Wuhan Coronavirus Resource Thread

Kakkaji · Post by **Kakkaji** » 14 Apr 2021 22:05

The big problems with the Pfizer vaccine are its cost, storage, and handling requirements, because of which it is not suitable for mass vaccination in India. Pfizer knew this, and that's why showed the indifferent attitude to India about the approvals for their vaccine.

Now that the GoI has allowed imports of vaccines that have been approved by 'credible' foreign health agencies, the door has been opened for its imports in India. Perhaps some 5-star private hospitals, that have the required storage and handling facilities, import some consignments of the Pfizer vaccine, and offer it at Rs 5,000 per dose, or above, to their posh clients that are enamored of this vaccine. It would be no skin off the GoI's nose, and it would let the posh journalists go ooh-aah ga-ga over how wonderful it is, and how superior they are to the hoi polloi.

Kakkaji · Post by **Kakkaji** » 14 Apr 2021 22:08

Kakkaji wrote:The big problems with the Pfizer vaccine are its cost, storage, and handling requirements, because of which it is not suitable for mass vaccination in India. Pfizer knew this, and that's why showed the indifferent attitude to India about the approvals for their vaccine.

Now that the GoI has allowed imports of vaccines that have been approved by 'credible' foreign health agencies, the door has been opened for its imports in India. Perhaps some 5-star private hospitals, that have the required storage and handling facilities, import some consignments of the Pfizer vaccine, and offer it at Rs 5,000 per dose, or above, to their posh clients that are enamored of this vaccine. It would be no skin off the GoI's nose, and it would let the posh journalists go ooh-aah ga-ga over how wonderful it is, and how superior they are to the hoi polloi.

Perhaps the said 5-star hospitals can also offer, free with a dose of vaccine, a hologramed shirt sticker saying 'I got the Pfizer vaccine, which one did you get?'

chetak · Post by **chetak** » 14 Apr 2021 22:45

Isn't RAJ a border state

This is proof of what RV Subramani @RudraVS is talking about.

more vaccine diversions are taking place from punjab and cashmere

Suraj · Post by **Suraj** » 14 Apr 2021 22:48

The talk about Pfizer needs to start with the understanding that a purchase done today will not generate any deliveries for several MONTHS.

The government has not 'allowed imports'. It has expedited the process to speeds up the bridging trials. Pfizer will still have to do bridging trials, just as Sputnik V just did.

They don't have any free pass to sell at market prices even when supplies are available in August or later. It'll at best be available at full price as a choice in private vaccination centers if someone wants to choose which vaccine to take, and that will still only be for people who are currently eligible to be vaccinated and have secured an appointment. Why ? Because vaccination is a public health problem and not a question of who has most money to bid for it.

The entire Caribbean and South America - the backyard of Pfizer and Moderna - was supplied by India. Pfizer refused their orders except under terms set by Pfizer.

3.14 million vaccinations as of 8pm Wednesday, total 114.3 million: https://www.pib.gov.in/PressReleseDetai ... ID=1711892

nachiket · Post by **nachiket** » 14 Apr 2021 23:06

Like someone said earlier, the reason Pfizer has been so inflexible and unwilling to even commit to trials is because they simply do not foresee strong sales in India and other developing countries due to the cost and storage requirements of the Pfizer vaccine. Same with Moderna. Still they would have already signed deals in these places by now if the other, cheaper vaccines with easier storage requirement did not exist.

vijayk · Post by **vijayk** » 14 Apr 2021 23:24

#COVID19 - Outbreak In India
@outbreak_india
·
Apr 14
#LargestVaccineDrive

Day 89: India #vaccination update till 8 PM

Day4 of #TikaUtsav 31,39,063

Total Doses: 11,43,18,455

Dose1: 10,00,21,692 27,19,964
Dose2: 1,42,96,763 4,19,099

Explore more https://outbreakindia.com/vaccination

We reach 4 mil on Day 1 ... why are we dropping down again?

vijayk · Post by **vijayk** » 14 Apr 2021 23:27

https://www.npr.org/sections/health-sho ... protective

CDC Studies 'Breakthrough' COVID Cases Among People Already Vaccinated

So far, more than 74 million people have gotten fully vaccinated in the United States. It's unclear how many have later gotten infected with the coronavirus anyway. But Michigan, Washington and other states have reported hundreds of cases. Most people have gotten only mildly ill, but some have gotten very sick. Some have even died.

Still, at a recent White House briefing, Dr. Anthony Fauci of the National Institutes of Health noted that such cases of lapses in full protection appear to be very rare. And the deaths seem to be happening primarily among frail elderly people who have other health problems

Kakkaji · Post by **Kakkaji** » 14 Apr 2021 23:56

Russia says Sputnik V vaccine does not cause blood clots

The developer of Russia's Sputnik V coronavirus vaccine said Wednesday its jab did not cause blood clots, a potential side effect that has disrupted rollouts in several Western countries.

Like the Johnson & Johnson and AstraZeneca vaccines, Russia's Sputnik V jab uses adapted strains of the adenovirus that causes the common cold.

On Wednesday, the state-run Gamaleya research institute, which developed Sputnik V vaccine, said there was no risk of blot clots from its jab.

"A comprehensive analysis of adverse events during clinical trials and over the course of mass vaccinations with the Sputnik V vaccine showed that there were no cases of cerebral venous sinus thrombosis," it said in a statement.

The Gamaleya institute said it was "ready to share its purification technology with other vaccine producers in order to help them minimise the risk of adverse effects during vaccination."

Atmavik · Post by **Atmavik** » 15 Apr 2021 00:01

This is anecdotal info from hyderabad. my uncle had a very tough time to get his 1st shot. he was turned away even after having the appointment. had to go to multiple hospitals before he could get it.

my parents second shot has been delayed by a few days. the hospital called them to postpone the appointment. looks like there are supply issues.

Suraj · Post by **Suraj** » 15 Apr 2021 00:19

nachiket wrote:Like someone said earlier, the reason Pfizer has been so inflexible and unwilling to even commit to trials is because they simply do not foresee strong sales in India and other developing countries due to the cost and storage requirements of the Pfizer vaccine. Same with Moderna. Still they would have already signed deals in these places by now if the other, cheaper vaccines with easier storage requirement did not exist.

Pfizer and Moderna are not going to save the world. Nor will COVAX/Gavi.

Let's look at the math. A cumulative 800 million vaccines have been produced so far. India alone has made over 300 million at this point, almost all of it from SII. 90% of the rest is US/EU (Pfizer has facilities in Belgium and Germany) + China .

But.. the world population is 8 billion. Let's assume 30% of that is in the high risk group needing urgent supply. That's around 2.5 billion people or 5 billion doses. At $20 a dose that is $100 billion cost if you go with Pfizer. No one's got that kind of money to vaccinate just the high risk group, forget the general population. Even Pfizer offering temporary discounts to only $10 per dose to some African countries won't make a dent - the total bill still exceeds the GDPs of many countries.

COVAX and Gavi won't solve anything. They are explicitly designed to protect IP and cross subsidize limited sales to poor countries using commercial sales to wealthier ones. The west will not share IP and will as required for their own needs, restrict APIs and inputs.

India is incredibly fortunate to have both its own IP and probably the largest production capability on the planet. It needs to cover the bits it will be denied by the grab for intermediate supplies by the west, support its entire population and will ultimately be responsible - along with China - for the safety of most of the developing world.

Uttam · Post by **Uttam** » 15 Apr 2021 00:49

Some more details on Sputnik V

https://www.businesstoday.in/current/ec ... 36620.html

The plan is to have 50 million doses of vaccines produced from India every month very soon. "Some of the Indian companies are already producing Sputnik and have passed all the necessary checks and quality controls that are done in Russia. But the real ramp up of capacity will take two to three months. Over the summer I believe we will see over 50 million doses of Sputnik produced a month," he said.

srai · Post by **srai** » 15 Apr 2021 01:02

^^^
+1 Suraj

The world requires every COVID-19 vaccine available. Who gets what is irrelevant in the larger scheme of things. The longer the pandemic continues to fester the world we knew prior remains beyond grasp. Rise of Coronavirus variants pose danger to the efficacy of current generation of vaccines. The world herd immunity needs to be achieved quickly.

Y I Patel · Post by **Y I Patel** » 15 Apr 2021 01:03

Novavax is likely to be the biggest beneficiary of GOI’s clearance for manufacturing of vaccines approved by major international organizations. It is already in Phase 3 trials in UK, and has a tie up with SII in place. Bridging trials started in India last month, but the latest decision will enable Novavax to bypass that.

Novavax does not require cryo storage, another plus.

Suraj · Post by **Suraj** » 15 Apr 2021 01:08

Novavax is more dependent on the western embargoed inputs than Covishield is, according to Adar Poonawalla a couple of days ago.
story on Swarajya

"By banning certain raw materials, companies like SII and many others will not be able to scale up to the extent we would want to. Fortunately, the ban of raw materials is not affecting Covishield but it is affecting Covovax, the Novavax candidate, which I am hoping to stockpile from next week", he added.

Atmavik · Post by **Atmavik** » 15 Apr 2021 01:10

Y I Patel wrote:Novavax is likely to be the biggest beneficiary of GOI’s clearance for manufacturing of vaccines approved by major international organizations. It is already in Phase 3 trials in UK, and has a tie up with SII in place. Bridging trials started in India last month, but the latest decision will enable Novavax to bypass that.

Novavax does not require cryo storage, another plus.

Hope J&J also gets approval. it can also be stored at 2 degrees Celsius and only one dose is needed. I took it a few days ago in the US.

Suraj · Post by **Suraj** » 15 Apr 2021 01:11

J&J use has been entirely halted in the US because of the blood clot risk. There is no estimate as to if and when it will resume.
FDA advises states to pause use of J&J Covid vaccine after rare blood-clotting issue affects 6 women, kills 1

Y I Patel · Post by **Y I Patel** » 15 Apr 2021 01:35

Suraj wrote:Novavax is more dependent on the western embargoed inputs than Covishield is, according to Adar Poonawalla a couple of days ago.
story on Swarajya
"By banning certain raw materials, companies like SII and many others will not be able to scale up to the extent we would want to. Fortunately, the ban of raw materials is not affecting Covishield but it is affecting Covovax, the Novavax candidate, which I am hoping to stockpile from next week", he added.

Understood. I have a gut feeling, however, that the withholding was part of pressure tactics by US to get India to approve an American vaccine. So my reading is that India has obliged by expediting approval process with Novavax being the implicit beneficiary. I could be wrong however.

nachiket · Post by **nachiket** » 15 Apr 2021 01:43

In an ideal scenario, BB and SII would come to an agreement to manufacture Covaxin in SII's facilities. It is unfortunate that we have a completely Indian vaccine with proven efficacy but are hampered by a manufacturing bottleneck despite being the largest vaccine manufacturer in the world. I don't get why a BB-SII deal is not possible if they can sign one for Novavax. It is not possible to scale up BB's manufacturing capacity to anywhere near SII levels in the immediate future.

Suraj · Post by **Suraj** » 15 Apr 2021 01:49

Maybe. There are lots of wheels within wheels here. India can simply respond to such pressure tactics by redirecting all available production to domestic use and tell COVAX/Gavi to take a hike if they want to play pressure games. Won't give us inputs ? Fine. You don't get your supply.

This is how the big boys play in the middle of a crisis. There are no rules. Whatever you say or do are the rules. We are fortunate we are one of the three big players, along with US+EU and China. In SII, we have the most impactful vaccine maker in the world: NIH study on SII impact. Table 4 is particularly revealing, in the extent to which SII vaccines are responsible for the world's broad spectrum infectious disease management.

Elsewhere, even in advanced countries, people die because that week Pfizer decided to switch priority to another country to supply. All their wealth and development means nothing while they sit and cry as people die.

If SII can indeed produce 1 billion doses of Covishield, another billion+ of Covovax, and to that add production of Covaxin and others that may cumulatively add up to another 2-3 billion doses, we're just doing what we have - be the world's vaccine maker.

The pressure tactics aren't going to work because bespoke gold plated vaccines are not going to save the world here. GoI needs a long term plan to wrest control over this IP whenever it can, using its manufacturing power.

Uttam · Post by **Uttam** » 15 Apr 2021 01:50

Developing a vaccine, like any other drug is a very risky endeavor. The short-term and long-term effects are unknown both in terms of efficacy and side-effects. We are better off having a diversified portfolio of vaccines. We are lucky that we have two vaccines. We should have as many as possible in the pipeline.

vera_k · Post by **vera_k** » 15 Apr 2021 01:51

Does look like alternatives to the adenovirus based vaccines need to be scaled up. Covaxin and the Zydus vaccine are the two that would be available over the next few months. The other vaccines are unlikely to be available until winter sets in.

Uttam · Post by **Uttam** » 15 Apr 2021 01:55

vera_k wrote:Does look like alternatives to the adenovirus based vaccines need to be scaled up. Covaxin and the Zydus vaccine are the two that would be available over the next few months. The other vaccines are unlikely to be available until winter sets in.

We are still waiting for more data on Covaxin's efficacy (the previous release of efficacy data had only about 1/3 of required infections for studying efficacy). It should be out any day now.

ZyCov-D is still in the middle of phase 3 trial. It should be out with data in another month or so. It will require three shots instead of 2, adding to the complexity of vaccination.

Y I Patel · Post by **Y I Patel** » 15 Apr 2021 02:03

India has been very smart in hedging vaccine bets. We will be looking at India manufacturing vaccines developed in three different countries in addition to possibly 2 locally developed ones. Slow take off due to necessarily strict approval process, but the ramp up is going to be huge.

Remember no one new what will work when these bets were placed late last year. Pfizer was too arrogant to play, and is going to be left out of the Indian market

PS
Great bets but the second wave has played spoiler on timelines and now delivery will need to speed up

Anujan · Post by **Anujan** » 15 Apr 2021 02:16

Suraj wrote:J&J use has been entirely halted in the US because of the blood clot risk. There is no estimate as to if and when it will resume.
FDA advises states to pause use of J&J Covid vaccine after rare blood-clotting issue affects 6 women, kills 1

So far statistically speaking, the blood clot risk for J&J is miniscule.

To give an idea, polio vaccine works by introducing a weakened polio virus. There is some chance that the weakened virus mutates, and causes real polio. A phenomenon called vaccine-derived poliovirus (VDPV)

This is rare, but has happened.

Look at it another way, 970 people died after being given a Pfizer or Moderna vaccination. 495 occurred after a Moderna shot, and 475 occurred after a Pfizer shot. Most of the deaths are likely statistical noise (people die due to many reasons, a randomly sampled population, even if you do nothing to them, will die). Some of the deaths though are likely due to the stress on the immune system placed by vaccines. Again, this is not whatsapp forward, Norway had 23 deaths in elderly patients after vaccination.

I understand that the regulators are stuck in no win situation.

a) They can either cover up blood clot deaths. There there will be conspiracy theories on twitter/facebook/youtube based on the kernel of truth that there are blood clots and soon you will have mobs who want to overthrow the US government

b) They can say "yes blood clots happened, no big deal" but then everyone will either day "Give me Pfizer/Moderna, not the junk J&J or they will be OUTRAGED!!!! and write a paper on "Impact of Wealth Inequality driven Intersectional minority identity with a view of gender discrimination in federal regulator response to vaccine safety concerns, and its impact on mental health in low income youths". And get invited to TED talks.

Suraj · Post by **Suraj** » 15 Apr 2021 02:25

Yes that is all true. GoI and ICMR have been roundly criticized for their conservatism at approving vaccines . The flip side is what you have in the US - the vaccine makers themselves pressuring the FDA historically. J&J was involved in the asbestos in talc scandal, where they pressured the FDA to look away.

Last December, the White House was busy pressuring the FDA to approve anything with the word 'vaccine' on it immediately, while also booking press conferences anywhere with the word 'four seasons' on it...

Yes the actual statistical risks are miniscule. The AZ vaccine risk is no better or worse than Pfizer/Moderna, but politics wins out. The west has collectively been grossly incompetent in relation to India, playing vaccine against vaccine, fear mongering, lack of policy uniformity and consistency, using old factories with mold problems, tossing out almost 80 million vaccines in the case of J&J due to contamination even before this latest pause.

If GoI had managed to be even a quarter as bad as the western countries, the Mudi Shud Rejine screams would have been audible from Jupiter, from where it could not escape due to precise escape velocity calculations from RaGa.

Anujan · Post by **Anujan** » 15 Apr 2021 02:30

This is an interesting article: https://newrepublic.com/article/162000/ ... d-vaccines

Please read it with a sense of perspective.

There are two conflicting forces, and I personally do not understand where vaccines fall

a) There is the perspective that free markets are more efficient than governments in technology development and commercialization. Therefore it is important to protect vaccine IP and deny transfer of manufacturing technology (what Bill Gates advocates) to preserve profits for Pharma companies. This in turn, will help them invest and discover many more vaccines. There is a kernel of truth here. Remember the 100$ computer project that was funded by governments ? The simputer, OLPC etc etc. I personally remember 2-3 such projects from my college days, all footed by government. Nothing remotely useful came out of it.

Today you have a $100 computer. It has screen, wifi, bluetooth, flash, TCP/IP software stack, cellular radio, decent processor (far faster than the ones I learned computer science on), a modern OS and browser. It is your cheap smartphone and can do many things. It is a product of globalized supply chains, technological innovation and profit motive

b) There is another perspective that governments and public ownership is great at producing basic investment and basic services. This is also true. Technological innovation in the US is tied to close regulation of electricity production, distribution and consumer pricing. Before that, power producers were like robber barons. The regulation and pricing of electricity has produced great societal benefit. Perhaps vaccines and public health is like electricity.

Bill Gates made his fortune on IP, closely guarding the OS and charging per seat for Office.
But the explosion in cloud computing is from Linux, which is free to install in as many machines as possible.

Uttam · Post by **Uttam** » 15 Apr 2021 02:34

On Day-4 of Tika Utsav, more than 31.39 lakh vaccine doses given till 8 pm pushes Cumulative Vaccine Coverage to more than 11.43 Cr doses

Suraj · Post by **Suraj** » 15 Apr 2021 02:38

Perhaps vaccines and public health is like electricity.

This has always been the stated and unstated rule - something like a vaccine for broad public use against a dangerous infectious disease is not to be treated the same as a designer drug where the ability to recoup investment is limited. This is the Jonas Salk/Albert Sabin model - such things are not to be patented and hoarded. They are mass produced at the entities most cost competitive at it, which is why in some years SII accounted for 80% of the world's vaccine supplies.

In comparison, Europe ordered 300 million doses of pfizer in November and another 300 million in February. US ordered about the same amount, while also giving Pfizer $2 billion in June 2020 for vaccine development. That's north of $20 billion in private earnings on publicly funded investment into vaccine development. This is the Gates model. It ensures 'innovashun'. Gates baba may not be in IT-vity anymore, but he still thinks the same.

V_Raman · Post by **V_Raman** » 15 Apr 2021 02:44

Pfizer is funded by USA and they also pay what they want for the manufactured vaccines - what is India's problem? we didnt pay anything in that $2 billion R&D

Suraj · Post by **Suraj** » 15 Apr 2021 02:47

India doesn't have a problem with Pfizer. Pfizer has a problem with India. See posts and the end of previous page and at the top of current page.

Anujan · Post by **Anujan** » 15 Apr 2021 02:48

V_Raman wrote:Pfizer is funded by USA and they also pay what they want for the manufactured vaccines - what is India's problem? we didnt pay anything in that $2 billion R&D

India's problem is that there is should be ToT for mRNA and viral vector covid vaccines. For Pfizer, Moderna, J&J

Manufacturers can pay them a percentage of their earnings. Like FRAND licensing for basic patents on cellular technology for example.

Suraj · Post by **Suraj** » 15 Apr 2021 02:53

Pfizer et all have a very limited time frame to maximize profits on mRNA vaccines. India already has an mRNA candidate (HGCO-19) from Gennova doing Phase 1/2 trials now. The Chinese have a new candidate too.

Pfizer et all have about a year to suck out tens of billions in profits for innovashun before commoditization takes hold in what will likely be a chronic infectious disease like seasonal flu in the long term.

Karan M · Post by **Karan M** » 15 Apr 2021 02:54

Anujan wrote:This is an interesting article: https://newrepublic.com/article/162000/ ... d-vaccines

Please read it with a sense of perspective.

There are two conflicting forces, and I personally do not understand where vaccines fall

a) There is the perspective that free markets are more efficient than governments in technology development and commercialization. Therefore it is important to protect vaccine IP and deny transfer of manufacturing technology (what Bill Gates advocates) to preserve profits for Pharma companies. This in turn, will help them invest and discover many more vaccines. There is a kernel of truth here. Remember the 100$ computer project that was funded by governments ? The simputer, OLPC etc etc. I personally remember 2-3 such projects from my college days, all footed by government. Nothing remotely useful came out of it.

.

Nothing came of them because the average person doesn't know the level of skulduggery that went on behind the scenes to make these programs fail. I learnt some of it recently and was gobsmacked. An acquaintance was at a premier GOI institute tasked with developing a software stack for commercial industry specific apps combined with Indian designed hardware. Despite successful devpt, their boss came in one fine day and said GOI had pulled the plug. They were all upset, over a year, whole team disappeared. Half to west, other to pvt sector players. The boss stayed on, till it was "safe", chose to leave too, and joined as the very firm the solution was meant to supplant. Connect the dots, if you will and see why many of these "it made so much sense but the program went nowhere" projects actually failed. Another favorite way to shut down programs. Change specifications, change people assigned to the program, others get frustrated and leave.

Uttam · Post by **Uttam** » 15 Apr 2021 02:55

Anujan wrote:This is an interesting article: https://newrepublic.com/article/162000/ ... d-vaccines

I read a part article and found it to be garbage.

In general, there is a difference between private goods and public goods. Public goods are those goods whose production/consumption affects not just one company or the person consuming them but the entire world. For example, the air we breathe, the climate we live in, a vaccine for a pandemic. Many goods fall in between. For example, electricity supply, potable water, etc. Medicine falls in the in-between category. Some of it is a purely private good, like Botox injections for removing frown. Some of it public good, like a vaccine against highly contagious disease. IP protection already has provisions to break monopolies if the public interest is severely hurt by IP protection of vaccines.

Taking away IP at every crisis will have severe repercussions in terms of innovators sharing knowledge. There is a robust culture of publicly shared research through publications and conferences because the innovator is not worried about somebody forcibly snatching away their knowledge. These publications and conferences further ignite innovation among competitors, who learn more from the original innovator but then come up with their own. Blaming one person, Bill Gates, is nothing but garbage journalism. The IP protection has been around since even before Bill Gates was born. WTO already has provisions for compulsory licenses to combat public emergencies. The current problem with vaccine production is not because there is a monopoly, it is because we more than 7 billion people and vaccine production takes time.

Before IP protection was put in place, alchemist, masons, etc. will pass on their knowledge to a select few. Knowledge dissemination was pitiful. The modern version of knowledge sharing is what makes it possible for everybody to not reinvent the wheel while making an automobile. The same applies to vaccine development. We have learned a lot by participating in this robust community that shares knowledge. Leaving this community will be perilous to our future.

Anujan · Post by **Anujan** » 15 Apr 2021 03:09

The critique of Bill Gates is more nuanced than that. Remember that just because there is a ton of lunatics accusing Gates of injecting everyone with 5G chips, does not mean that every critique of him is a nutjob.

In December 1997, the Mandela government passed a law giving the health ministry powers to produce, purchase, and import low-cost drugs, including unbranded versions of combination therapies priced by Western drug companies at $10,000 and more. In response, 39 drug multinationals filed suit against South Africa alleging violations of the country’s constitution and its obligations under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS. The industry suit was backed by the diplomatic muscle of the Clinton administration.....Dylan Mohan Gray notes it took Washington 40 years to threaten apartheid South Africa with sanctions and less than four to threaten the post-apartheid Mandela government over AIDS drugs. ....Even after the drug companies withdrew their lawsuit against the South African government and Indian-made generics began flowing to Africa, Gates stayed cool toward compromises that he saw as threats to the intellectual property paradigm

Apparently WTO's compulsory licenses to combat public emergencies wasnt working all that well. I remember this incident very well. There was massive insinuations that Dr Reddy's labs was "stealing" IP, numerous diplomatic protests and threats of sanctions against India (A few years back, US placed India on trade sanctions list for high import duty on ... tobacco! So much for the bleeding hearts willing to change trade policy based on public welfare).

Blaming one person, Bill Gates, is *not* garbage journalism. He is the richest man in the world. His involvement in Public health and the resources he can muster rivals WHO! On top of that his donations are so widespread that scientists and public health officials balk at publicly criticizing him. What would have happened to India, South Africa and indeed the world if Indian government did not stand firm on generics? The pharma companies seem to be doing fine despite the generics. mRNA was invented by Katie Kariko, who never saw a dollar from it. Was funded by public research, how many royalty did the government make? So much for IP protection incentivizing everyone for investing!

There are two models for addressing problems that affect all of humanity. Either we collectively collaborate or we preserve the status quo. Another issue that comes to mind is climate change. Most greenhouse gases have been emitted by developed countries. Now developing countries are massively industrializing so there is a pressure on them to reduce emissions. Otherwise the whole of humanity will bake. How much should companies in developed countries charge for their patents in Solar, nuclear and wind power generation?

Listen to this episode in NYTimes https://www.nytimes.com/2021/03/03/podc ... covax.html

Adopting one approach as some kind of divine gospel has its problems. Do you happen to know what happened to all medical patents owned by Bayer or aeronautical patents owned by BMW?

nachiket · Post by **nachiket** » 15 Apr 2021 03:37

How did IP protection issues not impact the AZ-SII deal for their vaccine or the deal they are making with Novavax? As far as we have seen the alarm raised by SII and other manufacturers has not been about IP sharing but US and other countries banning export of raw materials and equipment which can lead to a slowdown in production.

Suraj · Post by **Suraj** » 15 Apr 2021 04:09

The Gates Foundation had Oxford sign over the rights to AZ, who in turn licensed production right to SII . In return, 100 million doses were due to be given to COVAX. So far SII has delivered ~30 million . The same also applies to Novavax - 100m doses out of 1.1 billion are meant to go to COVAX. The rest is essentially understood to be half for India, half for ROW.

India sought IP sharing at the WTO meeting, not SII. At first a ban on Covid vaccine patents was sought and rejected. Now they're petitioning for a waiver instead.

It's not critical to India, since we have a significant pipeline of vaccine options and a very large production volume about to come onstream in the next 1-4 months. In addition we have at least 3-5 vaccine candidates (ZyCov-D, BB's intranasal candidate, HGCO-19 mRNA candidate) plus Sputnik V and Novavax.

disha · Post by **disha** » 15 Apr 2021 05:37

Uttam wrote:Blaming one person, Bill Gates, is nothing but garbage journalism. The IP protection has been around since even before Bill Gates was born. WTO already has provisions for compulsory licenses to combat public emergencies.

Uttam'ji, I had posted the article on Bill Gates vis-a-vis Covid two pages back. It got lost in this fast moving thread.

On Gates, please check out connections between Gates Foundation and its proxy in India an American NGO called PATH, GSK and Merck, UPA government and PATH in 2006. And cervical cancer and HPV vaccine.

Please do that. Note that if you find articles from Ballav Pagla* on the above, take it with a huge grain of salt.

In my world not calling Bill Gates garbage is blaming shoddy journalism. But again, please please do search on the above.

*I am dyxselic only.

vijayk · Post by **vijayk** » 15 Apr 2021 05:54

https://www.rediff.com/news/interview/a ... 210414.htm

Has AstraZeneca sent you a legal notice?

AstraZeneca has sent us a legal notice (for delays in supplying the vaccine) and the Indian government is also aware of that.

I cannot comment on the legal notice as it is confidential, but we are examining all avenues to amicably manage and resolve legal disputes over contractual obligations that Serum Institute is not able to fulfil due to its prioritisation of Indian supplies. Everyone has been very understanding so far.

The government is evaluating what it can do to resolve the issue.

You have sought funds from the government to ramp up production. What's the update?

We have submitted a formal proposal for an upfront grant, which will enable us to put up a factory. Otherwise, it is difficult for us to ramp up (vaccine production) because we have invested thousands of crores already and have borrowed Rs 1,500 crore (Rs 15 billion) in April to manage the additional opex (operating expense) requirements of these large volumes.

The government is examining the proposal. Hopefully, in the next seven days, it will be concluded.

We have sought a few thousand crores. We have buildings and everything ready in Pune. This would enable us to immediately double the capacity of Covishield.

This will be a grant, not a loan. We are only asking for the cost of the facility. We are asking for a replacement for the capex -- the building, the equipment, etc.

We will have to sacrifice one more facility to make Covishield. If we want a loan, I can go to a bank and get it. This is an out-of-the-box proposal, which was not needed even three months back. But, since I need to sacrifice one more facility, I need the government's help here.

Right now, the private market is not able to pay for it. If the funds come, we are ready to deliver double the quantity of vaccines within two months.

You have three more vaccines in the pipeline. When can we expect to see them?

Yes, the Novavax vaccine will come around September. Spy Biotech's vaccine should also come by the end of this year. The Codagenix vaccine is slightly delayed as we are doing the trials in the UK. We just got permission and started phase one, so it got delayed by a few months. It is expected in 2022.

We had to prioritise certain vaccines, which we knew were going to be licensed, scaled up and stock-piled.

We are so happy that Covishield is already doing so well.

The reason we got into three-four vaccines is that if one does not do well, then at least we have others.

Novavax has already proven an efficacy of 89 per cent, including efficacy against the South African, Brazilian and UK variants. This is very good news as on a head-to-head basis, other vaccines have not tested against all these strains.

By the end of this year, we will have three vaccines guaranteed.

Do you think the Indian price of the vaccine allows making profits?

The price of vaccines is around $20 on average globally, where we are making $2 per dose. To encourage new vaccine makers, including the existing ones, if the marketplace is not very quickly made into an environment where you can sell for $5-$7 per dose, then there is no incentive for the vaccine producer.

There is no incentive for private vaccine makers to scale up in this price environment.

Is shortage of raw materials coming in the way of scaling up production?

Yes, it is happening because the US has invoked the Defence Act and banned export of raw materials.

This is as good as banning vaccines. All vaccine producers are facing difficulties because of this.

It has already stalled the Novavax vaccine's production. Stock-piling of Novavax would happen to the tune of 50 per cent more if we had access to US raw materials.

Till the month of April, it was not really coming in the way. From this month onwards, whatever we stockpile of Novavax would be half of what we could do, had it not been for US restrictions.

There is a long list of raw materials which we import from the US -- filters, bags, certain media solutions, etc. To develop new suppliers in the eleventh hour will take a bit of time.

We will do that. We will not be dependent on the US after six months. The problem is we need now.

Kakkaji · Post by **Kakkaji** » 15 Apr 2021 05:56

Behind paywall, but this article has a lot of details that we have been speculating about on this thread:

Shortage of key chemical hits Bharat Biotech's Covaxin ramp-up plans

Bharat Biotech is trying to ramp up capacities of Covaxin to 12 million doses per month by July, from the current 5 million doses per month

With Hyderabad-based vaccine maker Bharat Biotech in the midst of ramping up its capacity for Covaxin, sources said the biotechnology company is facing challenges in procuring the adjuvant used in the vaccine.

The unsung hero of vaccines is a component called the adjuvant. It puts a ‘red flag’ on the antigenic component of the vaccine — an inactivated whole or part of a virus or bacteria — and instructs the immune system to mount a defence against that antigen whenever it is encountered.

Apparently this chemical is sourced from a company in Kansas.

The way I see it, by end of July the US would have vaccinated all the adults who choose to be vaccinated. After that, the US will be sitting on a large stockpile of vaccines, raw materials, intermediates, and spare production for the next 6 months until the need for booster shots comes up. I think the US will have to lift restrictions on exports at the end of July.