Are vaccines the light at the end of the tunnel?

[D C]

9 hours ago, markeb said:

More likely, they will become the predominant disease group. That’s basically math: as the older population that was most at risk before vaccination becomes immune, younger risk groups will predominate. Absolute numbers may stay low, but if kids become the largest unvaccinated population, they’ll make up the majority of hospitalizations and deaths. That’s already happened with other age groups. And the 30-55, for instance, is just bigger. Arguably, you might as get ahead of that effect by vaccinating kids. 

 

 

Becoming the predominant disease group isn't necessarily relevant.  Kids are remarkably resilient to covid with severe illness, hospitalization, and death being lower than rates for influenza.   Even long covid is rare in kids.   I'm hard pressed to believe that society isn't better served by giving those doses to people who actually need them to prevent severe illness and death. 

[TeeRick]

16 hours ago, hcat said:

Do you think there will be a rush  to vaccinate young  children?  

Unless schools require it,  or there are serious outbreaks, it might be quite awhile for that to take hold or  maybe after awhile studies will show it is completely  safe for youngsters.  Lots of college age students seem to be lining up,.schools are requiring it...hope no long range issues crop up down the road.

No rush to vaccinate.  There will be a lot of resistance by parents to vaccinate school age children.  The younger kids are primarily carriers of the COVID virus but rarely get sick and even more rarely get severe COVID.  There is not a lot of evidence of COVID being a major health risk between kids in classrooms.  So not sure what public schools will do.  The number of kids with COVID appears to be going up but this is relative to a more and more vaccinated adult population.  Many parents will evaluate the risk of their kids getting serious COVID versus the unknown risk of the vaccine (or unknown long term risk) as part of their personal decision and risk equation.  It is definitely not an easy decision.  Parents will be much more conservative with their kids.  So unless (or until) the vaccine is mandated at the state level for their public schools, I personally do not see the vaccine being put in the arms of many kids.  As a vaccine guy I believe it should be, but I understand the reasons behind the hesitancy with kids.

[mayleeman]

I am looking forward to General DeSantis drawing a sword and leading the Florida National Guard up a cruise ship gangway to seize all records of vaxxes.

[TeeRick]

Interesting news from Pfizer's Q1 earnings call today.

 

Pfizer will file for full approval of the COVID vaccine with the FDA by the end of May.  No surprise.  The BLA requires a full 6 months of data.

 

Here is some more relevant info from the company today (see article in the link).

 

"The company also said it expects to apply for an EUA for a booster shot that could protect against Covid variants during the second half of July, according to a slide presentation that accompanied the company’s earnings release. It expects to apply for authorization for its vaccine for use in toddlers and younger children in September and infants in November."

 

https://www.cnbc.com/2021/05/04/pfizer-pfe-earnings-q1-2021.html

[Homosassa]

2 hours ago, D C said:

Becoming the predominant disease group isn't necessarily relevant.  Kids are remarkably resilient to covid with severe illness, hospitalization, and death being lower than rates for influenza.   Even long covid is rare in kids.   I'm hard pressed to believe that society isn't better served by giving those doses to people who actually need them to prevent severe illness and death. 

Perhaps you need to spend some time researching reliable expert sources.

 

If you need to something to worry about, google Covid 19, male or males, fertility or infertility.

 

I would worry about any boy past puberty.

[markeb]

44 minutes ago, TeeRick said:

Interesting news from Pfizer's Q1 earnings call today.

 

Pfizer will file for full approval of the COVID vaccine with the FDA by the end of May.  No surprise.  The BLA requires a full 6 months of data.

 

Here is some more relevant info from the company today (see article in the link).

 

"The company also said it expects to apply for an EUA for a booster shot that could protect against Covid variants during the second half of July, according to a slide presentation that accompanied the company’s earnings release. It expects to apply for authorization for its vaccine for use in toddlers and younger children in September and infants in November."

 

https://www.cnbc.com/2021/05/04/pfizer-pfe-earnings-q1-2021.html

 

Interesting. Wonder when Moderna will file their BLA? They shouldn't be far behind. The EUAs for the same population could get dicey with a licensed vaccine, but that theoretically shouldn't impact CBER's review or the FDA's decision...

 

The infant market seems like it could be short lived, if most mothers are vaccinated and you see maternal immunity passing to infants, and possibly vaccine interference. I'm assuming they've been testing for that or plan to test for that, as you need some guidance for first dose timing in pediatrics as more adults (and in this case new mothers) have been vaccinated.

[TeeRick]

10 minutes ago, markeb said:

 

Interesting. Wonder when Moderna will file their BLA? They shouldn't be far behind. The EUAs for the same population could get dicey with a licensed vaccine, but that theoretically shouldn't impact CBER's review or the FDA's decision...

 

The infant market seems like it could be short lived, if most mothers are vaccinated and you see maternal immunity passing to infants, and possibly vaccine interference. I'm assuming they've been testing for that or plan to test for that, as you need some guidance for first dose timing in pediatrics as more adults (and in this case new mothers) have been vaccinated.

I would think that Moderna will file a BLA shortly after Pfizer.  As long as we are in a global pandemic I would think that EUA's for AZ and Novavax would proceed.  Particularly Novavax since it is different technology.  The approval of the AZ EUA in the US will make it an easier situation to ship the US doses to other countries where they are desperately needed.  The CureVac mRNA vaccine is already submitting for accelerated review in the EU which might come next month.  Watch for that one.  It is under the radar.

[markeb]

1 minute ago, TeeRick said:

I would think that Moderna will file a BLA shortly after Pfizer.  As long as we are in a global pandemic I would think that EUA's for AZ and Novavax would proceed.  Particularly Novavax since it is different technology.  The approval of the AZ EUA in the US will make it an easier situation to ship the US doses to other countries where they are desperately needed.  The CureVac mRNA vaccine is already submitting for accelerated review in the EU which might come next month.  Watch for that one.  It is under the radar.

 

I don't know that the EUA's are that simple. The public health emergency will still exist, but if Pfizer and Moderna can meet the need, other than potentially special populations (Novavax can probably make that argument), I just don't know if there will still be an unmet need. I think this is one of those where if you ask X number of lawyers, you'll get 1.5-3X different answers...

 

But you raise an interesting question on exporting a vaccine produced in the US, presumably under US regulatory oversight, but not licensed or approved in the US. I don't know if that's been done. Or if a US EUA would simplify that process. Someone here probably knows.

[TeeRick]

53 minutes ago, markeb said:

 

I don't know that the EUA's are that simple. The public health emergency will still exist, but if Pfizer and Moderna can meet the need, other than potentially special populations (Novavax can probably make that argument), I just don't know if there will still be an unmet need. I think this is one of those where if you ask X number of lawyers, you'll get 1.5-3X different answers...

 

But you raise an interesting question on exporting a vaccine produced in the US, presumably under US regulatory oversight, but not licensed or approved in the US. I don't know if that's been done. Or if a US EUA would simplify that process. Someone here probably knows.

I think politically (not scientifically) it would be easier to donate the AZ vaccine to other countries in great need if approved in the US by EUA.  Otherwise the case can be made by some that the US is getting rid of a vaccine not good enough for its own citizens.  This is an interesting one.

[zap99]

26 minutes ago, TeeRick said:

I think politically (not scientifically) it would be easier to donate the AZ vaccine to other countries in great need if approved in the US by EUA.  Otherwise the case can be made by some that the US is getting rid of a vaccine not good enough for its own citizens.  This is an interesting one.

In the UK we have been jabbing about 50/50 AZ and Pfizer.  Cases are lowest since September with one death from Covid yesterday. All adults will be Jabbed with 2 doses by end of June, or so. Just saying🤔

[D C]

48 minutes ago, TeeRick said:

I think politically (not scientifically) it would be easier to donate the AZ vaccine to other countries in great need if approved in the US by EUA.  Otherwise the case can be made by some that the US is getting rid of a vaccine not good enough for its own citizens.  This is an interesting one.

 

Oxford/AZ hasn't yet filed for an EUA in the US, correct?
There's a difference between "not yet approved" and "rejected" at play here, so other countries may well look at it as "too bad for the US that they're overly strict, but good for us"

[deadzone1003]

41 minutes ago, TeeRick said:

I think politically (not scientifically) it would be easier to donate the AZ vaccine to other countries in great need if approved in the US by EUA.  Otherwise the case can be made by some that the US is getting rid of a vaccine not good enough for its own citizens.  This is an interesting one.

With vaccination demand dropping I don't think anyone cares if we give away the AZ vaccine.  Just tell the complainers, what should we do with the AZ vaccine?  Give them away or throw them away?  Right now those are the only realistic options.  Right now, with a little work, you can literally choose which of the 3 vaccines as your choice of vaccination, at least, in large urban areas.  

[markeb]

18 minutes ago, zap99 said:

In the UK we have been jabbing about 50/50 AZ and Pfizer.  Cases are lowest since September with one death from Covid yesterday. All adults will be Jabbed with 2 doses by end of June, or so. Just saying🤔

 

It's not really a safety or effectiveness question here. We're getting into really good shape as well.

 

The law that allows emergency use requires a public health emergency, and a need that can't be met by licensed products. Pfizer, Moderna, and J&J seem to be doing a good job of meeting need. Pfizer and Moderna could have fully licensed products potentially by mid-summer (for the adult populations). The Novavax subunit vaccine is different, so if there are concerns about the other vaccine technologies in subpopulations, it's arguably the best studied technology of the group, and could address an unmet need. AZ is just in a different regulatory dilemma in the US.

 

The US went all in early on AZ, with significant funding and purchase commitments. Some of those appropriation authorities will probably complicate just releasing the product. I'm sure it can be done, but it could take effort. And the US normally doesn't release anything for export, from food to drugs to vaccines, that don't meet US requirements.

[TeeRick]

2 hours ago, deadzone1003 said:

With vaccination demand dropping I don't think anyone cares if we give away the AZ vaccine.  Just tell the complainers, what should we do with the AZ vaccine?  Give them away or throw them away?  Right now those are the only realistic options.  Right now, with a little work, you can literally choose which of the 3 vaccines as your choice of vaccination, at least, in large urban areas.  

I am not saying that citizens in the US will care one way or another if the AZ vaccine is FDA-approved by EUA.  It is not needed in the US.  I am thinking that if it is approved in the US it will be sending a positive message to other countries that need it.   Just like the UK continues to use the AZ vaccine and that sends a positive message.  The world needs this vaccine for a number of very good reasons.  Low cost, ease of distribution.  High effectiveness.

[4774Papa]

6 hours ago, Homosassa said:

Perhaps you need to spend some time researching reliable expert sources.

 

If you need to something to worry about, google Covid 19, male or males, fertility or infertility.

 

I would worry about any boy past puberty.

And you have some references for us?

[Homosassa]

1 hour ago, 4774Papa said:

And you have some references for us?

I could, but I won't.

 

It is time that those who are capable of doing their own research do so. 

 

It took years, but I finally understood those annoying teachers that when asked a question, would tell you to look it up. They were teachers, not enablers.

Edited May 4, 2021 by Homosassa

[kiwimum]

3 hours ago, TeeRick said:

I am not saying that citizens in the US will care one way or another if the AZ vaccine is FDA-approved by EUA.  It is not needed in the US.  I am thinking that if it is approved in the US it will be sending a positive message to other countries that need it.   Just like the UK continues to use the AZ vaccine and that sends a positive message.  The world needs this vaccine for a number of very good reasons.  Low cost, ease of distribution.  High effectiveness.

I would be really happy if AstraZeneca files in the US as DH have been fully vaccinated with AstraZeneca since early February.  We took part in a trial run by the US Navy in San Diego.   I had no side effects, DH had a small headache.   We were unblinded early April at our request so that we could receive another vaccine if needed.

 

[D C]

1 hour ago, Homosassa said:

I could, but I won't.

 

It is time that those who are capable of doing their own research do so. 

 

It took years, but I finally understood those annoying teachers that when asked a question, would tell you to look it up. They were teachers, not enablers.

If that's your approach, it might be helpful to actually communicate your concern before setting others off in search of the unknown with a few seemingly random search terms.  

[CI66774]

12 hours ago, TeeRick said:

No rush to vaccinate.  There will be a lot of resistance by parents to vaccinate school age children.  The younger kids are primarily carriers of the COVID virus but rarely get sick and even more rarely get severe COVID.  There is not a lot of evidence of COVID being a major health risk between kids in classrooms.  So not sure what public schools will do.  The number of kids with COVID appears to be going up but this is relative to a more and more vaccinated adult population.  Many parents will evaluate the risk of their kids getting serious COVID versus the unknown risk of the vaccine (or unknown long term risk) as part of their personal decision and risk equation.  It is definitely not an easy decision.  Parents will be much more conservative with their kids.  So unless (or until) the vaccine is mandated at the state level for their public schools, I personally do not see the vaccine being put in the arms of many kids.  As a vaccine guy I believe it should be, but I understand the reasons behind the hesitancy with kids.

Yep. Whether kid vaccine is mandated for school will be up to each individual state.

[CI66774]

On 5/3/2021 at 3:16 PM, Suzanne123 said:

Just thinking.  Our Lindblad cruise is requiring both vaccination and negative Covid test prior to boarding:

“Proof of Vaccination Card Upload

---

We will accept any FDA-recommended vaccine: Pfizer, Moderna, or Johnson & Johnson (Janssen). Guests will need to allow at least two weeks between the second vaccine dose (or only vaccine dose, if receiving the Johnson & Johnson vaccine) and the expedition departure date in order to allow the vaccine to be fully effective. For non-U.S. guests, we will accept any WHO-recommended vaccine. Blurry, incomplete, or poorly lit submissions will not be accepted.

Proof of vaccination can be uploaded at any time for future departure dates.”

 

Could cruise lines require proof of vaccination when you put down a deposit and refuse to complete the booking if you don’t comply?  

Good question. Everything still in flux. The next few months will be interesting.

[CI66774]

13 hours ago, 4774Papa said:

ChutChut,

What is the risk of dying from COVID19 for a healthy vaccinated person?

https://guardian.ng/opinion/risks-of-covid-19-infection-after-vaccination/

 

What age? No comorbidities? Probably very, very small risk. Now, I have the J&J vaccine and it’s has newer trials than Moderna/Pfizer so it appears to protect better against the new virus variants (at least according to its trials). But overall, death rate is incredibly small for young, healthy people regardless of vaccination status.

[CI66774]

On 5/3/2021 at 4:04 PM, Homosassa said:

 

As I repeatedly have posted, you must read and understand every word.

 

Read the last sentence.

 

The CDC is issuing guidance to the cruise industry.  The CDC is federal and supersedes state law. The CDC guidance recommends vaccination of the crew and passengers.  If a cruise line has an agreement with the CDC to follow and implement the guidance, then vaccinations are required and the cruise line will implement screening protocols to make sure crew and passengers are in compliance (proof of vaccination).

 

Wrong. CDC merely issues guidance. It does NOT make law not does it supersede state law.

[LGW59]

5 minutes ago, CI66774 said:

Wrong. CDC merely issues guidance. It does NOT make law not does it supersede state law.

well then, perhaps you can tell us why no cruises have resumed in 14 months, if not for the CDC then who?  It is NOT a complaint, they have done what needed to be done, and are now reviewing the process

[markeb]

30 minutes ago, CI66774 said:

Wrong. CDC merely issues guidance. It does NOT make law not does it supersede state law.

 

Uh, no. It doesn't make law; it executes law. Article I vs Article II. It has tremendous authority under federal law and regulation to control health issues at US borders. Enhanced by a national emergency declaration.

 

It also issues non-binding guidance, but their authority is pretty clear here.

[LGW59]

42 minutes ago, CI66774 said:

Wrong. CDC merely issues guidance. It does NOT make law not does it supersede state law.

Homosassa said exactly that, it is guidance, but their guidance has obviously carried a ton of weight, CDC can supersede

Edited May 5, 2021 by LGW59