Coronavirus

[mtrycrafts]

... feels like the Flu vaccine shots.

That's what you got.

 

[Mr._Clark]

The panel of advisers to the FDA recommended that the Moderna COVID-19 vaccine be authorized for emergency use in adults during the pandemic. The vote was 20-0 with 1 abstention.

FDA Panel Recommends Moderna's COVID-19 Vaccine For Emergency Use

Advisers to the Food and Drug Administration voted 20-0 to recommend that the agency authorize Moderna's vaccine for emergency use during the pandemic. There was a single abstention.

www.npr.org

With (hopefully) greater availability of vaccine doses from 2 sources, we won't have to wait until mid March before the general population can get vaccinated.

View attachment 42740

This is great news!

I'm hoping Moderna is able to deliver. They are apparently relying on contract manufacturing companies to make the ingredients and fill the vials.

>>>Catalent is probably the biggest drugmaker you've never heard of. . . . The [company] is working with Moderna on filling vials with the vaccine and preparing them for distribution. . . . Catalent is processing 500,000 doses per day, but the factory is hoping to ramp up to a million doses a day to fulfill its contractual obligations and deliver 100 million doses by the end of March . . .
Catalent is filling vials and getting them ready to send around the country, but other facilities are responsible for making the mRNA, the key substance at the heart of the vaccine, that Catalent puts in those vials.

Another well-known contract manufacturing company, Lonza, told investors in October that it is working with Moderna to make its coronavirus vaccine drug substance. Lonza is using two sites: one in Portsmouth, N.H., and another in Visp, Switzerland, and was aiming to complete the first batches by late October and early November, respectively.<<<

How Will Moderna Meet The Demand For Its COVID-19 Vaccine?

Despite being founded a decade ago, Moderna has never had a product make it to market. And the company registered its first factory with the Food and Drug Administration just this week.

www.npr.org

 

[GO-NAD!]

My Indian friends are saying the infection and death rates are at least 10X of what is reported. They are very worried about their families in Mumbai Delhi and elsewhere.

That would be horrible.

 

[AcuDefTechGuy]

That's what you got.

Well, maybe the COVID-19 vaccine does hurt a bit more. I noticed they used cotton balls + bandaid, instead of just plain bandaid.

 

[Mr._Clark]

More annoying news:

>>>Officials in several states have said the federal government told them to expect fewer doses of Pfizer's COVID-19 vaccine next week than originally anticipated.<<<

Meanwhile, Pfizer is sitting on millions of doses waiting for instructions:

>>>Pfizer said in a statement Wednesday that it has millions of doses "sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses."<<<

States say federal government cutting COVID-19 vaccine allocations

"This is disruptive and frustrating," Washington Gov. Jay Inslee said.

www.axios.com

I'm wondering if there are not enough shipping containers and temperature monitoring systems:

>>>Pfizer decision to turn off temperature sensors forced scramble to ensure Covid-19 vaccines kept ultra-cold

. . . At issue was how to monitor the temperature of the ultra-cold storage containers being used to distribute vials of the vaccine developed by Pfizer and its partner BioNTech. Pfizer, the officials told STAT, planned to disconnect temperature-monitoring sensors on the containers once they were delivered to health care providers — though many of the providers needed to use the boxes to store the vials for up to 30 days.<<<

Pfizer decision to turn off temperature sensors forced scramble to ensure Covid-19 vaccines kept ultra-cold

A last-minute snafu this fall threatened to disrupt the smooth rollout of the Pfizer-BioNTech Covid-19 vaccine, the first approved in the United States.

www.statnews.com

 

[highfigh]

Hope you knocked on some wood after that...

Pfft! That doesn't work. I like to swing a dead cat around my head during a full moon and whistle 'I Put A Spell On You'.

 

[highfigh]

We've been over this - there may be some correlation between population density and COVID cases, but only a little. In New Zealand's case, they brought in tough restrictions right from the get-go and they are on isolated islands, which helps control their borders.

Population Density - COVID-19 Cases (Total) - As Percentage of Population
New Zealand - 19 people/km^2 - 2,100 - 0.04%
Canada - 4 - 485,000 - 1.3
Russia - 9 - 2.7 million - 1.8
China - 146 - 94,500 - 0.007
USA - 34 - 16.7 million - 5.0
India - 411 - 9.9 million - 0.7
S. Korea - 516 - 45,400 - 0.09

I'm not seeing a pattern between population density and case numbers. I don't know how reliable China's or India's numbers are - China, because of their penchant for secrecy and India, because of health services infrastructure. Regardless, if they had numbers anywhere close to those of the US, as a percentage of population, there would be no way to cover them up.

The keys to keeping case numbers down:
- Strong, smart health measures, right from the start
- Strict border controls
- Public buy-in

But the people who refuse to isolate, at least to some degree, are spreading this. In higher density areas, there are more spreaders and more targets in close proximity. On its own, high density isn't a problem.

 

[highfigh]

This is disappointing:

>>>The majority of the doses of COVID-19 antibody drugs sent to states have not been used, Moncef Slaoui, head of Operation Warp Speed, the US government’s coronavirus vaccine effort, told CNBC. Around 65,000 doses of the drugs, which can help protect people at high risk of severe COVID-19 from developing serious cases of the disease, go out each week. Only 5 to 20 percent end up going to patients.<<<

Most doses of a COVID-19 treatment are going unused

Less than a quarter go to patients.

www.theverge.com

A local news channel put a video on YouTube stating that some of the vaccine is left over after administering it. Why, are they shorting the dose, or is the vial filled past the needed amount?

 

[GO-NAD!]

But the people who refuse to isolate, at least to some degree, are spreading this. In higher density areas, there are more spreaders and more targets in close proximity. On its own, high density isn't a problem.

Well, that's it, isn't it? People refusing to isolate, reduce social contact, maintain social distance, wear a mask, etc. In Hong Kong, with a population density of 6,800 people/km^2 - practically stacked like cordwood - and a population 7,500,000, they've managed to keep case numbers down to 7,900.

Just to be clear, I'm not picking on the US. While Canada may be doing better, we don't have anything to brag about. Well, the Atlantic provinces do...

 

[highfigh]

Well, that's it, isn't it? People refusing to isolate, reduce social contact, maintain social distance, wear a mask, etc. In Hong Kong, with a population density of 6,800 people/km^2 - practically stacked like cordwood - and a population 7,500,000, they've managed to keep case numbers down to 7,900.

Just to be clear, I'm not picking on the US. While Canada may be doing better, we don't have anything to brag about. Well, the Atlantic provinces do...

I don't buy China's stats for a minute.

Go ahead and pick on the US- plenty of reasons to do that.

 

[Mr._Clark]

A local news channel put a video on YouTube stating that some of the vaccine is left over after administering it. Why, are they shorting the dose, or is the vial filled past the needed amount?

As I understand it, the vials are intentionally overfilled somewhat to account for variations in the fill amount and because a little more than the correct dose is initially drawn with a syringe, and the extra is then pushed out of the needle to get the exact dose. In some cases the vials were overfilled enough to permit an additional dose to be drawn.

 

[GO-NAD!]

I don't buy China's stats for a minute.

Go ahead and pick on the US- plenty of reasons to do that.

I'm not sure if China controls Hong Kong's public health authority...yet. But, I certainly regard any "official" info from Beijing with some skepticism.

 

[Mr._Clark]

Here's an opinion piece to the effect that we should start single-dose trials to see if a single vaccination shot is effective. It seems like it's worth a try.

I've also wondered if somewhat lower doses might be effective. It's unclear to me how the doses for the original trials were determined.

>>>If we start examining the effectiveness of a single dose now, and if we find that the data warrants it, we can go forward with it as quickly as possible. The possibility of adding hundreds of millions to those who can be vaccinated immediately in the coming year is not something to be dismissed.<<<

Opinion | Can We Do Twice as Many Vaccinations as We Thought? (Published 2020)

Data suggests significant protection even without a second shot. If studies prove that’s true, it could be a game changer.

www.nytimes.com

 

[panteragstk]

https://www.watoday.com.au/world/south-america/brazilian-supreme-court-rules-against-covid-anti-vaxxers-20201218-p56ooe.html

Dang, Brazil isn't messing around.

 

[Trell]

As I understand it, the vials are intentionally overfilled somewhat to account for variations in the fill amount and because a little more than the correct dose is initially drawn with a syringe, and the extra is then pushed out of the needle to get the exact dose. In some cases the vials were overfilled enough to permit an additional dose to be drawn.

Sounds like excellent engineering to me but I would not depend on that "fudge factor" in my planning, well, not for every vial, that is

 

[Swerd]

As I understand it, the vials are intentionally overfilled somewhat to account for variations in the fill amount and because a little more than the correct dose is initially drawn with a syringe, and the extra is then pushed out of the needle to get the exact dose. In some cases the vials were overfilled enough to permit an additional dose to be drawn.

It is common practice to slightly overfill vials so that no vial is under-filled. Remember that many thousands of these vials are filled at a time, under sterile conditions where the air is particle-free to class 100 standards.

The standard Pfizer vaccine dose is 30 micrograms (µg) of material in 0.3 milliliters (mL). And there are supposed to be at least 5 doses in each vial. But vials were filled with a 5-fold concentrated solution. That means each vial was filled with 0.3 mL of a 5× concentrated solution. Once thawed, 1.2 mL sterile saline is added to the vial, mixed, and given to 5 people.

The machinery used to fill vials is fast, sterilizable, and reliable, but it does not have the precision to deliver exactly 0.3 mL per vial. So they account for that by slightly over filling the vials. Also, be aware that a 5× concentrated solution of vaccine is thicker than plain saline. The size of each drop will be larger, and it's surface tension is different, it flows differently.

 

[Mr._Clark]

It is common practice to slightly overfill vials so that no vial is under-filled. Remember that many thousands of these vials are filled at a time, under sterile conditions where the air is particle-free to class 100 standards.

The standard Pfizer vaccine dose is 30 micrograms (µg) of material in 0.3 milliliters (mL). And there are supposed to be at least 5 doses in each vial. But vials were filled with a 5-fold concentrated solution. That means each vial was filled with 0.3 mL of a 5× concentrated solution. Once thawed, 1.2 mL sterile saline is added to the vial, mixed, and given to 5 people.

The machinery used to fill vials is fast, sterilizable, and reliable, but it does not have the precision to deliver exactly 0.3 mL per vial. So they account for that by slightly over filling the vials. Also, be aware that a 5× concentrated solution of vaccine is thicker than plain saline. The size of each drop will be larger, and it's surface tension is different, it flows differently.

The FDA said it's okay to use every full dose that's available, but mixing leftover partial doses is not okay. I wonder if there's a way to safely use partial doses.

>>>Both Pfizer and FDA said that leftover vaccine from multiple vials should not be mixed, because of the contamination risk.<<<

FDA says Pfizer vaccine vials hold extra doses, expanding supply

Using every drop from overfilled vials could boost available doses by up to 40 percent.

www.politico.com

 

[John Parks]

Mail Online Videos: Top News & Viral Videos, Clips & Footage | Daily Mail Online

Check out the latest breaking news videos and viral videos covering showbiz, sport, fashion, technology, and more from the Daily Mail and Mail on Sunday.

www.dailymail.co.uk

 

[Swerd]

The FDA said it's okay to use every full dose that's available, but mixing leftover partial doses is not okay. I wonder if there's a way to safely use partial doses.

>>>Both Pfizer and FDA said that leftover vaccine from multiple vials should not be mixed, because of the contamination risk.<<<

FDA says Pfizer vaccine vials hold extra doses, expanding supply

Using every drop from overfilled vials could boost available doses by up to 40 percent.

www.politico.com

In general, mixing doses from different vials is not a good thing to do. It's probably covered under the Good Clinical Practice guidelines.

Good clinical practice - Wikipedia

en.wikipedia.org

 

[TLS Guy]

In general, mixing doses from different vials is not a good thing to do. It's probably covered under the Good Clinical Practice guidelines.

Good clinical practice - Wikipedia

en.wikipedia.org

You are correct. Mixing vials is a strictly forbidden practice. If there is less then a full dose remaining it has to be discarded.