Is it time to start producing the next vaccine?

[ChrisGreene]

I just read this article about concerns that a variant of COVID from South Africa might be resistant to the vaccine after all.

https://www.cnn.com/2021/01/12/health/co...index.html

Is it time to start production of mRNA vaccines for this variant? Supposedly it takes only days to design the vaccine. 

If the vaccine is "similar" to ones that already have EUA, can it be approved without Phase 3 trials. We get a new flu vaccine every year without having them go through Phase 3 trials. I've speculated that this is possible because the new vaccines are similar to the old ones in some way that gives confidence in safety.

It might make sense to pay companies to start up entirely new manufacturing lines for key variants. It would cost a lot less than going through this mess again.

[cardcrimson]

Kinda like prayer, what's the harm. . . .

[M_T]

Tremendous harm, if you mean "produce".  Production is running at full blast and resources are being diverted to the current vaccines.

By my calculation, Moderna & Pfizer will just barely cover Phase 1A and 65+, with all that has been (pre) purchased and expected delivery by July 31.  Take away production from those and people will die from the current COVID.   Reduce the delivery of vaccinations now, and more variants will spring forth before we can get herd immunity for the current virus variants.

If you mean "test", are you thinking that we stop the current testing on 12-16yo so they can be approved some day?

If you mean "design", that may be ok, but it took most of a year to get the current two vaccines approved and into production.  It will have to go through design, and then 3 phases of testing, EUA, and production.

[cardcrimson]

All the production and distribution issues will be resolved tomorrow. A friend is the chief of staff for an influential dem in the Bay Area, and he assured me so just today. As cynical as I am, I hope he’s right.

[ChrisGreene]

M_T:

I do not see why vaccine production is a zero sum game. I never said to divert resources, I said we should use money to create new capacity.

I do agree that we can not afford to reduce production of current vaccines. The faster we vaccinate, the fewer the deaths, the fewer opportunities to breed new variants.

I do not understand your comment "If you mean "test", are you thinking that we stop the current testing on 12-16yo so they can be approved some day?" because I did not mention the word "test" nor did I discuss 12-16 year olds.

I did, however, comment on the fact that new flu vaccines are introduced yearly. I don't know the time frame, but they clearly don't have phase 3 trials. Decision on the new strain and production take way less than a year. How do they do that? Do they assume safety due to some measure of similarity to a prior flu vaccine? It's a good question because a vaccine designed for a covid variant may benefit from such a thing.

RE "If you mean "design", that may be ok". May be OK? How would this worsen the crisis? How could some scientist developing the next vaccine in a laboratory harm our currently insufficient production capacity.

cardcrimson:

I suppose I am more cynical than you. After the "second doses that were withheld disappearing" I wonder what other skeletons are in our vaccine manufacturing closet.

[magnus]

Maybe just a (social) media echo chamber but more and more comments about the vaccine not lasting for more than a few months or that it won't be effective against new strains.

If either of those are true, it's definitely time to take a look at our vaccine development process and see where we can streamline the process to get faster TAT and production.  Otherwise, we'll always be 2 steps behind and never rid of this virus. =(

[ChrisGreene]

The worst that can happen is that we construct factories for vials, syringes, bioreactors or whatever, etc that end up operating under utilization. Wait, we should have that!

[Snorlax94]

You were right,chris.

Moderna announced there is a sixfold reduction in the neutralizing response to the S African strain and They are looking into tweaking its vaccine.

https://www.statnews.com/2021/01/25/mode...e-variant/

We have yet to see  what a sixfold reduction means — will the vaccine still be effective? Will it still be extremely protective against serious cases?

Anyway, I think this is very bad news. I’m surprised the stock markets aren’t tanking. Less developed countries lacking the ability to mass vaccinate with a tweaked formula every year could be screwed, which could in turn, lead to more mutations.

I guess one upside of having to wait so long to be vaccinated is that maybe by then I’ll be getting the updated vaccine.

[dabigv13]

The vaccines are all going to continue being highly efficacious. A 6 fold reduction in neutralizing antibodies may make zero clinical difference, and antibodies are just one small part of the picture. Your immune system generates a robust response to the whole spike protein so even with several mutations, the vaccines should be in good shape with antibodies and T-cells directed at different parts of the spike protein.

If we did get a bad enough variant, a tweak to the mRNA vaccines would take days to design and could probably be released without a full 30k person trial.

[M_T]

Thanks, dabigv.

From the article that Snorlax posted

scientists found that there was a sixfold reduction in the vaccine’s neutralizing power against the variant, called B.1.351, than against earlier forms of the coronavirus, Moderna reported.

There was no loss in neutralization levels against a different variant, called B.1.1.7, that was first identified in the United Kingdom.

Moderna said that despite the reduction in neutralizing antibodies against B.1.351, the antibody levels generated by its vaccine “remain above levels that are expected to be protective.”

Pfizer and BioNTech scientists have already reported their vaccine holds up against B.1.1.7, though they have not reported data yet against B.1.351.