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  • COVID-19 vaccine discussion


    Texas Jeff

    I thought it might be helpful to have a separate topic related to the vaccine.  If this is too much duplication, mods please delete this thread.  I thought it would be good to talk about who can get the vaccine, where they can get it, what side effects people are seeing, and in general what is going on with distribution.

    The CDC has published vaccine distribution guidelines, and if you care, they are worth reading.  They are dividing the timeline into:

    • Phase 1 - Potentially limited supply of COVID-19 vaccine doses available
    • Phase 2 - Large number of vaccine doses available
    • Phase 3 - Sufficient supply of vaccine doses for entire population

    Who you are will determine if you are eligible for a vaccine in the various phases.

    Phase 1 is divided into a Phase 1a and a Phase 1b:

    • Phase 1a - Mostly healthcare workers
    • Phase 1b - Other essential workers, people with higher risks, people over 65

    If you are eligible to get the vaccine and they have in in stock and you want to get it, it is important to go get it.  Both of the first two vaccines can spoil, so if a dose is sitting there and you aren't there to get it, they might have to throw it away.

    Both vaccines require two shots.  It is important to go get that second shot.

    Who fits in phase 1b and who has to wait until phase 2 might be a sticking point.  The "people in higher risks" category includes a lot of folks, maybe more than you would think might be in that category.  Hopefully we can quickly get to phase 2 so that we don't spend too long arguing about who is or is not in Phase 1b.

    Anyway, I'm interested in everyone's experience with the vaccine and especially getting the word out for those that can go get it, so that every dose ends up in an arm rather than in the trash.

     

     


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    20 minutes ago, Anastasis said:

    The data are pretty promising, even moreso the data on severe disease prevention. Roll it out, and hope for the best on the longer term safety data imo. Bells palsy appears to be a low frequency issue to track.  Gonna be interesting to see what happens as you scale from 10s of thousands to millions. 

    Why the hell would someone get inflammation of a single cranial nerve from a vaccine against the spike protein of coronavirus?

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    2 minutes ago, Bevo said:

    Why the hell would someone get inflammation of a single cranial nerve from a vaccine against the spike protein of coronavirus?

    The incidence of Bell’s palsy was about on par with the population in general that was not in the trial. It just so happened that the people receiving placebo didn’t have any incidental cases.

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    1 minute ago, Newdoc said:

    The incidence of Bell’s palsy was about on par with the population in general that was not in the trial. It just so happened that the people receiving placebo didn’t have any incidental cases.

    Thanks. I figured it was just some noise in the data.

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    It’s an extremely small number of cases but represents a numerical imbalance and an issue to track. Nothing to get nuclear about but it should be on the surveillance list as we scale exposure. 

    Edited by Anastasis
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    Bell's Palsy is also temporary and usually goes away in a few months.  My dad had it a few years ago and it wasn't too big of a deal.

    Edited by kevwun
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    Question that I’m not going to bother looking up thread for an answer to: if I have had COVID, could I reasonably expect not to have the vaccine side effects being discussed? Not that I won’t get the vaccine, but after having it (albeit a thankfully mild case) the idea of having  another day being knocked on my ass sucks.

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    This headline cracked me up. 

    I’m not saying this should or would play a role in anybody’s decision making, but it is funny that this is one time a giant Pharma CEO doesn’t want to cut in front of the plebs. 

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    Most of this is mentioned piecemeal throughout this thread but thought this is a helpful, concise thing about kids and the vaccine protocol:  

    Is the COVID-19 vaccine approved for children right now?

    No. The Pfizer vaccine has been approved for ages 16 and up. The FDA advisory committee meeting expressed some concern about the limited data on 16 and 17 year olds in the initial study, but ultimately felt that the benefit to teens with health issues in that age group was greater than the potential risk. Pfizer has enrolled children down to age 12 in ongoing studies, and Moderna and Janssen plan to enroll children ages 12 and up as well. Astra Zeneca plans to enroll children ages 5-12 in the UK but none are included in the US study thus far. Younger children will likely be included in these studies over the coming months.

     

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    Thanks for that. We had “loosely” agreed that we would not get our son vaccinated as he is extremely low risk. We aren’t anti-vax by any stretch, but we also don’t want to have our son get anything that isn’t completely necessary.

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    It's from our pediatrician's newsletter to us.  My wife trusts her because she was a department head at Harvard's pediatric teaching hospital.  

    I trust her because she looks a lot like the adult film star, Danica Dillan.  Like, a lot.  

    What the fuck were we just talking about?  

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    32 minutes ago, GreenspointTexas said:

    Is there any other info on this?  This just shows scheduling an appointment but doesn't specify it's for the vaccine.

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    1 minute ago, htown85 said:

    Is there any other info on this?  This just shows scheduling an appointment but doesn't specify it's for the vaccine.

    Minimize your window and look at title bar. Its for the vaccine

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    15 hours ago, midtown said:

    Truth but a lot of bad decisions don't spread to others per say. But I'll drop it because it's a discussion on vaccines.

    People who write "per say" instead of "per se."

    Oh wait, wrong thread, belongs in "Trivial things that make you surly."

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    1 hour ago, GreenspointTexas said:

    Methodist basically giving the vaccine to anyone that wants one. They have to use their thawed shots by Friday and dont have enough people to give it to... lol

    Oh good. The Pfizer execs should fly down and get their shots. 

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    Well shit.

    NY Times reporting Alaska Health Worker Had a Serious Allergic Reaction After Pfizer’s Vaccine

    Quote

    It’s unclear whether the person had a history of severe allergies. Two similar reactions happened last week in Britain.

    By Noah Weiland, Sharon LaFraniere and Katie Thomas

    Dec. 16, 2020, 12:20 p.m. ET
    WASHINGTON — A health worker in Alaska had a serious allergic reaction after getting Pfizer’s coronavirus vaccine on Tuesday and was hospitalized, according to three people familiar with official reports of the person’s health. The person is in stable condition.

    Government officials were scrambling on Wednesday to learn more about the case. It was not immediately clear if the worker had a history of allergies, which makes it difficult to assess the broader significance of the incident as millions of Americans are vaccinated over the coming weeks. The reaction was believed to be similar to the anaphylactic reactions two health workers in Britain experienced after receiving the Pfizer-BioNTech vaccine last week. Both of them recovered.

    The company’s trial in the United States involving more than 40,000 people did not find any serious adverse events caused by the vaccine, although many participants did experience aches, fevers and other side effects. Severe allergic reactions to vaccines are typically linked to the vaccine because of their timing.

    A Pfizer representative did not immediately comment on the case.

    After the workers in Britain fell ill, British authorities initially warned against giving the vaccines to anyone with a history of severe allergic reactions, but then clarified their concerns, changing the wording from “severe allergic reactions” to specify that the vaccine should not be given to anyone who has ever had an anaphylactic reaction to a food, medicine or vaccine. That type of reaction to a vaccine is “very rare,” they said.

    Pfizer officials have said the two British people who had the reaction had a history of severe allergies. One, a 49-year-old woman, had a history of egg allergies. The other, a 40-year-old woman, had a history of allergies to several different medications. Both carried EpiPen-like devices to inject themselves with epinephrine in case of such a reaction.

    Pfizer has said that its vaccine does not contain egg ingredients.

    The British update also said that a third patient had a “possible allergic reaction,” but did not describe it.

    In the United States, federal regulators issued a broad authorization for the vaccine on Friday to adults 16 years and older. Health care providers were warned not to give the vaccine to anyone with a “known history of a severe allergic reaction” to any component of the vaccine, which they said was a standard warning for vaccines.

    But because of the British cases, F.D.A. officials have said they would require Pfizer to increase its monitoring for anaphylaxis and submit data on it once the vaccine comes into use. Pfizer also said that the vaccine is recommended to be administered in settings that have access to equipment to manage anaphylaxis. Last weekend, the Centers for Disease Control and Prevention said that people with serious allergies can be safely vaccinated, with close monitoring for 30 minutes after receiving the shot.

    Anaphylaxis can be life-threatening, with impaired breathing and drops in blood pressure that usually occur within minutes or even seconds after exposure to a food or medicine, or even a substance like latex to which the person is allergic.

    Might be prudent for vaccinations to occur only where facility is able to treat anaphylaxis on site and for people with history of allergies to require monitoring for a period of time (like 30 minutes to an hour) before leaving.

    Edited by DDD Dad
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    31 minutes ago, DDD Dad said:

    Might be prudent for vaccinations to occur only where facility is able to treat anaphylaxis on site and for people with history of allergies to require monitoring for a period of time (like 30 minutes to an hour) before leaving.

    I have a client who is a director at Texas Tech's HSC School of Nursing.  She is also a nurse practitioner.   She has allergies and carries an epipen.  She is getting her vaccination this week and is required to stay for at least 30 mins and will have her pen with her.   Agreed that would be a good policy for all.

    Edited by midtown
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    How do you go about scheduling your second shot through that since this could be a onetime deal?  I signed  myself and the wife up just in case, but gonna need more info before we actually show up for it.

    Edited by kevwun
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    Looks like some hospital pharmacists figured out that PFE is overfilling the multidose vials sufficient that they can stretch 6 doses out per vial, not 5 as labeled. Given concerns about packaging potentially changing over time and second dose pacing considerations, the extra injection was initially being wasted by some sites.  Others have started using the extra dose.  Fuck that shit, don't throw any away. Stick it in someone's arm. 

    https://www.statnews.com/2020/12/16/labeling-confusion-led-to-wasted-doses-of-pfizer-covid-19-vaccine-in-first-days-of-rollout/

    Quote

     

    With the Covid-19 vaccine in short supply, hospital pharmacists found themselves in the unexpected position of throwing away one in every six doses of the first Pfizer-BioNTech vaccines distributed this week in the United States.

    The confusion came over labeling: The vaccine comes in vials labeled as containing enough for five doses. But pharmacists discovered that, after thawing and mixing the contents with a dilutent, each vial contained enough vaccine for six doses. Without explicit approval from the manufacturer, that final dose had to be discarded.

    “It was overtly clear early on there’s some extra volume,” said Russell Findlay, pharmacy manager at University of Utah Health. His colleagues called Pfizer on Tuesday to ask if they could use the extra dose, said Findlay, but the company wouldn’t give a definitive answer.

    Pharmacists and executives at several health care systems said they didn’t feel they could risk using the extra dose, especially as Pfizer’s vaccine requires two doses, 21 days apart, to be effective. “We’re not fully confident of our future supply. Let’s say we use the six but we get fewer doses in the future, we might not have enough for the second dose,” said Findlay. “We need to be very cautious in managing that supply.”

    Across the country in Boston, Paul Biddinger, medical director for emergency preparedness at Mass General Brigham, said he’d heard of the extra doses from the British vaccine rollout earlier this month. Despite being prepared, his team still had to throw out the additional doses on the first day of distribution.

    In Texas, the extra doses were discarded on the first day of distribution but, by Wednesday morning, Houston Methodist Hospital chief executive Roberta Schwartz said her team heard from Pfizer that it was okay to use what’s in the vial.

    Finally, on Wednesday afternoon, the U.S. Food and Drug Administration updated its guidance, saying health care providers should feel free to use all the full doses within each vial. “At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue,” spokesperson Abigail Capobianco wrote in an email to STAT. But any spare half doses should not be combined with half doses from other vials to create a whole one, she added.

    But Pfizer was less definitive. Each vial contains enough vaccine for at least five doses, spokesperson Sharon Castillo said in an email to STAT, and each dose must contain 0.3ml. “The amount of vaccine remaining in the multidose vial after removal of 5 doses can vary, depending on the type of needles and syringes used,” she wrote.  ”At this time, we cannot provide a recommendation on the use of the remaining amount of vaccine from each vial. Vaccinators need to consult their institution’s policies for the use of multidose vials.”

    If the dosing confusion was raised in the U.K., the FDA and Pfizer ideally should have issued clearer instructions about using the extra dose before distribution began this week in the U.S., said John Grabenstein, adviser to the American Pharmacists Association. “In a situation of limited supply, any waste is unfortunate.”

    But all injectable medicines have overfill, he said, and the first stages of clinical practice normally raise small issues. “There’s a thousand matters to address in the first week. This one might only now rise to the level of getting checked out,” he said.

    It makes sense to have some left-over liquid in a vial, said Findlay. Slight variations in the syringes used by different health systems could have small effects on the size of each dose, and changes in air pressure at different altitudes could also affect the volume of vaccine in a vial.

    Even with the confusion over dosing, the first day of administering vaccines was a success, he said: “Yesterday was the best day of work I’ve ever had.”

     

     

    Edited by Anastasis
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    21 hours ago, Newdoc said:

    The incidence of Bell’s palsy was about on par with the population in general that was not in the trial. It just so happened that the people receiving placebo didn’t have any incidental cases.

    Fuck that Sooner Blake Bell and his damn palsy!

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    15 minute waiting area after getting the vaccine, and then once no immediate concerns, could leave

    Able to sign up for 2nd dose appointment before leaving. Should occur on or before the 6th of Jan, so 21 days. They asked to make sure you can make the 2nd appointment before giving the 1st dose.

     

    Edited by naija
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    12 minutes ago, naija said:

    15 minute waiting area after getting the vaccine, and then once no immediate concerns, could leave

    Able to sign up for 2nd dose appointment before leaving. Should occur on or before the 6th of June, so 21 days. They asked to make sure you can make the 2nd appointment before giving the 1st dose.

     

    Was this through Methodist?

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    14 minutes ago, naija said:

    15 minute waiting area after getting the vaccine, and then once no immediate concerns, could leave

    Able to sign up for 2nd dose appointment before leaving. Should occur on or before the 6th of June, so 21 days. They asked to make sure you can make the 2nd appointment before giving the 1st dose.

     

    21 days from now is the 6th of June?

    jan 6 typo?

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    1 minute ago, Bevo in VA said:

    Was this through Methodist?

    No. I'm not currently in Texas. Just posting my experience. Does Methodist use Epic? Scheduling of appointments/tests etc has been made much easier with mobile platforms.

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    Just now, Bevo in VA said:

    Ah - got it.  Was just wondering if anyone had signed up through the link above.  They have appointments for weeks out.  Just seems strange they are offering this to anyone.

    I am pretty sure if a rando from surly off the street shows up you ain't getting a shot. 

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    Buddy just approved for fema duty and is at the Sheraton in downtown Dallas. Been there 3 days and haven't got word on a vaccine but got told at 6pm he is going to brownwood tomorrow. Brownwood/Early sucks was the only advice I could him, but he did say he was getting paid about 9k for 10 days

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    Someone trustworthy needs to set up a rumor control hub. A direct feed needs to go to healthcare workers who have direct contact with patients. 

    Pharma/JD has such a defensive posture, one can't see the forest for the trees.

    Thanks for keeping the info factual on this thread. 

    Hook 'em.

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