COVID-19 vaccine discussion

[SizzleChest 8283]

44 minutes ago, Baboontyme said:

I've got a beef. I am not a scientist, nor do I design clinical trials. I am in the Moderna trial and I was unblinded and given the actual first dose on 1/25. 

Now, during phase 3 over the summer/fall when I got my (placebo) shots, for 10 days afterward I had to complete a daily e-diary in an app - fever, aches, chills, swelling, gland issues, etc questions in addition to obviously have you attained (shout out to Earv) Covid, been in proximity with someone etc. Additionally there were safety calls every few days where someone would ask similar questions and then answer any questions that you had.

So if I agreed to stay in the study and provide periodic blood draws, as long as I'm in, shouldn't they be doing the same after I actually received the shot a couple of weeks ago? And again after I receive dose 2? I've already pledged my participation, why not have me do the e-diary? They asked for nothing. I have a weekly check in on the app I still have to do that asks if I got Covid and that's about it. Seems like a big missed opportunity. 

I suppose the trial met its endpoint so they don't care? There are a whole lot of people out there, especially in minority communities, that are hesitant to get these shots because the after affects have been studies for less than a year. Why would they pass up the opportunity to collect additional data from study participants?

I started thinking more about this after I had a very strange episode with uncontrollable chills the other night after waking up in the morning...10ish days after dose 1. Could be totally unrelated but shrug... Never happened to me before. 10 days out is very inconsistent with what I've heard from others. Myself I just had a sore arm for about 36 hours immediately after. I'm not worried about myself at all, I just feel like it's a missed opportunity to gather data and convince folks that these vaccines are safe..

There should be an 800 number you can call or a website managed by Moderna (or a third-party on their behalf) to report issues or symptoms.  Post-approval afety surveillance is required by regulators and codified as part of any FDA (or other global regulators) agreement with a pharma company as part of the approval for a drug to be marketed.

The e-diary data is collected to support the trial only occurs during the trial.  You signed an informed consent form that outlined the parameters and expectations for you as a patient in the trial.  E-diary collection because a patient received placebo and the company offered to provide you with active vaccine after the blind was broken (effectively ending the trial for you as a patient) is just not typically part of vaccine clinical trial designs.

[SizzleChest 8283]

There is also an app sponsored by the CDC called V-safe that collects vaccine symptoms.  I don't know for sure, but would have to believe this information is collated and shared with the vaccine manufacturers.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html

Edited February 6, 2021 by SizzleChest

[Bevo 13568]

1 hour ago, Baboontyme said:

I started thinking more about this after I had a very strange episode with uncontrollable chills the other night after waking up in the morning...10ish days after dose 1. Could be totally unrelated but shrug... Never happened to me before. 10 days out is very inconsistent with what I've heard from others. Myself I just had a sore arm for about 36 hours immediately after. I'm not worried about myself at all, I just feel like it's a missed opportunity to gather data and convince folks that these vaccines are safe..

1. It is possible that you contracted COVID. I don't know the likelihood, but it is possible. Chills 10 days out is inconsistent with the vaccine and I would imagine that the mRNA vaccine and the spike protein binding site subunit that it transcribed would be out of your system by day 10.

2. The follow-up studies may be helpful but they would be unblinded and would give unreliable data because both you and the investigators know that you have now received the vaccine. So there would be better studies to prove or disprove whatever hypothesis that you want to investigate.

[Baboontyme 2809]

Good points both, especially on being unblinded. Yeah def don't think it's Covid. It lasted only a couple of minutes and I was able to get warm and fall back asleep under some blankets. Nothing else, no temp, can taste/smell just fine. And no real avenue to get it, either. Not worried about it, just thought it seemed like a wasted opportunity. 

[Neonmoon 38129]

15 minutes ago, Baboontyme said:

Good points both, especially on being unblinded. Yeah def don't think it's Covid. It lasted only a couple of minutes and I was able to get warm and fall back asleep under some blankets. Nothing else, no temp, can taste/smell just fine. And no real avenue to get it, either. Not worried about it, just thought it seemed like a wasted opportunity. 

Is it possible you were having an acid flashback? 

[TexPx 2322]

Denton County kicks ass. We registered at probably 7-8 different areas around the state for a shot and Denton is the only one that: a) tells you via email what number you are in line, every week, and where in the line they are in giving vaccines; b) is moving at light speed. We are 88k in the line, and they’ve jumped from 0 to 72k in a very short period of time. Whoever managed this for Denton needs a raise and a bigger job. 

Denton County got something like 30k doses at the end of the month. Weren’t they the ones doing the TMS drive through? We registered over a month ago and have never received anything from them.


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[TexPx 2322]

APH had them last week but you had to continually hit refresh for like 10+ minutes for one of the blue appointment buttons to appear.

Online registration in Frisco was a clusterfuck. They set a time when it would open and 75,000 people apparently tried to register at once.

The next day they just gave a general time and then announced when it would open via email. Still fucked up.

If you were lucky enough to get through getting the shot was a piece of cake. 30 to 45 minutes to get the shot and your second dose scheduled.


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[Neonmoon 38129]

https://www.kxan.com/texas-coronavirus-vaccine/texas-to-get-more-than-400000-first-doses-of-covid-19-vaccine-in-week-9-of-distribution/

The link was posted yesterday but in case no one clicked. Here is how the numbers are being distributed in central Texas for week of Feb. 8

Not a lot. 

• Austin Public Health (hub) – 12,000
• UT Health Austin (Dell Medical School Hub) – 2,950
• Austin Public Safety Wellness – 500
• CommCommunitycare -Care Connection Clinic – 100
• Communitycare ARCH – 200
• Communitycare David Powell Clinic – 200
• Communitycare – Hancock – 200
• Communitycare North Central – 200
• Communitycare Oak Hill – 100
• Communitycare Rundberg – 100
• Communitycare – South Austin – 100
• Communitycare South East Health And Wellness Clinic – 100
• Lone Star Circle Of Care At Collinfield – 100
• Lone Star Circle Of Care At El Buen Samaritano – 100
• Lone Star Circle of Care at Northwest Austin – 100
• Texas Department Of Public Safety – 500
• Wellmed Ben White – 400
• Wellmed St. John – 400
• Wellmed Pflugerville – 400

WILLIAMSON COUNTY

• Family Emergency Rooms Cedar Park (hub) – 8,000
• Lone Star Circle Of Care At Cedar Park – 100
• Lone Star Circle of Care at Lake Aire Medical Center – Senior Health – 100
• Wellmed Leander – 400
• Lone Star Circle of Care at Texas A&M Health Science Center – 100
• Williamson County and Cities Health District Round Rock – 1,000

HAYS COUNTY

• Hays County Health Department (hub) – 1,950
• First Medical Response of Texas, Inc – 900

 

BASTROP COUNTY

• A+ Life Style Medical Group (hub) – 1,000
• Lone Star Circle of Care at Bastrop – 100
• DSHS Elgin – 100

BURNET COUNTY

• Baylor Scott & White Medical Center Marble Falls (hub) – 975
• Lone Star Circle of Care Family Care Center At Marble Falls – 100

CALDWELL COUNTY

• DSHS Lockhart – 300
• DIsmukesRx, LLC – 200
• Seton Edgar B Davis Hospital – 200

MASON COUNTY

Frontera Healthcare Network Mason Clinic – 200

MILAM COUNTY

• Milam County Health Department – 300
• Brookshires Pharmacy 19 Rockdale – 100

[Message Board User 12395]

Thanks a lot Biden.

[TexasGrunt 72]

There is also an app sponsored by the CDC called V-safe that collects vaccine symptoms.  I don't know for sure, but would have to believe this information is collated and shared with the vaccine manufacturers.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html

When I got my first shot in Fort Bend one of the things they have you do is scan barcode that gives you option to sign up for VSafe. I did it and I received a texts in the afternoon with a few questions about the effects of shot. So there is some tracking going on but users have to agree to it and they have to sign up.

[RPM 26317]

I've been checking the DSHS site daily and unless you live in a metro area you're fucked. Rural counties are out of the small amount of vaccine they were shipped for round 1. All the new shipments have been to metro area hubs.

[Message Board User 12395]

 

[Message Board User 12395]

 

[shnsajax 3591]

Got the first Moderna shot today. Pretty pumped about it.

[Bevo 13568]

The next act for messenger RNA could be bigger than covid vaccines

New messenger RNA vaccines to fight the coronavirus are based on a technology that could transform medicine. Next up: sickle cell and HIV.

by

• Antonio Regalado archive page

February 5, 2021

 

 

On December 23, as part of a publicity push to encourage people to get vaccinated against covid-19, the University of Pennsylvania released footage of two researchers who developed the science behind the shots, Katalin Karikó and Drew Weissman, getting their inoculations. The vaccines, icy concoctions of fatty spheres and genetic instructions, used a previously unproven technology based on messenger RNA and had been built and tested in under a year, thanks to discoveries the pair made starting 20 years earlier.

In the silent promotional clip, neither one speaks or smiles as a nurse inserts the hypodermic into their arms. I later asked Weissman, who has been a physician and working scientist since 1987, what he was thinking in that moment. “I always wanted to develop something that helps people,” he told me. “When they stuck that needle in my arm, I said, ‘I think I’ve finally done it.’”

The infection has killed more than 2 million people globally, including some of Weissman’s childhood friends. So far, the US vaccine campaign has relied entirely on shots developed by Moderna Therapeutics of Cambridge, Massachusetts, and BioNTech in Mainz, Germany, in partnership with Pfizer. Both employ Weissman’s discoveries. (Weissman’s lab gets funding from BioNTech, and Karikó now works at the company.)

Unlike traditional vaccines, which use live viruses, dead ones, or bits of the shells that viruses come cloaked in to train the body’s immune system, the new shots use messenger RNA—the short-lived middleman molecule that, in our cells, conveys copies of genes to where they can guide the making of proteins.

The message the mRNA vaccine adds to people’s cells is borrowed from the coronavirus itself—the instructions for the crown-like protein, called spike, that it uses to enter cells. This protein alone can’t make a person sick; instead, it prompts a strong immune response that, in large studies concluded in December, prevented about 95% of covid-19 cases.

Beyond potentially ending the pandemic, the vaccine breakthrough is showing how messenger RNA may offer a new approach to building drugs.

In the near future, researchers believe, shots that deliver temporary instructions into cells could lead to vaccines against herpes and malaria, better flu vaccines, and, if the covid-19 germ keeps mutating, updated coronavirus vaccinations, too.

But researchers also see a future well beyond vaccines. They think the technology will permit cheap gene fixes for cancer, sickle-cell disease, and maybe even HIV.

For Weissman, the success of covid vaccines isn’t a surprise but a welcome validation of his life’s work. “We have been working on this for over 20 years,” he says. “We always knew RNA would be a significant therapeutic tool.”

Perfect timing

Despite those two decades of research, though, messenger RNA had never been used in any marketed drug before last year.

“None of us were ready” to manufacture genetic vaccines for a billion people

The CEO of Moderna, whose novel covid vaccine could be authorized this week, is worried about how to make enough of the product.

Then, in December 2019, the first reports emerged from Wuhan, China, about a scary transmissible pneumonia, most likely some kind of bat virus. Chinese government censors at first sought to cover up the outbreak, but on January 10, 2020, a Shanghai scientist posted the germ’s genetic code online through a contact in Australia. The virus was already moving quickly, jumping onto airplanes and popping up in Hong Kong and Thailand. But the genetic information moved even faster. It arrived in Mainz at the headquarters of BioNTech, and in Cambridge at Moderna, where some researchers got the readout as a Microsoft Word file.

Scientists at Moderna, a biotech specializing in messenger RNA, were able to design a vaccine on paper in 48 hours, 11 days before the US even had its first recorded case. Inside of six weeks, Moderna had chilled doses ready for tests in animals.

Unlike most biotech drugs, RNA is not made in fermenters or living cells—it’s produced inside plastic bags of chemicals and enzymes. Because there’s never been a messenger RNA drug on the market before, there was no factory to commandeer and no supply chain to call on.

When I spoke to Moderna CEO Stéphane Bancel in December, just before the US Food and Drug Administration authorized his company’s vaccine, he was feeling confident about the shot but worried about making enough of it. Moderna had promised to make up to a billion doses during 2021. Imagine, he said, that Henry Ford was rolling the first Model T off the production line, only to be told the world needed a billion of them.

Bancel calls the way covid-19 arrived just as messenger RNA technology was ready an “aberration of history.”

In other words, we got lucky.

Human bioreactors

The first attempt to use synthetic messenger RNA to make an animal produce a protein was in 1990. It worked but a big problem soon arose. The injections made mice sick. “Their fur gets ruffled. They lose weight, stop running around,” says Weissman. Give them a large dose, and they’d die within hours. “We quickly realized that messenger RNA was not usable,” he says.

The culprit was inflammation. Over a few billion years, bacteria, plants, and mammals have all evolved to spot the genetic material from viruses and react to it. Weissman and Karikó’s next step, which “took years,” he says, was to identify how cells were recognizing the foreign RNA.

As they found, cells are packed with sensing molecules that distinguish your RNA from that of a virus. If these molecules see viral genes, they launch a storm of immune molecules called cytokines that hold the virus at bay while your body learns to cope with it. “It takes a week to make an antibody response; what keeps you alive for those seven days is these sensors,” Weissman says. But too strong a flood of cytokines can kill you.

The eureka moment was when the two scientists determined they could avoid the immune reaction by using chemically modified building blocks to make the RNA. It worked. Soon after, in Cambridge, a group of entrepreneurs began setting up Moderna Therapeutics to build on Weissman’s insight.

Vaccines were not their focus. At the company’s founding in 2010, its leaders imagined they might be able to use RNA to replace the injected proteins that make up most of the biotech pharmacopoeia, essentially producing drugs inside the patient’s own cells from an RNA blueprint. “We were asking, could we turn a human into a bioreactor?” says Noubar Afeyan, the company’s cofounder and chairman and the head of Flagship Pioneering, a firm that starts biotech companies.

If so, the company could easily name 20, 30, or even 40 drugs that would be worth replacing. But Moderna was struggling with how to get the messenger RNA to the right cells in the body, and without too many side effects. Its scientists were also learning that administering repeat doses, which would be necessary to replace biotech blockbusters like a clotting factor that’s given monthly, was going to be a problem. “We would find it worked once, then the second time less, and then the third time even lower,” says Afeyan. “That was a problem and still is.”

Moderna pivoted. What kind of drug could you give once and still have a big impact? The answer eventually became obvious: a vaccine. With a vaccine, the initial supply of protein would be enough to train the immune system in ways that could last years, or a lifetime.

A second major question was how to package the delicate RNA molecules, which last for only a couple of minutes if exposed. Weissman says he tried 40 different carriers, including water droplets, sugar, and proteins from salmon sperm. It was like Edison looking for the right filament to make an electric lamp. “Almost anything people published, we tried,” he says. Most promising were nanoparticles made from a mixture of fats. But these were secret commercial inventions and are still the basis of patent disputes. Weissman didn’t get his hands on them until 2014, after half a decade of attempts.

When he finally did, he loved what he saw. “They were better than anything else we had tried,” he says. “It had what you wanted in a drug. High potency, no adverse events.” By 2017, Weissman’s lab had shown how to vaccinate mice and monkeys against the Zika virus using messenger RNA, an effort that soon won funding from BioNTech. Moderna was neck and neck.  It quickly published results of an early human test of a new mRNA influenza vaccine and would initiate a large series of clinical studies involving diseases including Zika.

Pivoting to vaccines did have a drawback for Moderna. Andrew Lo, a professor at MIT’s Laboratory for Financial Engineering, says that most vaccines lose money. The reason is that many shots sell for a “fraction of their economic value.” Governments will pay $100,000 for a cancer drug that adds a month to a person’s life but only want to pay $5 for a vaccine that can protect against an infectious disease for good. Lo calculated that vaccine programs for emerging threats like Zika or Ebola, where outbreaks come and go, would deliver a -66% return on average. “The economic model for vaccines is broken,” he says.

So you got the vaccine. Can you still infect people? Pfizer is trying to find out.

For now, even if you’ve had covid-19 or been given the shot, it's smart to keep your mask on.

On the other hand, vaccines are more predictable. When Lo’s team analyzed thousands of clinical trials, they found that vaccine programs frequently succeed. Around 40% of vaccine candidates in efficacy tests, called phase 2 clinical trials, proved successful, a rate 10 times that of cancer drugs.

Adding to mRNA vaccines’ chance of success was a lucky break. Injected into the arm, the nanoparticles holding the critical instructions seemed to home in on dendritic cells, the exact cell type whose job is to train the immune system to recognize a virus. What’s more, something about the particles put the immune system on alert. It wasn’t planned, but they were working as what’s called a vaccine adjuvant. “We couldn’t believe the effect,” says Weissman.

Vaccines offered Moderna’s CEO, Bancel, a chance to advance a phalanx of new products. Since every vaccine would use the same nanoparticle carrier, they could be rapidly reprogrammed, as if they were software. (Moderna had even trademarked the name “mRNA OS,” for operating system.) “The way we make mRNA for one vaccine is exactly the same as for another,” he says. “Because mRNA is an information molecule, the difference between our covid vaccine, Zika vaccine, and flu vaccine is only the order of the nucleotides.”

95% effective

Back in March 2020, when the vaccine programs were getting under way, skeptics said messenger RNA was still an unproven technology. Even this magazine said a vaccine would take 18 months, at a minimum—a projection that proved off by a full nine months. “Sometimes things take a long time just because people think it does,” says Afeyan. “That weighs on you as a scientific team. People are saying, ‘Don’t go any faster!’”

The shots from Moderna and BioNTech proved effective by December and were authorized that month in the US. But the record speed was not due only to the novel technology. Another reason was the prevalence of infection. Because so many people were catching covid-19, the studies were able to amass evidence quickly.

Is messenger RNA really a better vaccine? The answer seems to be a resounding yes. There are some side effects, but both shots are about 95% effective (that is, they stop 95 out of 100 cases), a record so far unmatched by other covid-19 vaccines and far better than the performance of flu vaccines. Another injection, made by AstraZeneca using an engineered cold virus, is around 75% effective. A shot developed in China using deactivated covid-19 germs protected only half the people who got it, although it did stop severe disease.

“This could change how we make vaccines from here on out,” says Ron Renaud, the CEO of Translate Bio, a company working with the technology.

The potency of the shots, and the ease with which they can be reprogrammed, mean researchers are already preparing to go after HIV, herpes, infant respiratory virus, and malaria—all diseases for which there’s no successful vaccine. Also on the drawing board: “universal” flu vaccines and what Weissman calls a “pan-coronavirus” shot that could offer basic protection against thousands of pathogens in that category, which have led not only to covid-19 but, before that, to the infection SARS and probably other pandemics throughout history.

“You have to assume we’re going to have more,” Weissman says. “So instead of shutting down the world for a year while you make a new vaccine, we’ll have a vaccine ready to go.”

Facilities of the biopharmaceutical company Lonza in Switzerland and New Hampshire, which are helping to manufacture Moderna’s vaccine.

Last spring, Bancel began petitioning the government to pay for vast manufacturing centers to make messenger RNA. He imagined a megafactory that “companies could use in peacetime” but that could be quickly reoriented to churn out shots during the next pandemic. That would be insurance, he says, against a nightmare scenario of a germ that spreads as fast as covid but has the 50% fatality rate of Ebola. If “governments spend billions on nuclear weapons they hope to never use,” Bancel argued in April, then “we should equip ourselves so this never happens again.”

Later that month, as part of Operation Warp Speed, the US effort to produce the vaccines, Moderna was effectively picked as a national champion to build such centers. The government handed it nearly $500 million to develop its vaccine and expand manufacturing.

Beyond vaccines

After the covid vaccines, some researchers expect Moderna and BioNTech to return to their original plans for the technology, like treating more conventional ailments such as heart attacks, cancer, or rare inherited diseases. But there’s no guarantee of success in that arena.

“Although there are a lot of potential therapeutic applications for synthetic mRNA in principle, in practice the problem of delivering sufficient amounts of mRNA to the right place in the body is going to be a huge and possibly insurmountable challenge in most cases,” says Luigi Warren, a biotech entrepreneur whose research as a postdoc formed the nucleus of Moderna.

What went wrong with America’s $44 million vaccine data system?

The CDC ordered software that was meant to manage the vaccine rollout. Instead, it has been plagued by problems and abandoned by most states.

There is one application in addition to vaccines, however, where brief exposure to messenger RNA could have effects lasting years, or even a lifetime.

In late 2019, before covid-19, the US National Institutes of Health and the Bill and Melinda Gates Foundation announced they would spend $200 million developing affordable gene therapies for use in sub-Saharan Africa. The top targets: HIV and sickle-cell disease, which are widespread there.

Gates and the NIH didn’t say how they would make such cutting-edge treatments cheap and easy to use, but Weissman told me that the plan may depend on using messenger RNA to add instructions for gene-editing tools like CRISPR to a person’s body, making permanent changes to the genome. Think of mass vaccination campaigns, says Weissman, except with gene editing to correct inherited disease.

Right now, gene therapy is complex and expensive. Since 2017, several types have been approved in the US and Europe. One, a treatment for blindness, in which viruses carry a new gene to the retina, costs $425,000 per eye.

A startup called Intellia Therapeutics is testing a treatment that packages CRISPR into RNA and then into a nanoparticle, with which it hopes to cure a painful inherited liver disease. The aim is to make the gene scissors appear in a person’s cells, cut out the problem gene, and then fade away. The company tested the drug on a patient for the first time in 2020.

It’s not a coincidence that Intellia is treating a liver disease. When dripped into the bloodstream through an IV, lipid nanoparticles tend to all end up in the liver—the body’s house-cleaning organ. “If you want to treat a liver disease, great—anything else, you have a problem,” says Weissman.

But Weissman says he’s figured out how to target the nanoparticles so that they wind up inside bone marrow, which constantly manufactures all red blood cells and immune cells. That would be a hugely valuable trick—so valuable that Weissman wouldn’t tell me how he does it. It’s a secret, he says, “until we get the patents filed.”

He intends to use this technique to try to cure sickle-cell disease by sending new instructions into the cells of the body’s blood factory. He’s also working with researchers who are ready to test on monkeys whether immune cells called T cells can be engineered to go on a seek-and-destroy mission after HIV and cure that infection, once and for all.

What all this means is that the fatty particles of messenger RNA may become a way to edit genomes at massive scales, and on the cheap. A drip drug that allows engineering of the blood system could become a public health boon as significant as vaccines. The burden of sickle-cell, an inherited disease that shortens lives by decades (or, in poor regions, kills during childhood), falls most heavily on Black people in equatorial Africa, Brazil, and the US. HIV has also become a lingering scourge: about two-thirds of people living with the virus, or dying from it, are in Africa.

Moderna and BioNTech have been selling their covid-19 vaccine shots for $20 to $40 a dose. What if that were the cost of genetic modification, too? “We could correct sickle-cell with a single shot,” Weissman says. “We think that is groundbreaking new therapy.”

There are fantastic fortunes to be made in mRNA technology. At least five people connected to Moderna and BioNTech are now billionaires, including Bancel. Weissman is not one of them, though he stands to get patent royalties. He says he prefers academia, where people are less likely to tell him what to research—or, just as important, what not to. He’s always looking for the next great scientific challenge: “It’s not that the vaccine is old news, but it was obvious they were going to work.” Messenger RNA, he says, “has an incredible future.”

Edited February 7, 2021 by Bevo

[Bevo 13568]

So you got the vaccine. Can you still infect people? Pfizer is trying to find out.

For now, even if you’ve had covid-19 or been given the shot, it's smart to keep your mask on.

by

• Antonio Regalado archive page

February 2, 2021

 

Sebastián De Toma joined Pfizer’s clinical trial last year, getting his shots in August and September. The Argentinian journalist still doesn’t know if he got the real covid-19 vaccine or the placebo, but on Sunday, January 31, the trial doctors called him with a new offer.

Would De Toma be willing to undergo a series of nasal swabs to regularly test for the virus? He says the doctors offered to send Cabify (a Spanish ride-sharing service) to bring him to the Hospital Militar in Buenos Aires. “They’ll swab me on the go, through the car window, and that’s it,” says De Toma.

The extra coronavirus tests, being offered to some volunteers in Argentina and in the US, are part of a plan by Pfizer to help answer a key covid unknown—how often vaccinated people develop asymptomatic coronavirus infections and whether they can still spread the virus, despite getting the shot.

Whether or not the vaccines stop “onward transmission” of the virus is likely to be a critical variable in determining how the pandemic plays out and how soon life goes back to normal. Right now, researchers say, their best guess is that vaccines will reduce transmission but may not prevent it entirely.

“We don’t know, but it’s an important question because the answer will influence mask wearing; it will influence behavior; it relates to comfort going to restaurants and movies and the overall benefit we can expect with vaccines,” says Lawrence Corey, who leads operations for the Covid-19 Prevention Network, which carried out several US vaccine trials.

The silent spreader mystery

“There are three things a vaccine can do: stop you from acquiring the disease altogether, stop onward transmission, and stop symptoms,” says Jeffrey Shaman, a public health researcher at Columbia University. A perfect vaccine would create what is called “sterilizing” immunity, which means the virus can’t get a foothold in your body at all. Some inoculations, however, do allow low-level infections that people's immune systems fight off without any symptoms. Their bodies still accumulate a certain quantity of the virus, which they may be able to transmit to others.

The reason we don’t know how well vaccines stop this transmission is that it’s expensive and complicated to measure. When companies like Pfizer, Novavax, Moderna Therapeutics, and others launched big studies of their new covid-19 vaccines last year, they were testing whether the vaccines could prevent people who caught the disease from getting sick or dying. The results on that count were impressive: hardly anyone who is vaccinated ends up in an ICU on a respirator.

What went wrong with America’s $44 million vaccine data system?

The CDC ordered software that was meant to manage the vaccine rollout. Instead, it has been plagued by problems and abandoned by most states.

What they didn’t measure was the “indirect” effect of vaccines in preventing the further spread of the virus, even though some computer models have predicted that blocking transmission could save more lives. One model, published in August by a team at Emory University, found that a vaccine that’s good at stopping spread, but not very good at stopping disease, would still lead to fewer deaths overall because it would slow the outbreak enough to reduce the total number of people who get infected.

A step toward understanding how often vaccinated people spread the virus is what Pfizer is doing now: trying to figure out whether people like De Toma are getting infected without ever feeling sick.

The evidence so far suggests that vaccines should cut the chance of transmission, but may not eliminate it. For example, vaccinated monkeys spritzed with the virus do get infected but don’t become particularly sick. Overall, they have much less virus in their airways. “There is strong evidence that contagiousness is correlated with symptoms. If you can cut down symptoms, you are probably cutting down transmission,” says Shaman.

But that doesn’t mean there is no spread. Early in the pandemic, researchers discovered that some people who caught the coronavirus and never felt sick were still spreading the disease. The evidence now suggests that the role of such “silent spreaders” is substantial, even though they tend to infect fewer people on average. In a report published January 7,  a team including epidemiologists at the Centers for Disease Control and Prevention estimated that a third of people infected with the coronavirus never develop symptoms and that they cause about a quarter of all spread.

Moderna Therapeutics, maker of another vaccine, did not reply to questions about whether it is studying transmission. However, preliminary data the company submitted to the US Food and Drug Administration in December offered one clue: people who got one dose of the vaccine were 66% less likely to turn up positive on a coronavirus test than those who got the placebo. Moderna suggested that “that some asymptomatic infections start to be prevented after the first dose.”

While looking for the virus in people’s noses can detect silent infections, it doesn’t actually prove whether these people can then infect others. To figure that out, researchers at the Covid-19 Prevention Network last year proposed studying more than 20,000 students on two dozen US campuses, including Louisiana State University. They proposed “almost daily” nose swabs to monitor exactly when the virus appeared, and in what amounts, in the airways of both vaccinated and unvaccinated students. Then, with contact tracing, they hoped to map how often vaccinated students spread the virus.

“You can learn a lot by understanding the acquisition and viral titers in the nose,” says Corey. “Then close contact tracing could estimate how often the people spread the virus, which is known as forward transmission.”

On December 31, the Wall Street Journal reported that the proposed study had failed to win funding, because of high costs and questions over its feasibility. Corey says the group has since updated the proposal and that it again being considered by the National Institutes of Health. He believes the study is worth the effort. “We just need to know,” he says. “Because we may need to turn our attention to the kinds of vaccines that do reduce transmission.”

Stemming the flood

Researchers know that stopping transmission is the only way to get rid of the coronavirus for good. One way the pandemic can end is via “herd immunity”—that is, when enough people are vaccinated, or infected, for the outbreak to recede on its own because there aren’t enough people left to infect. That threshold is commonly thought to be about 70% of the population.

But if vaccinated people are “leaky”—if they can still spread the virus sometimes—the threshold will rise. In fact, according to basic outbreak math, if the vaccine stops anything less than two-thirds of transmission events, it’s impossible to reach herd immunity at all. And that’s not even considering that many people will refuse the vaccine, nor mounting evidence that immunity may not last against new variants of the virus.

 

People are fed up with broken vaccine appointment tools — so they're building their own

From Google Docs to Airtable spreadsheets, Americans are trying to answer one seemingly simple question: Where can I get a vaccine?

So if the vaccines don’t almost completely stop transmission, “you will still have continued circulation and there won’t be much herd immunity,” Corey says. “It’s going to be in the population a long time.”  

Jody Lanard, a medical risk communicator who has worked with the World Health Organization, says until questions about vaccine transmission are answered, public health officials will likely send out contradictory messages. On the one hand, she says, exhorting people to “keep wearing a mask” implies that a vaccinated person can still transmit the virus. At the same time, encouraging everyone to get vaccinated, even those who are not in a high-risk group, “leans heavily on the notion that transmission will likely be reduced by vaccination.”

Lanard herself took extreme measures to avoid the virus, barely venturing out; when she did, she wore special masks and goggles in her building’s elevator. She says she recently managed to get a vaccine appointment, and now that she’s had the shot, she thinks she may loosen up and visit with some younger relatives.

But Lanard says she is still going to wear a mask at least until case numbers in New York, where she lives, go back down. “It would be so stupid to catch covid at this point in the pandemic,” she says. “I’m a fairly well-protected grandmom now, thanks to the vaccine. The last thing I want to do is infect some unprotected grandmom.”

[kevwun 15764]

15 hours ago, RPM said:

I've been checking the DSHS site daily and unless you live in a metro area you're fucked. Rural counties are out of the small amount of vaccine they were shipped for round 1. All the new shipments have been to metro area hubs.

Not true, the hub in Washington County has been getting regular shipments.  They vaccinated 4,000 people this week with 1st shots in one day.

[RPM 26317]

12 minutes ago, kevwun said:

Not true, the hub in Washington County has been getting regular shipments.  They vaccinated 4,000 people this week with 1st shots in one day.

[kevwun 15764]

11,000 already and they have only been up for about 2.5 weeks.  They are setting up appointments for another round right now.  The rural hubs service multiple counties because of population density.  You might have to drive 45 minutes or an hour, but they are getting vaccines in to arms.  They can open up more hubs when the JNJ vaccine is up and running, but the cold temps needed to store Pfizer and Moderna vaccines means it's not feasible to throw up hubs all over the place if the infrastructure wasn't already there.  Just about every 1B person I know of in rural areas that has made an effort to get a shot, has gotten it.

Edited February 7, 2021 by kevwun

[Surly Bevo 24908]

Isn't having to go into the big city for rarer things kind of the general rural experience?  

[kevwun 15764]

Yeah, people in rural areas are used to driving 30 minutes or an hour for shopping or to do things.

Edited February 7, 2021 by kevwun

[NAVY 6740]

Following up on my post from Jan 24 about volunteering at vaccine distribution hubs. I've been accepted into the UT Medical Reserve Corps and will start volunteer shifts this week at Gregory gym. 

Hook'em 

[NAVY 6740]

Was just walking my dog on campus to figure out parking for covid hub. 
 

This view never gets old. Also albino squirrel quickly spotted by law school 

[Anastasis 23463]

Well shit.

 

 

[XYZ 2154]

“Black health experts”? Is it relevant that they are black?

[Bevo 13568]

38 minutes ago, XYZ said:

“Black health experts”? Is it relevant that they are black?

Maybe if you are South African

[SizzleChest 8283]

1 hour ago, XYZ said:

“Blek health experts”? Is it relevant that they are blek?

Fify.

[Texas Jeff 1945]

Texas first shots crossed 10% today, seniors with first shots are at 26%.  At the 7 day rate, seniors will reach 50% coverage on March 3rd, everyone over 16 will get to 50% on June 7th.  I'm using estimated 2021 Texas population -- the official websites are using a 2018 number.

[B00M 6414]

8 hours ago, Texas Jeff said:

Texas first shots crossed 10% today, seniors with first shots are at 26%.  At the 7 day rate, seniors will reach 50% coverage on March 3rd, everyone over 16 will get to 50% on June 7th.  I'm using estimated 2021 Texas population -- the official websites are using a 2018 number.

Are you saying 50% of seniors will have at least 1 shot by March 3? Or 50% will have both shots? Either way, thanks for doing the math.

[Armybrat 40822]

I will be getting my first shot this morning. Mrs. Brat got hers this past Tuesday. My oldest brother (a Luddite type) & his wife are waiting to see if we keel over.

[XYZ 2154]

Good luck Armybrat, we’re all counting on you.

[George 491]

Pfizer round 1 knocked out in McKinney. 40 minutes door to door. 
 

[vicerous 169]

 

Meanwhile APH can't get their head out of their ass - Is any other provider struggling to provide timely second shots? Unbelievable but not really. 

[HookEm 2463]

Does anybody know how the hubs are handling extra doses at the end of the day? I would imagine that they don't know until the last minute how many extra doses they are going to have (from getting 6 shots out of 5-shot vials or from no-shows).   It seems like they should have an in-person wait list at the end of the day to distribute them.  Don't think there would be time to start calling people.

My in-laws got their 2nd vaccine in Lubbock on Saturday.  The volunteers there said that if people show up at 4:00 on the days they have a clinic (this was at the civic center), then they will give them a vaccine if they have any leftover (and they usually do). 

It has to be a similar situation at the other hubs I would think.  It isn't like they have huge freezers out at these stadiums and civic centers.

[Heme Doc 417]

Lots of confusion/concern out there about the AZ vaccine effectiveness against South African variant.  So I’ll try to help explain...

The AZ trial in question looked at healthy adults age 18-65 in South Africa.  AZ vaccine is super cheap ($3/dose) so it’s the one a lot of poor countries are betting on.  They designed the trial to show 60% effectiveness against getting symptomatic COVID.  They only enrolled 1789 participants and only had 42 cases of COVID in the trial (19 in vaccine and 23 in placebo).  So it was quite under powered to show what they wanted it to.  Of those 42 cases, all were mild.  Nobody needed the hospital or oxygen.  But that’s what you might expect in a younger healthier study population.  

So this was a small study but protection against SEVERE disease with AZ is unknown but probable.  J&J vaccine shows excellent protection (89%) against severe disease due to the SA variant.  

Thanks for reading.  

I will bill the surly fund for $1,000.  

 

 

[Liquor and Poker 3659]

14 minutes ago, Heme Doc said:

Lots of confusion/concern out there about the AZ vaccine effectiveness against South African variant.  So I’ll try to help explain...

The AZ trial in question looked at healthy adults age 18-65 in South Africa.  AZ vaccine is super cheap ($3/dose) so it’s the one a lot of poor countries are betting on.  They designed the trial to show 60% effectiveness against getting symptomatic COVID.  They only enrolled 1789 participants and only had 42 cases of COVID in the trial (19 in vaccine and 23 in placebo).  So it was quite under powered to show what they wanted it to.  Of those 42 cases, all were mild.  Nobody needed the hospital or oxygen.  But that’s what you might expect in a younger healthier study population.  

So this was a small study but protection against SEVERE disease with AZ is unknown but probable.  J&J vaccine shows excellent protection (89%) against severe disease due to the SA variant.  

Thanks for reading.  

I will bill the surly fund for $1,000.  

 

 

So they fucked up on trial design?  That's really all that happened?

[Brisketexan 105072]

22 minutes ago, HookEm said:

Does anybody know how the hubs are handling extra doses at the end of the day? I would imagine that they don't know until the last minute how many extra doses they are going to have (from getting 6 shots out of 5-shot vials or from no-shows).   It seems like they should have an in-person wait list at the end of the day to distribute them.  Don't think there would be time to start calling people.

My in-laws got their 2nd vaccine in Lubbock on Saturday.  The volunteers there said that if people show up at 4:00 on the days they have a clinic (this was at the civic center), then they will give them a vaccine if they have any leftover (and they usually do). 

It has to be a similar situation at the other hubs I would think.  It isn't like they have huge freezers out at these stadiums and civic centers.

I will note that I talked to someone with the UT program (through the UT Dell Medical school), and they are begging people to please NOT show up and hang out hoping for a dose, because UT actually has its shit together, is running its scheduling smoothly, and rarely has any leftover doses (and when they do, it's literally 3-4, and they have easily found people in the hospital/system to take them).

Other places, though...."show up and hope for leftovers" is a sound strategy.  There is no consistency even area-wide, much less statewide.

[dcar00 14154]

45 minutes ago, vicerous said:

 

Meanwhile APH can't get their head out of their ass - Is any other provider struggling to provide timely second shots? Unbelievable but not really. 

these people are idiots.  no surprise at all given who runs this show.

Edit: My guess is they have them but they are calling their "list".

Edited February 8, 2021 by dcar00

[Liquor and Poker 3659]

45 minutes ago, vicerous said:

Meanwhile APH can't get their head out of their ass - Is any other provider struggling to provide timely second shots? Unbelievable but not really. 

Some other places have that issue (I think back East), and there have been rumors about it for a while.  But I'm not aware of this actually being a problem anywhere else in Texas.

[smoky 840]

Little bit of a delay in the data, but APHs dashboard shows 8k first doses administered for the week ending 1/29/2021.

According to Texas dept of health distribution list, APH received 12k first doses for the same week.

Did 4k doses fall off a truck somewhere along the way?

[HookEm 2463]

30 minutes ago, Brisketexan said:

I will note that I talked to someone with the UT program (through the UT Dell Medical school), and they are begging people to please NOT show up and hang out hoping for a dose, because UT actually has its shit together, is running its scheduling smoothly, and rarely has any leftover doses (and when they do, it's literally 3-4, and they have easily found people in the hospital/system to take them).

Other places, though...."show up and hope for leftovers" is a sound strategy.  There is no consistency even area-wide, much less statewide.

I wonder if this is different if they are administering the doses at a hospital where they can just go two floors down and pull out another few vials from the freezer - vs. being at a high school stadium where they have to transport in vials from a location across the city and can't just put them back in once they are out.

[Neonmoon 38129]

APH is the biggest clusterfuck operation I’ve seen so far 

[Brisketexan 105072]

Just now, HookEm said:

I wonder if this is different if they are administering the doses at a hospital where they can just go two floors down and pull out another few vials from the freezer - vs. being at a high school stadium where they have to transport in vials from a location across the city and can't just put them back in once they are out.

I suspect that's part of it.  And, the hospital has a rotating supply of potential recipients for the 3-4 extras that might be left over occasionally, so they have no problem getting those shots into arms.

[gyroprotagonist 2592]

32 minutes ago, Brisketexan said:

I will note that I talked to someone with the UT program (through the UT Dell Medical school), and they are begging people to please NOT show up and hang out hoping for a dose, because UT actually has its shit together, is running its scheduling smoothly, and rarely has any leftover doses (and when they do, it's literally 3-4, and they have easily found people in the hospital/system to take them).

Other places, though...."show up and hope for leftovers" is a sound strategy.  There is no consistency even area-wide, much less statewide.

anecdotally finding a number and calling in to the shot center seems to work. my wife's parents and my parents were getting shut out on the vax online but called in were able to get appts when the websites were saying no dice.

[dcar00 14154]

6 minutes ago, smoky said:

Little bit of a delay in the data, but APHs dashboard shows 8k first doses administered for the week ending 1/29/2021.

According to Texas dept of health distribution list, APH received 12k first doses for the same week.

Did 4k doses fall off a truck somewhere along the way?

they are there and being prioritized.

[Bevo 13568]

1 hour ago, Heme Doc said:

Lots of confusion/concern out there about the AZ vaccine effectiveness against South African variant.  So I’ll try to help explain...

The AZ trial in question looked at healthy adults age 18-65 in South Africa.  AZ vaccine is super cheap ($3/dose) so it’s the one a lot of poor countries are betting on.  They designed the trial to show 60% effectiveness against getting symptomatic COVID.  They only enrolled 1789 participants and only had 42 cases of COVID in the trial (19 in vaccine and 23 in placebo).  So it was quite under powered to show what they wanted it to.  Of those 42 cases, all were mild.  Nobody needed the hospital or oxygen.  But that’s what you might expect in a younger healthier study population.  

So this was a small study but protection against SEVERE disease with AZ is unknown but probable.  J&J vaccine shows excellent protection (89%) against severe disease due to the SA variant.  

Thanks for reading.  

I will bill the surly fund for $1,000.  

 

 

I haven't seen the study so I can only go with what you posted. It looks like the vaccine and placebo were roughly equivalent. No one from either group had severe COVID while the number of non-severe cases were 19 in vaccine and 23 in placebo. Based on that info., it is hard to tell if different endpoints would have helped differentiate the vaccine from placebo.

[Armybrat 40822]

From what I had read on several sites about the spread between getting the two vaccinations, it was a 3-4 week interval.

At the FHS administered vax site today (Kelly Reeves football stadium on Parmer in Wilco) the volunteers said we would be emailed for the 2nd shot appointment in 28-42 days. Is that the new MO?

I got the Moderna vaccine.

 

[dcar00 14154]

6 minutes ago, Armybrat said:

From what I had read on several sites about the spread between getting the two vaccinations, it was a 3-4 week interval.

At the FHS administered vax site today (Kelly Reeves football stadium on Parmer in Wilco) the volunteers said we would be emailed for the 2nd shot appointment in 28-42 days. Is that the new MO?

I got the Moderna vaccine.

 

MOderna is 28. pfizer is 21.  most are saying if you get it within a few weeks of the 21st/28th day you should be fine.  Lets hope APH gets unfucked by then.

since you are FHS my guess is you will be fine.

[gsoda3 3247]

10 minutes ago, Armybrat said:

From what I had read on several sites about the spread between getting the two vaccinations, it was a 3-4 week interval.

At the FHS administered vax site today (Kelly Reeves football stadium on Parmer in Wilco) the volunteers said we would be emailed for the 2nd shot appointment in 28-42 days. Is that the new MO?

I got the Moderna vaccine.

 

FHS has been sending out emails within a week after first injection with designated 2nd shot appt times scheduled out appropriately according to when you got your first stick.  

[gmr548 16576]

these people are idiots.  no surprise at all given who runs this show.
Edit: My guess is they have them but they are calling their "list".

So, just to be clear, these people are incompetent as fuck and can’t do anything right, totally fucked up the prioritization thing and publicly backed off, but are managing to go beyond simply prioritizing and are actively rerouting vaccine doses that would be second shots? And doing so without any sort of evidence or leaks or whatever?

That’s a take.