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US support for waiving COVID-19 vaccine patent rights puts pressure on drugmakers – but what would a waiver actually look like?

The process will take months, if it’s even approved. But just the threat of waiving intellectual property rights could spur faster action.



A COVID-19 surge has pushed hospitals in India beyond their capacity. A stadium in New Delhi was being used as a makeshift ward on May 2, 2021. Getty Images

The U.S. and Europe are debating waiving patent rights for COVID-19 vaccines, a move that could allow more companies to produce the vaccine around the world. But it’s not as simple as it might sound.

When the U.S. announced on May 5, 2021, that it supported the idea of a temporary waiver, the statement was vague. Some European countries still oppose even a narrow waiver.

Any agreement will take weeks of negotiation among the World Trade Organization’s 164 members, and then months more for production to begin.

That long timeline won’t solve the immediate problem. Many poor countries have vaccinated less than 1% of their populations, while 44% of the vaccine doses have gone to Europe and North America, where wealthy countries secured large vaccine contracts. At the same time, the disease is spreading quickly in South Asia, and new variants are raising the risks around the world.

The idea of temporarily waiving World Trade Organization rules on intellectual property rights for the COVID-19 vaccines was first proposed by South Africa and India in late 2020. The original proposal was broad, covering patents, copyrights, trade secrets and industrial designs related to the “prevention, containment or treatment of COVID-19.”

The U.S. is suggesting a much narrower approach, but exactly what that would look like isn’t yet clear.

Some European countries with vaccine industries, including Germany, argue that waiving intellectual property rights would pose a danger to future vaccine innovation and is unnecessary. Others pointed out that most countries in need lack the facilities, technology and skilled technicians to produce the vaccines even if patent rights were waived, and said the bigger problem was countries like the U.S. and Britain preventing their vaccines and ingredients from being exported to the rest of the world.

Critics are correct that, by itself, a temporary waiver is not sufficient to address the gap in production. They are correct that vaccine ingredients and other supplies remain a major blockage.

But it is also clear that vaccine makers are not voluntarily licensing their vaccines at the scale needed to expand production enough to stop the pandemic.

An employee in full protective gear works on assembling vaccine doses.
India’s Serum Institute is one of a few companies outside North America and Europe licensed to produce patented COVID-19 vaccines. Punit Paranjpe/AFP via Getty Images

The UNICEF COVID Dashboard shows that Moderna and Pfizer/BioNTech, which both use new mRNA technology in their vaccines, have licensed to few other companies. Moderna had voluntarily agreed not to enforce its patents but has not shared trade secrets or know-how. Johnson & Johnson and AstraZeneca have primarily licensed to companies with which they carried out national clinical trials, and these may be limited just to production for export for existing developed country contracts or purely domestic supply. Refusals to license to experienced drug manufacturers such a Biolyse in Canada or Teva in Israel present a serious problem.

I have worked on legal issues related to access to medicines since 2004 and have been involved in these debates at the WTO and the World Intellectual Property Organization. I believe that U.S. support of the waiver proposal can lead to an effective outcome if minimum criteria are met: The vaccine makers will have to give up some control, and the countries must ensure those companies are appropriately compensated.

The waiver could build on the existing system for compulsory licensing of patents and extend that to trade secrets and knowledge. The negotiations around access to HIV/AIDS medicines in the 1990s ended up with a similar framework.

How to make compulsory licenses work for vaccines

When a country approves a patent, it gives the patent holder a monopoly for a limited term, usually 20 years, for new and highly inventive ideas. The key phrase is “limited time.” This makes sure that once a patent runs out, others can make the product. Generic drugs are an example.

For emergencies, the patent system has safety valves that allow governments to intervene before that limited time is up. Based on public needs – including health emergencies – a government can allow others to make the product, usually with a reasonable royalty, or fee, paid to the patent owner. This is known as a compulsory license.

Today, any country that has issued a patent to a COVID-19 vaccine maker can use that patent simply by issuing a compulsory license to enable production by its own companies.

The problem is that many countries don’t have vaccine production facilities within their borders – they need to rely on imports. But under Article 31 of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property, or TRIPS, compulsory licenses can’t be used to produce vaccines for exporting to other countries. That means countries like China and the Philippines that have thriving pharmaceutical industries can’t use compulsory licenses to send vaccines to Africa, for example.

A person wearing a mask and gloves holds up a small vial.
A medical worker in Algeria holds a vial of Russia’s Sputnik V vaccine. Ryad Kramdi/AFP via Getty Images

There have been several attempts to solve this problem, including a change to the TRIPS Agreement approved in 2005. But only one country – Rwanda – has used that system to access drugs, and it was deemed too difficult to use. Rwanda was able to import 7 million doses from Canada, but it took almost two years, and the Canadian generic producer declared the system economically unsustainable for a private company.

The technologies in COVID-19 vaccines, especially those based on mRNA vaccines, are complex and involve multiple patents, trade secrets and know-how. The TRIPS Agreement requires countries to provide protection for trade secrets. Some countries’ laws, such as the U.S. Defense Production Act, allow for requiring such technology transfer, but many countries don’t want to violate the agreement.

To successfully expand vaccine production, countries need a relatively seamless system. The waiver must lift the TRIPS limitations on exports and allow countries to require sharing of trade secrets and know-how. This would let a country like the Philippines issue a blanket license for COVID-19 technologies, allow its companies to produce vaccines developed elsewhere and export those vaccines to countries that lack their own manufacturing capacity.

Lifting those restrictions could help ensure that the world is not still in the same position in 2022. And that is what the proposal is truly aimed at.

How soon could the world see results?

Both the threat of the waiver and its actual implementation could accomplish several things.

First, they increase the incentive for companies to voluntarily license their vaccines and transfer knowledge to trusted partners in other countries. Provided there is pressure to do so, they could allow production for export to additional countries.

Second, they increase the leverage developing country companies and governments have in negotiations with vaccine makers for licenses, like the production agreement between Merck and Johnson & Johnson brokered by the Biden administration.

Finally, if implemented, the waiver would ensure that pharmaceutical companies are compensated for their work in developing vaccines while ensuring that they cannot prevent wider production.

This is an international emergency that requires “extraordinary measures,” as U.S. Trade Representative Katherine Tai noted. These measures do not need to be taken at the cost of either innovation or access.

This article updates a version published April 14, 2021.

Dalindyebo Shabalala is affiliated with the Center for International Environmental Law (CIEL) as a Board Member. He has previously worked at the South Centre, an intergovernmental organization of developing countries on Access to Medicines projects funded by the Rockefeller Foundation, SIDA, and GIZ among others

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COVID-19 may never go away, but practical herd immunity is within reach

It is unlikely that we will reach full herd immunity for COVID-19. However, we are likely to reach a practical kind of herd immunity through vaccination.

The level of immunity needed — either through vaccination or infection — for practical herd immunity is uncertain, but may be quite high. (Shutterstock)

When people say that we won’t reach “herd immunity” to COVID-19, they are usually referring to an ideal of “full” population immunity: when so many people are immune that, most of the time, there is no community transmission.

With full herd immunity, most people will never be exposed to the virus. Even those who are not vaccinated are protected, because an introduction is so unlikely to reach them: it will sputter out, because so many others are immune — as is the case now with diseases like polio and mumps.

The fraction of the population that needs to be immune in order for the population to have “full” herd immunity depends on the transmissibility of the virus in the population, and on the control measures in place.

It is unlikely we’ll reach full herd immunity for COVID-19.

For one thing, it appears that immunity to COVID-19 acquired either by vaccination or infection wanes over time. In addition, SARS-CoV-2 will continue to evolve. Over time, variants that can infect people with immunity (even if this only results in mild disease) will have a selective advantage, just as until now selection has mainly favoured variants with higher transmission potential.

Electron micrograph of a yellow virus particle with green spikes, against a blue background.
The B.1.1.7 variant of the SARS-CoV-2 virus. Over time, variants of concern will likely continue to emerge. NIAID, CC BY

Also, our population is a composition of different communities, workplaces and environments. In some of these, transmission risk might be high enough and/or immunity low enough to allow larger outbreaks to occur, even if overall in the population we have high vaccination and low transmission.

Finally, SARS-CoV-2 can infect other animals. This means that other animal populations may act as a “reservoir,” allowing the virus to be reintroduced to the human population.

Practical herd immunity

Nonetheless, we are likely to reach a practical kind of herd immunity through vaccination. In practical herd immunity, we can reopen to near-normal levels of activity without needing widespread distancing or lockdowns. This would be a profound change from the situation we have been in for the past 18 months.

Practical herd immunity does not mean that we never see any COVID-19. It will likely be with us, just at low enough levels that we will not need to have widespread distancing measures in place to protect the health-care system.

Read more: COVID-19 variants FAQ: How did the U.K., South Africa and Brazil variants emerge? Are they more contagious? How does a virus mutate? Could there be a super-variant that evades vaccines?

What level of immunity (either through vaccination or infection) we need for practical herd immunity is uncertain, but it may be quite high. The original strain of SARS-CoV-2 was highly transmissible and transmission is thought to be higher still for some variants of concern.

Empty vials of Pfizer's COVID-19 vaccine
To achieve two-thirds immunity, 90 per cent of the eligible population would need to be vaccinated or infected naturally. (AP Photo/John Locher)

The amount of immunity we need will also depend on what level of controls we are willing to maintain indefinitely. Continued masking, contact tracing, symptomatic and asymptomatic testing and outbreak control measures will mean we will require less immunity than we would without these in place.

Some estimates suggest that we may need two thirds of the population to be protected either by successful vaccination or natural infection. If 90 per cent of the population is eligible for vaccination, and vaccines are 85 per cent effective against infection, we can obtain this two thirds with about 90 per cent of the eligible population being vaccinated or infected naturally.

The United Kingdom has already exceeded these rates in some age groups. Higher rates are even better, because there is still uncertainty about the level of transmissibility and vaccine efficacy against infection (although research shows they are very good against severe disease). We don’t want to discover that we do not have enough immunity through vaccination and have another serious wave of infection.

Emerging variants

A sticker reading 'I'm COVID-19 vaccinated' from Vancouver Coastal Health
Booster vaccinations will hopefully allow us to maintain long-term practical herd immunity against future variants of COVID-19. THE CANADIAN PRESS/Jonathan Hayward

Higher vaccine uptake will mean there are fewer infections before we reach practical herd immunity. The remaining unvaccinated individuals will be safer, protected indirectly by the immunity of those around them. Outbreaks will be smaller and rarer, and there will be fewer opportunities for vaccine escape variants to arise and spread.

That said, variants of SARS-CoV-2 will continue to emerge, and selection will favour variants that escape our immunity. Vaccine developers will continue to broaden the spectrum of the vaccines that are available, and boosters will hopefully allow us to maintain long-term practical herd immunity.

It’s possible that an immune escape variant will emerge that is severe enough, and transmissible enough, that it will cause a new pandemic for which we do not have even practical herd immunity. But barring that, while we may not be free of COVID-19, we can be confident that in the not-too-distant future it will be manageable when we return to near-normal life.

Caroline Colijn's research group receives funding from the Natural Sciences and Engineering Research Council of Canada, Genome British Columbia, the Michael Smith Foundation for Health Research, the Public Health Agency of Canada and Canada 150 Research Chair program of the Federal Government of Canada.

Paul Tupper's research group receives funding from the Natural Sciences and Engineering Research Council of Canada.

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Venezuela Says US Sanctions Blocking COVID Vaccines: ‘Global Health System’ As Geopolitical Weapon

Venezuela Says US Sanctions Blocking COVID Vaccines: ‘Global Health System’ As Geopolitical Weapon

Authored by Brett Wilkins via via,

Venezuelan Vice President Delcy Rodríguez has accused the US-backed international financia



Venezuela Says US Sanctions Blocking COVID Vaccines: 'Global Health System' As Geopolitical Weapon

Authored by Brett Wilkins via via,

Venezuelan Vice President Delcy Rodríguez has accused the US-backed international financial system of blocking the country's access to Covid-19 vaccines under the COVAX program, even though Venezuela has paid all but $10 million of the $120 million it owes.

Appearing in a televised address, Rodríguez said Venezuela was unable to pay the remaining $10 million because it was being blocked from transferring funds to the Switzerland-based GAVI Vaccine Alliance, which directs COVAX. "The financial system that also hides behind the U.S. lobby has the power to block resources that can be used to immunize the population of Venezuela," she said.

Via Reuters

Venezuelan Foreign Minister Jorge Arreaza tweeted a letter from COVAX stating that it "received notification from UBS Bank" that four payments, totaling just over $4.6 million, were "blocked and under investigation."

Arreaza said that "Venezuela has paid all of its commitments," adding that "the bank has arbitrarily blocked" the country's final payments and calling the situation "a crime."

The vice president and foreign minister's remarks follow accusations from Venezuelan President Nicolás Maduro last week that "organizations of US imperialism" are engaged in an effort to stop vaccine producers from selling doses to the country.

"Venezuela might be the only country in the world that is subject to a persecution against its right to freely purchase vaccines," said Maduro, according to Venezuelanalysis. "Venezuela is besieged so that it cannot buy vaccines."

A mural in Caracas symbolically shows Venezuela and Russia uniting to defeat the coronavirus, with the caption: "We will beat Covid-19 together." Image: AFP via Getty

Successive US administrations have targeted Venezuela with economic sanctions that critics say have devastated the nation's once-thriving economy and have caused tremendous suffering for the poor and working-class people whose dramatic uplift was once hailed as the great success of the Bolivarian Revolution launched under the late President Hugo Chávez. 

According to a 2019 report from the Center for Economic and Policy Research, a progressive think tank based in Washington, D.C., as many as 40,000 Venezuelans have died due to sanctions, which have made it much more difficult for millions of people to obtain food, medicine, and other necessities. 

Maduro also denounced the World Health Organization (WHO) for its role in delaying vaccine delivery to Venezuela. The president had expected "many millions" of the Covid-19 jabs to be delivered in July and August. "The COVAX system owes a debt to Venezuela," asserted Maduro. "We made a deposit in April and we are waiting for the vaccines."

That $64 million deposit to GAVI came after a rare deal between the Maduro administration and Juan Guaidó, the coup leader recognized by the United States and dozens of other nations as Venezuela's legitimate head of state despite never having been elected.

Adept at circumventing US interference in its affairs, Venezuela turned to China, Russia, and Cuba to launch its mass vaccination program, which aims to inoculate 70% of the population this year. Earlier this month, the country reached a deal to buy and locally manufacture the Russian EpiVacCorona vaccine. Venezuela has also already acquired about three million doses of the Russian Sputnik V and Chinese Sinopharm jabs, and last month began clinical trials on Cuba's Adbala vaccine.

Compared to other nations in the region, Venezuela has reported a very low rate of coronavirus infections and deaths. According to Johns Hopkins University's Coronavirus Resource Center, there have been nearly 248,000 reported cases and 2,781 deaths in the country of 28.5 million people during the ongoing pandemic. Neighboring Colombia, with just over 50 million people, has reported more than 3.6 million cases and over 94,000 deaths.

Tyler Durden Sat, 06/12/2021 - 16:30

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UK Government Adviser Says Mask Mandates Should Continue “Forever”

UK Government Adviser Says Mask Mandates Should Continue "Forever"

Authored by Paul Joseph Watson via Summit News,

A UK government adviser and former Communist Party member Susan Michie says that mask mandates and social distancing should…



UK Government Adviser Says Mask Mandates Should Continue "Forever"

Authored by Paul Joseph Watson via Summit News,

A UK government adviser and former Communist Party member Susan Michie says that mask mandates and social distancing should continue “forever” and that people should adopt such behaviour just as they did with wearing seatbelts.

Michie, who is a Professor of Health Psychology at UCL and a leading member of SAGE, said such control measures should become part of people’s “normal” routine behaviour.

"Vaccines are a really important part of pandemic control but it is only one part. [A] test, trace and isolate system, [as well as] border controls, are really essential. And the third thing is people’s behaviour. That is, the behaviour of social distancing, of… making sure there’s good ventilation [when you’re indoors], or if there’s not, wearing face masks, and [keeping up] hand and surface hygiene."

"We will need to keep these going in the long term, and that will be good not only for Covid but also to reduce other [diseases] at a time when the NHS is [struggling]… I think forever, to some extent…"

"I think there’s lots of different behaviours that we have changed in our lives. We now routinely wear seatbelts – we didn’t use to. We now routinely pick up dog poo in the parks – we didn’t use to. When people see that there is a threat and there is something they can do to reduce that [to protect] themselves, their loved ones and their communities, what we have seen over this last year is that people do that."

Michie’s comments once again emphasize how many scientific advisers have become drunk on COVID-19 power and never want to relinquish it.

“Unsurprisingly, Channel 5 News made absolutely no effort to scrutinise these claims. The programme’s presenter raised no objection to the idea that mask-wearing and social distancing could continue “forever”, resorting only to friendly laughter,” writes Michael Curzon.

“Professor Michie’s co-panellist, a fellow scientist at UCL, Dr Shikta Das, said:

“I think Susan has made a very good point here,” adding that the vaccine roll-out has created a “false sense of security”.

She concluded:

“I don’t think we are yet ready to unlock.”

How’s all that for balance!

Perhaps unsurprisingly, Michie is known to be a long-time Communist hardliner and was so zealous in her beliefs she garnered the nickname “Stalin’s nanny.”

Her sentiment echoes that of fellow government adviser Professor Neil Ferguson, who once acknowledged that he was surprised authorities were able to “get away with” the same draconian measures that Communist China imposed at the start of the pandemic.

“[China] is a communist one-party state, we said. We couldn’t get away with [lockdown] in Europe, we thought… and then Italy did it. And we realised we could,” said Ferguson.

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Tyler Durden Sat, 06/12/2021 - 11:30

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