !

Perhaps you could start your own thread to explore this fascinating theory?