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COVID-19, Pandemic
plastic
post Posted: Jun 21 2021, 06:35 PM
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In Reply To: early birds's post @ Jun 21 2021, 11:09 AM

Too late for mully n co.

He probably got his jab because he wanted a day off work...🙄




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What did Uncle Mel do to us?
 
early birds
post Posted: Jun 21 2021, 11:09 AM
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In Reply To: plastic's post @ Jun 21 2021, 03:51 AM

https://www.msn.com/en-au/news/australia/tg...mber/ar-AALee4r

Australian's medicines regulator says it does not expect key data from the country's third major COVID-19 vaccine hopeful Novavax to land before September after delays to the company's global regulatory filings.


Australia still has 51 million doses of the Novavax vaccine on order, which are expected to land later this year. At the start of this week, the company revealed phase 3 trial data showing its product had 90 per cent efficacy and was 100 per cent effective in protecting against moderate and severe disease.

The studies that are going on right now are going to show how our vaccine is effective at boosting and has a safety profile that's favourable."

Novavax has no operations in Australia so is partnering with Sydney business Biocelect to lodge documents for regulatory approval of its vaccine.

"Timing of approval is still the subject of ongoing interactions with the regulatory authorities; however, Novavax and Biocelect are working towards having final submissions sometime in Q3 2021," a spokesman for the companies said.

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hope we can see prop data ----esp from safety side of thingy!!

 
plastic
post Posted: Jun 21 2021, 03:51 AM
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I guess with all the delays encountered by them it must just be coincidence that US data is to be released in Independence Day week. Even though British data has been known for a long time.

Occasionally you just have to stop and wonder if it is all some sort of rigged game.


https://www.biocentury.com/article/637086/n...ubmission-in-3q



QUOTE
By Steve Usdin, Washington Editor Jun 11, 2021 | 12:30 PM NZSTNovavax expects to disclose results from the U.S. Phase III trial of its COVID-19 vaccine next week, Stanley Erck, its president and CEO, said Thursday at an event marking the start of construction of the company's new campus in Gaithersburg, Maryland.




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What did Uncle Mel do to us?

Said 'Thanks' for this post: early birds  
 
plastic
post Posted: Jun 19 2021, 10:29 AM
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Wonder if this has anything to do with the delays Novavax is encountering. TPP delays were all about biologic data.

https://www.nzherald.co.nz/nz/new-zealand-a...QCM7GGWB57WTI4/

QUOTE
New Zealand and UK aim to conclude trade talks in August.


Trade Minister Damien O'Connor is in London for talks over a free trade agreement between New Zealand and the UK. Photo / RNZ
Trade Minister Damien O'Connor is in London for talks over a free trade agreement between New Zealand and the UK. Photo / RNZ


New Zealand and the UK have committed to accelerating their free trade agreement (FTA) negotiations with the aim of reaching an agreement in principle this August, Trade Minister Damien O'Connor says.

"We've held constructive and productive discussions towards the conclusion of a high-quality and comprehensive FTA that will support sustainable and inclusive trade, and help drive New Zealand's economic recovery from Covid," O'Connor said in a statement.




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What did Uncle Mel do to us?
 
plastic
post Posted: Jun 18 2021, 03:00 PM
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She's done it!
https://www.nzherald.co.nz/nz/covid-19-coro...ZTY2FJ2P7PFINM/




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What did Uncle Mel do to us?
 
plastic
post Posted: Jun 18 2021, 02:29 PM
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I read somewhere that the PFE vaccine contains over 80 different patents with probably just as many patent owners. In other words, the PFE patent is not owned by PFE.

Who is clipping the ticket on these patents for the vaccine? Biontech was their partner and it was said to have been developed by them. But nobody knows who owns the patents they used.
Merck v Integra stipulated the parameters for safe harbour use until commercialization. The funny thing is, deploying the vaccine under EUA conditions probably, somehow sidesteps this decision and can therefore sidestep the royalties and other commercial issues.

Thus, no deal so far. But only two weeks to go before Independence Day.




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What did Uncle Mel do to us?
 


nipper
post Posted: Jun 18 2021, 01:30 PM
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In Reply To: nipper's post @ Jun 18 2021, 10:37 AM

https://www.bbc.com/news/world-asia-57492961
QUOTE
Australia. New Zealand. Singapore. Vietnam. Japan. Hong Kong. South Korea. Taiwan.

These places in the Asia Pacific region have all been praised for their pandemic response; with several ranked among the best in the world.

All were able to get on top of Covid 19 in 2020 through aggressive actions like strict lockdowns and contact tracing, which were later often replicated by the rest of the world.

Yet in the second year of the pandemic, they are being challenged by new issues. Stronger variants have broken through established defences, creating the worst outbreaks yet in some countries. ......




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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
 
nipper
post Posted: Jun 18 2021, 10:37 AM
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In Reply To: early birds's post @ Jun 18 2021, 09:50 AM

and that is pushing things out well into 2022.



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"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
 
early birds
post Posted: Jun 18 2021, 09:50 AM
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We have been very clear all along that that external supply from outside Australia is limited for the time being. We will be increasing, over the next couple of months and particularly towards the end of the year, where we will have 40 million doses of Pfizer by the end of the year. They have promised us that.

ďWe will have Moderna coming as well in September and onwards and the Novavax vaccine we have prepurchased. We still donít have a date for that one but that is on the horizon.Ē

https://www.afr.com/politics/federal/victor...20210617-p5821q

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by year end to have novavax..... tongue.gif



 
early birds
post Posted: Jun 16 2021, 02:02 PM
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Bio in Brief: Dr Norman Begg MBChB DTM&H FFPH Independent Vaccine Consultant; Former Chief Medical Officer, GlaxoSmithKline Vaccines



Background: Public healthy physician from the UK. Also worked at CDC and WHO. Then moved to GSK (CMO for several years). Left GSK 4 years ago and working as independent consultant. On SAB for a couple of vaccine companies.

View on key benefits around mRNA technology? Very simple vaccines, take genetic material of virus and inject it. Genetic material acts as antigen to stimulate immune response. Several benefits, including much more simple and rapid to make mRNA vaccine (2 months for COVID vaccine). Traditional vaccine (inactivated), virus needs to grow (takes several weeks), harvest, inactivate, purify it, much longer and more complex process. Because antigen is produced inside the cell, stimulates humoral and cellular immunity. Has played out in astonishingly high efficacy, would never have predicted that both mRNA vaccines would have efficacy >90%. FDA threshold was 50%, exceeded all expectations. Seeing efficacy seems to be durable for limited period we have, high efficacy in all populations studied so far, and pretty good protection against variant versions (not as good as original). On safety, there was theoretical concern about auto-immunity but this hasnít played out yet. Because so simple to manufacture, very positive benefit there.

Need for handling conditions? MRNA is very unstable, has very short life. If you injected naked mRNA, would be very quickly destroyed. Manufacturers have wrapped them in LNP, but still seems like these vaccines are relatively unstable, so need to be kept at cold temperatures. Not all the same, requirements for PFE more stringent than MRNA. Other one is CVAC that can be stored at normal fridge temperatures. Difference is not clear, what makes it more thermostable. Appears that by changing structure of mRNA, can make them more stable. Now a limiting factor, but ways of getting over that (changing structure). Manufacturers getting more data and finding they're more stable than initially thought. For now a disadvantage compared to one that can be transported and stored at fridge temperatures.

Differences between modified and unmodified mRNA's? Orientation, physical-chemical structure is slightly different. The folding affects stability. Also, which LNP is used, different LNP confers different stability. No one has figured out exactly what it is, trial and error with different formulations.

Theoretical difference for CVAC/TBIO vs. MRNA/PFE? Would appear to be an advantage in stability for CVAC, based on data so far (on CVAC SAB, so can't comment too much). For TBIO, they appear to have found a way to increase stability of vaccines.

It's a hurdle but not insurmountable? Yes, in pandemic situation so stability optimization was not a priority.

Were the mRNA companies lucky that COVID seems to have a good response? Beyond COVID-19, how widely applicable is mRNA? Based on other technologies, because you succeed with one virus doesnít mean you'll succeed with another, particularly in another category. Can product/develop vaccine much faster, more simply and probably lower cost, so platform has many advantages. Much less certain for pathogens beyond COVID-19. Would not have predicted outcome of mRNA in COVID based on data available for other pathogens.

Are there pathogens that mRNA would not be suited to? The two main areas of focus are viral and oncology vaccines. Good reasons why those are a promising approach. Would put lower priority on areas where existing viral vaccines are quite good and hard to see how mRNA would be better (measles, polio, HepA). If you could make vaccine much cheaper or much easier schedule might be worth the effort but probably not. Other area that's challenging is bacterial vaccines (tuberculosis, meningitis, malaria). These are much more complex constructs. Viruses are simple beasts, typically one or few antigens of focus, whereas bacteria are much more complex, not clear which antigens are important to target. Have to think about efficacy/safety and for many diseases it's not worth the effort. For diseases with unmet need (tuberculosis and malaria), possibly, but won't be half as easy as it is with viral vaccine.

So for pediatric combo vaccines, hepatitis, MMR? Donít see those being taken over by mRNA vaccines relatively soon.

And years of established safety for those? Yes. Would be full development, couldnít just get new DDP vaccine on immunogenicity data, would have to do full development.

Would you put shingles and HPV in there? I would treat those differently. For shingles, there are two vaccines licensed - Zostavax (almost 0) and GSK Shingrix, which is very high efficacy but two-dose schedule and has an adjuvant. Could see mRNA vaccine squeezing it out if you could get a one-dose vaccine. For HPV, one-dose vaccine might work. Extraordinarily high efficacy against range of viruses for approved vaccine. The other problem is for neither vaccine is there an established correlate of protection. Couldnít just measure antibodies. Would have to do full development including Ph3 trial (big numbers, big resources).

Opportunity for shingles because manufacturing shortage? Yes, but GSK building another manufacturing facility.

For HPV, there's vaccine and therapeutic for high-risk strains which is high unmet need? Yes. HPV, HepB, there's certainly unmet need and there mRNA vaccines may have opportunity, more of a niche but definitely an opportunity.

Talk about influenza? Think mRNA very well suited to flu, because simplicity of manufacture and reformulating. Flu even more unstable virus than COVID. Manufacturers have horrible scramble every year to try to grow the four strains. Some years get the match not too well so efficacy very low, so definitely room for improvement. If you could speed up production cycle and tailor more rapidly to emerging flu strains. At the moment, there's two seasons (Northern and Southern hemisphere), see opportunity to disrupt that. Flu vaccines are not as efficacious as they should be, 70% on a good year. And particularly in the elderly. There's a lot of room for improvement on efficacy. If mRNA vaccines were efficacious, think they could displace existing technologies.

MRNA highlighted picking strains earlier, how much benefit would that give you? For flu, there isn't a correlate of protection but reasonable good relationship between Ab and efficacy, so if higher Ab then much better shot at higher efficacy. Will be able to pick and choose to develop vaccines. Question is to what extent public health community and payer community will want to do that. Feel COVID raised barrier a little in terms of expectations. There is a cutoff that FDA and EMA use for approval of annual boosters, where if you've above a certain level you're approved. For initial approval, efficacy studies need to be done and have to generate a huge safety database.

Believe that mRNA for flu would need to for first flu vaccine run real efficacy study vs. approval on correlates? Yes. They would have to generate a huge safety database. FDA might give approval on Ab, but if I was MRNA and running huge trial with 50K subjects, would try to generate efficacy data, because need to differentiate from other vaccines. Not sure if there is public info on approval pathway.

SNY has suggested they will have to do the full program. When I was at GSK ran full-blown efficacy trial, which didn't work out.

If we believe delta variant will continue, could you have annual flu and COVID vaccine in single shot conceptually. Conceptually, you could do that. Variants for flu and COVID appear at different rates, so might not need to reformulate your COVID vaccine. Maybe you don't need to reformulate, COVID doesnít mutate as fast as flu. If this was pediatric vaccine, more imperative to have single shot, but less imperative in adult population. Not sure combined vaccine is default position. Also combination vaccines have their own challenges, potential unexpected interference between components, manufacturing considerations. From marketing perspective, could imagine it would be a highly beautiful thing to be able to talk about, but from technical and R&D POV, not a no-brainer.

Think there have been mRNA pandemic flu vaccines developed with two doses. Think pandemic mRNA flu vaccine without adjuvant single dose is viable? Probably not. Depends on the pandemic strain and how drifted it is from other strains. The H1N1 strain clearly needed an adjuvant to develop efficacious vaccine. Had there been an mRNA vaccine developed, would expect it would have been two-dose vaccine. Flu basically changes in drift (small changes) and shift (big leaps). For drift in strain (what most strains are), think one dose would be fine. For shift, think you'd need two doses.

What about RSV (notoriously difficult vaccine to develop)? RSV has checkered history. Inactivated vaccine produced enhanced disease. Several platforms in development (fusion protein +/- adjuvant, live-attenuated, mRNA). In terms of POS, donít think there's an inherent reason mRNA would have more likely success vs. GSK fusion protein vaccine for example. Advantage will be that mRNA vaccines are simpler to make/get in clinic. If you fail with first formulation, back in clinic a lot quicker. Much faster R&D cycle with mRNA vaccine, but in terms of inherent POS, donít see that mRNA vaccines are more likely to succeed than other approaches. Also have different indications, pediatric, elderly and maternal.

Assuming it's the same antigen? Yes.

No inherent disadvantage to NVAX for example? Adjuvants carry some degree of risk in certain populations. That's why GSK not testing in maternal population.

What about CMV? Think mRNA has distinct head start on CMV, because it's simpler to manufacture this relatively complex structure. Also, CMV will be given to women of childbearing potential, some of whom will be pregnant. For other approaches, may need an adjuvant, which might perceptually not do as well in that population. Donít see any potential pregnancy risk for mRNA vaccine. It's not science, it's perception.

For dengue and chikungunya, are those viable indications for mRNA? Dengue is definitely an unmet medical need, vaccine has highly restricted use. Dengue is a complex disease, several different strains, so certainly there's room for a better vaccine, no question. High unmet medical need, shortfall of existing vaccines.

On safety, thoughts on mRNA as potential causality for heart inflammation? Way too early to know if (1) it's real, will hear more about that. There's a lot of slips in determining AE causality. Lots of ways to mistakenly ascribe even when there's an imbalance in incidence. Way too early to know if it's a genuine link and beyond that if it's a class effect. Way too early to tell.

Thought process around what's driving that? Could it just be high efficacy? Donít think efficacy per se would be driving it, don't buy into that one. Start to think about auto-immunity possibly, because that's been raised. Myocarditis covers very broad spectrum, maybe there's another circulating virus, can make up reasons all day for excess of myocarditis.

Does look like MRNA G3 AE rate goes up with 3rd booster dose. Is that normal? Yes, it's what you see for pretty much every other vaccine with a few exceptions. Most vaccines have increased reactogenicity with subsequent doses. From what I understand these are G3 reactions, means they're around for a few days and go away. Donít think it's a class effect, wouldn't be surprised if you saw it for other vaccines.

Pre-print that modified mRNA vaccine might downregulate innate immunity so may be more prone to other infections? Heard about it, but haven't studied in detail. Have heard many theories about other vaccines and most don't play out. Needs to be checked out and followed, but not something I get excited about.

Class effect on safety of mRNA vaccines? When will we hear more on length of protection? Do mRNA vaccines provide same level of protection presenting small piece of antigen vs. traditional vaccine? There's noise now around myocarditis, will accept that when I see it properly reviewed. At this stage would not say there is a class effect. Sure we'll see more signals popping up. For length of protection, original Ph3 trials will follow for two years, I'm sure companies will be highly motivated to publish regular updates at least every 6 months on duration of protection. Will get a lot more real-world data as vaccines roll out. Will continue to amass a huge database on duration of protection. mRNA vaccines get into cell and immediately start generating Ab that specifically target antigen of interest. Traditional vaccine is more of a blunderbuss, blast the entire virus knowing bits of it will stimulate the immune response knowing bits of it will stimulate immune response. Also traditional vaccine doesnít get inside cells, so no is the short answer to last question.

To what extent can flu vaccine makers shift to mRNA to protect market share? Everything is possible. GSK working CVAC, can do anything by partnering, but it's a commercial question, not sure I can say more than that.

On durability, booster need related to mild vs. moderate/severe disease? Memory T cells vs. neutralizing Ab? Think it's highly likely these vaccines will give reasonable long-term protection against hospitalization and death. Think more important driver is what's going to happen with variants. Think driver of boosters will be evolution of variants vs. durability. There will be variant boosters, fairly certain of it.

Dynamics of whether people will take those? They will be available, whole sociological debate about how people will respond to need for another vaccination when disease rates are relatively low.

Protein-based + adjuvants. Perception of adjuvant safety from FDA and adolescents? Adjuvants have had perceptually a negative impact. I think they've moved on from that a bit, have licensed multiple adjuvant vaccine, so a lot more experience with adjuvants, far greater database now so think FDA is less concerned.

Is there a rationale for mRNA resulting in less immunogenicity relative to viral vaccine for cancer? Cancer vaccines are much harder nut to crack. There have been multiple attempts, most of which have failed. POS has increased for mRNA cancer vaccine on ability to personalize but much lower vs. infectious diseases.

Viral vaccine potentially more effective? Yes.

For flu, is not the same construct used, so to get flu vaccine approved would be same approval pathway? COVID is public health emergency, flu is a priority. Can't say that it will be the same regulatory pathway. Asking FDA to take two leaps of faith vs. one, and that's not the FDA's style. Not a regulatory expert.

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i try really hard to understand some Techy thingy in this article , but i'm not up to the task. have put it in here . might have someone can understand these jagons far better than me!! sadsmiley02.gif

hope we have fine discussion !! tongue.gif


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