COVID-19 vaccine discussion

Sorry, I can’t go through 46 pages in order to avoid asking a dumb question...

But if I’m lucky enough to get this vaccine and respond with antibodies, I’m still capable of contracting this virus and of spreading it??

31 minutes ago, JohnnyRage said:

Sorry, I can’t go through 46 pages in order to avoid asking a dumb question...

But if I’m lucky enough to get this vaccine and respond with antibodies, I’m still capable of contracting this virus and of spreading it??

Disclaimer *NOT A DOCTOR* But as I understand it:

You can get it but you are much less likely to spread it because your immune system immediately starts to fight it instead of dicking around for a few days allowing the virus to replicate in your body and build a viral load.

43 minutes ago, JohnnyRage said:

Sorry, I can’t go through 46 pages in order to avoid asking a dumb question...

But if I’m lucky enough to get this vaccine and respond with antibodies, I’m still capable of contracting this virus and of spreading it??

It's not known.  Was not part of the trials.  I believe there is some early research from the field that says there is some protection against contracting and passing on.

Johnson& Johnson (one shot) has finally applied for FDA vaccine approval. So I guess we go into the "Yeah, maybe...when we get around to it" phase before they actually ship it around and start injecting people.

http://apnews.com/article/coronavirus-pandemic-coronavirus-vaccine-0bbaa5693035bab95cf4ccf9c8d3b98f?utm_campaign=SocialFlow&utm_medium=AP&utm_source=Twitter

Quote

So I guess we go into the "Yeah, maybe...when we get around to it" phase before they actually ship it around and start injecting people.

If they rush it through everyone will bitch about the FDA not carefully evaluating.  

Edited February 4, 2021 by midtown

 

 

Why do they have to wait till the 26th?

Just now, Neonmoon said:

Why do they have to wait till the 26th?

At least part of it is the legally required public notice period to hold the adcomm. The adcomm is not however mandatory. 

Unless there has been more recent reporting to the contrary JNJ doesn't have material supply ready to ship in any event so not like the delay really matters much.  Doesn't sound like JNJ will be a big player until late March/April.

Edited February 5, 2021 by Skipper

 

48 minutes ago, Skipper said:

Unless there has been more recent reporting to the contrary JNJ doesn't have material supply ready to ship in any event so not like the delay really matters much.  Doesn't sound like JNJ will be a big player until late March/April.

Yeah. I’ve seen numbers all over the place since early Jan.  Single digit millions late feb to 100 million in April to 100m by end of June. Either way, this is going to be huge. They need to be ready to move whatever they have as soon as authorized and ramp production. 

10 minutes ago, Message Board User said:

 

Good shit

Here’s something I just ran across from nyt today on jnj production. 
 

There is also still uncertainty about how many doses Johnson & Johnson will be able to provide in the days and months after getting emergency clearance, when the company may have only about seven million ready, according to federal officials familiar with its production. About 30 million doses, made at facilities in the Netherlands and Baltimore, could be available by early April.

The company said on Thursday that it expected to supply the 100 million doses it has promised the U.S. by the end of June.

I am traveling out of the country in a few weeks for a short trip and have been vaccinated. The state department says that for re-entry a negative COVID test is necessary regardless of vaccination status. In lieu of a negative COVID test, documentation of recovery from COVID will suffice. It is a very short trip and I don't think I can take a COVID test there and get results back quick enough for my return flight. So, it sounds like my only choice is to have a colleague state that I have recovered from COVID. It seems stupid so I wonder if I am interpreting things correctly.

I took my mother for her first dose at U. of Penn. They had been snowed out the two previous days and were trying to cram all the appointments in on Wednesday, and doing a great job managing the crowd safely. I'm sure that happened all over the northeast, so keep that in mind when you see record numbers for Feb. 3.

I am traveling out of the country in a few weeks for a short trip and have been vaccinated. The state department says that for re-entry a negative COVID test is necessary regardless of vaccination status. In lieu of a negative COVID test, documentation of recovery from COVID will suffice. It is a very short trip and I don't think I can take a COVID test there and get results back quick enough for my return flight. So, it sounds like my only choice is to have a colleague state that I have recovered from COVID. It seems stupid so I wonder if I am interpreting things correctly.

You have to have a negative test within 3 days of your departure into the US. Doesn't specify where the test has to be done

Lots of interesting international regulatory decisions taking place. SwissMedic gives the Oxford shot a soft rejection, says to resubmit, they want more data.  Pfizer withdrawals their submission in India. 

https://www.ft.com/content/a6a6d64c-a337-4af4-9525-d194571c7887?

https://www.reuters.com/article/health-coronavirus-india-pfizer/exclusive-pfizer-withdraws-application-for-emergency-use-of-its-covid-19-vaccine-in-india-idUSL4N2KB1NZ

 

Pfizer withdrawals their submission in India. 

Interesting. Seems like Pfizer is saying FU, we’ll take our talents elsewhere.

1 minute ago, Axle Hongsnort said:

Interesting. Seems like Pfizer is saying FU, we’ll take our talents elsewhere.

Might be good for us and other western countries to not have India also competing for supply.  

1 hour ago, Anastasis said:

Lots of interesting international regulatory decisions taking place. SwissMedic gives the Oxford shot a soft rejection, says to resubmit, they want more data.  Pfizer withdrawals their submission in India. 

https://www.ft.com/content/a6a6d64c-a337-4af4-9525-d194571c7887?

https://www.reuters.com/article/health-coronavirus-india-pfizer/exclusive-pfizer-withdraws-application-for-emergency-use-of-its-covid-19-vaccine-in-india-idUSL4N2KB1NZ

 

It always was going to be the ME, Africa, and parts of S. America for Oxford.

 

2 hours ago, SizzleChest said:

It always was going to be the ME, Africa, and parts of S. America for Oxford.

India still sore about that whole colonial thing? Psh, that ended like 70 years ago

3 hours ago, Axle Hongsnort said:

Interesting. Seems like Pfizer is saying FU, we’ll take our talents elsewhere.

More like India in the summer does not reflect the kind of infrastructure or logistics necessary to successfully deliver vaccines for a product that has to be kept at -90 C.  I assume Pfizer balked at the commitment because India didn't want to pay for vaccine along the distribution pathway where Pfizer was no longer responsible.  I'm guessing it wasn't much of a negotiation.

Hello Janssen and AZ.

7 hours ago, Bevo said:

I am traveling out of the country in a few weeks for a short trip and have been vaccinated. The state department says that for re-entry a negative COVID test is necessary regardless of vaccination status. In lieu of a negative COVID test, documentation of recovery from COVID will suffice. It is a very short trip and I don't think I can take a COVID test there and get results back quick enough for my return flight. So, it sounds like my only choice is to have a colleague state that I have recovered from COVID. It seems stupid so I wonder if I am interpreting things correctly.

You are interpreting things correctly.

And I don’t think you can just have a doc state that you’ve recovered from COVID.  You need to provide a positive COVID test result within 90 days of travel.  

34 minutes ago, Heme Doc said:

And I don’t think you can just have a doc state that you’ve recovered from COVID.  You need to provide a positive COVID test result within 90 days of travel.

If he's willing to have a coworker falsify that he had covid and present that false document to the US Government and commit fraud why not falsify a positive test.    My last test result looked like it was done by a fifth grader

1 hour ago, midtown said:

If he's willing to have a coworker falsify that he had covid and present that false document to the US Government and commit fraud why not falsify a positive test.    My last test result looked like it was done by a fifth grader

You want a positive test?  I can get ya a positive test dude.  Believe me there are ways dude.  I can get ya a positive test result by 3 o’clock this afternoon.  With nail polish.
 

17 minutes ago, Heme Doc said:

You want a positive test?  I can get ya a positive test dude.  Believe me there are ways dude.  I can get ya a positive test result by 3 o’clock this afternoon.  With nail polish.
 

You laugh, but it is so stupid that I have to consider this. I am over there for 4 days. If they are too slow getting the results back or I get a false positive, I am screwed. And at some point, it needs to stop. Does evidence show that there is a greater chance of getting COVID after vaccination with Moderna than there is from a person who has recovered from COVID? Eventually, the authorities need to trust the vaccine, otherwise we will never get over the pandemic. I can't imagine having to wear a mask in public for the rest of my life.

13 minutes ago, Bevo said:

You laugh, but it is so stupid that I have to consider this. I am over there for 4 days. If they are too slow getting the results back or I get a false positive, I am screwed. And at some point, it needs to stop. Does evidence show that there is a greater chance of getting COVID after vaccination with Moderna than there is from a person who has recovered from COVID? Eventually, the authorities need to trust the vaccine, otherwise we will never get over the pandemic. I can't imagine having to wear a mask in public for the rest of my life.

Does it say the neg test has to be from while you were there?  Get one right before you leave.  Assuming it turns out negative, it will probably be final while you are gone.  Then show it to them when you get back.  

Maybe they figure it out, but I doubt it.

It's 100% a publicity issue.  It does nothing as long as you allow domestic travel with zero restrictions.   And from everything Ive hear and read.  Most countries (well except for maybe Mexico) take mask wearing and social distancing very serious.   The test has to be within 3 days of departure back to US.   Which means you can get a test the day after you arrived.  So as long as you don't get covid in the first 24 hours you should be fine. 

More like India in the summer does not reflect the kind of infrastructure or logistics necessary to successfully deliver vaccines for a product that has to be kept at -90 C.  I assume Pfizer balked at the commitment because India didn't want to pay for vaccine along the distribution pathway where Pfizer was no longer responsible.  I'm guessing it wasn't much of a negotiation.
Hello Janssen and AZ.

article said india would require pfizer to do additional trials, pfizer said nope. odd card for india to play.

6 minutes ago, Axle Hongsnort said:

article said india would require pfizer to do additional trials, pfizer said nope. odd card for india to play.

Most likely stability trials to understand how far they could stretch product, but the overarching theme here was no doubt political.  Smart for Pfizer to tell them to pound sand.

 

3 minutes ago, Message Board User said:

 

Seems low.

I wonder if the 2nd doses are now eating into the total.  331K+ 2nd doses seems like a lot.

2 hours ago, Bevo said:

You laugh, but it is so stupid that I have to consider this. I am over there for 4 days. If they are too slow getting the results back or I get a false positive, I am screwed. And at some point, it needs to stop. Does evidence show that there is a greater chance of getting COVID after vaccination with Moderna than there is from a person who has recovered from COVID? Eventually, the authorities need to trust the vaccine, otherwise we will never get over the pandemic. I can't imagine having to wear a mask in public for the rest of my life.

Agree that it’s totally stupid.  As a vaccinated person who had to cancel international travel because of this, you’re absolutely preaching to the choir here.  

Anyone have an Austin place link for 1B people that has vaccines now?  Trying to help someone out 

1 hour ago, HookEm said:

I wonder if the 2nd doses are now eating into the total.  331K+ 2nd doses seems like a lot.

Yeah, think that has to be the case.  This is the first week where we've had a huge batch of 2nd doses.

37 minutes ago, Skipper said:

Yeah, think that has to be the case.  This is the first week where we've had a huge batch of 2nd doses.

the first big week of doses was almost 4 weeks ago IIRC.

1 hour ago, Neonmoon said:

Anyone have an Austin place link for 1B people that has vaccines now?  Trying to help someone out 

My wife and I have been checking daily...it’s like trying to get a PS5 before Christmas. Slots open and are filled five minutes later. My dad was able to get one Thursday now I just need to get my mom in.

There are now are more people in Texas who have received their first shot than have had a confirmed case of COVID.

Anyone have an Austin place link for 1B people that has vaccines now?  Trying to help someone out 

If you are registered with APH try logging back in and choosing dove springs. They weren’t at capacity today. I’m not sure why/how, but I know a couple of people who got spots today at dove springs and just registered yesterday.

6 hours ago, 4th_and_18 said:

If you are registered with APH try logging back in and choosing dove springs. They weren’t at capacity today. I’m not sure why/how, but I know a couple of people who got spots today at dove springs and just registered yesterday.

Could be a number of reasons that spots open up: no shows from previous days leave doses for future days, people cancel appointments, conservative estimates of how many doses will be used, added distribution to a site.

I’m not sure this offer means as much today while vaccine supplies are still somewhat limited. I do think it’s critical that we keep people in line out of the elements especially up north but many football stadiums are not climate controlled even in the concourse. It’s not as sexy as nfl stadiums but I would think convention centers with large parking lots would be the ideal locations.

I’m sure the nfl offer is sincere but seems a bit self serving to announce it on super bowl week.

Anyone have an Austin place link for 1B people that has vaccines now?  Trying to help someone out 

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.

23 minutes ago, Axle Hongsnort said:

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.

You gotta do what you gotta do, but people hitting refresh continually is why the website doesn’t work well. And if the appointment process fails at the next step, it’s due to everyone hitting refresh.

tragedy of the commons. There’s no prize for stepping back and letting everyone else go first.

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 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. 

It's amazing and terrible that basic logistics like that are so impressive.

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..

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.