#towfic

[babedur]

Well, between "ADA gets a human body for some reason," "Maisie's mom time travels to the future somehow," and "Alex Hawthorne just shows up one day on the Unreliable," the last one won the fight for my brain today.

We’ll see who wins tomorrow.

--

Alex only hit the button because it was his only option, and braced himself. The scientists outside were yelling- at him, at each other, at the guards. The guards were yelling at him, too, and the scientists, and probably at each other, too, just to cap it off, except it was getting harder to hear over the whir of the machine he’d trapped himself inside.

If he lived, this was the last scientist job he was taking. No more scientists and corporate espionage. Smuggling and scavenging exclusively. Though he was certain to break this promise to himself, because, first of all, espionage tended to pay, and second of all, it was actually getting kind of difficult to hear himself, and everything was starting to tingle, and the tingling turned into needling, then piercing, and-

and he was in the dark, someplace a little cold and smelling a little bit like socks and the leftovers of a meal that involved hot saltuna, with a fine undercurrent of recycled ship air. 

Alex patted himself down. All his fingers seemed to be in order and he could only assume the same for his toes. It was an odd feeling, going from extreme pain to extreme… neutralness, in an instant. He had the feeling it would be coming back at any moment to hit him like a ton of bricks. Or maybe a ton of bullets. Where the hell was he?

The lights flicked on. He had a moment of relief- the Unreliable’s galley, what were the odds- before ADA’s voice rang through the entire ship: “ALERT! INTRUDER in the GALLEY. I repeat, INTRUDER in the-“

“ADA,” Alex hissed. “It’s me! Not sure how, if I’m being honest, but-“

One of the closed doors in the unused crews quarters slid open. A guy with sleep-tousled curly hair, one sock, and a blade slid out into the hallway. 

“What the fuck,” Alex said, lifting his pistol. “ADA, who the hell did you let onto my ship?”

“Hey!” the guy- the kid, really- barked. “How did you get onto our ship!”

“‘Our?’” Alex repeated. “This is the Unreliable. My ship, thank you.”

“I don’t understand,” ADA said, sounding lost. “I don’t- I don’t understand.”

Another door slid open. A short-haired woman aimed a bolter pistol right at his chest. “ADA,” she said, sounding half-asleep for all that her pistol hand didn’t waver as he switched his aim to her. “You falling asleep at the wheel? How the hell did we get two days away from Scylla and no one noticed we had a stowaway?”

“I don’t think that’s what happened,” ADA said.

“Damn right,” Alex muttered, and a third and fourth door opened- just how many people were here? Last time the Unreliable had had more than one person, it had just been him and Lucky, and even that had been too many people. ADA had complained for weeks about the intrusion. As it was, he was now being held at gunpoint in his own galley by four different strangers in various stages of asleep and unclothed, and most of them looked like they meant business.

“Drop the gun,” the woman with pink hair who apparently slept with a fucking axe said. She tried to circle around behind him.

“Since you asked so nicely, I’ll consider it,” Alex said, backing up to keep her in his sights. It wouldn’t last forever. 

The redhead cocked her bolter and lowered her aim to his legs. “Don’t worry,” she said cheerfully, “I’m pretty sure I can patch up most of what we’ll do to you if that gun doesn’t hit the gun right now.”

Alex compromised. He put the gun on the table. The woman with pink hair immediately circled the table completely and started frisking him, finding his backup pistol and belt knife, then his boot knife. “Buy me dinner, first.”

“Is the captain awake?” A young woman with a big hammer asked.

ADA hesitated for a full two seconds. That was a long damn time, for an astrogator with ADA’s processing power. “Maisie is coming. Please standby.”

Okay. Okay. Current theory: ADA had been hacked while he was gone. 

“ADA,” Alex said quietly, even as the redhead raised her gun in warning. “Do you recognize me?”

“Of course I do,” ADA said, her voice completely flat. “You’re Alex Hawthorne. But I don’t- I don’t understand. You’re dead.”

“Obviously not,” the woman with pink hair said. “You sure it’s him, ADA? You haven’t been hacked, somehow?”

“That’s my line,” Alex snapped. “Why else would ADA let anyone else onto my ship?”

Two more people- that made six, now- approached. He knew, with a sinking feeling of dread and violation, that they’d come from the captain’s quarters. The man was older, built like a tossballer and idly carrying a deadly-looking shotgun somewhat at odds with his pyjamas and slippers. The woman was older, too, with an eyepatch covering what looked like some real damage on her left eye, and acid scarring on her right cheek. Her remaining eye looked him over. 

“Alright,” she said. “I’ve got a lot of questions.”

“You?” Alex snapped, kicking away the woman who was currently relieving him of his gunbelt. She just unceremoniously shoved him into one of the couches while the rest of the intruders formed a semi-circle. “You have questions? I’ve got a fucking question, lady, who died and made you captain of my ship?”

“You did, I think,” she said mildly. “Quick question, what day do you think it is?”

“Thursday, probably.”

Her mouth pulled in what could have been either amusement or exasperation. “What month and year.”

“March 3rd,” Alex said. 

“And the year? 2355?”

“Of course. What other year would it be?”

“The current day,” the woman said, “is February 8th, 2356. I’ve been captain of the Unreliable for almost a year, in May, since her previous captain, Alex Hawthorne, died in the Emerald Vale by standing too close to an escape pod’s landing beacon.”

Alex blinked. And snorted. “Nice one,” he said. 

“No,” ADA said. “She isn’t lying to you. That… happened.”

“It’s not possible. I was just…” he frowned. “Hey, ADA, did I get paid for the Cedar Springs job?”

“No,” ADA said. “As I recall, shortly after landing you decided that it was too risky and that your contact was, I quote, ‘a flaky son of a rungleech who didn’t have enough bits to make me piss on a sleeping UDL recruit, let alone storm an entire compound of them.’” (The young fellow barked a laugh.)

“That sounds like me,” Alex admitted. “But that isn’t what happened. I took the job. Got trapped inside. There was some big…” he gestured, outlining the platform inside the huge science-y cage thing. He received blank stares in return. “…science thing, and I pushed the button, figuring it would distract them.”

“And then…?” the captain- ugh, no, the woman- prodded.

“And then I was here, being threatened and robbed on my own ship.”

“Not quite time travel,” the woman mused, leaning comfortably on the back of one of the chairs. “Alternate universes?”

“That’s fairly far-fetched,” the older man said. “But if any company would try to research and monetize it, it would be UDL. Or, some clever hacker has convinced ADA that he matches the description of her deceased captain, and given her a fake memory or two to match.”

“Fuck you,” Alex snapped. “I put so much work into this ship I may as well have built her from scratch. You see that panel?” he pointed. Only the young woman and the guy actually looked, but that was beside the point. “I spent four hours behind it, wiring the cameras so ADA could see the table.”

“I could tell you had some trouble,” the young woman piped up. “Everything back there was covered in shrink wrap, like you’d had to strip back so far on the wire you needed to add more. A lot more.” Under his stare, she flushed. “I mean, uh, you got the job done, obviously, it’s just…”

“Great,” Alex muttered. “You stole my ship, suborned my astrogator, and now you’re insulting my engineering.”

“Let’s say we believe you’re Alex Hawthorne,” their leader said. “What happens now?”

“You put down your guns and kindly escort yourselves to the airlock?” Alex said hopefully. 

The other captain shook her head. Behind her, her crew bristled. 

“Worth a shot. Well, you’re the ones with the guns, you got any ideas on what to do with me?”

“You mentioned the airlock,” the redhead said thoughtfully.

“Absolutely not,” ADA said, calm voice at odds with the sudden increase in volume from her speakers throughout the ship. 

“Message received,” the redhead said. “No spacing the ex-captain.”

“Ex-captain,” Alex repeated with disgust. “Current captain, thanks.”

“Do you have your ID cart?” the older man asked, which was the important question.

“Not on me,” Alex lied, and the other captain looked to the table. There it was, sitting on top of the things the pink-haired woman had filched from him, the ID cart designating him as the captain of the Unreliable. “Oh, that’s a fake.”

“I’ll just be taking that anyway,” she said, and there went one of his options for regaining control of ADA, right into her jacket pocket. The others would take more finesse and time, both of which were fragile things where you were a prisoner. “We’re currently on a job, but once we’re done with that, it seems we’re going to Cedar Springs. Any objections?”

“Who’s going to pay us for that?” the pink-haired woman asked.

“I’m sure we can find something Gladys will be interested in,” their leader said. “Or Phineas.” And that was something, that she was on first-name basis with Dr. Welles. “We’ll be solidly in the black once we collect on this one, anyhow.” 

“What, after all this you’re just going to do me a good turn?” Alex said, as the crew read something in their leader’s body language which made them start to relax a little. 

“Well, that’s part of it,” she said. “I know what it’s like, to wake up in a place you don’t really belong. On top of that, I’ve never met a horrific science facility that didn’t end up profiting me somehow. And, most importantly-“ she patted the pocket with his ID cart in it. “-in some other world, there’s a ship that needs a captain. I aim to return him to her.”

[stephenmccull]

To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA to Relax Vaccine Handling Advice

President Joe Biden has promised enough covid vaccine to immunize every willing adult by June 1. But right now, the gap between supply and demand is so dramatic that vaccinators are discovering ways to suck the final drops out of each vaccine vial — if federal regulators will let them.

This story also ran on Los Angeles Times. It can be republished for free.

Pharmacists involved in the covid vaccination drive say it’s common to have half a dose left in a Pfizer vial after five or even six doses have been administered — and to have half a dose left after 10 doses have been drawn out of a Moderna vial. Combining two half-doses could increase vaccinations by thousands at a time when 2 million or so doses are being administered every day in the country.

So, they want to use a single hypodermic needle to withdraw leftover vaccine from two vials from which all full doses already have been removed. The American Society of Health-System Pharmacists asked the Food and Drug Administration consider granting permission to do so in a recent letter. The governors of Colorado and Oregon also have sought permission to allow their pharmacists to pool covid vaccine vials.

Federal health regulators, however, have long opposed the reuse of drug vials because of the risk of introducing a bacterial contaminant. From 1998 to 2014 more than 50 outbreaks of viral or bacterial disease were reported as a result of unsafe injection practices, including injecting multiple patients with a drug from the same vial.

The FDA wouldn’t comment on the pharmacists’ letter but restated to KHN its current policy that “doses not be pooled from different vaccine vials, especially for coronavirus vaccines, which are not formulated with a preservative.” On its website, the Centers for Disease Control and Prevention explicitly tells vaccinators to discard vials “when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials to obtain a dose.”

“It’s a recipe for disaster,” said Ann Marie Pettis, president of the Association for Professionals in Infection Control and Epidemiology. There is always a tiny chance that one of the two vials has previously been contaminated, which would contaminate a shot that combined their contents, she said. Spokespeople for both Moderna and Pfizer said excess portions of their vaccines must be discarded and never pooled. Johnson & Johnson had no comment on the issue.

Before the covid vaccination program, public health officials generally frowned on giving multiple patients doses of medicine from a single vial, unless it contained an antibacterial preservative. Most children’s vaccines, for example, have been shipped and stored in syringes or single-dose vials since 2001, when drug companies stopped using a preservative containing traces of mercury in some shots.

Rajesh Gupta, a biologics consultant who set up a sterility testing lab while serving at the FDA’s Center for Biologics Evaluation and Research from 2006 to 2013, sees little risk in the covid vaccination process, or even in using a single needle to combine vaccine from two vials.

The covid vaccines are being used so quickly after removal from cold storage that there’s no danger of contamination, he said. “I can say with some degree of confidence that it’s scientifically sound,” if vaccinators carefully wipe the rubber stopper atop the vial with disinfectant before each penetration with a syringe, he said.

While their plea for combining vial contents may fall on deaf ears at the FDA, pharmacists already are taking many other steps to maximize the yield of the mRNA vaccines, which have quite finicky shipment, handling and administration requirements.

Documents leaked through a cyberattack on the European drug regulatory agency suggest that Pfizer has had difficulty assuring the quality of the mRNA in its vaccine. The company said in a response that all the vaccine doses it has put on the market had been “double tested to ensure compliance” with regulatory specifications.

Michael Hogue, president of the American Pharmacists Association and dean of the Loma Linda University School of Pharmacy in California, runs a clinic at a university gymnasium that has been administering up to 10,000 vaccines each week since Jan. 28. It’s nowhere near as simple as administering flu shots at a pharmacy, he said.

“The planning and procedures for these mRNA vaccines [made by Pfizer-BioNTech and Moderna] require a tremendous amount of focus,” said Hogue. “You have to pay close attention to what’s going on in the moment.”

The Pfizer vaccine, which until recently was always stored in dry ice, is especially challenging. After Pfizer vials are removed from a freezer and thawed, saline solution is squirted into each vial. If the syringe preparer doesn’t withdraw air from the vial after adding the saline, vaccine will shoot out.

After adding the solution, “you take the vial between thumb and forefinger and make a rainbow sweeping motion 10 times gently to mix the liquids together,” Hogue said. Shaking the vaccine could render it ineffective.

Each Pfizer vaccination contains just a bead of liquid — about 1/16th of a teaspoon — and pharmacists must use tiny syringes in which air bubbles tend to form. But they can’t tap on the syringe to get the bubble out, because that, too, could damage the vaccine, Hogue said.

To get six doses out of the Pfizer vials requires a type of plunger that pushes the last trace of vaccine out of the syringe. But about 15% of the syringes the federal government has been shipping to Loma Linda have larger needles that leave a bit of vaccine in the syringe, making it impossible to extract all six doses, he said. So, Loma Linda has been purchasing its own syringes to replace the inadequate ones.

U.S. Pharmacopeia, a nonprofit agency that issues standards for use of medical products, issued an 11-page guide on how to store, handle and administer the covid vaccines. Among other things, it urges that vaccine sites set up clean rooms — separate from the areas where vaccines are being administered — to prepare the syringes, said Farah Towfic, CEO of operations for USP.

“That way we don’t have clients breathing on it,” not to mention the distraction of greeting old acquaintances who are bubbling over with enthusiasm about getting vaccinated, said Patricia Slattum, a retired Virginia Commonwealth University pharmacy school professor who has been volunteering at a mass vaccination site in Richmond, Virginia. “There’s a lot of love to go around in there.”

Another technique is to inject each needle into a different spot on the rubber vial stopper. If the syringe goes into the same location over and over, it can create a big hole that causes leakage. This tip is especially important now that Moderna is in talks with FDA to include up to 15 doses of vaccine in each vial, meaning 15 punctures of the stopper, noted Anna Legreid Dopp, director of clinical guidelines and quality improvement at the American Society of Health-System Pharmacists.

“To draw up the vaccine, you stick a needle through the rubber stopper, then turn the vial upside down,” said Slattum. “If you stick it in the same place, drops will leak down the needle. So there’s an art to not losing vaccine.”

Slattum hopes the FDA will consider allowing vaccinators to draw the leftover vaccine from two vials. “We who are doing this work all feel this pressure, that our doing it well is one of the ways we’re going to get out of this pandemic,” said Slattum. “You just don’t want to waste any vaccine!”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

USE OUR CONTENT

This story can be republished for free (details).

To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA to Relax Vaccine Handling Advice published first on https://smartdrinkingweb.weebly.com/

[gordonwilliamsweb]

To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA to Relax Vaccine Handling Advice

President Joe Biden has promised enough covid vaccine to immunize every willing adult by June 1. But right now, the gap between supply and demand is so dramatic that vaccinators are discovering ways to suck the final drops out of each vaccine vial — if federal regulators will let them.

This story also ran on Los Angeles Times. It can be republished for free.

Pharmacists involved in the covid vaccination drive say it’s common to have half a dose left in a Pfizer vial after five or even six doses have been administered — and to have half a dose left after 10 doses have been drawn out of a Moderna vial. Combining two half-doses could increase vaccinations by thousands at a time when 2 million or so doses are being administered every day in the country.

So, they want to use a single hypodermic needle to withdraw leftover vaccine from two vials from which all full doses already have been removed. The American Society of Health-System Pharmacists asked the Food and Drug Administration consider granting permission to do so in a recent letter. The governors of Colorado and Oregon also have sought permission to allow their pharmacists to pool covid vaccine vials.

Federal health regulators, however, have long opposed the reuse of drug vials because of the risk of introducing a bacterial contaminant. From 1998 to 2014 more than 50 outbreaks of viral or bacterial disease were reported as a result of unsafe injection practices, including injecting multiple patients with a drug from the same vial.

The FDA wouldn’t comment on the pharmacists’ letter but restated to KHN its current policy that “doses not be pooled from different vaccine vials, especially for coronavirus vaccines, which are not formulated with a preservative.” On its website, the Centers for Disease Control and Prevention explicitly tells vaccinators to discard vials “when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials to obtain a dose.”

“It’s a recipe for disaster,” said Ann Marie Pettis, president of the Association for Professionals in Infection Control and Epidemiology. There is always a tiny chance that one of the two vials has previously been contaminated, which would contaminate a shot that combined their contents, she said. Spokespeople for both Moderna and Pfizer said excess portions of their vaccines must be discarded and never pooled. Johnson & Johnson had no comment on the issue.

Before the covid vaccination program, public health officials generally frowned on giving multiple patients doses of medicine from a single vial, unless it contained an antibacterial preservative. Most children’s vaccines, for example, have been shipped and stored in syringes or single-dose vials since 2001, when drug companies stopped using a preservative containing traces of mercury in some shots.

Rajesh Gupta, a biologics consultant who set up a sterility testing lab while serving at the FDA’s Center for Biologics Evaluation and Research from 2006 to 2013, sees little risk in the covid vaccination process, or even in using a single needle to combine vaccine from two vials.

The covid vaccines are being used so quickly after removal from cold storage that there’s no danger of contamination, he said. “I can say with some degree of confidence that it’s scientifically sound,” if vaccinators carefully wipe the rubber stopper atop the vial with disinfectant before each penetration with a syringe, he said.

While their plea for combining vial contents may fall on deaf ears at the FDA, pharmacists already are taking many other steps to maximize the yield of the mRNA vaccines, which have quite finicky shipment, handling and administration requirements.

Documents leaked through a cyberattack on the European drug regulatory agency suggest that Pfizer has had difficulty assuring the quality of the mRNA in its vaccine. The company said in a response that all the vaccine doses it has put on the market had been “double tested to ensure compliance” with regulatory specifications.

Michael Hogue, president of the American Pharmacists Association and dean of the Loma Linda University School of Pharmacy in California, runs a clinic at a university gymnasium that has been administering up to 10,000 vaccines each week since Jan. 28. It’s nowhere near as simple as administering flu shots at a pharmacy, he said.

“The planning and procedures for these mRNA vaccines [made by Pfizer-BioNTech and Moderna] require a tremendous amount of focus,” said Hogue. “You have to pay close attention to what’s going on in the moment.”

The Pfizer vaccine, which until recently was always stored in dry ice, is especially challenging. After Pfizer vials are removed from a freezer and thawed, saline solution is squirted into each vial. If the syringe preparer doesn’t withdraw air from the vial after adding the saline, vaccine will shoot out.

After adding the solution, “you take the vial between thumb and forefinger and make a rainbow sweeping motion 10 times gently to mix the liquids together,” Hogue said. Shaking the vaccine could render it ineffective.

Each Pfizer vaccination contains just a bead of liquid — about 1/16th of a teaspoon — and pharmacists must use tiny syringes in which air bubbles tend to form. But they can’t tap on the syringe to get the bubble out, because that, too, could damage the vaccine, Hogue said.

To get six doses out of the Pfizer vials requires a type of plunger that pushes the last trace of vaccine out of the syringe. But about 15% of the syringes the federal government has been shipping to Loma Linda have larger needles that leave a bit of vaccine in the syringe, making it impossible to extract all six doses, he said. So, Loma Linda has been purchasing its own syringes to replace the inadequate ones.

U.S. Pharmacopeia, a nonprofit agency that issues standards for use of medical products, issued an 11-page guide on how to store, handle and administer the covid vaccines. Among other things, it urges that vaccine sites set up clean rooms — separate from the areas where vaccines are being administered — to prepare the syringes, said Farah Towfic, CEO of operations for USP.

“That way we don’t have clients breathing on it,” not to mention the distraction of greeting old acquaintances who are bubbling over with enthusiasm about getting vaccinated, said Patricia Slattum, a retired Virginia Commonwealth University pharmacy school professor who has been volunteering at a mass vaccination site in Richmond, Virginia. “There’s a lot of love to go around in there.”

Another technique is to inject each needle into a different spot on the rubber vial stopper. If the syringe goes into the same location over and over, it can create a big hole that causes leakage. This tip is especially important now that Moderna is in talks with FDA to include up to 15 doses of vaccine in each vial, meaning 15 punctures of the stopper, noted Anna Legreid Dopp, director of clinical guidelines and quality improvement at the American Society of Health-System Pharmacists.

“To draw up the vaccine, you stick a needle through the rubber stopper, then turn the vial upside down,” said Slattum. “If you stick it in the same place, drops will leak down the needle. So there’s an art to not losing vaccine.”

Slattum hopes the FDA will consider allowing vaccinators to draw the leftover vaccine from two vials. “We who are doing this work all feel this pressure, that our doing it well is one of the ways we’re going to get out of this pandemic,” said Slattum. “You just don’t want to waste any vaccine!”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

USE OUR CONTENT

This story can be republished for free (details).

To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA to Relax Vaccine Handling Advice published first on https://nootropicspowdersupplier.tumblr.com/

[dynamitecomics]

Tweeted

Here's my favorite Vampirella painting by Boris Vallejo. pic.twitter.com/G5ozB8NC18

— Towfic Kassis (@TowficMagus) October 1, 2019