Coronavirus

[Trell]

Both Moderna and Pfizer would be smart to license out their vaccines to sub-contractors for increased production. Moderna was founded, in part, based on research that was funded with money from NIAID. I don't know any details, but there may already be such an agreement between Moderna and the US government.
I agree we will have to live with this virus. It doesn't seem like it will go away on it's own. ...

Pfizer, without prior approval, started to charge for an extra dose in each vial delivered to EU that most (?) cannot extract in any case. That, to put it mildly, did not go down well. Sweden stopped paying bills from Pfizer and are very upset.

 

[Mr._Clark]

Both Moderna and Pfizer would be smart to license out their vaccines to sub-contractors for increased production. Moderna was founded, in part, based on research that was funded with money from NIAID. I don't know any details, but there may already be such an agreement between Moderna and the US government.

I don't disagree. However, the federal government has sovereign immunity and it can only be sued if it has consented to be sued, and the remedies are limited to those defined in the law governing the consent.

The federal government could just contract directly with other companies if it wants to and Moderna and Pfizer would have to suck lemons (pick your own analogy). 35 USC 1498 limits patent owners to reasonable royalties and possibly attorney fees. In other words, a patent owner cannot get an injunction or lost profit damages (by "suck lemons" I mean try to recover royalties after the fact)(realistically, the government would try to avoid completely screwing these companies, so the lemons could be quite lucrative).

Even if the government had signed a contract with these companies agreeing that it would not contract with other suppliers, the government could still breach the contract and do it anyway. There isn't a court in this country that would issue an injunction against the federal government for breach of contract under these circumstances. It would boil down to a damages issue (i.e. how much the government would have to pay).

There's been a fair amount of discussion in the media about licensing and march in rights under the Bayh-Dole Act. The fact is the government don't need no stinking license or march in rights. The only real issue between relying on section 1498 and march in rights under the Bayh-Dole is how much the government has to pay (in my opinion march in rights are ultimately a losing proposition, so it's basically a moot point)(but there's an argument to made, and asserting march in rights would undoubtly result in many years of high cost litigation).

Suing for Patent Infringement if the Government Takes Your Intellectual Property During the COVID-19 Pandemic

As COVID-19 continues to rapidly sweep the globe, government agencies at all levels are taking measures to curb the spread of the virus. This, in turn, has led to concerns that the government may appropriate private intellectual property rights in order to combat the virus.

www.ipwatchdog.com

 

[Irvrobinson]

Dr. Fauci says Covid vaccines can be easily adapted to new variants, drugmakers working on boosters

The newly developed mRNA technology used to make the Covid vaccines makes it easy to adapt to the new strains from South Africa and the U.K., Fauci said.

www.cnbc.com

 

[Irvrobinson]

The federal government could just contract directly with other companies if it wants to and Moderna and Pfizer would have to suck lemons (pick your own analogy). 35 USC 1498 limits patent owners to reasonable royalties and possibly attorney fees. In other words, a patent owner cannot get an injunction or lost profit damages (by "suck lemons" I mean try to recover royalties after the fact)(realistically, the government would try to avoid completely screwing these companies, so the lemons could be quite lucrative).

Even if the government had signed a contract with these companies agreeing that it would not contract with other suppliers, the government could still breach the contract and do it anyway. There isn't a court in this country that would issue an injunction against the federal government for breach of contract under these circumstances. It would boil down to a damages issue (i.e. how much the government would have to pay).

There's been a fair amount of discussion in the media about licensing and march in rights under the Bayh-Dole Act. The fact is the government don't need no stinking license or march in rights. The only real issue between relying on section 1498 and march in rights under the Bayh-Dole is how much the government has to pay (in my opinion march in rights are ultimately a losing proposition, so it's basically a moot point)(but there's an argument to made, and asserting march in rights would undoubtly result in many years of high cost litigation).

Suing for Patent Infringement if the Government Takes Your Intellectual Property During the COVID-19 Pandemic

As COVID-19 continues to rapidly sweep the globe, government agencies at all levels are taking measures to curb the spread of the virus. This, in turn, has led to concerns that the government may appropriate private intellectual property rights in order to combat the virus.

www.ipwatchdog.com

35 USC 1498 was also the basis for the drug pricing negotiation sections of Medicare for All. All of this, of course, is based on eminent domain law. Private property can be confiscated for the public good, and compensation, while guaranteed, is adjudicated in the US Court of Federal Claims. Pharma companies usually think they can lobby their way out of these actions, but their bad pricing attitude is why I don't like to invest. It's sort of like betting a recalcitrant child won't get penalized.

 

[TLS Guy]

Recriminations escalate in the omnishambles vaccine roll out in the EU.

Production of the Oxford vaccine, they call Covishield, at the serum institute in Pune, near Mumbai India are ramping up fast and going out all over India. Unfortunately there has been a serious fire with six killed in an additional plant they were building to increase production of the Oxford vaccine.

The vaccine crisis in the EU is serious, and may well cause the EU project to unravel. It underscores the wisdom of UK voters to exit the EU project. The fact is that no one, and yet everyone, is responsible, and no one will ever be called to account. None of those involved, can or will, be able to be held responsible by the electorate. That is the core of the quarrel the British people had with the EU.

The fact is that the UK and US funded production of the Moderna and Oxford vaccines at risk. In the UK they built plants and produced vaccines at risk. The EU did not, and are late to the table, and are paying the price.

In India vaccine production has been developed and produced at risk by the very wealthy Dr Cyrus S. Poonwalla. All this has been done with the assistance of the Oxford university team and the UK government. This is facility is the best hope for getting the world's population eventually vaccinated. The fire was a setback in this effort.

 

[Trell]

Coronavirus: Germany recommends against using AstraZeneca jab for over-65s – as it happened

www.ft.com

"Germany recommends not using AstraZeneca jab for over-65s​

​

Guy Chazan​

The German authorities have recommended that the OzAstraZeneca vaccine against Covid-19 should not be used for people aged over 65.​

A statement by the Standing Vaccine Commission at the Robert Koch Institute, Germany's main public health agency, said there were "insufficient data currently available to ascertain how effective the vaccination is above 65 years".​

For that reason, the commission recommended that it only be used for people aged between 18 and 64.​

The RKI said that the two vaccines that had been approved by the EU authorities - from BioNTech/Pfizer and Moderna - were judged to be "equivalent in terms of safety and efficacy".​

"​

 

[TLS Guy]

Coronavirus: Germany recommends against using AstraZeneca jab for over-65s – as it happened

www.ft.com

"Germany recommends not using AstraZeneca jab for over-65s​

​

Guy Chazan​

The German authorities have recommended that the OzAstraZeneca vaccine against Covid-19 should not be used for people aged over 65.​

A statement by the Standing Vaccine Commission at the Robert Koch Institute, Germany's main public health agency, said there were "insufficient data currently available to ascertain how effective the vaccination is above 65 years".​

For that reason, the commission recommended that it only be used for people aged between 18 and 64.​

The RKI said that the two vaccines that had been approved by the EU authorities - from BioNTech/Pfizer and Moderna - were judged to be "equivalent in terms of safety and efficacy".​

"​

The problem is that the Germans are just plain wrong about this. I read the data submitted to the regulator, and the vaccine is highly effective in all age groups over 18 years in whom it was tested. Both Oxford, the UK regulator, the UK government and Astrazeneca have pushed back against this nonsense. It is just that, total nonsense. It is obviously a crude face saving ploy to try and detract from the disastrous EU vaccine procurement.

 

[highfigh]

Yes, but those are only the ones we know about. Due to US incompetence the numbers will be in the thousands by now. I think unless the vaccine rolls out faster than predicted, we will be in a really bad crisis in six weeks.

Meanwhile the EU is in a row with the UK and Astrazeneca. The EU are demanding 75 million doses of the Oxford vaccine they have not even approved yet, be provided from UK factories. This is certain to be rejected and a major row will worsen.

As with everything the EU touches, they have made a total mess of vaccine acquisition and roll out, and are now looking for someone else to blame.

Despite Brexit, the EU wanted the UK to join the EU vaccination acquisition program. The UK wisely refused. So this issue will certainly raise anti EU feeling in member EU states. This fiasco seems sure to stoke it.

EU demands the vaccine? And people question Brexit?

 

[highfigh]

Now that California and New York have eased or eliminated restrictions for staying at home, we can see how their case totals may skyrocket.

 

[TLS Guy]

Now the Belgian police under orders from the EU have raided the Astrazeneca factory in Belgium and seized documents. This is going to turn into a very nasty situation.
This is all over supply of a vaccine the EU have not approved, ordered late, and now say is no good!

I have said for years the EU is a totally awful and insidious construct. Time to end the whole charade.

 

[GO-NAD!]

Recriminations escalate in the omnishambles vaccine roll out in the EU.

Production of the Oxford vaccine, they call Covishield, at the serum institute in Pune, near Mumbai India are ramping up fast and going out all over India. Unfortunately there has been a serious fire with six killed in an additional plant they were building to increase production of the Oxford vaccine.

The vaccine crisis in the EU is serious, and may well cause the EU project to unravel. It underscores the wisdom of UK voters to exit the EU project. The fact is that no one, and yet everyone, is responsible, and no one will ever be called to account. None of those involved, can or will, be able to be held responsible by the electorate. That is the core of the quarrel the British people had with the EU.

The fact is that the UK and US funded production of the Moderna and Oxford vaccines at risk. In the UK they built plants and produced vaccines at risk. The EU did not, and are late to the table, and are paying the price.

In India vaccine production has been developed and produced at risk by the very wealthy Dr Cyrus S. Poonwalla. All this has been done with the assistance of the Oxford university team and the UK government. This is facility is the best hope for getting the world's population eventually vaccinated. The fire was a setback in this effort.

The current silly squabbling over vaccines leaves me somewhat bemused. The planet is flying the airplane while flying it and fighting over the parts. EU threats to curb exports of vaccine in order to paper over their byzantine approval process is unacceptable - especially if it results in violation of contractual obligations.

German complaints about vaccination rates are a bit over the top. They are currently sitting tied with Canada for vaccination rate, at 7th out of 195 countries. Sure, we all want to get it done faster, but there are limits to how quickly it can be produced, distributed and administered. Australia and New Zealand still haven't started vaccinations (NZ hasn't even approved one yet).

Looking at it from a national perspective, versus a global perspective is short-sighted as well. Until the entire planet is sufficiently vaccinated, it's a problem for everyone.

Speaking of national perspectives, the Canadian government inexplicably signed a research and production agreement between the NRC and Chinese pharmaceutical company CanSino Biologics. The vaccine developed from the Canadian created cell-line, Ad5-nCoV was to be sent to the Canadian Centre for Vaccinology at Dalhousie University in Halifax, Nova Scotia, for Phase 1 trials in late May. But, due to typical Chinese government fcukery, the samples weren't shipped and the agreement collapsed. My view is that any statement by a Chinese government official should be assumed to be a lie and any signed agreement is not worth the paper it's written on.

 

[Trell]

The problem is that the Germans are just plain wrong about this. I read the data submitted to the regulator, and the vaccine is highly effective in all age groups over 18 years in whom it was tested. Both Oxford, the UK regulator, the UK government and Astrazeneca have pushed back against this nonsense. It is just that, total nonsense. It is obviously a crude face saving ploy to try and detract from the disastrous EU vaccine procurement.

What are they actually trying to achieve? Like you, there will be other researchers/medical doctors looking at the same data, assuming all of it is public, and they'll draw their own conclusions. Trump-style rhetoric is not something I associate with the German government.

 

[Mr._Clark]

This is not a surprise, but the South African variant has now been detected in the U.S.

>>>The South Carolina Department of Health and Environmental Control said the two cases of the B.1.351 variant of South African origin appear to be unrelated to one another. Neither of the two adults were known to have had a travel history, the department said.<<<

First known U.S. cases of potent South African COVID-19 variant found in South Carolina

A potent coronavirus variant originating in South Africa and found to be partly resistant to current vaccines and antibody treatments has been detected for the first time in the United States in two South Carolina patients, health officials said on Thursday.

www.reuters.com

 

[Mr._Clark]

What are they actually trying to achieve?

I'm wondering the same thing. Perhaps it's a political dodge (i.e. the government can rebut criticism that they haven't been vaccinating quickly enough by asserting that the vaccine isn't actually effective anyway).

 

[Trell]

I'm wondering the same thing. Perhaps it's a political dodge (i.e. the government can rebut criticism that they haven't been vaccinating quickly enough by asserting that the vaccine isn't actually effective anyway).

A political dodge, if that what it is, will not last for very long when the same data is evaluated by others. There is no Trump-style FDA/CDC in EU to cover things up.

 

[TLS Guy]

What are they actually trying to achieve? Like you, there will be other researchers/medical doctors looking at the same data, assuming all of it is public, and they'll draw their own conclusions. Trump-style rhetoric is not something I associate with the German government.

This is the issue. The Oxford vaccine was trialled across all age groups. It is true that because the elderly are more cautious there were less people in the older age group who came ill with the virus, including the controls. However the antibody and T-cell response was studied in all groups. The elderly population had a slightly better but not significantly better response. None of them were harmed by the vaccination. So, if the immune response was as good, it is illogical to say that the vaccine is not effective in the over 65s. That is just ridiculous in the extreme.

In any event Germany is breaking ranks, and has done, and is today frantically trying to put deals together outside the EU procurement. Germany, Holland and especially Italy are becoming increasingly Eurosceptic. I expect when the bills come in, German Euroscepticism will rise off the clock.

Lastly the EU leads the world in obfuscation and sleight of hand.

 

[Mr._Clark]

My view is that any statement by a Chinese government official should be assumed to be a lie and any signed agreement is not worth the paper it's written on.

I'm guessing you are disinclined to get the new Chinese "anal swab coronavirus test"? Perhaps these swabs are "recycled" agreements, in which case the agreements may yet have some utility.

>>>Months-long lockdowns. Entire city populations herded through the streets for mandatory testing. The people of China could be forgiven for thinking they had seen it all during the coronavirus pandemic.

But now they face a new indignity: the addition of anal swabs — yes, you read that right — to the testing regimen for those in quarantine.<<<

https://www.washingtonpost.com/world/asia_pacific/anal-swab-china-coronavirus/2021/01/27/cc284f56-6054-11eb-a177-7765f29a9524_story.html

 

[Mr._Clark]

According to the NYTimes, the Novavx vaccine is effective except not against the South African variant. The article also states that many people who already had COVID-19 were reinfected.

"Not encouraging" is one way to put it.

Hopefully the J&J vaccine is more effective against the SA variant.

>>>Novavax, which makes one of six vaccine candidates supported by Operation Warp Speed last summer, has been running trials in Britain, South Africa, the United States and Mexico. It said Thursday that an early analysis of its 15,000-person trial in Britain revealed that the two-dose vaccine had an efficacy rate of nearly 90 percent there. But in a small trial in South Africa, the efficacy rate dropped to just under 50 percent. Almost all the cases that scientists have analyzed there so far were caused by the variant, known as B.1.351. The data also showed that many trial participants were infected with the variant even after they had already had Covid-19. . . .

The fact that three vaccines all appeared to show lowered effectiveness against the variant from South Africa is not encouraging, and the results Novavax announced Thursday were the first to occur outside of a laboratory, testing how well a vaccine worked in people infected with a new variant. Johnson & Johnson is also on the cusp of announcing results of its Covid-19 vaccine trials, and has also tested its candidate in South Africa. <<<

Covid-19 Live Updates: Novavax’s Vaccine Works Well Except on Variant First Found in South Africa

That variant has now been found in the United States. New York severely undercounted virus deaths in nursing homes, a state attorney general’s investigation concluded. The European Union has locked horns with drug makers over delivery problems, and Germany said its shortage of doses could last...

www.nytimes.com

 

[trochetier]

The current silly squabbling over vaccines leaves me somewhat bemused. The planet is flying the airplane while flying it and fighting over the parts. EU threats to curb exports of vaccine in order to paper over their byzantine approval process is unacceptable - especially if it results in violation of contractual obligations.

German complaints about vaccination rates are a bit over the top. They are currently sitting tied with Canada for vaccination rate, at 7th out of 195 countries. Sure, we all want to get it done faster, but there are limits to how quickly it can be produced, distributed and administered. Australia and New Zealand still haven't started vaccinations (NZ hasn't even approved one yet).

Looking at it from a national perspective, versus a global perspective is short-sighted as well. Until the entire planet is sufficiently vaccinated, it's a problem for everyone.

Speaking of national perspectives, the Canadian government inexplicably signed a research and production agreement between the NRC and Chinese pharmaceutical company CanSino Biologics. The vaccine developed from the Canadian created cell-line, Ad5-nCoV was to be sent to the Canadian Centre for Vaccinology at Dalhousie University in Halifax, Nova Scotia, for Phase 1 trials in late May. But, due to typical Chinese government fcukery, the samples weren't shipped and the agreement collapsed. My view is that any statement by a Chinese government official should be assumed to be a lie and any signed agreement is not worth the paper it's written on.

EU approval through EMA is good in all EU States. The process is similar to FDA the data and data presentation format requirements are similar too with some variations, thanks to ICH. There is still the old decentralized country by country National approval system in Europe but it is very rarely used - that process is truly byzantine.

 

[trochetier]

Novavax vaccine news -

Novavax Vaccine Is 89% Effective Against Covid-19 in U.K. Study

The company has asked U.K. authorities to approve use of the vaccine based on the results. It is developing a booster shot, after the vaccine didn’t perform as well in a South Africa study.

www.wsj.com

I will believe the data only when they successfully complete Phase 3.

That's a company that was called "The little company that couldn't" after their spectacular Phase 3 failure with RSV vaccine for seniors even though they had extremely good Phase 2 results. They have been also working with other vaccines too with little progress for years. They have been kept alive with repeated share issuance, Gates Foundation and BARDA money. I know I bought and still holding their shares while they were in early Phae 2 trial for their RSV vaccine for seniors.