Jump to content

CR: COVID-19 --Political Talk


Mrs Whiggins

Recommended Posts

Another article from 3 days ago.

https://www.wsj.com/articles/long-a-holdout-from-covid-19-restrictions-sweden-ends-its-pandemic-experiment-11607261658

However I am sure that people will say WSJ is a paper owned and funded by Obama and Clintons so don’t believe them. Or was that last week’s conspiracy theory? I get so confused by all of them.  

Link to comment
Share on other sites

Rona is more contagious than the flu, and mitigation is working really well against the flu, and merely mitigating the spread of Rona?
Fake pos rep for your avatar, fake neg rep for your posts; no idea what point you are trying to make; (oh look at the double semicolon dumbassery on my part) - carry on.
Link to comment
Share on other sites

5 hours ago, PassiveAggressiveCoach said:

 BTW what happened to flu cases? Corona eats flu? Best flu season in the history of man. Hmmm

This thread is over 600 pages so here's a 3x5 pass for perhaps missing that discussion. Here's another 3x5 pass for dismissing what I'm about to say because I have a female user name. Not saying you will, but it happens and you might need it.

What happened to the flu cases?

Couple of things. Look at the R naught value. Flu is less than COVID which is less than measles. The R naught value is not static but it's a good measure for how a disease spreads. So, here you mention the flu, a disease where the R naught is lower ( less infectious) and fewer people are going out and about due to restrictions AS WELL AS having mitigation measures in place such as social distancing and masks and crazy as it may seem NOT GOING TO WORK SICK due to quarantining from the other virus. To top that off, in any given year, according to the CDC about 50 percent of the American population receives the flu VACCINE, while of the other half about 25 percent get the flu and the rest do not. So with a flu vaccine available in the past, only 25 percent of citizens were actually getting the flu. Those people going around saying "Ah, I never get the flu, so I don't get a vaccine!" Yeah, they were likely protected by people who get the vaccine, their own immune system (yes, I grant your point that a healthy immune system is ideal), and dumb luck. You don't get a pass for this because anyone who stopped to think about it could come to this conclusion. Cutting out half the population susceptible to a virus has an effect on the amount of spread. In addition, we won't know until the season is complete, but the health care providers were pushing the flu inoculations this year for this very reason. It could be the percent of folks getting the flu vaccine is now greater than half. Contracting successive infections that attack the lungs leads to poor outcomes. Once one has had pneumonia, one becomes more susceptible to it. Pneumonia can be viral or bacterial and for this very reason, I receive a pneumonia vaccine to improve my odds of holding it at bay.

Finally, here is some cell biology: you can have coinfections with viruses, you can have successive infections with viruses (which is why you should get a flu vaccine), but often one virus has a tendency to suppress the other. For example, with a RSV vs the flu one or the other will succeed in infecting the same cell. Scientists are still studying this new virus to determine if it is similar to that outcome.

 

Edited by Mrs Whiggins
  • Hook 'Em 2
  • Like 2
Link to comment
Share on other sites

The avg median age of a covid death is 78.  Listen, I'm not saying the virus can't kill people. I had it. It wrecked me for 10 days.  My taste weeks later isnt right. I'm in my 40s.  If I was compromised or with comorbid conditions definitely I'd be in the hospital. There are common sense ways to deal with this. It isn't the Spanish Flu. 
Ah the typical Conservative personal antedotal story. "I had it and survived so nbd"

Go fuck yourself - my healthy friends who died from this shit.

Ps- Go fuck yourself - hospital workers xo
  • Hook 'Em 1
Link to comment
Share on other sites

LOL OK call it Trump land or whatever. There is literally almost no flu now. You don't find that odd?  Listen, I voted for Obama once. I'm not one of these hard core Trumpers you hate. Covid is a thing. It kills mostly a select group of people. Why are flu numbers almost 0?  That's never happened. Ever. 
It was predicted by scientist that we would have low flu numbers due to high mask usage in the southern hemisphere during thier winter.
Also extreme measures to mitigate an infectious virus mitigate another infectious virus and that's a conspiracy?

You are dumb as fuck. Add you to the ignore list with such illustrious company as Icono and Johnny Sack and all the dumb fucks I can't recall because I don't enjoy reading stupid shit written by chucklefucks.
Link to comment
Share on other sites

Dude's transformation from "masks and social distancing are important, but I think we're going overboard on lockdowns; also, I'm not sure I'll get the vaccine since I already had it" (all reasonable positions) to playing all the hits of the Facebook/far-right message board crowd (we're only worse because we count more, they're counting all deaths as COVID, why are there no more flu deaths, I only wear a mask to appease Karens, look at the data sheep) is so hilariously predictable. Pretty sure we all knew exactly what was coming two pages ago. They just can't help but brag about what great independent, critical thinkers they are (as they parrot the same half dozen talking points they read on I'mright.com).

  • Hook 'Em 1
  • Like 2
Link to comment
Share on other sites

Just doing some back of the envelope math, if:

we are able to vaccinate 40M people per month starting this month

70% of a population need immunity to get infection rate low enough to make it go away

People under 30 don’t need to be vaccinated due to incredibly low mortality rate

15M people have already had it

Rough math would indicate that enough people would have been vaccinated by mid-April.

However, I don’t think we would necessarily need to get to that point before cases begin dropping dramatically.  I suspect that by mid February we will have seen a dramatic decrease in daily new cases, and that by mid-March we will see most areas in the country lifting all restrictions except possibly mask wearing and reduced capacity in bars/restaurants.  The next 6 weeks will suck and a lot of people will die who didn’t need to (Donald Trump is a piece of shit), but I think it’s almost over.

Edited by Snake Diggity
Fuck Donald Trump
  • Hook 'Em 3
  • Like 2
Link to comment
Share on other sites

5 hours ago, PassiveAggressiveCoach said:

LOL OK call it Trump land or whatever. There is literally almost no flu now. You don't find that odd?  Listen, I voted for Obama once. I'm not one of these hard core Trumpers you hate. Covid is a thing. It kills mostly a select group of people. Why are flu numbers almost 0?  That's never happened. Ever. 

Ah the old “I voted for Obama card “ but here’s a bunch of right wing propaganda bullshit for y’all to consider. 
 

Where’s the YouTube video? 

  • Like 3
Link to comment
Share on other sites

Damn, PassiveAggressiveCoach is over on the football board whining about the CR now.

Shit is so predictable. Every time.

- Enter CR, post stupid shit you saw on Facebook with high levels of confidence
- Get owned by facts
- Make no effort to defend your case with facts of your own
- Go to the football board or Daily Texan and cry about the mean old CR cabal that hurt your feelings

Edited by BradInATX
  • Hook 'Em 2
  • Like 1
  • Haha 4
Link to comment
Share on other sites

This should be the vaccination schedule:

Dec: healthcare workers, people over 80

Jan: teachers, people age 70-80

Feb: other essential workers, people age 50-70

Mar: people age 30-50, people under 30 with risk factors

Apr: people under 30

 

I have no idea if the number of doses will be available to meet it, but under that schedule, I think we’d see the hospitalization and death rate plummet starting in mid February, which means most restrictions/worries could be gone by early/mid March.  We’d still probably see high numbers of cases until early May, but aside from a mask mandate and possibly reduced bar/restaurant capacity, life would be back to normal.

Link to comment
Share on other sites

Deaths from covid in the US started ramping up in mid-March.  We're currently losing ~ 3K Americans every day, and that number is climbing.  We will likely start to see some positive effects from vaccines in the next couple of months.  I'll go out on a limb and suggest that those two effects will largely cancel each other, and it will not surprise me one bit to see us lose another 300K Americans by mid-March.  (I'm spitballing here, I'm not posting error bars.)

If this plays out, covid will tie cancer in that 12-month span for 2nd leading cause of death in the US, slightly behind heart disease.

Anyone arguing "per capita" (of which there are many types, DJT) can go fuck themselves.

  • Hook 'Em 1
Link to comment
Share on other sites

29 minutes ago, BradInATX said:

Damn, PassiveAggressiveCoach is over on the football board whining about the CR now.

Shit is so predictable. Every time.

- Enter CR, post stupid shit you saw on Facebook with high levels of confidence
- Get owned by facts
- Make no effort to defend your case with facts of your own
- Go to the football board or Daily Texan and cry about the mean old CR cabal that hurt your feelings

This has quickly become a tradition unlike any other.  Roll up in here with their chests puffed out talmbout masks/lockdowns don't work, Covid is a nothingberder, etc.  Numerous well-informed posters provide links and evidence showing this is plainly BS, then the concerned troll retreats to DT to whine about the libtard echo chamber that the CR has become.

Reality has a liberal bias.

  • Hook 'Em 4
  • Like 1
  • Rage+1 1
Link to comment
Share on other sites

17 minutes ago, Snake Diggity said:

This should be the vaccination schedule:

Dec: healthcare workers, people over 80

Jan: teachers, people age 70-80

Feb: other essential workers, people age 50-70

Mar: people age 30-50, people under 30 with risk factors

Apr: people under 30

 

I have no idea if the number of doses will be available to meet it, but under that schedule, I think we’d see the hospitalization and death rate plummet starting in mid February, which means most restrictions/worries could be gone by early/mid March.  We’d still probably see high numbers of cases until early May, but aside from a mask mandate and possibly reduced bar/restaurant capacity, life would be back to normal.

This will be how it really goes:

Health Care Workers

Nursing home types

Rich people/celebrities

Front line workers whose jobs are essential for corporations but not so essential we'll pay them more

Upper middle class types

Pets of rich people/celebrities

Everyone else

  • Hook 'Em 1
  • Haha 1
Link to comment
Share on other sites

1 hour ago, Snake Diggity said:

Just doing some back of the envelope math, if:

we are able to vaccinate 40M people per month starting this month

70% of a population need immunity to get infection rate low enough to make it go away

People under 30 don’t need to be vaccinated due to incredibly low mortality rate

15M people have already had it

Rough math would indicate that enough people would have been vaccinated by mid-April.

However, I don’t think we would necessarily need to get to that point before cases begin dropping dramatically.  I suspect that by mid February we will have seen a dramatic decrease in daily new cases, and that by mid-March we will see most areas in the country lifting all restrictions except possibly mask wearing and reduced capacity in bars/restaurants.  The next 6 weeks will suck and a lot of people will die who didn’t need to (Donald Trump is a piece of shit), but I think it’s almost over.

Yeah uh, if almost 60% of americans dont get the one-shot flu vaccine every year, a fuck ton of americans arent going to opt for this vaccine (especially if its a two shot/series one).

 

Im starting to warm on the notion that we will not have to wear masks in 2022, but other than that, all bets are off imo.

 

we are talking about the largest vaccination campaign in human history here. I just dont see “normalcy” returning before next Labor Day

Link to comment
Share on other sites

2 hours ago, Snake Diggity said:

People under 30 don’t need to be vaccinated due to incredibly low mortality rate

I don't get this.  People under 30 may not die from it (as much as those older) but they can certainly be infected and pass that infection on to others.  I believe the herd immunity number of 70% thrown about refers to the general population, not just the most vulnerable, right?

  • Hook 'Em 1
Link to comment
Share on other sites

3 minutes ago, 27-25 said:

I don't get this.  People under 30 may not die from it (as much as those older) but they can certainly be infected and pass that infection on to others.  I believe the herd immunity number of 70% thrown about refers to the general population, not just the most vulnerable, right?

Correct.

I think that the protocol for those under 18 is still being figured out, but I also think that the general recommendation will be for every adult to get it in order to achieve herd immunity so as to sharply limit outbreaks.

Link to comment
Share on other sites

19 hours ago, SizzleChest said:

Having worked in organizations where studies had to be repeated (errors in randomization design, clinical supply fuckups, etc.), this is the first one I've seen that revealed a clinically beneficial outcome.

Clown show.

https://www.nytimes.com/2020/12/08/business/covid-vaccine-oxford-astrazeneca.html?

Behind the tags.

Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner

The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused it to fall behind in the U.S.

490

Testing blood samples for the Oxford vaccine. When Covid-19 emerged, Oxford researchers already had a vaccine platform that was safely used against a similar coronavirus.Credit...Andrew Testa for The New York Times

By Rebecca Robbins, Sharon LaFraniere, Noah Weiland, David D. Kirkpatrick and Benjamin Mueller

Dec. 8, 2020

On the afternoon of Sept. 8, AstraZeneca officials had a conference call with the Food and Drug Administration. The discussion covered important ground: What would AstraZeneca need to do to win the F.D.A.’s blessing for the coronavirus vaccine it was developing with the University of Oxford?

But the AstraZeneca representatives neglected to mention a crucial development: Two days earlier, the company had quietly halted trials of its vaccine around the world, including a late-stage study in the United States. It acted after a participant in Britain fell ill.

A few hours after the conference call, the story broke about the halted trials. That was how key F.D.A. officials heard the news, according to people with knowledge of the discussions.

The F.D.A.’s commissioner, Dr. Stephen Hahn, was stunned by AstraZeneca’s failure to disclose the halt to regulators, one of the people said. The U.S. government had pledged more than $1 billion to AstraZeneca to finance the development and manufacturing of its vaccine and to supply the United States with 300 million doses if it proved effective. F.D.A. regulators expected to be kept in the loop.

Image

AstraZeneca’s failure to disclose a hiccup in its vaccine trial was said to have stunned the F.D.A.’s commissioner, Dr. Stephen Hahn.Credit...Pool photo by Graeme Jennings

The episode might have been chalked up to a simple miscue. But it was part of a pattern of communication blunders by AstraZeneca that has damaged the company’s relationship with regulators, raised doubts about whether its vaccine will stand up to intense public and scientific scrutiny and, in at least one instance, slowed the vaccine’s development.

Gift Subscriptions to The Times, Cooking and Games.

Starting at $25.

The result is that a vaccine that was expected to account for a substantial portion — by one metric, as much as 60 percent — of the total vaccine supply in the United States faces an uncertain future. Two other highly effective vaccines are nearing federal authorization. But with more than 2,000 Americans dying daily, a delay of even a few weeks in deploying another effective vaccine could have deadly repercussions.

Federal officials and public health experts viewed AstraZeneca’s vaccine, which is less expensive and easier to store for long periods than some rival vaccines, as a leading candidate to help bring a swift end to the pandemic.

AstraZeneca officials repeatedly said they hoped to roll out their vaccine in the United States as early as October. Today, though, AstraZeneca hasn’t even finished enrolling people in its U.S. clinical trial. A key reason: The trial was grounded for nearly seven weeks because the company was slow to provide the F.D.A. with evidence that the vaccine was not associated with neurological symptoms that had appeared in two clinical-trial participants, according to the people with knowledge of the discussions.

Editors’ Picks

Here’s Why Vaccinated People Still Need to Wear a Mask

Watching What We Flush Could Help Keep a Pandemic Under Control

For a Nation on Edge, Antacids Become Hard to Find

Continue reading the main story

On Tuesday, Oxford researchers published detailed data from their clinical trials in the scientific journal The Lancet. The study built on findings that the developers had announced last month showing that their vaccine worked, but that its effectiveness varied widely depending on the strength of doses.

Regulators in Britain, India and several other countries, armed with data from clinical trials outside the United States, are expected to authorize the vaccine’s use in the coming weeks. But in the United States, where regulators have been frustrated with AstraZeneca and want to examine data from a greater number of participants, that approval appears further off.

Developing vaccines is hard, and it is common for the work to fall behind schedule. Moderna and Pfizer, whose coronavirus vaccines appear to be 95 percent effective and are awaiting federal authorization, also faced delays. And even with the problems, AstraZeneca and Oxford’s vaccine is likely to be among the fastest ever developed.

Yet independent scientists and industry analysts have criticized AstraZeneca and Oxford for not being sufficiently transparent about their early results, the design of their studies and safety issues. Most critically, it is not clear how well the vaccine works.

“The world bet on this vaccine,” said Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego. “What a disappointment.”

He added, “If they just were upfront on safety, on efficacy, on dosing, on everything, from the get-go, they’d be in such a better position. But what they’ve done now is diminish credibility, and I don’t know how they’re going to regain that.”

In an interview on Tuesday, Prof. Andrew Pollard, the lead investigator of the Oxford vaccine trial, said the Oxford team had been “as transparent as we can all along.” He noted the team’s publication of peer-reviewed articles and trial blueprints.

“We continue to share all data with the F.D.A. and other regulators around the world in a timely manner,” said an AstraZeneca spokeswoman, Michele Meixell.

An F.D.A. spokeswoman declined to comment.

Years in the Making

Scientists at Oxford had been laying the groundwork for a vaccine for years.

The vaccine uses an approach that scientists have been testing for decades. It involves genetically modifying a harmless virus, known as an adenovirus, that causes the common cold in chimpanzees so that it can train the immune system to respond to a threatening virus — in this case, the one that causes Covid-19.

In 2018, Oxford researchers had run a safety study using a vaccine deploying that approach to protect against the coronavirus that causes Middle East respiratory syndrome, or MERS. Last December, as the virus now known to cause Covid-19 was spreading undetected in China, a second trial to test that MERS vaccine got underway in Saudi Arabia.

So when Covid-19 emerged, Oxford researchers had at the ready a vaccine platform that had been shown to be safe in use against a similar coronavirus.

When Chinese researchers released the genetic sequence of the virus that causes Covid-19 on Jan. 9, an Oxford vaccine researcher, Dr. Sarah Gilbert, was able to start work the very next day.

Dr. Gilbert’s team raced to insert genetic material from Covid-19 into its adenovirus platform. By March, the vaccine was being tested in monkeys in Montana.

A next step for Oxford was to find a pharmaceutical company to shepherd the vaccine through development — and, eventually, to mass-produce and distribute it.

At the time, the Trump administration was fighting for first-in-line access for certain vaccines. British health officials, who provided early funding to the Oxford team, believed that any homegrown vaccine should be quickly and easily accessible to Britons. “They made it pretty clear to me and others that they wanted to know about the deal and they were anxious about vaccine nationalism,” Dr. John Bell, an Oxford professor and a member of the British government’s vaccine task force, said in an interview in September.

CORONAVIRUS BRIEFING: An informed guide to the global outbreak, with the latest developments and expert advice.

Sign Up

AstraZeneca was not Oxford’s first choice. Dr. Gilbert’s team had been in discussions with “a previous company or two,” Adrian Hill, one of the Oxford scientists, said last month. One was the American pharmaceutical giant Merck, The Wall Street Journal reported.

But those talks fell apart, and AstraZeneca, a British company, emerged as a safe alternative. The company agreed to distribute the vaccine worldwide at cost — only a few dollars per dose — until at least July 2021 and in poorer countries forever.

The downside was that AstraZeneca, which is known for drugs to treat cancer, asthma and other chronic conditions, had scant experience with vaccines.

Hundreds of Millions of Doses

Image

Vaccine lab workers at Oxford. The U.S. government in May awarded AstraZeneca up to $1.2 billion in exchange for 300 million doses.Credit...Andrew Testa for The New York Times

From the start, Oxford scientists expressed great confidence. In April, Dr. Gilbert told a British newspaper that she was 80 percent sure the vaccine would work, even though it had not been tested in humans. By then, Moderna had already started testing its vaccine candidate on people.

The Oxford team’s claims encountered skepticism from some scientists who expressed doubts about the approach and the ambitious timeline. “Some were a little cynical of the hubristic claims that were being made,” said Stuart Neil, a virologist at King’s College London.

The British and American governments nonetheless poured money into the vaccine.

Britain ordered 100 million doses, with the goal that 30 million would be delivered by September.

In the United States, Operation Warp Speed, the federal initiative to fast-track vaccine development, in May made what was then its biggest investment. The government awarded AstraZeneca up to $1.2 billion for development and manufacturing of the vaccine in exchange for 300 million doses. Alex M. Azar II, the health secretary, played up the deal as “a major milestone” in the program’s work. AstraZeneca’s stock hit a record high.

Those 300 million doses represent 60 percent of what the United States has ordered from the three manufacturers that have announced late-stage results so far. If other vaccines reach fruition or if the U.S. government exercises options to buy more doses, the reliance on the AstraZeneca candidate would decline substantially.

More countries soon placed orders. Even if other vaccines become available, the AstraZeneca offering is on track to account for 43 percent of all doses available in low- and middle-income countries, according to Airfinity, an analytics firm that tracks deals between vaccine manufacturers and governments.

AstraZeneca, however, would not begin testing its vaccine in the United States until August, three months after the Warp Speed deal. That was long after Oxford had started running trials elsewhere in the world — a delay that would prove fateful for the United States.

A Strange Discrepancy

In Britain, Oxford researchers wrapped up their first safety trial in May. No serious problems surfaced. Their next step was a larger so-called Phase 2/3 study, involving thousands of British participants, to assess how well the vaccine worked.

Oxford hired an outside manufacturer to produce large quantities of the vaccine for the trial. But when researchers received a sample of the vaccine and measured its strength, they noticed something strange. Using a different measurement technique than the manufacturer, Oxford found the concentration of viral particles in the vaccine to be double the level that the manufacturer had found.

Oxford researchers didn’t know which measurement to trust. They decided to use a lower-strength dose. That way, even if their measurement was wrong, the dosage was sure to be safe, albeit smaller than originally intended.

Participants would get two injections, which were supposed to be about a month apart. Oxford began administering the vaccine. Within a few days, participants reported fewer side effects like sore arms or slight fevers than participants had during the first trial. The Oxford researchers later identified an ingredient in the outside manufacturer’s vaccine batch that had skewed their measurement upward. That confirmed they were using a half-strength dose.

When the confusion over the dosing emerged months later, it would complicate efforts by scientists and public health officials to understand how well the vaccine worked.

In the meantime, public health authorities were increasingly embracing the inexpensive, easy-to-produce vaccine. In June, Soumya Swaminathan, the World Health Organization’s chief scientist, called it “probably the leading candidate.” In July, the head of the British government’s vaccine task force, Kate Bingham, told lawmakers that it was “the most advanced vaccine anywhere in the world.”

Trump administration officials, too, were enthusiastic. The White House chief of staff, Mark Meadows, told congressional leaders on July 30 that the Oxford-AstraZeneca vaccine could win emergency authorization from the F.D.A. as early as September, two people briefed on the discussion previously told The New York Times. (A spokesman for Mr. Meadows disputed that he had discussed AstraZeneca’s prospects.)

Such optimism was premature.

Federal health officials had said in June that in order to authorize a vaccine, the F.D.A. would likely need to see late-stage data from at least 30,000 trial participants. By then, Oxford’s trials in Britain and Brazil were underway, and even if their results were pooled they would fall short of that F.D.A. threshold. (The agency has never closed the door on relying entirely on data from overseas trials to authorize a vaccine.)

AstraZeneca planned for its U.S. trial to include 30,000 people. But that trial was weeks away from even starting.

Image

A vaccine volunteer in Oxford. A trial for the Oxford-AstraZeneca vaccine had a prolonged delay in the United States after a safety scare.Credit...Andrew Testa for The New York Times

Neurological Symptoms

Then came a safety scare.

A British participant in the Phase 2/3 trial developed neurological symptoms consistent with transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections, according to a notice given to participants dated July 12. That trial was briefly paused.

The Road to a Coronavirus Vaccine

Words to Know About Vaccines

Confused by the all technical terms used to describe how vaccines work and are investigated? Let us help:

Adverse event: A health problem that crops up in volunteers in a clinical trial of a vaccine or a drug. An adverse event isn’t always caused by the treatment tested in the trial.

Antibody: A protein produced by the immune system that can attach to a pathogen such as the coronavirus and stop it from infecting cells.

Approval, licensure and emergency use authorization: Drugs, vaccines and medical devices cannot be sold in the United States without gaining approval from the Food and Drug Administration, also known as licensure. After a company submits the results of  clinical trials to the F.D.A. for consideration, the agency decides whether the product is safe and effective, a process that generally takes many months. If the country is facing an emergency — like a pandemic — a company may apply instead for an emergency use authorization, which can be granted considerably faster.

Background rate: How often a health problem, known as an adverse event, arises in the general population. To determine if a vaccine or a drug is safe, researchers compare the rate of adverse events in a trial to the background rate.

Efficacy: The benefit that a vaccine provides compared to a placebo, as measured in a clinical trial. To test a coronavirus vaccine, for instance, researchers compare how many people in the vaccinated and placebo groups get Covid-19. Effectiveness, by contrast, is the benefit that a vaccine or a drug provides out in the real world. A vaccine's effectiveness may turn out to be lower or higher than its efficacy.

Phase 1, 2, and 3 trials: Clinical trials typically take place in three stages. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. Phase 2 trials, involving hundreds of people, allow researchers to try out different doses and gather more measurements about the vaccine’s effects on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and efficacy of the vaccine or drug by waiting to see how many people are protected from the disease it’s designed to fight.

Placebo: A substance that has no therapeutic effect, often used in a clinical trial. To see if a vaccine can prevent Covid-19, for example, researchers may inject the vaccine into half of their volunteers, while the other half get a placebo of salt water. They can then compare how many people in each group get infected.

Post-market surveillance: The monitoring that takes place after a vaccine or drug has been approved and is regularly prescribed by doctors. This surveillance typically confirms that the treatment is safe. On rare occasions, it detects side effects in certain groups of people that were missed during clinical trials.

Preclinical research: Studies that take place before the start of a clinical trial, typically involving experiments where a treatment is tested on cells or in animals.

Viral vector vaccines: A type of vaccine that uses a harmless virus to chauffeur immune-system-stimulating ingredients into the human body. Viral vectors are used in several experimental Covid-19 vaccines, including those developed by AstraZeneca and Johnson & Johnson. Both of these companies are using a common cold virus called an adenovirus as their vector. The adenovirus carries coronavirus genes.

Trial protocol: A series of procedures to be carried out during a clinical trial.

Neither AstraZeneca nor Oxford announced the pause. Ms. Meixell, the AstraZeneca spokeswoman, said the company informed the F.D.A. about the illness on July 15 “in order to be as transparent as possible.” But at least some top F.D.A. officials didn’t learn about it, according to the people with knowledge of the discussions between AstraZeneca and the F.D.A. (The participant was later found to have multiple sclerosis, deemed unrelated to the vaccine.)

Later in the summer, another participant in the same trial fell ill with similar symptoms. It wasn’t necessarily a catastrophe: Transverse myelitis can be caused by a variety of factors. And a small percentage of people in any big vaccine trial are likely to develop conditions unrelated to the vaccine. Still, it was concerning, because there was a chance that it was linked to the vaccine.

On Sept. 6, AstraZeneca paused its global trials to investigate. The news became public two days later. F.D.A. officials were blindsided.

A day later, Pascal Soriot, AstraZeneca’s chief executive, compounded the problem. Instead of publicly releasing more information about the participant’s illness, he provided new details to investors in a private conference call organized by the investment bank J.P. Morgan.

ADVERTISEMENT

Continue reading the main story

In Britain, Brazil, India and South Africa, regulators allowed testing to resume in less than a week. In Japan, the pause was just under a month.

But in the United States, the delay dragged on. During the prolonged pause, new participants couldn’t be enrolled in the study — and that the small number of volunteers who had gotten their first inoculation in the early days of the trial couldn’t get their booster shot about a month later.

AstraZeneca was in part to blame for the delay, said the people with knowledge of the F.D.A. talks. The company was slow to provide the F.D.A. with all the data that regulators wanted to review before allowing the trial to start up again.

Far Behind

In late October, after 47 days, the F.D.A. cleared the U.S. trial to restart.

It was now even further behind the late-stage trials that Pfizer and Moderna had begun in the United States about a month before AstraZeneca’s trial started. One consequence was that, at least initially, AstraZeneca would not be able to combine the data from the U.S. and overseas trials in order to hit the F.D.A.’s 30,000-person threshold.

In November, Pfizer and Moderna each reported that analyses had found their vaccines to be about 95 percent effective. The spectacular results set a high bar against which to measure rival vaccines.

Still, the vaccines from Pfizer and Moderna had drawbacks compared with the Oxford-AstraZeneca approach. They were more expensive — and the companies had not pledged to forgo profits on them. Plus, they couldn’t be stored outside ultracold freezers for more than a few weeks.

As a result, the global public health community was hotly anticipating Oxford and AstraZeneca’s results. They came on Nov. 23.

ADVERTISEMENT

Continue reading the main story

The good news was that the vaccine seemed to work. It appeared safe. And no one who had been vaccinated had developed severe Covid-19 or been hospitalized.

Things got messier from there.

AstraZeneca and Oxford researchers said their vaccine was up to 90 percent effective, but only among those who received the initial half-strength dose. Among the larger group of participants who got two full-strength doses, the vaccine was only 62 percent effective.

That seemed counterintuitive. And the Oxford researchers couldn’t explain with certainty why the vaccine worked so much better when participants got a half-strength initial dose. In The Lancet on Tuesday, the scientists said they still weren’t sure.

Image

Dr. Moncef Slaoui, the head of Operation Warp Speed, has said approval for the Oxford vaccine is unlikely to be imminent.Credit...Evan Vucci/Associated Press

‘I’m Very Confident’

The situation only got worse. The day after the results were announced, Dr. Moncef Slaoui, the head of Operation Warp Speed, told reporters that the promising half-strength dose had not been tested in people over the age of 55. That was concerning because some vaccines don’t work as well in older adults, who are also more vulnerable to Covid-19. It also raised the question of why the vaccine developers hadn’t themselves disclosed that important caveat.

The unclear results further sapped the confidence of American regulators. Absent a clear explanation of why the half-strength initial dose worked so much better, the results most likely “will not be sufficient for an approval,” Dr. Slaoui said last week.

Another wrinkle emerged on Tuesday. The Lancet article said some participants who got the initial half-strength dose didn’t receive their second shot until at least three months later. They were supposed to get the booster about a month after the first dose. For clinical trials that are usually carefully scripted, that represented another unusual deviation from the original plan.

ADVERTISEMENT

Continue reading the main story

Developers at Oxford and AstraZeneca have been frustrated by the torrent of questions overshadowing what they regard as their vaccine’s impressive efficacy.

“I’m very confident we have a vaccine that is effective,” a senior AstraZeneca executive, Menelas Pangalos, said in an interview.

But for Dr. Jesse L. Goodman, the F.D.A.’s chief scientist from 2009 to 2014, AstraZeneca’s missteps reinforce the importance of clear, transparent communication. “People need to know what is known and what is not known so they can trust in the process,” he said.

AstraZeneca is now considering a new global trial that will enroll several thousand participants to gather more data on the regimen involving an initial half-strength dose. Regardless, the vaccine is likely to become available soon in Britain and some other countries.

Not in the United States. As of last week, AstraZeneca’s U.S. trial was halfway to its goal of enrolling 30,000 people.

AstraZeneca executives said on Tuesday that, based on feedback from the F.D.A., they didn’t expect to receive federal authorization for their vaccine until after the company gets results from its U.S. trial. That could happen in January.

In the meantime, U.S. public health authorities are preparing to begin vaccinating a tiny percentage of the population using the Pfizer and Moderna vaccines, which will soon be available in limited quantities.

Katie Thomas and Nicholas Kulish contributed reporting.

Rebecca Robbins joined The Times in 2020 as a business reporter focused on covering Covid-19 vaccines. She has been reporting on health and medicine since 2015. @RebeccaDRobbins

Sharon LaFraniere is an investigative reporter. She was part of a team that won a Pulitzer Prize in 2018 for national reporting on Donald Trump’s connections with Russia. @SharonLNYT

Noah Weiland is a reporter in the Washington bureau of The New York Times, covering health care. He was raised in East Lansing, Michigan and graduated from the University of Chicago. @noahweiland

David D. Kirkpatrick is an international correspondent based in London and the author of "Into the Hands of the Soldiers: Freedom and Chaos in Egypt and the Middle East." In 2020 he shared a Pulitzer Prize for reporting on covert Russian interference in other governments and as the Cairo bureau chief from 2011 to 2015 he led coverage of the Arab Spring uprisings. @ddknyt • Facebook

Benjamin Mueller is a United Kingdom correspondent for The New York Times. Before that, he had been a police and law enforcement reporter on the Metro desk since 2014. @benjmueller

 

Link to comment
Share on other sites

10 minutes ago, 27-25 said:

I don't get this.  People under 30 may not die from it (as much as those older) but they can certainly be infected and pass that infection on to others.  I believe the herd immunity number of 70% thrown about refers to the general population, not just the most vulnerable, right?

My assumption is that 90% of olds will get vaccinated.  People under 30 can indeed get it and pass it on, but they can only pass it on to people who do not have immunity.  Because of the risk profile of this virus, I do not think we need to get herd immunity via vaccination; we only need to vaccinate everyone who is at relatively high risk of dying from it (along with their caretakers and other essential workers).

I am only talking priorities for saving lives and returning to normal as quickly as possible.  Eventually, everyone should be vaccinated (hopefully done by Labor Day 2021).

Edited by Snake Diggity
Link to comment
Share on other sites

Maybe this was discussed a few pages back, but I scanned through and didn't see anything. What's the story on the US not getting as much of Pfizer's vaccine? I see the administration's response that "they weren't going to put all their eggs in one basket early on." I can understand that point. But I also read brief references to there having been multiple offers from Pfizer after their data showed the vaccine likely to be successful. Has anybody put together a timeline on that? Was there actually good data available to show that purchasing more was a good idea?

Link to comment
Share on other sites

9 hours ago, PassiveAggressiveCoach said:

BTW what happened to flu cases? Corona eats flu? Best flu season in the history of man. Hmmm

to the extent you're suggesting stats are juked so that covid deaths are flu deaths re-coded, please see below.  a whole whole whole lot of people are dying from something.  and that something didn't really impact the US prior April 2020.  

 

 

Excess-Deaths.png

Edited by BehoId, The Underminer!
  • Like 1
Link to comment
Share on other sites

18 minutes ago, Anastasis said:

Now Canada has authorized the Pfizer vaccine.  

 

FDA still fingering their butthole waiting for an advisory committee meeting to take place. 

Why are we taking so long? Is it just red tape, incompetence  or are they getting it distributed so it’s ready when they approve it?

Link to comment
Share on other sites

12 minutes ago, SquishMitten said:

Maybe this was discussed a few pages back, but I scanned through and didn't see anything. What's the story on the US not getting as much of Pfizer's vaccine? I see the administration's response that "they weren't going to put all their eggs in one basket early on." I can understand that point. But I also read brief references to there having been multiple offers from Pfizer after their data showed the vaccine likely to be successful. Has anybody put together a timeline on that? Was there actually good data available to show that purchasing more was a good idea?

I think it comes down to the simple fact that Donald Trump is a narcissistic asshole who cares about nothing but money & power.

Link to comment
Share on other sites

Someone referenced Ron Johnson the other day, but I don't remember who or what the reference was about.  Here's an article about Ron's anti-science behavior in his official role.  The mind boggles.  (It shouldn't at this point, but it does.)

Oh, Ron

Spoiler

Elevating Fringe Theories, Ron Johnson Questions Virus Science
The Wisconsin Republican has transformed his Senate panel into a forum for amplifying dubious theories and questionable treatments pushed by President Trump.


Senator Ron Johnson of Wisconsin has been willing to echo the most conspiracy-minded and anti-science impulses of President Trump.Credit...Anna Moneymaker for The New York Times
Catie EdmondsonNicholas Fandos
By Catie Edmondson and Nicholas Fandos
Dec. 7, 2020
WASHINGTON — In choosing a slate of doctors to testify about coronavirus treatments before his committee on Tuesday, Senator Ron Johnson has assembled a cast of witnesses who question much of the public health consensus about the virus.

There is a prominent vaccine skeptic, an outspoken critic of masking and social distancing, and at least two doctors who have promoted the use of an anti-parasitic drug that government scientists have recommended against using to treat the coronavirus.

It is the latest example of how Mr. Johnson, a Wisconsin Republican who has used his powerful investigative panel to amplify groundless accusations pushed by President Trump, has now embraced the role of the Senate’s leading Covid contrarian.

Even as some of his Republican colleagues have sought to use their platforms to encourage Americans to take precautions against the spread of the virus and persuade the public that vaccines against it will be safe and vital, Mr. Johnson has suggested that the dangers of the coronavirus have been overblown and excessively regulated. And twice in the past three weeks, Mr. Johnson has used his gavel on the Homeland Security and Governmental Affairs Committee to elevate voices who public health experts say represent fringe beliefs.

It has set off something of a quiet mutiny on the panel, enraging Democrats who plan to essentially boycott the traditional cross-examination of witnesses and unsettling some Republicans who are planning to skip Tuesday’s session lest their presence be seen as lending credence to the proceeding.

The selections underscore the extent to which Mr. Johnson, a former plastics baron who has made little secret of his disdain for the Washington establishment, has eagerly echoed the most conspiracy-minded and anti-science impulses of Mr. Trump and waded headfirst into battles even the president’s usually reliable phalanx of congressional defenders have been unwilling to fight.

Gift Subscriptions to The Times, Cooking and Games.
Starting at $25.
Mr. Johnson spent much of the year pursuing a corruption inquiry into President-elect Joseph R. Biden Jr. and his son, Hunter, that he conceded was driven by Mr. Biden’s political campaign, and that ultimately found no wrongdoing by the elder Mr. Biden. Since the election, he has questioned whether Mr. Biden won fairly, saying last week that Attorney General William P. Barr should produce proof to back up his statement that the Justice Department had found no evidence of the kind of widespread voter fraud Mr. Trump has baselessly insisted cost him the election.

Mr. Johnson is unfazed by the criticism he has attracted.

In an interview on Monday, he said that while he supported widespread vaccination and masking, he believed that many of his colleagues had been too deferential to a public health establishment that, because of its obsession with finding a vaccine and lack of experience treating coronavirus patients, had undermined, neglected and even “censored” other potential treatments that he believes could help.

“We have grossly overreacted to this,” Mr. Johnson said of the virus. “We have not been smart. We should have isolated the sick, protected the vulnerable and then the rest of us carry on with our lives as safely as possible.”

Editors’ Picks

‘S.N.L.’ Parodies Rudy Giuliani and Melissa Carone’s Disastrous Hearing

Rachel Maddow and Michael Yarvitz Tell the Full Sordid Story of Spiro Agnew

The Long and Tortured History of Cancel Culture
Mr. Johnson’s lead witness on Tuesday, Dr. Jane M. Orient, has cast doubts on coronavirus vaccines and has pushed for the use of hydroxychloroquine, an antimalarial drug pushed by Mr. Trump, as a treatment. She helps run a group that believes government vaccine mandates violate human rights.

Another, the Washington cardiologist Ramin Oskoui, said on Fox News last month that it was “settled science” that “social distancing doesn’t work, quarantining doesn’t work, masks don’t work.” On the contrary, it is settled science that all three are effective in limiting the spread of the virus.

NICHOLAS KRISTOF: A behind-the-scenes look at Nicholas Kristof’s gritty journalism, as he travels around the world.
Sign Up
Two others promote the use of ivermectin, a drug often used to fight lice and pinworms, to treat coronavirus patients, despite the National Institutes of Health’s recommendation against its use outside clinical trials.

Mr. Johnson said he felt that the public had a right to learn about early treatments they might not otherwise be aware of.

“There’s a blackout on good information in social media and media,” he said. “So people are being denied information to make intelligent choices themselves.”

Senator Gary Peters of Michigan, the top Democrat on the panel, fretted that the witnesses would “amplify theories that are at odds with the broader scientific community and, according to experts, could cause harm.”

“These fringe views run counter to what the Senate should be doing — working on a bipartisan basis to protect the American people and tackle this deadly pandemic,” Mr. Peters said.


ImageMr. Johnson is likely to seek a third term in 2022 and would benefit from Mr. Trump’s vocal support.
Mr. Johnson is likely to seek a third term in 2022 and would benefit from Mr. Trump’s vocal support.Credit...Gabriella Demczuk for The New York Times
He pointedly declined to invite a witness to Tuesday’s hearing, and his aides said he did not plan to engage with the witnesses during the session. Instead, he is working with a group of a dozen prominent health experts to draft a letter to submit for the Congressional Record challenging their views.

Mr. Johnson’s inflammatory public statements and his decision to give a platform to an assortment of contrarian doctors promoting alternative treatments have also irked some fellow Republicans, who have privately groused that he is acting irresponsibly. But in the clubby Senate, few are willing to criticize a colleague openly or challenge a chairman on how he runs his committee.

Senator Mitt Romney of Utah, who had criticized the Hunter Biden inquiry as politicized, conspicuously skipped questioning witnesses at the earlier coronavirus hearing and does not plan to attend on Tuesday. Senator Rob Portman of Ohio, who is slated to take the top Republican slot on the panel in January after Mr. Johnson’s term as chairman ends, has gone out of his way to project trust for the scientific consensus on the coronavirus, publicly announcing last month that he had signed up for a vaccine trial in part to persuade Americans that it was safe.

Dr. Ashish Jha, the dean of the Brown University School of Public Health, who tangled with Mr. Johnson at a November hearing dedicated to hydroxychloroquine, called that event “a powerful reminder that not even Congress is immune to toxic conspiracy theories.”

At the hearing, Mr. Johnson wondered aloud why medical professionals like Dr. Jha had scorned the drug, which has repeatedly been shown to be ineffective at treating coronavirus patients, and were supporting another drug, remdesivir, which has been shown to work but is more expensive.

“I question the fact that because this cocktail costs about $20 and remdesivir costs $3,000, that maybe there’s a little bias, maybe there’s a little conflict, maybe there’s a little agenda,” he said.

“He’s giving platforms to people who are way outside of the mainstream medical community,” Dr. Jha said in an interview.

Mr. Johnson said his own coronavirus infection in early October — “I had two positive tests. I guess they’re valid,” he said — did not require treatment.

Mr. Johnson’s interest in health issues is longstanding and consistent with his more recent statements. He was the lead sponsor, for example, of so-called right-to-try legislation that Congress overwhelmingly approved in 2018 to allow seriously ill patients to bypass the Food and Drug Administration and use unproven experimental treatments.

“He has always been a contrarian person,” said Mark Becker, the former county chairman of the Wisconsin Republican Party, who recently wrote an op-ed for The Bulwark, a website with a bent toward “Never Trump” conservatism, about a recent call with Mr. Johnson.

“But everything on the Republican side has turned to be a political argument, even a public health crisis,” Mr. Becker said. “And he still cares about not pissing off those Trumpers. He said that to me very clearly: ‘I’m not going to piss them off.’”

The calculation is most likely a shrewd one as the senator looks toward running for a third term in 2022 in a competitive state where he has twice been elected by narrow margins. Though he initially pledged to serve only two terms, Mr. Johnson has since hinted that he may feel compelled to run again, arguing that times have changed. Mr. Trump’s vocal support could be key.

Thomas Nelson, the Outagamie County executive and a Democrat challenging Mr. Johnson, predicted that voters would remember Mr. Johnson using a powerful perch in Washington to publicly explore “rabbit holes of bizarre conspiracies.”

“What’s wrong with you? I mean, what is wrong with you?” Mr. Nelson said in an interview. “Do you not see the existential threat that communities like your hometown are facing, have been facing?”

 

Link to comment
Share on other sites

4 minutes ago, jimmyjazz said:

 

Quote

“What’s wrong with you? I mean, what is wrong with you?” Mr. Nelson said in an interview. “Do you not see the existential threat that communities like your hometown are facing, have been facing?”

 

Last quote from the spoilered article above. It isn't just not wanting to piss off his Trumper loyalists.

My reply, which includes a quote from an Esquire article the day after the tweet below.

image.png.de30bddc4f71e20497bef6829b46a8ce.png


 

Quote

 

Pretty standard holiday bunting-draped bunkum, no? That’s only if you ignore that:

a) when this entry was posted, Johnson was in Russia as part of a GOP-only delegation trying to make sure the road is smoothed for the president*’s annual performance review in Helsinki;

b) that it was posted while Johnson was in Russia not three days after the Senate Intelligence Committee joined with the entire U.S. intelligence community in concluding that Russia had ratfcked the 2016 election on behalf of the current president*;

c) that it was posted while Johnson was in Russia the same day in which two more Britons were felled by the same nerve agent that had nearly killed a Russian defector and his daughter;

and, finally, d) that it was posted while Johnson was in Russia on the Fourth of Freaking July, aka Independence Day.----Esquire, "This Ought to Run in Campaign Ads from Now Through Eternity" by Charles P. Pierce Link: https://www.esquire.com/news-politics/politics/a22063027/republican-senators-russia-4th-of-july/

 

https://theweek.com/speedreads/783676/freshly-returned-from-moscow-gop-sen-ron-johnson-says-needs-rethink-russia-sanctions

https://www.cnn.com/2018/06/21/politics/senators-russia-congressional-delegation/index.html

https://www.esquire.com/news-politics/politics/a34042751/ron-johnson-ukraine-joe-biden-investigation-russia/

https://www.justsecurity.org/71947/how-sen-ron-johnsons-investigation-became-an-enabler-of-russian-disinformation-part-i/

 

Link to comment
Share on other sites



×
×
  • Create New...