Are vaccines the light at the end of the tunnel?

[D C]

2 hours ago, TeeRick said:

I think the distribution of the vaccine is controlled by CDC and Warp Speed in the US.  Everything after that in the hands of the states and counties and cities.  

 

I was more wondering about the dosing and dosing protocols.  One dose to more people?  A half dose to more people?  Versus the current two doses.  Who decides?  The FDA?  HHS?  I think this is above a state level decision.

Same as I'm wondering.  I don't think there is authority at the federal level.   The FDA, CDC, and vaccine manufacturers all recommend two doses appropriately timed.   If the Executive branch says "one for everyone", I don't believe there's a legal requirement for the states to obey. 

 

(and those in here from commonwealth countries are thinking "wow, y'all are even stranger than we thought!" 🙂 ) 

[wrk2cruise]

What I've heard through the media about the new administrations change of plan for vaccine distribution seems to me to be getting "enhanced" by the media.   What I've heard is they want to modify the distribution plan to not hold back the distribution of the second dose.   If I take this literally all it means is that the manufacturer would distribute it to the entity it is allocated to at the time of manufacture.

 

What the media seems to be implying is that they would all be used for first doses like is being done in the UK.   Wouldn't that need  a modification to the FDA EUA? 

 

I honestly don't understand where this will make a difference as there is plenty of doses sitting locally waiting to be administered and will only make an impact when number of doses being administered outpaces the manufacture/distribution.

[ABoatNerd]

Here in Ontario Canada, Ottawa, there seems to be no intent to distribute the 2 vaccine protocol per the Pfizer product protocol. There simply is few if any information from the "government" of Ontario.

I am able to have a vaccine due to being a primary care giver to my father in a retirement home, but the Ottawa Health Agency would not guarantee I would get the 2nd Pfizer vaccine according to the manufacturer's protocol. They simply refused to give me a second date.

 

As per the post above, many jurisdictions seem to be using the Pfizer doses to give as many as possible a single dose and then who knows what.

 

So what specifically is the benefit of a single dose of the Pfizer??  I have been on the CDC site, no information.

 

 

 

 

[Ken the cruiser]

Here's hoping J&J as well as AZ are also allowed to add their vaccines to the available inventory in the US within the next 100 days. In addition, here's to hoping the various autorized federal, state and local agencies, to include authorized pharmacies and hospitals, start creating pre-registration websites for applicable individuals to request an appointment to get the vaccine rather than having folks call a 1-800 number to make a vaccine reservation or just showing up at first come first serve vaccination locations like what's happening in Florida.

[SJSULIBRARIAN]

5 hours ago, TeeRick said:

Definitely check with your state or county health authority about your situation.

Thanks for suggesting I do so. I did and found out the vaccine allotment for long term care facilities comes from the federal government to CVS and Walgreens for on-site vaccination starting with the largest facilities. Since my husband's facility is not large, his will be later.

This is separate from the allotment the county health department receives from the State. These are two separate concurrent processes.

[markeb]

1 hour ago, D C said:

Same as I'm wondering.  I don't think there is authority at the federal level.   The FDA, CDC, and vaccine manufacturers all recommend two doses appropriately timed.   If the Executive branch says "one for everyone", I don't believe there's a legal requirement for the states to obey. 

 

(and those in here from commonwealth countries are thinking "wow, y'all are even stranger than we thought!" 🙂 ) 

 

The authority really is federal. And it's the FDA, not the CDC. The CDC is recommending who should get vaccinated and when; the FDA approved use of the vaccines as labeled.

 

The vaccine manufacturers performed pre-clinical studies, and Phase I and Phase II clinical studies. Out of those, you get data to recommend the amount of material (mRNA in this case) in each dose and the initial vaccine schedule. That's what's then tested in the Phase III trial and proposed to the FDA for approval (usually in a Biological License Application, but this is an Emergency Use Authorization). The FDA approved the EUA for each vaccine based on the dosage of mRNA used in the Phase III trial, and the schedule (Day 0 and either Day 21 (Pfizer) or Day 28 (Moderna)). In the US, any other use (less material, different vaccine schedule, etc.) would require the FDA to issue a new EUA, and the advisory committee to review data. And so far, the problem is giving the shots, not making and shipping the vaccine.

[drarill]

6 hours ago, TeeRick said:

I think the distribution of the vaccine is controlled by CDC and Warp Speed in the US.  Everything after that in the hands of the states and counties and cities.  

 

I was more wondering about the dosing and dosing protocols.  One dose to more people?  A half dose to more people?  Versus the current two doses.  Who decides?  The FDA?  HHS?  I think this is above a state level decision.

Rick, did you see this? https://news.yahoo.com/moderna-releases-getting-2nd-vaccine-132450965.html

I also have a question; do you think is a good idea to get a serologic test a couple of weeks after the second dose? I have friends that are already doing this, before the second dose🙄, and some are getting IgG+ with IgM- or both of them positives.  I didn't want to bother you but I can't find anything about this and will like to read more about this topic.  

BTW, my husband received his second Pfizer dose and didn't have any side effects but some of our friends did feel awful for over 24 hrs.  This morning (62 hrs post vaccination) he woke up with swollen nodes in his arm, but I think that's a good thing.

Thanks for all your help!!

[wrk2cruise]

CDC has documented a 4 day grace period where it says it's valid to get the second dose 4 days prior to the 3/4 week time but shouldn't be done regularly. 

 

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

[nocl]

5 hours ago, wrk2cruise said:

What I've heard through the media about the new administrations change of plan for vaccine distribution seems to me to be getting "enhanced" by the media.   What I've heard is they want to modify the distribution plan to not hold back the distribution of the second dose.   If I take this literally all it means is that the manufacturer would distribute it to the entity it is allocated to at the time of manufacture.

 

What the media seems to be implying is that they would all be used for first doses like is being done in the UK.   Wouldn't that need  a modification to the FDA EUA? 

 

I honestly don't understand where this will make a difference as there is plenty of doses sitting locally waiting to be administered and will only make an impact when number of doses being administered outpaces the manufacture/distribution.

The FDA has already declined to approve any modifications for either dose or timing of the second dose with the statement that there is not any data that would support modification.

[D C]

1 hour ago, nocl said:

The FDA has already declined to approve any modifications for either dose or timing of the second dose with the statement that there is not any data that would support modification.

Right. Given that, there is little legal standing for any sort of order from the executive branch that contradicts the FDA. 

[TeeRick]

3 hours ago, drarill said:

Rick, did you see this? https://news.yahoo.com/moderna-releases-getting-2nd-vaccine-132450965.html

I also have a question; do you think is a good idea to get a serologic test a couple of weeks after the second dose? I have friends that are already doing this, before the second dose🙄, and some are getting IgG+ with IgM- or both of them positives.  I didn't want to bother you but I can't find anything about this and will like to read more about this topic.  

BTW, my husband received his second Pfizer dose and didn't have any side effects but some of our friends did feel awful for over 24 hrs.  This morning (62 hrs post vaccination) he woke up with swollen nodes in his arm, but I think that's a good thing.

Thanks for all your help!!

I had not seen that so thanks for posting.  Here is what the FDA says:

https://www.fda.gov/news-events/press-announcements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines

We have discussed the second dose of vaccines here a few times.  It is a booster dose that really reinforces and enhances the immune response against the virus going forward.  This is quite common for many vaccines.  The timing of the second dose of these COVID vaccines matches exactly what was done in the clinical trials to achieve the reported efficacy.  So that is why it is either 3 weeks or 4 weeks depending on which mRNA vaccine you receive.  In my personal opinion the exact timing of the booster second dose will be further studied and my guess is that there will be some wiggle room in the timing ultimately.  But for now not likely to change unless the FDA sees data otherwise.  I am not sure why anybody would need a serological test after vaccination.  This was all studied in the clinical trials.  Now maybe 6 months or longer post second dose to see if antibodies are still present- but lots of vaccinated people in trials are being followed for 2 years.  I would not know of any good reason to do this unless for personal knowledge.

[mimbecky]

WHO: Amid short supplies, vaccine doses can be 6 weeks apart

https://www.google.com/amp/s/www.fox61.com/amp/article/news/health/coronavirus/vaccine/world-health-organization-vaccine-input/507-176f93de-b4a4-46df-ac1c-9e19025ed9e8

 

Edited January 11, 2021 by mimbecky

[markeb]

13 minutes ago, mimbecky said:

WHO: Amid short supplies, vaccine doses can be 6 weeks apart

https://www.google.com/amp/s/www.fox61.com/amp/article/news/health/coronavirus/vaccine/world-health-organization-vaccine-input/507-176f93de-b4a4-46df-ac1c-9e19025ed9e8

 

 Interesting, but so far irrelevant in the US. I’ve seen no data to support that presented to the FDA, and the US problem right now is getting vaccines into arms, not the amount of available vaccine or the timing of the second dose. 

[LGW59]

12 minutes ago, markeb said:

 Interesting, but so far irrelevant in the US. I’ve seen no data to support that presented to the FDA, and the US problem right now is getting vaccines into arms, not the amount of available vaccine or the timing of the second dose. 

Very well said, markeb!  Stop with nonsense already with posting this stuff people.  Each country will do what they deem appropriate.  I'm going to opine or try to adjudicate what US (or any other country) coulda/shoulda/woulda done.  Go wherever you want to get the vaccine, if they will take you.  I for one would NOT go to another country to try to circumvent the process or my place in line and take it from a citizen there.   I frankly don't don't care if you own a home in another country where you are not a citizen, IMO you are then stealing it.   Get in line in your country as I will do in mine.  OK I feel better, needed to vent.

[cantstopingcruising]

18 minutes ago, LGW59 said:

Very well said, markeb!  Stop with nonsense already with posting this stuff people.  Each country will do what they deem appropriate.  I'm going to opine or try to adjudicate what US (or any other country) coulda/shoulda/woulda done.  Go wherever you want to get the vaccine, if they will take you.  I for one would NOT go to another country to try to circumvent the process or my place in line and take it from a citizen there.   I frankly don't don't care if you own a home in another country where you are not a citizen, IMO you are then stealing it.   Get in line in your country as I will do in mine.  OK I feel better, needed to vent.

It's interesting how different people can look at the same thing and have a totally different reaction.

 

I don't think of it as "Stealing".

 

There are many snowbirds in Florida every winter. Most did not go this year. But those who did are eligible for the vaccine there. If you, an American, got the vaccine and your neighbour (not an American) didn't, wouldn't you  worry that he/she could be a carrier?  Giving the vaccine to all, protects all.

[Ken the cruiser]

6 minutes ago, cantstopingcruising said:

It's interesting how different people can look at the same thing and have a totally different reaction.

 

I don't think of it as "Stealing".

 

There are many snowbirds in Florida every winter. Most did not go this year. But those who did are eligible for the vaccine there. If you, an American, got the vaccine and your neighbour (not an American) didn't, wouldn't you  worry that he/she could be a carrier?  Giving the vaccine to all, protects all.

Just curious, if a Canadian "snowbird" comes to Florida and gets a COVID vaccine while they're here, do they have to pay for it or is it free like it is if you lived in the US?

[LGW59]

6 minutes ago, cantstopingcruising said:

It's interesting how different people can look at the same thing and have a totally different reaction.

 

I don't think of it as "Stealing".

 

There are many snowbirds in Florida every winter. Most did not go this year. But those who did are eligible for the vaccine there. If you, an American, got the vaccine and your neighbour (not an American) didn't, wouldn't you  worry that he/she could be a carrier?  Giving the vaccine to all, protects all.

Well since Canada does not have an influx of snowbirds coming in for the winter, I don't expect many will be taking the rightful vaccines designated for Canadian citizens, as IMO it should be.  Florida in some respects is doing well with vaccine distribution, but not by allowing people to fly in for sole purpose of the vaccine from another country.  Sorry but my neighbor in the home next door, get in line, but my neighbor in another country, no.  As I said, I'd not do it to another country, is very selfish to me.  

[LGW59]

5 minutes ago, Ken the cruiser said:

Just curious, if a Canadian "snowbird" comes to Florida and gets a COVID vaccine while they're here, do they have to pay for it or is it free like it is if you lived in the US?

It is free.  Trust me I am the ultimate total liberal, but this policy just makes no sense to me.

[drarill]

6 minutes ago, LGW59 said:

It is free.  Trust me I am the ultimate total liberal, but this policy just makes no sense to me.

also it looks like not only Canadians citizens are taking advantage of this "policy" https://www.miamiherald.com/news/nation-world/world/americas/article248347830.html

[cantstopingcruising]

32 minutes ago, LGW59 said:

Well since Canada does not have an influx of snowbirds coming in for the winter, I don't expect many will be taking the rightful vaccines designated for Canadian citizens, as IMO it should be.  Florida in some respects is doing well with vaccine distribution, but not by allowing people to fly in for sole purpose of the vaccine from another country.  Sorry but my neighbor in the home next door, get in line, but my neighbor in another country, no.  As I said, I'd not do it to another country, is very selfish to me.  

I really doubt that anyone would go to Florida in order to get the vaccine. They go to escape the cold.

 

For your interest, our government is asking us to stay home and many people are angry about all those who travelled during the xmas break. Some politicians  went away and were reprimanded or fired. Some people who are being careful and staying put are upset that those who didn't will be vaccinated in Florida way before we are.

 

As long as we stay healthy, I really don't care about what others do or get.

Edited January 11, 2021 by cantstopingcruising

[LGW59]

2 minutes ago, cantstopingcruising said:

I really doubt that anyone would go to Florida in order to get the vaccine. They go to escape the cold.

In normal times, yes, in current times, you are definitely wrong, do some research, read the post above.

[mimbecky]

1 hour ago, LGW59 said:

Stop with nonsense already with posting this stuff people

I fail to see what is nonsensical about it?  Someone had just posted about the CDC saying a 4 day grace period for second doses was acceptable. I was just posting that the World Health Organization is saying up to 6 weeks between vaccines is ok. It isn't like I was pulling it out of my you know where. And although there isn't necessarily a shortage of vaccines now, there may very well be as more people seek their second doses. I also realize that the FDA would need to approve this but the post was informational only.

Edited January 11, 2021 by mimbecky

[wrk2cruise]

1 hour ago, mimbecky said:

Someone had just posted about the CDC saying a 4 day grace period for second doses was acceptable.

 

The someone was me.  The 4 day grace period was for an early second dose.  That's why I posed the reference.

 

"Persons should not be scheduled to receive the second dose earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech] or 1 month [Moderna]). However, second doses administered within a grace period of 4 days earlier than the recommended date for the second dose are still considered valid. Doses inadvertently administered earlier than the grace period do not need to be repeated."

[phoenix_dream]

On 1/9/2021 at 9:59 PM, nocl said:

1. License Plates both the state and the dealership mentioned around the plate. Observing which vehicle they got out of or returned to

2. Talking and listening to people (visitors will usual say where they are visiting from to just about anyone they meet).

3. Behavior - One can get a pretty good idea by observing the locals vs visitors. One recognizes the locals that frequent the beach area simple because you have seen them week after week. Keep in mind that Pismo Beach is around 8,200 people.  Even if you lump in the 5 cities you are talking 50,000. if someone is fishing from the pier they are usually local, if the chairs they use on the beach are used they are usually local.  If they have chairs that have a hotels name or have one of the hotels beach towels they are usually visitors.  People hitting the tourist focused gift shops are usually visitors. If someone enters or leaves one of the local hotels or vacation rentals they are usually not local. On and on.  In this small of a community, that tends to be a tourist destination, one gets a good idea who is local and who is not.

 

 

Point #1 is a little disturbing.  Do people really stand around checking out license plates??  Not sure that's a community I would even want to visit (and if I did, I would follow each and every virus mitigation law for the record).  And I don't think I would be standing around talking to people who were virus deniers discussing where they were traveling from (or be near enough to overhear their conversations either).  I'm also not sure why locals would be hanging around gift shops or hotels or vacation rentals checking to see who is following restrictions and who is not.  If they were the owners/managers, they could be denying entry to those who do not comply.

 

So overall still seems to me to be a bit of confirmation bias on the part of locals.  But I can't prove that any more than you can prove your points.  I do think that states like California, Arizona, and Florida  experience greater risk simply because in the winter they attract many of us from much colder climates trying to escape the snow and cold.  I understand why during a pandemic these states would by and large prefer that people stay put and don't visit.  At the same time, most of those visitors tend to be from areas where we are very used to following tight restrictions (Canada, New York, Chicago area). 

 

I'm not sure about California, but I know that Florida, long before the snowbirds starting flying in, was doing a horrible job in enacting mitigation measures in many areas.  Can't blame the snowbirds for that.  Arizona was as well this past summer, although after a time most of the large metropolitan areas wised up and put restrictions in place.  I can tell you that when I visited Arizona in early November (following the tight protocols I am used to here in the Chicago area) , I found the majority of people in gift shops and tourist areas wearing masks, social distancing, etc..  I also found that in many cases it was the shop owners (clearly locals) who were the ones not wearing the masks.  

Edited January 11, 2021 by phoenix_dream

[sr4mjc]

Floridian here.. It's my understanding that the snowbirds who own second homes and most will have a FL id would be able to get the vaccine.   I was having this argument with my MIL whether or not that is 'right', the reality is if they plan on living 4-6 months in the community and use the medical resources, it is in the interest of the whole community to have them vaccinated quickly as well.   To her response 'sure, but AFTER the 'real FL residents'.  😛    It is not the intention people should fly here, be vaccinated and leave.

 

I'm in Hillsborough and was remarkably surprised how organized the drive through vaccination sites were last week, provided you got an appointment.

Edited January 11, 2021 by sr4mjc