The Virus and the Vaccine

[electro]

19 minutes ago, BirdTravels said:

This is a powder. You mix with liquid. If there is 20%-33% extra liquid, you are watering down the powder. 33% extra diluent is not “a bit extra”.
 

Many vaccines, like the shingles vaccine, are single dose. You take a vile of vaccine powder and add one vile of diluent and give to a single individual. 

The current Pfizer vaccine is not a powder. They are working on a powder version to solve the distribution at extreme temp issue.

 

https://www.pharmamanufacturing.com/industrynews/2020/pfizer-working-on-powder-form-of-covid-19-vax/

[4774Papa]

On 12/4/2020 at 5:00 PM, mianmike said:

 

I still don't see where FDA regulatory requirements have been truncated.  But again, I may be missing something.  Hard requirements are different than typical development procedures.  The FDA has sped-up the approval process though. 

 

"The FDA staff have been looking at individual patient data to ask whether its statisticians come to the same conclusions as the companies did. The process is one that "typically would take us months," Dr. Hahn said.  Groups have been working in shifts, nights and weekends, looking in parallel at issues of clinical effectiveness and safety, and of levels of antibodies to confirm the way the vaccine is working."    https://www.morningstar.com/news/dow-jones/2020120212073/fda-head-defends-covid-19-vaccine-approval-process

 

But, IMO you bring up some valid questions.  The main question not answered is: "What is the vaccines long term safety profile?"  That's the risk/reward conundrum.  We know there are documented long-term effects from a covid infection, we don't know if there are long-term side effects from a vaccine.  This vaccine is certainly not 100% risk free.  If it weren't for thousands of people dying everyday and 100s of thousands suffering from the effects and the trashed economy I'd say let's wait and get more data.  It's a calculated risk based on increased knowledge learned from previous pandemic vaccine development re: medical advancements, computer modeling and DNA sequencing.  I'm feeling good our scientists are not putting my health at unnecessary risk.    

 

As for your other questions:

"Will it break transmission?

How long will effectiveness last?"

These questions are valid, will be answered as more data is collected and are something that are important to know, but not critical to the vaccine safety profile such that the vaccine should be delayed.   

   

  

All good questions.

However, it comes down to do you consider the risk a vaccine to be greater than the risk of contracting the disease.

While COVID-19 has a low fatality rate for healthy persons with no co-morbities (less than 1% fatality rate), I suspect that risks from the vaccine are far lower.   Further, if you want to travel again, the answer leans heavily toward the vaccine.

[BirdTravels]

1 hour ago, TopangaMacNamammy said:

 

The COVID-19 vaccine is NOT a powder. This is FAKE NEWS.

 

2 hours ago, Sissy Voofta said:

 

That's not true, you are wrong about that. 

 

🌺 ~ SV ~ 🛳️

CDC instructions 

 

 

 

[DCGuy64]

On 12/18/2020 at 7:35 PM, BirdTravels said:

I have never seen this behavior in the US.
 

The only place that is close is Hawaii where the state COVID cases have been down about 100 per day. And the people who are not complying are the tourists from the continental US (the mainland). 
 

Since the start of the pandemic, people are constantly pushing up against each other and reaching over each other mask-less or with improperly worn masks in every store.
 

We were at Charlotte airport last week and there was zero social distancing in any line (checkin, food, stores, boarding). I can already see this on ships. 

Interesting. My wife and I flew through Charlotte on 25 and 30 November and it was the exact opposite:

masks worn everywhere. Hopefully your experience was an anomaly.

[DCGuy64]

8 hours ago, Sissy Voofta said:

 

 

 

🕊️

 

🌺 ~ SV ~ 🛳️
https://youtu.be/-5th39yLuJ0?t=129 

Facts? But what about my feelings???? LOL 😁😁🤣

[JamieLogical]

@BirdTravels I believe those are the instructions for diluting the vaccine with saline just prior to injection. Those don't have anything to do with the vaccine as it is shipped (currently in a liquid form). So would not pertain to the bit if excess vaccine that is packaged and shipped, which is meant to compensate for any spillage or loss in transit. That bit of extra vaccine that is meant to compensate for spillage and loss is how they are managing to get an extra dose out of some vials. If there is little/no spillage or loss, some vials contain enough vaccine for a a full extra dose. I have heard that current guidelines do not allow that extra vaccine from multiple, separate vials be combined for additional doses.

[Homosassa]

44 minutes ago, JamieLogical said:

@BirdTravels I believe those are the instructions for diluting the vaccine with saline just prior to injection. Those don't have anything to do with the vaccine as it is shipped (currently in a liquid form). So would not pertain to the bit if excess vaccine that is packaged and shipped, which is meant to compensate for any spillage or loss in transit. That bit of extra vaccine that is meant to compensate for spillage and loss is how they are managing to get an extra dose out of some vials. If there is little/no spillage or loss, some vials contain enough vaccine for a a full extra dose. I have heard that current guidelines do not allow that extra vaccine from multiple, separate vials be combined for additional doses.

 

What spillage or loss?

 

There is a  septum on the top of the vials. If a vial spills, that means the vial is broken.

[JamieLogical]

28 minutes ago, Homosassa said:

 

What spillage or loss?

 

There is a  septum on the top of the vials. If a vial spills, that means the vial is broken.

 

The article I read from a UK pharmacist said that there can be spillage and loss as the vaccine is removed from the vial, sometimes due to pressurization from transport or expansion/contraction from temperature changes, or the types of instruments/syringes used to remove the vaccine from the vial. So it is common for manufacturers to include small amounts of extra drug to compensate for that potential loss. I will see if I can find the article again and link it.

[Homosassa]

On 12/21/2020 at 10:29 AM, JamieLogical said:

 

The article I read from a UK pharmacist said that there can be spillage and loss as the vaccine is removed from the vial, sometimes due to pressurization from transport or expansion/contraction from temperature changes, or the types of instruments/syringes used to remove the vaccine from the vial. So it is common for manufacturers to include small amounts of extra drug to compensate for that potential loss. I will see if I can find the article again and link it.

 

Once again, the vaccine is shipped as a two part vial system. One part contains the concentrated vaccine, the second vial contains the diluent.  

 

Using an aseptic technique, the diluent is drawn up through the septum of  its vial  and injected through the septum of the vial with the vaccine.

 

After mixing by shaking, the increased pressure from the reduction of the headspace in the vaccine vial is reduced by  aseptically withdrawing air through the vaccine vial  septum.

 

Again, loss from either components vial of the vaccine means the vial is broken or leaking. If leaking, sterility is compromised and the vials will be discarded.

 

Sloppy technique on the part of the person preparing the vaccine or injection is another problem entirely.

 

 

Edited December 23, 2020 by Homosassa

[Homosassa]

28 minutes ago, Homosassa said:

 

 

 

After mixing by shaking, the increased pressure from the reduction of the headspace in the vaccine vial is reduced by  aseptically withdrawing air through the vaccine vial  septum.

 

 

 

 

Correction: The air is withdrawn to equalize pressure  after the diluent is added and before mixing.