Vaccine/Antibody updates

[Warriors4ever]

I just watched the video of Dr. Murphy from Northwestern who is on the WGN morning news everyday. He said that the feds bought millions of doses from a number of different companies working on possible vaccines, which he said is what they had to do. And sometimes those work out great, and sometimes the vaccines don’t work out, so basically you are hedging your bets. You cannot put all your eggs in one basket. He was more optimistic about the Moderna also entering the picture right now than the Astra-Zeneca.

[GooooMarquette]

Forgetful, could you (or anyone else) explain a little about how these pre-purchases work?  I'm generally far from a Trump administration apologist, but it seems like a really tough spot to determine how to purchase/reserve from a number of competing vaccines, all before any have received any approvals and it seems even before release of sufficient testing data to project which will be the most successful?  I'm not jazzed about what I'm hearing about the untested nature of the Moderna technology nor their track record of bringing products to market, but was the alternative to put all of our eggs in the Pfizer basket? In that case, would it have been possible that another vaccine proved more effective than Pfizer, and we'd be blaming the administration for just throwing gobs of money at Pfizer without sufficient evidence that it shouldn't have been diversifying among the vaccine candidates?

First, we didn't have to fund only one mRNA vaccine manufacturer. That was an Administration decision. They could just as easily funded both Pfizer and Moderna. Frankly, that would have been my choice.

But once it got down to a choice between the two, my preference would have been for a company that has successfully brought many products to market. Even a 6-month delay due to a supply chain issue would be devastating, so I'd rather bet on a company who has vast experience with such matters.

[forgetful]

Forgetful, could you (or anyone else) explain a little about how these pre-purchases work?  I'm generally far from a Trump administration apologist, but it seems like a really tough spot to determine how to purchase/reserve from a number of competing vaccines, all before any have received any approvals and it seems even before release of sufficient testing data to project which will be the most successful?  I'm not jazzed about what I'm hearing about the untested nature of the Moderna technology nor their track record of bringing products to market, but was the alternative to put all of our eggs in the Pfizer basket? In that case, would it have been possible that another vaccine proved more effective than Pfizer, and we'd be blaming the administration for just throwing gobs of money at Pfizer without sufficient evidence that it shouldn't have been diversifying among the vaccine candidates?

Gooo has already hit on some important details, but I'll add another.

Eventually we will need 600+M doses for our country. Does that mean you only order 400M..., 600M doses? For an extra $2-3B we could have secured another 100M doses from Pfizer. Worst case scenario, we don't need them and can donate/sell them to other countries.

We should have over bought if anything. Make sure that we have insurance plans in case some don't pan out, don't skimp.

Not to mention that prepurchasing more, would have likely led them to invest more in production allowing more doses to come online faster.

Extremely short-sighted and odd move.

[MU Fan in Connecticut]

Extremely short-sighted and odd move.

Not really for the most incompetent administration of all time.

[MUBurrow]

Thanks to everyone that responded. I am pretty ignorant on how the particulars of buying doses before approval or full development of the data, so this has been helpful.

[Jockey]

Thanks to everyone that responded. I am pretty ignorant on how the particulars of buying doses before approval or full development of the data, so this has been helpful.

Forgetful and Goo have been outstanding resources here.

[Skatastrophy]

Looks like WI heath officials are guessing that the population of WI will be vaccinated by Fall 2021

https://www.wisn.com/article/covid-19-wisconsin-warns-most-wont-get-vaccine-until-fall-of-2021/34908664

> Department of Health Services Secretary Andrea Palm: "It really is hard to express how long it will take to vaccinate enough folks to get to a place where we can get back to normal," she said. "I think our best guess is the late summer, fall timeframe."

> She added that of the COVID-19 tests done in Wisconsin to date, about 2.6 million, are still fewer than the number of Wisconsinites who must be vaccinated.

[GooooMarquette]

Somewhere in one of these threads, somebody asked if a person still needs to wear a mask once they get the vaccine. I believe forgetful already answered that question (YES) and briefly explained why, but I found this NYTimes article to be a good reminder as well:

https://www.nytimes.com/2020/12/08/health/covid-vaccine-mask.html?action=click&algo=lda&block=editors_picks_recirc&fellback=false&imp_id=415636143&impression_id=18cfdcc2-3b20-11eb-9899-d99550749359&index=2&pgtype=Article&region=ccolumn&req_id=44031104&surface=home-featured&variant=1_lda&action=click&module=editorContent&pgtype=Article&region=CompanionColumn&contentCollection=Trending

[Jockey]

The advisory panel voted 17-4 for approval of the vaccine.

Is it normal to have about 20% of the panel go against a vaccine and still have it OK’d? Is it usually unanimous or closer to it?

[GooooMarquette]

The advisory panel voted 17-4 for approval of the vaccine.

Is it normal to have about 20% of the panel go against a vaccine and still have it OK’d? Is it usually unanimous or closer to it?

Drugs are often approved with split votes. In this case, I would not be too troubled by the four dissenting votes. As I understand it, the chief concern was use in 16 and 17-year-olds. Frankly, I was surprised that they even considered this, and expected it only to be considered (and approved) for ages 18 and up.

[Jockey]

Drugs are often approved with split votes. In this case, I would not be too troubled by the four dissenting votes. As I understand it, the chief concern was use in 16 and 17-year-olds. Frankly, I was surprised that they even considered this, and expected it only to be considered (and approved) for ages 18 and up.

Thanks, Goo. Kinda what I thought, but wasn’t sure.

[forgetful]

Drugs are often approved with split votes. In this case, I would not be too troubled by the four dissenting votes. As I understand it, the chief concern was use in 16 and 17-year-olds. Frankly, I was surprised that they even considered this, and expected it only to be considered (and approved) for ages 18 and up.

I didn't realize they approved it for 16 an 17 year olds. That is surprising, and kind of odd, as I think it is completely unnecessary to authorize it for 16 and 17 year olds at the moment as they will not be remotely near any priority groups.

[Jockey]

I just saw that Pfizer said that the 100 million doses might be all we get until June.

Not good news.

[forgetful]

I just saw that Pfizer said that the 100 million doses might be all we get until June.

Not good news.

That's what happens when the US government passes on buying more doses and the rest of the world is beating down their door.

[GooooMarquette]

I didn't realize they approved it for 16 an 17 year olds. That is surprising, and kind of odd, as I think it is completely unnecessary to authorize it for 16 and 17 year olds at the moment as they will not be remotely near any priority groups.

Yep.

In addition to being unnecessary, I think it was a really bad strategic move. They needed to bolster public confidence in the midst of widespread concerns about people declining to take the vaccine, and a unanimous vote might have helped. Instead, they virtually guaranteed dissenting votes by including minors. And in so doing, they just made public health officials’ jobs harder....

[mu_hilltopper]

https://www.axios.com/coronavirus-vaccine-priority-enforcement-b42245dc-cdf0-4eec-9d6b-0769af4f63e6.html

Jumping the line for a vaccine will be pretty easy

..Experts have spent months debating the ins and outs of a complex prioritization system for these vaccines, all in the hopes of saving as many lives as possible. But the actual process will likely rely heavily on the honor system.

..providers will likely have to take people’s claims that they’re members of certain priority groups at face value.

..If you say you have diabetes, they’re not going to want to see your blood sugar,” said Eric Toner, a senior scholar with the Johns Hopkins Center for Health Security.

[Jockey]

Trump orders FDA chief to authorize vaccine today or he will be fired.

[GooooMarquette]

Trump orders FDA chief to authorize vaccine today or he will be fired.

I suspect he is actually trying to undermine public confidence in the vaccine by creating the illusion that it was approved due to political pressure...so then he can blame Biden later when distribution and administration of the vaccine hits roadblocks.

Or it could just be his Napoleon complex....

[mu_hilltopper]

Trump orders FDA chief to authorize vaccine today or he will be fired.

That's so delicious.

[forgetful]

Trump orders FDA chief to authorize vaccine today or he will be fired.

For those saying Trump wouldn't/couldn't do something like this. Well here you go.

Fortunately, they've at least been able to collect the 2-months of safety data, and have the panel undergo a full review of the data.

Still...seriously, WTF.

[MU82]

This is exactly what Vice President-Elect Harris was talking about when she said she absolutely would listen to the scientists but would not take it just because the outgoing, lame-duck president was pushing it.

Exactly.

[MU Fan in Connecticut]

Maybe it's a controlling rights and patent issue thing, but could say Phizer and Moderna contract out production of the vaccine recipes to other pharmaceutical companies to ramp up production and availability way quicker?

[GooooMarquette]

Maybe it's a controlling rights and patent issue thing, but could say Phizer and Moderna contract out production of the vaccine recipes to other pharmaceutical companies to ramp up production and availability way quicker?

Absolutely; this happens all the time. They just need to make sure the facility meets FDA guidelines for manufacturing ("Good Manufacturing Practices"). As a matter of fact, I'd be very surprised if smaller companies like Moderna haven't done this.

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

[forgetful]

Maybe it's a controlling rights and patent issue thing, but could say Phizer and Moderna contract out production of the vaccine recipes to other pharmaceutical companies to ramp up production and availability way quicker?

I've wondered bout this myself, from the standpoint of the defense production act. I really don't think it is a rights/patent issue thing. Although I don't know the exact formulation, which is important for long-term stability and other factors, I could pretty much vaccinate myself (will not, because 1) its dangerous. 2) I don't know the exact formulations).

I think the bigger issue is that we really haven't ever mass produced an mRNA vaccine, so the types of production facilities for making these formulations on scale, and also even making and validating the mRNA sequences on this type of scale, never really existed until Moderna and Pfizer built it.

So really not excess production ability out there. Could be made on smaller scales in more localized places, but validation/quality control still becomes a bit of an issue, and is part of the overall approval.

I think in terms of production infrastructure, this would have needed to be done earlier...maybe that is what Moderna did, as Goooo suggests.

[GooooMarquette]

I think the bigger issue is that we really haven't ever mass produced an mRNA vaccine, so the types of production facilities for making these formulations on scale, and also even making and validating the mRNA sequences on this type of scale, never really existed until Moderna and Pfizer built it.

Excellent point. Even though they could theoretically contract out the manufacturing, the practical aspect of finding a GMP-certified facility for mRNA vaccines might be a problem.